what is the benefit of random assignment in an experiment

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

• Knowledge Base

Methodology

• Random Assignment in Experiments | Introduction & Examples

Random Assignment in Experiments | Introduction & Examples

Published on March 8, 2021 by Pritha Bhandari . Revised on June 22, 2023.

In experimental research, random assignment is a way of placing participants from your sample into different treatment groups using randomization.

With simple random assignment, every member of the sample has a known or equal chance of being placed in a control group or an experimental group. Studies that use simple random assignment are also called completely randomized designs .

Random assignment is a key part of experimental design . It helps you ensure that all groups are comparable at the start of a study: any differences between them are due to random factors, not research biases like sampling bias or selection bias .

Table of contents

Why does random assignment matter, random sampling vs random assignment, how do you use random assignment, when is random assignment not used, other interesting articles, frequently asked questions about random assignment.

Random assignment is an important part of control in experimental research, because it helps strengthen the internal validity of an experiment and avoid biases.

In experiments, researchers manipulate an independent variable to assess its effect on a dependent variable, while controlling for other variables. To do so, they often use different levels of an independent variable for different groups of participants.

This is called a between-groups or independent measures design.

You use three groups of participants that are each given a different level of the independent variable:

• a control group that’s given a placebo (no dosage, to control for a placebo effect ),
• an experimental group that’s given a low dosage,
• a second experimental group that’s given a high dosage.

Random assignment to helps you make sure that the treatment groups don’t differ in systematic ways at the start of the experiment, as this can seriously affect (and even invalidate) your work.

If you don’t use random assignment, you may not be able to rule out alternative explanations for your results.

• participants recruited from cafes are placed in the control group ,
• participants recruited from local community centers are placed in the low dosage experimental group,
• participants recruited from gyms are placed in the high dosage group.

With this type of assignment, it’s hard to tell whether the participant characteristics are the same across all groups at the start of the study. Gym-users may tend to engage in more healthy behaviors than people who frequent cafes or community centers, and this would introduce a healthy user bias in your study.

Although random assignment helps even out baseline differences between groups, it doesn’t always make them completely equivalent. There may still be extraneous variables that differ between groups, and there will always be some group differences that arise from chance.

Most of the time, the random variation between groups is low, and, therefore, it’s acceptable for further analysis. This is especially true when you have a large sample. In general, you should always use random assignment in experiments when it is ethically possible and makes sense for your study topic.

Receive feedback on language, structure, and formatting

Professional editors proofread and edit your paper by focusing on:

• Academic style
• Vague sentences
• Style consistency

See an example

Random sampling and random assignment are both important concepts in research, but it’s important to understand the difference between them.

Random sampling (also called probability sampling or random selection) is a way of selecting members of a population to be included in your study. In contrast, random assignment is a way of sorting the sample participants into control and experimental groups.

While random sampling is used in many types of studies, random assignment is only used in between-subjects experimental designs.

Some studies use both random sampling and random assignment, while others use only one or the other.

Random sampling enhances the external validity or generalizability of your results, because it helps ensure that your sample is unbiased and representative of the whole population. This allows you to make stronger statistical inferences .

You use a simple random sample to collect data. Because you have access to the whole population (all employees), you can assign all 8000 employees a number and use a random number generator to select 300 employees. These 300 employees are your full sample.

Random assignment enhances the internal validity of the study, because it ensures that there are no systematic differences between the participants in each group. This helps you conclude that the outcomes can be attributed to the independent variable .

• a control group that receives no intervention.
• an experimental group that has a remote team-building intervention every week for a month.

You use random assignment to place participants into the control or experimental group. To do so, you take your list of participants and assign each participant a number. Again, you use a random number generator to place each participant in one of the two groups.

To use simple random assignment, you start by giving every member of the sample a unique number. Then, you can use computer programs or manual methods to randomly assign each participant to a group.

• Random number generator: Use a computer program to generate random numbers from the list for each group.
• Lottery method: Place all numbers individually in a hat or a bucket, and draw numbers at random for each group.
• Flip a coin: When you only have two groups, for each number on the list, flip a coin to decide if they’ll be in the control or the experimental group.
• Use a dice: When you have three groups, for each number on the list, roll a dice to decide which of the groups they will be in. For example, assume that rolling 1 or 2 lands them in a control group; 3 or 4 in an experimental group; and 5 or 6 in a second control or experimental group.

This type of random assignment is the most powerful method of placing participants in conditions, because each individual has an equal chance of being placed in any one of your treatment groups.

Random assignment in block designs

In more complicated experimental designs, random assignment is only used after participants are grouped into blocks based on some characteristic (e.g., test score or demographic variable). These groupings mean that you need a larger sample to achieve high statistical power .

For example, a randomized block design involves placing participants into blocks based on a shared characteristic (e.g., college students versus graduates), and then using random assignment within each block to assign participants to every treatment condition. This helps you assess whether the characteristic affects the outcomes of your treatment.

In an experimental matched design , you use blocking and then match up individual participants from each block based on specific characteristics. Within each matched pair or group, you randomly assign each participant to one of the conditions in the experiment and compare their outcomes.

Sometimes, it’s not relevant or ethical to use simple random assignment, so groups are assigned in a different way.

When comparing different groups

Sometimes, differences between participants are the main focus of a study, for example, when comparing men and women or people with and without health conditions. Participants are not randomly assigned to different groups, but instead assigned based on their characteristics.

In this type of study, the characteristic of interest (e.g., gender) is an independent variable, and the groups differ based on the different levels (e.g., men, women, etc.). All participants are tested the same way, and then their group-level outcomes are compared.

When it’s not ethically permissible

When studying unhealthy or dangerous behaviors, it’s not possible to use random assignment. For example, if you’re studying heavy drinkers and social drinkers, it’s unethical to randomly assign participants to one of the two groups and ask them to drink large amounts of alcohol for your experiment.

When you can’t assign participants to groups, you can also conduct a quasi-experimental study . In a quasi-experiment, you study the outcomes of pre-existing groups who receive treatments that you may not have any control over (e.g., heavy drinkers and social drinkers). These groups aren’t randomly assigned, but may be considered comparable when some other variables (e.g., age or socioeconomic status) are controlled for.

Prevent plagiarism. Run a free check.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Student’s  t -distribution
• Normal distribution
• Null and Alternative Hypotheses
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Data cleansing
• Reproducibility vs Replicability
• Peer review
• Prospective cohort study

Research bias

• Implicit bias
• Cognitive bias
• Placebo effect
• Hawthorne effect
• Hindsight bias
• Affect heuristic
• Social desirability bias

In experimental research, random assignment is a way of placing participants from your sample into different groups using randomization. With this method, every member of the sample has a known or equal chance of being placed in a control group or an experimental group.

Random selection, or random sampling , is a way of selecting members of a population for your study’s sample.

In contrast, random assignment is a way of sorting the sample into control and experimental groups.

Random sampling enhances the external validity or generalizability of your results, while random assignment improves the internal validity of your study.

Random assignment is used in experiments with a between-groups or independent measures design. In this research design, there’s usually a control group and one or more experimental groups. Random assignment helps ensure that the groups are comparable.

In general, you should always use random assignment in this type of experimental design when it is ethically possible and makes sense for your study topic.

To implement random assignment , assign a unique number to every member of your study’s sample .

Then, you can use a random number generator or a lottery method to randomly assign each number to a control or experimental group. You can also do so manually, by flipping a coin or rolling a dice to randomly assign participants to groups.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the “Cite this Scribbr article” button to automatically add the citation to our free Citation Generator.

Bhandari, P. (2023, June 22). Random Assignment in Experiments | Introduction & Examples. Scribbr. Retrieved March 20, 2024, from https://www.scribbr.com/methodology/random-assignment/

Is this article helpful?

Pritha Bhandari

Other students also liked, guide to experimental design | overview, steps, & examples, confounding variables | definition, examples & controls, control groups and treatment groups | uses & examples, "i thought ai proofreading was useless but..".

I've been using Scribbr for years now and I know it's a service that won't disappoint. It does a good job spotting mistakes”

Random Assignment in Psychology: Definition & Examples

Julia Simkus

Editor at Simply Psychology

BA (Hons) Psychology, Princeton University

Julia Simkus is a graduate of Princeton University with a Bachelor of Arts in Psychology. She is currently studying for a Master's Degree in Counseling for Mental Health and Wellness in September 2023. Julia's research has been published in peer reviewed journals.

Learn about our Editorial Process

Saul Mcleod, PhD

Editor-in-Chief for Simply Psychology

BSc (Hons) Psychology, MRes, PhD, University of Manchester

Saul Mcleod, PhD., is a qualified psychology teacher with over 18 years of experience in further and higher education. He has been published in peer-reviewed journals, including the Journal of Clinical Psychology.

Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

Olivia Guy-Evans is a writer and associate editor for Simply Psychology. She has previously worked in healthcare and educational sectors.

In psychology, random assignment refers to the practice of allocating participants to different experimental groups in a study in a completely unbiased way, ensuring each participant has an equal chance of being assigned to any group.

In experimental research, random assignment, or random placement, organizes participants from your sample into different groups using randomization. 

Random assignment uses chance procedures to ensure that each participant has an equal opportunity of being assigned to either a control or experimental group.

The control group does not receive the treatment in question, whereas the experimental group does receive the treatment.

When using random assignment, neither the researcher nor the participant can choose the group to which the participant is assigned. This ensures that any differences between and within the groups are not systematic at the onset of the study. 

In a study to test the success of a weight-loss program, investigators randomly assigned a pool of participants to one of two groups.

Group A participants participated in the weight-loss program for 10 weeks and took a class where they learned about the benefits of healthy eating and exercise.

Group B participants read a 200-page book that explains the benefits of weight loss. The investigator randomly assigned participants to one of the two groups.

The researchers found that those who participated in the program and took the class were more likely to lose weight than those in the other group that received only the book.

Importance 

Random assignment ensures that each group in the experiment is identical before applying the independent variable.

In experiments , researchers will manipulate an independent variable to assess its effect on a dependent variable, while controlling for other variables. Random assignment increases the likelihood that the treatment groups are the same at the onset of a study.

Thus, any changes that result from the independent variable can be assumed to be a result of the treatment of interest. This is particularly important for eliminating sources of bias and strengthening the internal validity of an experiment.

Random assignment is the best method for inferring a causal relationship between a treatment and an outcome.

Random Selection vs. Random Assignment 

Random selection (also called probability sampling or random sampling) is a way of randomly selecting members of a population to be included in your study.

On the other hand, random assignment is a way of sorting the sample participants into control and treatment groups. 

Random selection ensures that everyone in the population has an equal chance of being selected for the study. Once the pool of participants has been chosen, experimenters use random assignment to assign participants into groups. 

Random assignment is only used in between-subjects experimental designs, while random selection can be used in a variety of study designs.

Random Assignment vs Random Sampling

Random sampling refers to selecting participants from a population so that each individual has an equal chance of being chosen. This method enhances the representativeness of the sample.

Random assignment, on the other hand, is used in experimental designs once participants are selected. It involves allocating these participants to different experimental groups or conditions randomly.

This helps ensure that any differences in results across groups are due to manipulating the independent variable, not preexisting differences among participants.

When to Use Random Assignment

Random assignment is used in experiments with a between-groups or independent measures design.

In these research designs, researchers will manipulate an independent variable to assess its effect on a dependent variable, while controlling for other variables.

There is usually a control group and one or more experimental groups. Random assignment helps ensure that the groups are comparable at the onset of the study.

How to Use Random Assignment

There are a variety of ways to assign participants into study groups randomly. Here are a handful of popular methods: 

• Random Number Generator : Give each member of the sample a unique number; use a computer program to randomly generate a number from the list for each group.
• Lottery : Give each member of the sample a unique number. Place all numbers in a hat or bucket and draw numbers at random for each group.
• Flipping a Coin : Flip a coin for each participant to decide if they will be in the control group or experimental group (this method can only be used when you have just two groups) 
• Roll a Die : For each number on the list, roll a dice to decide which of the groups they will be in. For example, assume that rolling 1, 2, or 3 places them in a control group and rolling 3, 4, 5 lands them in an experimental group.

When is Random Assignment not used?

• When it is not ethically permissible: Randomization is only ethical if the researcher has no evidence that one treatment is superior to the other or that one treatment might have harmful side effects. 
• When answering non-causal questions : If the researcher is just interested in predicting the probability of an event, the causal relationship between the variables is not important and observational designs would be more suitable than random assignment. 
• When studying the effect of variables that cannot be manipulated: Some risk factors cannot be manipulated and so it would not make any sense to study them in a randomized trial. For example, we cannot randomly assign participants into categories based on age, gender, or genetic factors.

Drawbacks of Random Assignment

While randomization assures an unbiased assignment of participants to groups, it does not guarantee the equality of these groups. There could still be extraneous variables that differ between groups or group differences that arise from chance. Additionally, there is still an element of luck with random assignments.

Thus, researchers can not produce perfectly equal groups for each specific study. Differences between the treatment group and control group might still exist, and the results of a randomized trial may sometimes be wrong, but this is absolutely okay.

Scientific evidence is a long and continuous process, and the groups will tend to be equal in the long run when data is aggregated in a meta-analysis.

Additionally, external validity (i.e., the extent to which the researcher can use the results of the study to generalize to the larger population) is compromised with random assignment.

Random assignment is challenging to implement outside of controlled laboratory conditions and might not represent what would happen in the real world at the population level. 

Random assignment can also be more costly than simple observational studies, where an investigator is just observing events without intervening with the population.

Randomization also can be time-consuming and challenging, especially when participants refuse to receive the assigned treatment or do not adhere to recommendations. 

What is the difference between random sampling and random assignment?

Random sampling refers to randomly selecting a sample of participants from a population. Random assignment refers to randomly assigning participants to treatment groups from the selected sample.

Does random assignment increase internal validity?

Yes, random assignment ensures that there are no systematic differences between the participants in each group, enhancing the study’s internal validity .

Does random assignment reduce sampling error?

Yes, with random assignment, participants have an equal chance of being assigned to either a control group or an experimental group, resulting in a sample that is, in theory, representative of the population.

Random assignment does not completely eliminate sampling error because a sample only approximates the population from which it is drawn. However, random sampling is a way to minimize sampling errors. 

When is random assignment not possible?

Random assignment is not possible when the experimenters cannot control the treatment or independent variable.

For example, if you want to compare how men and women perform on a test, you cannot randomly assign subjects to these groups.

Participants are not randomly assigned to different groups in this study, but instead assigned based on their characteristics.

Does random assignment eliminate confounding variables?

Yes, random assignment eliminates the influence of any confounding variables on the treatment because it distributes them at random among the study groups. Randomization invalidates any relationship between a confounding variable and the treatment.

Why is random assignment of participants to treatment conditions in an experiment used?

Random assignment is used to ensure that all groups are comparable at the start of a study. This allows researchers to conclude that the outcomes of the study can be attributed to the intervention at hand and to rule out alternative explanations for study results.

Further Reading

• Bogomolnaia, A., & Moulin, H. (2001). A new solution to the random assignment problem .  Journal of Economic theory ,  100 (2), 295-328.
• Krause, M. S., & Howard, K. I. (2003). What random assignment does and does not do .  Journal of Clinical Psychology ,  59 (7), 751-766.

• Bipolar Disorder
• Therapy Center
• When To See a Therapist
• Types of Therapy
• Best Online Therapy
• Best Couples Therapy
• Best Family Therapy
• Managing Stress
• Sleep and Dreaming
• Understanding Emotions
• Self-Improvement
• Healthy Relationships
• Student Resources
• Personality Types
• Verywell Mind Insights
• 2023 Verywell Mind 25
• Mental Health in the Classroom
• Editorial Process
• Meet Our Review Board
• Crisis Support

The Definition of Random Assignment According to Psychology

Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

Emily is a board-certified science editor who has worked with top digital publishing brands like Voices for Biodiversity, Study.com, GoodTherapy, Vox, and Verywell.

Materio / Getty Images

Random assignment refers to the use of chance procedures in psychology experiments to ensure that each participant has the same opportunity to be assigned to any given group in a study to eliminate any potential bias in the experiment at the outset. Participants are randomly assigned to different groups, such as the treatment group versus the control group. In clinical research, randomized clinical trials are known as the gold standard for meaningful results.

Simple random assignment techniques might involve tactics such as flipping a coin, drawing names out of a hat, rolling dice, or assigning random numbers to a list of participants. It is important to note that random assignment differs from random selection .

While random selection refers to how participants are randomly chosen from a target population as representatives of that population, random assignment refers to how those chosen participants are then assigned to experimental groups.

Random Assignment In Research

To determine if changes in one variable will cause changes in another variable, psychologists must perform an experiment. Random assignment is a critical part of the experimental design that helps ensure the reliability of the study outcomes.

Researchers often begin by forming a testable hypothesis predicting that one variable of interest will have some predictable impact on another variable.

The variable that the experimenters will manipulate in the experiment is known as the independent variable , while the variable that they will then measure for different outcomes is known as the dependent variable. While there are different ways to look at relationships between variables, an experiment is the best way to get a clear idea if there is a cause-and-effect relationship between two or more variables.

Once researchers have formulated a hypothesis, conducted background research, and chosen an experimental design, it is time to find participants for their experiment. How exactly do researchers decide who will be part of an experiment? As mentioned previously, this is often accomplished through something known as random selection.

Random Selection

In order to generalize the results of an experiment to a larger group, it is important to choose a sample that is representative of the qualities found in that population. For example, if the total population is 60% female and 40% male, then the sample should reflect those same percentages.

Choosing a representative sample is often accomplished by randomly picking people from the population to be participants in a study. Random selection means that everyone in the group stands an equal chance of being chosen to minimize any bias. Once a pool of participants has been selected, it is time to assign them to groups.

By randomly assigning the participants into groups, the experimenters can be fairly sure that each group will have the same characteristics before the independent variable is applied.

Participants might be randomly assigned to the control group , which does not receive the treatment in question. The control group may receive a placebo or receive the standard treatment. Participants may also be randomly assigned to the experimental group , which receives the treatment of interest. In larger studies, there can be multiple treatment groups for comparison.

There are simple methods of random assignment, like rolling the die. However, there are more complex techniques that involve random number generators to remove any human error.

There can also be random assignment to groups with pre-established rules or parameters. For example, if you want to have an equal number of men and women in each of your study groups, you might separate your sample into two groups (by sex) before randomly assigning each of those groups into the treatment group and control group.

Random assignment is essential because it increases the likelihood that the groups are the same at the outset. With all characteristics being equal between groups, other than the application of the independent variable, any differences found between group outcomes can be more confidently attributed to the effect of the intervention.

Example of Random Assignment

Imagine that a researcher is interested in learning whether or not drinking caffeinated beverages prior to an exam will improve test performance. After randomly selecting a pool of participants, each person is randomly assigned to either the control group or the experimental group.

The participants in the control group consume a placebo drink prior to the exam that does not contain any caffeine. Those in the experimental group, on the other hand, consume a caffeinated beverage before taking the test.

Participants in both groups then take the test, and the researcher compares the results to determine if the caffeinated beverage had any impact on test performance.

A Word From Verywell

Random assignment plays an important role in the psychology research process. Not only does this process help eliminate possible sources of bias, but it also makes it easier to generalize the results of a tested sample of participants to a larger population.

Random assignment helps ensure that members of each group in the experiment are the same, which means that the groups are also likely more representative of what is present in the larger population of interest. Through the use of this technique, psychology researchers are able to study complex phenomena and contribute to our understanding of the human mind and behavior.

Lin Y, Zhu M, Su Z. The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials . Contemp Clin Trials. 2015;45(Pt A):21-25. doi:10.1016/j.cct.2015.07.011

Sullivan L. Random assignment versus random selection . In: The SAGE Glossary of the Social and Behavioral Sciences. SAGE Publications, Inc.; 2009. doi:10.4135/9781412972024.n2108

Alferes VR. Methods of Randomization in Experimental Design . SAGE Publications, Inc.; 2012. doi:10.4135/9781452270012

Nestor PG, Schutt RK. Research Methods in Psychology: Investigating Human Behavior. (2nd Ed.). SAGE Publications, Inc.; 2015.

By Kendra Cherry, MSEd Kendra Cherry, MS, is a psychosocial rehabilitation specialist, psychology educator, and author of the "Everything Psychology Book."

Purpose and Limitations of Random Assignment

In an experimental study, random assignment is a process by which participants are assigned, with the same chance, to either a treatment or a control group. The goal is to assure an unbiased assignment of participants to treatment options.

Random assignment is considered the gold standard for achieving comparability across study groups, and therefore is the best method for inferring a causal relationship between a treatment (or intervention or risk factor) and an outcome.

Random assignment of participants produces comparable groups regarding the participants’ initial characteristics, thereby any difference detected in the end between the treatment and the control group will be due to the effect of the treatment alone.

How does random assignment produce comparable groups?

1. random assignment prevents selection bias.

Randomization works by removing the researcher’s and the participant’s influence on the treatment allocation. So the allocation can no longer be biased since it is done at random, i.e. in a non-predictable way.

This is in contrast with the real world, where for example, the sickest people are more likely to receive the treatment.

2. Random assignment prevents confounding

A confounding variable is one that is associated with both the intervention and the outcome, and thus can affect the outcome in 2 ways:

Either directly:

Or indirectly through the treatment:

This indirect relationship between the confounding variable and the outcome can cause the treatment to appear to have an influence on the outcome while in reality the treatment is just a mediator of that effect (as it happens to be on the causal pathway between the confounder and the outcome).

Random assignment eliminates the influence of the confounding variables on the treatment since it distributes them at random between the study groups, therefore, ruling out this alternative path or explanation of the outcome.

3. Random assignment also eliminates other threats to internal validity

By distributing all threats (known and unknown) at random between study groups, participants in both the treatment and the control group become equally subject to the effect of any threat to validity. Therefore, comparing the outcome between the 2 groups will bypass the effect of these threats and will only reflect the effect of the treatment on the outcome.

These threats include:

• History: This is any event that co-occurs with the treatment and can affect the outcome.
• Maturation: This is the effect of time on the study participants (e.g. participants becoming wiser, hungrier, or more stressed with time) which might influence the outcome.
• Regression to the mean: This happens when the participants’ outcome score is exceptionally good on a pre-treatment measurement, so the post-treatment measurement scores will naturally regress toward the mean — in simple terms, regression happens since an exceptional performance is hard to maintain. This effect can bias the study since it represents an alternative explanation of the outcome.

Note that randomization does not prevent these effects from happening, it just allows us to control them by reducing their risk of being associated with the treatment.

What if random assignment produced unequal groups?

Question: What should you do if after randomly assigning participants, it turned out that the 2 groups still differ in participants’ characteristics? More precisely, what if randomization accidentally did not balance risk factors that can be alternative explanations between the 2 groups? (For example, if one group includes more male participants, or sicker, or older people than the other group).

Short answer: This is perfectly normal, since randomization only assures an unbiased assignment of participants to groups, i.e. it produces comparable groups, but it does not guarantee the equality of these groups.

A more complete answer: Randomization will not and cannot create 2 equal groups regarding each and every characteristic. This is because when dealing with randomization there is still an element of luck. If you want 2 perfectly equal groups, you better match them manually as is done in a matched pairs design (for more information see my article on matched pairs design ).

This is similar to throwing a die: If you throw it 10 times, the chance of getting a specific outcome will not be 1/6. But it will approach 1/6 if you repeat the experiment a very large number of times and calculate the average number of times the specific outcome turned up.

So randomization will not produce perfectly equal groups for each specific study, especially if the study has a small sample size. But do not forget that scientific evidence is a long and continuous process, and the groups will tend to be equal in the long run when a meta-analysis aggregates the results of a large number of randomized studies.

So for each individual study, differences between the treatment and control group will exist and will influence the study results. This means that the results of a randomized trial will sometimes be wrong, and this is absolutely okay.

BOTTOM LINE:

Although the results of a particular randomized study are unbiased, they will still be affected by a sampling error due to chance. But the real benefit of random assignment will be when data is aggregated in a meta-analysis.

Limitations of random assignment

Randomized designs can suffer from:

1. Ethical issues:

Randomization is ethical only if the researcher has no evidence that one treatment is superior to the other.

Also, it would be unethical to randomly assign participants to harmful exposures such as smoking or dangerous chemicals.

2. Low external validity:

With random assignment, external validity (i.e. the generalizability of the study results) is compromised because the results of a study that uses random assignment represent what would happen under “ideal” experimental conditions, which is in general very different from what happens at the population level.

In the real world, people who take the treatment might be very different from those who don’t – so the assignment of participants is not a random event, but rather under the influence of all sort of external factors.

External validity can be also jeopardized in cases where not all participants are eligible or willing to accept the terms of the study.

3. Higher cost of implementation:

An experimental design with random assignment is typically more expensive than observational studies where the investigator’s role is just to observe events without intervening.

Experimental designs also typically take a lot of time to implement, and therefore are less practical when a quick answer is needed.

4. Impracticality when answering non-causal questions:

A randomized trial is our best bet when the question is to find the causal effect of a treatment or a risk factor.

Sometimes however, the researcher is just interested in predicting the probability of an event or a disease given some risk factors. In this case, the causal relationship between these variables is not important, making observational designs more suitable for such problems.

5. Impracticality when studying the effect of variables that cannot be manipulated:

The usual objective of studying the effects of risk factors is to propose recommendations that involve changing the level of exposure to these factors.

However, some risk factors cannot be manipulated, and so it does not make any sense to study them in a randomized trial. For example it would be impossible to randomly assign participants to age categories, gender, or genetic factors.

6. Difficulty to control participants:

These difficulties include:

• Participants refusing to receive the assigned treatment.
• Participants not adhering to recommendations.
• Differential loss to follow-up between those who receive the treatment and those who don’t.

All of these issues might occur in a randomized trial, but might not affect an observational study.

• Shadish WR, Cook TD, Campbell DT. Experimental and Quasi-Experimental Designs for Generalized Causal Inference . 2nd edition. Cengage Learning; 2001.
• Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of Clinical Trials . 5th ed. 2015 edition. Springer; 2015.

Further reading

• Posttest-Only Control Group Design
• Pretest-Posttest Control Group Design
• Randomized Block Design

Random Assignment in Psychology (Definition + 40 Examples)

Have you ever wondered how researchers discover new ways to help people learn, make decisions, or overcome challenges? A hidden hero in this adventure of discovery is a method called random assignment, a cornerstone in psychological research that helps scientists uncover the truths about the human mind and behavior.

Random Assignment is a process used in research where each participant has an equal chance of being placed in any group within the study. This technique is essential in experiments as it helps to eliminate biases, ensuring that the different groups being compared are similar in all important aspects.

By doing so, researchers can be confident that any differences observed are likely due to the variable being tested, rather than other factors.

In this article, we’ll explore the intriguing world of random assignment, diving into its history, principles, real-world examples, and the impact it has had on the field of psychology.

History of Random Assignment

Stepping back in time, we delve into the origins of random assignment, which finds its roots in the early 20th century.

The pioneering mind behind this innovative technique was Sir Ronald A. Fisher , a British statistician and biologist. Fisher introduced the concept of random assignment in the 1920s, aiming to improve the quality and reliability of experimental research .

His contributions laid the groundwork for the method's evolution and its widespread adoption in various fields, particularly in psychology.

Fisher’s groundbreaking work on random assignment was motivated by his desire to control for confounding variables – those pesky factors that could muddy the waters of research findings.

By assigning participants to different groups purely by chance, he realized that the influence of these confounding variables could be minimized, paving the way for more accurate and trustworthy results.

Early Studies Utilizing Random Assignment

Following Fisher's initial development, random assignment started to gain traction in the research community. Early studies adopting this methodology focused on a variety of topics, from agriculture (which was Fisher’s primary field of interest) to medicine and psychology.

The approach allowed researchers to draw stronger conclusions from their experiments, bolstering the development of new theories and practices.

One notable early study utilizing random assignment was conducted in the field of educational psychology. Researchers were keen to understand the impact of different teaching methods on student outcomes.

By randomly assigning students to various instructional approaches, they were able to isolate the effects of the teaching methods, leading to valuable insights and recommendations for educators.

Evolution of the Methodology

As the decades rolled on, random assignment continued to evolve and adapt to the changing landscape of research.

Advances in technology introduced new tools and techniques for implementing randomization, such as computerized random number generators, which offered greater precision and ease of use.

The application of random assignment expanded beyond the confines of the laboratory, finding its way into field studies and large-scale surveys.

Researchers across diverse disciplines embraced the methodology, recognizing its potential to enhance the validity of their findings and contribute to the advancement of knowledge.

From its humble beginnings in the early 20th century to its widespread use today, random assignment has proven to be a cornerstone of scientific inquiry.

Its development and evolution have played a pivotal role in shaping the landscape of psychological research, driving discoveries that have improved lives and deepened our understanding of the human experience.

Principles of Random Assignment

Delving into the heart of random assignment, we uncover the theories and principles that form its foundation.

The method is steeped in the basics of probability theory and statistical inference, ensuring that each participant has an equal chance of being placed in any group, thus fostering fair and unbiased results.

Basic Principles of Random Assignment

Understanding the core principles of random assignment is key to grasping its significance in research. There are three principles: equal probability of selection, reduction of bias, and ensuring representativeness.

The first principle, equal probability of selection , ensures that every participant has an identical chance of being assigned to any group in the study. This randomness is crucial as it mitigates the risk of bias and establishes a level playing field.

The second principle focuses on the reduction of bias . Random assignment acts as a safeguard, ensuring that the groups being compared are alike in all essential aspects before the experiment begins.

This similarity between groups allows researchers to attribute any differences observed in the outcomes directly to the independent variable being studied.

Lastly, ensuring representativeness is a vital principle. When participants are assigned randomly, the resulting groups are more likely to be representative of the larger population.

This characteristic is crucial for the generalizability of the study’s findings, allowing researchers to apply their insights broadly.

Theoretical Foundation

The theoretical foundation of random assignment lies in probability theory and statistical inference .

Probability theory deals with the likelihood of different outcomes, providing a mathematical framework for analyzing random phenomena. In the context of random assignment, it helps in ensuring that each participant has an equal chance of being placed in any group.

Statistical inference, on the other hand, allows researchers to draw conclusions about a population based on a sample of data drawn from that population. It is the mechanism through which the results of a study can be generalized to a broader context.

Random assignment enhances the reliability of statistical inferences by reducing biases and ensuring that the sample is representative.

Differentiating Random Assignment from Random Selection

It’s essential to distinguish between random assignment and random selection, as the two terms, while related, have distinct meanings in the realm of research.

Random assignment refers to how participants are placed into different groups in an experiment, aiming to control for confounding variables and help determine causes.

In contrast, random selection pertains to how individuals are chosen to participate in a study. This method is used to ensure that the sample of participants is representative of the larger population, which is vital for the external validity of the research.

While both methods are rooted in randomness and probability, they serve different purposes in the research process.

Understanding the theories, principles, and distinctions of random assignment illuminates its pivotal role in psychological research.

This method, anchored in probability theory and statistical inference, serves as a beacon of reliability, guiding researchers in their quest for knowledge and ensuring that their findings stand the test of validity and applicability.

Methodology of Random Assignment

Implementing random assignment in a study is a meticulous process that involves several crucial steps.

The initial step is participant selection, where individuals are chosen to partake in the study. This stage is critical to ensure that the pool of participants is diverse and representative of the population the study aims to generalize to.

Once the pool of participants has been established, the actual assignment process begins. In this step, each participant is allocated randomly to one of the groups in the study.

Researchers use various tools, such as random number generators or computerized methods, to ensure that this assignment is genuinely random and free from biases.

Monitoring and adjusting form the final step in the implementation of random assignment. Researchers need to continuously observe the groups to ensure that they remain comparable in all essential aspects throughout the study.

If any significant discrepancies arise, adjustments might be necessary to maintain the study’s integrity and validity.

Tools and Techniques Used

The evolution of technology has introduced a variety of tools and techniques to facilitate random assignment.

Random number generators, both manual and computerized, are commonly used to assign participants to different groups. These generators ensure that each individual has an equal chance of being placed in any group, upholding the principle of equal probability of selection.

In addition to random number generators, researchers often use specialized computer software designed for statistical analysis and experimental design.

These software programs offer advanced features that allow for precise and efficient random assignment, minimizing the risk of human error and enhancing the study’s reliability.

Ethical Considerations

The implementation of random assignment is not devoid of ethical considerations. Informed consent is a fundamental ethical principle that researchers must uphold.

Informed consent means that every participant should be fully informed about the nature of the study, the procedures involved, and any potential risks or benefits, ensuring that they voluntarily agree to participate.

Beyond informed consent, researchers must conduct a thorough risk and benefit analysis. The potential benefits of the study should outweigh any risks or harms to the participants.

Safeguarding the well-being of participants is paramount, and any study employing random assignment must adhere to established ethical guidelines and standards.

Conclusion of Methodology

The methodology of random assignment, while seemingly straightforward, is a multifaceted process that demands precision, fairness, and ethical integrity. From participant selection to assignment and monitoring, each step is crucial to ensure the validity of the study’s findings.

The tools and techniques employed, coupled with a steadfast commitment to ethical principles, underscore the significance of random assignment as a cornerstone of robust psychological research.

Benefits of Random Assignment in Psychological Research

The impact and importance of random assignment in psychological research cannot be overstated. It is fundamental for ensuring the study is accurate, allowing the researchers to determine if their study actually caused the results they saw, and making sure the findings can be applied to the real world.

Facilitating Causal Inferences

When participants are randomly assigned to different groups, researchers can be more confident that the observed effects are due to the independent variable being changed, and not other factors.

This ability to determine the cause is called causal inference .

This confidence allows for the drawing of causal relationships, which are foundational for theory development and application in psychology.

Ensuring Internal Validity

One of the foremost impacts of random assignment is its ability to enhance the internal validity of an experiment.

Internal validity refers to the extent to which a researcher can assert that changes in the dependent variable are solely due to manipulations of the independent variable , and not due to confounding variables.

By ensuring that each participant has an equal chance of being in any condition of the experiment, random assignment helps control for participant characteristics that could otherwise complicate the results.

Enhancing Generalizability

Beyond internal validity, random assignment also plays a crucial role in enhancing the generalizability of research findings.

When done correctly, it ensures that the sample groups are representative of the larger population, so can allow researchers to apply their findings more broadly.

This representative nature is essential for the practical application of research, impacting policy, interventions, and psychological therapies.

Limitations of Random Assignment

Potential for implementation issues.

While the principles of random assignment are robust, the method can face implementation issues.

One of the most common problems is logistical constraints. Some studies, due to their nature or the specific population being studied, find it challenging to implement random assignment effectively.

For instance, in educational settings, logistical issues such as class schedules and school policies might stop the random allocation of students to different teaching methods .

Ethical Dilemmas

Random assignment, while methodologically sound, can also present ethical dilemmas.

In some cases, withholding a potentially beneficial treatment from one of the groups of participants can raise serious ethical questions, especially in medical or clinical research where participants' well-being might be directly affected.

Researchers must navigate these ethical waters carefully, balancing the pursuit of knowledge with the well-being of participants.

Generalizability Concerns

Even when implemented correctly, random assignment does not always guarantee generalizable results.

The types of people in the participant pool, the specific context of the study, and the nature of the variables being studied can all influence the extent to which the findings can be applied to the broader population.

Researchers must be cautious in making broad generalizations from studies, even those employing strict random assignment.

Practical and Real-World Limitations

In the real world, many variables cannot be manipulated for ethical or practical reasons, limiting the applicability of random assignment.

For instance, researchers cannot randomly assign individuals to different levels of intelligence, socioeconomic status, or cultural backgrounds.

This limitation necessitates the use of other research designs, such as correlational or observational studies , when exploring relationships involving such variables.

Response to Critiques

In response to these critiques, people in favor of random assignment argue that the method, despite its limitations, remains one of the most reliable ways to establish cause and effect in experimental research.

They acknowledge the challenges and ethical considerations but emphasize the rigorous frameworks in place to address them.

The ongoing discussion around the limitations and critiques of random assignment contributes to the evolution of the method, making sure it is continuously relevant and applicable in psychological research.

While random assignment is a powerful tool in experimental research, it is not without its critiques and limitations. Implementation issues, ethical dilemmas, generalizability concerns, and real-world limitations can pose significant challenges.

However, the continued discourse and refinement around these issues underline the method's enduring significance in the pursuit of knowledge in psychology.

By being careful with how we do things and doing what's right, random assignment stays a really important part of studying how people act and think.

Real-World Applications and Examples

Random assignment has been employed in many studies across various fields of psychology, leading to significant discoveries and advancements.

Here are some real-world applications and examples illustrating the diversity and impact of this method:

• Medicine and Health Psychology: Randomized Controlled Trials (RCTs) are the gold standard in medical research. In these studies, participants are randomly assigned to either the treatment or control group to test the efficacy of new medications or interventions.
• Educational Psychology: Studies in this field have used random assignment to explore the effects of different teaching methods, classroom environments, and educational technologies on student learning and outcomes.
• Cognitive Psychology: Researchers have employed random assignment to investigate various aspects of human cognition, including memory, attention, and problem-solving, leading to a deeper understanding of how the mind works.
• Social Psychology: Random assignment has been instrumental in studying social phenomena, such as conformity, aggression, and prosocial behavior, shedding light on the intricate dynamics of human interaction.

Let's get into some specific examples. You'll need to know one term though, and that is "control group." A control group is a set of participants in a study who do not receive the treatment or intervention being tested , serving as a baseline to compare with the group that does, in order to assess the effectiveness of the treatment.

• Smoking Cessation Study: Researchers used random assignment to put participants into two groups. One group received a new anti-smoking program, while the other did not. This helped determine if the program was effective in helping people quit smoking.
• Math Tutoring Program: A study on students used random assignment to place them into two groups. One group received additional math tutoring, while the other continued with regular classes, to see if the extra help improved their grades.
• Exercise and Mental Health: Adults were randomly assigned to either an exercise group or a control group to study the impact of physical activity on mental health and mood.
• Diet and Weight Loss: A study randomly assigned participants to different diet plans to compare their effectiveness in promoting weight loss and improving health markers.
• Sleep and Learning: Researchers randomly assigned students to either a sleep extension group or a regular sleep group to study the impact of sleep on learning and memory.
• Classroom Seating Arrangement: Teachers used random assignment to place students in different seating arrangements to examine the effect on focus and academic performance.
• Music and Productivity: Employees were randomly assigned to listen to music or work in silence to investigate the effect of music on workplace productivity.
• Medication for ADHD: Children with ADHD were randomly assigned to receive either medication, behavioral therapy, or a placebo to compare treatment effectiveness.
• Mindfulness Meditation for Stress: Adults were randomly assigned to a mindfulness meditation group or a waitlist control group to study the impact on stress levels.
• Video Games and Aggression: A study randomly assigned participants to play either violent or non-violent video games and then measured their aggression levels.
• Online Learning Platforms: Students were randomly assigned to use different online learning platforms to evaluate their effectiveness in enhancing learning outcomes.
• Hand Sanitizers in Schools: Schools were randomly assigned to use hand sanitizers or not to study the impact on student illness and absenteeism.
• Caffeine and Alertness: Participants were randomly assigned to consume caffeinated or decaffeinated beverages to measure the effects on alertness and cognitive performance.
• Green Spaces and Well-being: Neighborhoods were randomly assigned to receive green space interventions to study the impact on residents’ well-being and community connections.
• Pet Therapy for Hospital Patients: Patients were randomly assigned to receive pet therapy or standard care to assess the impact on recovery and mood.
• Yoga for Chronic Pain: Individuals with chronic pain were randomly assigned to a yoga intervention group or a control group to study the effect on pain levels and quality of life.
• Flu Vaccines Effectiveness: Different groups of people were randomly assigned to receive either the flu vaccine or a placebo to determine the vaccine’s effectiveness.
• Reading Strategies for Dyslexia: Children with dyslexia were randomly assigned to different reading intervention strategies to compare their effectiveness.
• Physical Environment and Creativity: Participants were randomly assigned to different room setups to study the impact of physical environment on creative thinking.
• Laughter Therapy for Depression: Individuals with depression were randomly assigned to laughter therapy sessions or control groups to assess the impact on mood.
• Financial Incentives for Exercise: Participants were randomly assigned to receive financial incentives for exercising to study the impact on physical activity levels.
• Art Therapy for Anxiety: Individuals with anxiety were randomly assigned to art therapy sessions or a waitlist control group to measure the effect on anxiety levels.
• Natural Light in Offices: Employees were randomly assigned to workspaces with natural or artificial light to study the impact on productivity and job satisfaction.
• School Start Times and Academic Performance: Schools were randomly assigned different start times to study the effect on student academic performance and well-being.
• Horticulture Therapy for Seniors: Older adults were randomly assigned to participate in horticulture therapy or traditional activities to study the impact on cognitive function and life satisfaction.
• Hydration and Cognitive Function: Participants were randomly assigned to different hydration levels to measure the impact on cognitive function and alertness.
• Intergenerational Programs: Seniors and young people were randomly assigned to intergenerational programs to study the effects on well-being and cross-generational understanding.
• Therapeutic Horseback Riding for Autism: Children with autism were randomly assigned to therapeutic horseback riding or traditional therapy to study the impact on social communication skills.
• Active Commuting and Health: Employees were randomly assigned to active commuting (cycling, walking) or passive commuting to study the effect on physical health.
• Mindful Eating for Weight Management: Individuals were randomly assigned to mindful eating workshops or control groups to study the impact on weight management and eating habits.
• Noise Levels and Learning: Students were randomly assigned to classrooms with different noise levels to study the effect on learning and concentration.
• Bilingual Education Methods: Schools were randomly assigned different bilingual education methods to compare their effectiveness in language acquisition.
• Outdoor Play and Child Development: Children were randomly assigned to different amounts of outdoor playtime to study the impact on physical and cognitive development.
• Social Media Detox: Participants were randomly assigned to a social media detox or regular usage to study the impact on mental health and well-being.
• Therapeutic Writing for Trauma Survivors: Individuals who experienced trauma were randomly assigned to therapeutic writing sessions or control groups to study the impact on psychological well-being.
• Mentoring Programs for At-risk Youth: At-risk youth were randomly assigned to mentoring programs or control groups to assess the impact on academic achievement and behavior.
• Dance Therapy for Parkinson’s Disease: Individuals with Parkinson’s disease were randomly assigned to dance therapy or traditional exercise to study the effect on motor function and quality of life.
• Aquaponics in Schools: Schools were randomly assigned to implement aquaponics programs to study the impact on student engagement and environmental awareness.
• Virtual Reality for Phobia Treatment: Individuals with phobias were randomly assigned to virtual reality exposure therapy or traditional therapy to compare effectiveness.
• Gardening and Mental Health: Participants were randomly assigned to engage in gardening or other leisure activities to study the impact on mental health and stress reduction.

Each of these studies exemplifies how random assignment is utilized in various fields and settings, shedding light on the multitude of ways it can be applied to glean valuable insights and knowledge.

Real-world Impact of Random Assignment

Random assignment is like a key tool in the world of learning about people's minds and behaviors. It’s super important and helps in many different areas of our everyday lives. It helps make better rules, creates new ways to help people, and is used in lots of different fields.

Health and Medicine

In health and medicine, random assignment has helped doctors and scientists make lots of discoveries. It’s a big part of tests that help create new medicines and treatments.

By putting people into different groups by chance, scientists can really see if a medicine works.

This has led to new ways to help people with all sorts of health problems, like diabetes, heart disease, and mental health issues like depression and anxiety.

Schools and education have also learned a lot from random assignment. Researchers have used it to look at different ways of teaching, what kind of classrooms are best, and how technology can help learning.

This knowledge has helped make better school rules, develop what we learn in school, and find the best ways to teach students of all ages and backgrounds.

Workplace and Organizational Behavior

Random assignment helps us understand how people act at work and what makes a workplace good or bad.

Studies have looked at different kinds of workplaces, how bosses should act, and how teams should be put together. This has helped companies make better rules and create places to work that are helpful and make people happy.

Environmental and Social Changes

Random assignment is also used to see how changes in the community and environment affect people. Studies have looked at community projects, changes to the environment, and social programs to see how they help or hurt people’s well-being.

This has led to better community projects, efforts to protect the environment, and programs to help people in society.

Technology and Human Interaction

In our world where technology is always changing, studies with random assignment help us see how tech like social media, virtual reality, and online stuff affect how we act and feel.

This has helped make better and safer technology and rules about using it so that everyone can benefit.

The effects of random assignment go far and wide, way beyond just a science lab. It helps us understand lots of different things, leads to new and improved ways to do things, and really makes a difference in the world around us.

From making healthcare and schools better to creating positive changes in communities and the environment, the real-world impact of random assignment shows just how important it is in helping us learn and make the world a better place.

So, what have we learned? Random assignment is like a super tool in learning about how people think and act. It's like a detective helping us find clues and solve mysteries in many parts of our lives.

From creating new medicines to helping kids learn better in school, and from making workplaces happier to protecting the environment, it’s got a big job!

This method isn’t just something scientists use in labs; it reaches out and touches our everyday lives. It helps make positive changes and teaches us valuable lessons.

Whether we are talking about technology, health, education, or the environment, random assignment is there, working behind the scenes, making things better and safer for all of us.

In the end, the simple act of putting people into groups by chance helps us make big discoveries and improvements. It’s like throwing a small stone into a pond and watching the ripples spread out far and wide.

Thanks to random assignment, we are always learning, growing, and finding new ways to make our world a happier and healthier place for everyone!

Related posts:

• 19+ Experimental Design Examples (Methods + Types)
• Cluster Sampling vs Stratified Sampling
• 41+ White Collar Job Examples (Salary + Path)
• 47+ Blue Collar Job Examples (Salary + Path)
• McDonaldization of Society (Definition + Examples)

Reference this article:

About The Author

Free Personality Test

Free Memory Test

Free IQ Test

PracticalPie.com is a participant in the Amazon Associates Program. As an Amazon Associate we earn from qualifying purchases.

Follow Us On:

Youtube Facebook Instagram X/Twitter

Psychology Resources

Developmental

Personality

Relationships

Psychologists

Serial Killers

Psychology Tests

Personality Quiz

Memory Test

Depression test

Type A/B Personality Test

© PracticalPsychology. All rights reserved

Privacy Policy | Terms of Use

Want to create or adapt books like this? Learn more about how Pressbooks supports open publishing practices.

As previously mentioned, one of the characteristics of a true experiment is that researchers use a random process to decide which participants are tested under which conditions. Random assignation is a powerful research technique that addresses the assumption of pre-test equivalence – that the experimental and control group are equal in all respects before the administration of the independent variable (Palys & Atchison, 2014).

Random assignation is the primary way that researchers attempt to control extraneous variables across conditions. Random assignation is associated with experimental research methods. In its strictest sense, random assignment should meet two criteria.  One is that each participant has an equal chance of being assigned to each condition (e.g., a 50% chance of being assigned to each of two conditions). The second is that each participant is assigned to a condition independently of other participants. Thus, one way to assign participants to two conditions would be to flip a coin for each one. If the coin lands on the heads side, the participant is assigned to Condition A, and if it lands on the tails side, the participant is assigned to Condition B. For three conditions, one could use a computer to generate a random integer from 1 to 3 for each participant. If the integer is 1, the participant is assigned to Condition A; if it is 2, the participant is assigned to Condition B; and, if it is 3, the participant is assigned to Condition C. In practice, a full sequence of conditions—one for each participant expected to be in the experiment—is usually created ahead of time, and each new participant is assigned to the next condition in the sequence as he or she is tested.

However, one problem with coin flipping and other strict procedures for random assignment is that they are likely to result in unequal sample sizes in the different conditions. Unequal sample sizes are generally not a serious problem, and you should never throw away data you have already collected to achieve equal sample sizes. However, for a fixed number of participants, it is statistically most efficient to divide them into equal-sized groups. It is standard practice, therefore, to use a kind of modified random assignment that keeps the number of participants in each group as similar as possible.

One approach is block randomization. In block randomization, all the conditions occur once in the sequence before any of them is repeated. Then they all occur again before any of them is repeated again. Within each of these “blocks,” the conditions occur in a random order. Again, the sequence of conditions is usually generated before any participants are tested, and each new participant is assigned to the next condition in the sequence. When the procedure is computerized, the computer program often handles the random assignment, which is obviously much easier. You can also find programs online to help you randomize your random assignation. For example, the Research Randomizer website will generate block randomization sequences for any number of participants and conditions ( Research Randomizer ).

Random assignation is not guaranteed to control all extraneous variables across conditions. It is always possible that, just by chance, the participants in one condition might turn out to be substantially older, less tired, more motivated, or less depressed on average than the participants in another condition. However, there are some reasons that this may not be a major concern. One is that random assignment works better than one might expect, especially for large samples. Another is that the inferential statistics that researchers use to decide whether a difference between groups reflects a difference in the population take the “fallibility” of random assignment into account. Yet another reason is that even if random assignment does result in a confounding variable and therefore produces misleading results, this confound is likely to be detected when the experiment is replicated. The upshot is that random assignment to conditions—although not infallible in terms of controlling extraneous variables—is always considered a strength of a research design. Note: Do not confuse random assignation with random sampling. Random sampling is a method for selecting a sample from a population; we will talk about this in Chapter 7.

Research Methods, Data Collection and Ethics Copyright © 2020 by Valerie Sheppard is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

Share This Book

• Yale Directories

Institution for Social and Policy Studies

Advancing research • shaping policy • developing leaders, why randomize.

About Randomized Field Experiments Randomized field experiments allow researchers to scientifically measure the impact of an intervention on a particular outcome of interest.

What is a randomized field experiment? In a randomized experiment, a study sample is divided into one group that will receive the intervention being studied (the treatment group) and another group that will not receive the intervention (the control group). For instance, a study sample might consist of all registered voters in a particular city. This sample will then be randomly divided into treatment and control groups. Perhaps 40% of the sample will be on a campaign’s Get-Out-the-Vote (GOTV) mailing list and the other 60% of the sample will not receive the GOTV mailings. The outcome measured –voter turnout– can then be compared in the two groups. The difference in turnout will reflect the effectiveness of the intervention.

What does random assignment mean? The key to randomized experimental research design is in the random assignment of study subjects – for example, individual voters, precincts, media markets or some other group – into treatment or control groups. Randomization has a very specific meaning in this context. It does not refer to haphazard or casual choosing of some and not others. Randomization in this context means that care is taken to ensure that no pattern exists between the assignment of subjects into groups and any characteristics of those subjects. Every subject is as likely as any other to be assigned to the treatment (or control) group. Randomization is generally achieved by employing a computer program containing a random number generator. Randomization procedures differ based upon the research design of the experiment. Individuals or groups may be randomly assigned to treatment or control groups. Some research designs stratify subjects by geographic, demographic or other factors prior to random assignment in order to maximize the statistical power of the estimated effect of the treatment (e.g., GOTV intervention). Information about the randomization procedure is included in each experiment summary on the site.

What are the advantages of randomized experimental designs? Randomized experimental design yields the most accurate analysis of the effect of an intervention (e.g., a voter mobilization phone drive or a visit from a GOTV canvasser, on voter behavior). By randomly assigning subjects to be in the group that receives the treatment or to be in the control group, researchers can measure the effect of the mobilization method regardless of other factors that may make some people or groups more likely to participate in the political process. To provide a simple example, say we are testing the effectiveness of a voter education program on high school seniors. If we allow students from the class to volunteer to participate in the program, and we then compare the volunteers’ voting behavior against those who did not participate, our results will reflect something other than the effects of the voter education intervention. This is because there are, no doubt, qualities about those volunteers that make them different from students who do not volunteer. And, most important for our work, those differences may very well correlate with propensity to vote. Instead of letting students self-select, or even letting teachers select students (as teachers may have biases in who they choose), we could randomly assign all students in a given class to be in either a treatment or control group. This would ensure that those in the treatment and control groups differ solely due to chance. The value of randomization may also be seen in the use of walk lists for door-to-door canvassers. If canvassers choose which houses they will go to and which they will skip, they may choose houses that seem more inviting or they may choose houses that are placed closely together rather than those that are more spread out. These differences could conceivably correlate with voter turnout. Or if house numbers are chosen by selecting those on the first half of a ten page list, they may be clustered in neighborhoods that differ in important ways from neighborhoods in the second half of the list. Random assignment controls for both known and unknown variables that can creep in with other selection processes to confound analyses. Randomized experimental design is a powerful tool for drawing valid inferences about cause and effect. The use of randomized experimental design should allow a degree of certainty that the research findings cited in studies that employ this methodology reflect the effects of the interventions being measured and not some other underlying variable or variables.

5.2 Experimental Design

Learning objectives.

• Explain the difference between between-subjects and within-subjects experiments, list some of the pros and cons of each approach, and decide which approach to use to answer a particular research question.
• Define random assignment, distinguish it from random sampling, explain its purpose in experimental research, and use some simple strategies to implement it
• Define several types of carryover effect, give examples of each, and explain how counterbalancing helps to deal with them.

In this section, we look at some different ways to design an experiment. The primary distinction we will make is between approaches in which each participant experiences one level of the independent variable and approaches in which each participant experiences all levels of the independent variable. The former are called between-subjects experiments and the latter are called within-subjects experiments.

Between-Subjects Experiments

In a  between-subjects experiment , each participant is tested in only one condition. For example, a researcher with a sample of 100 university  students might assign half of them to write about a traumatic event and the other half write about a neutral event. Or a researcher with a sample of 60 people with severe agoraphobia (fear of open spaces) might assign 20 of them to receive each of three different treatments for that disorder. It is essential in a between-subjects experiment that the researcher assigns participants to conditions so that the different groups are, on average, highly similar to each other. Those in a trauma condition and a neutral condition, for example, should include a similar proportion of men and women, and they should have similar average intelligence quotients (IQs), similar average levels of motivation, similar average numbers of health problems, and so on. This matching is a matter of controlling these extraneous participant variables across conditions so that they do not become confounding variables.

Random Assignment

The primary way that researchers accomplish this kind of control of extraneous variables across conditions is called  random assignment , which means using a random process to decide which participants are tested in which conditions. Do not confuse random assignment with random sampling. Random sampling is a method for selecting a sample from a population, and it is rarely used in psychological research. Random assignment is a method for assigning participants in a sample to the different conditions, and it is an important element of all experimental research in psychology and other fields too.

In its strictest sense, random assignment should meet two criteria. One is that each participant has an equal chance of being assigned to each condition (e.g., a 50% chance of being assigned to each of two conditions). The second is that each participant is assigned to a condition independently of other participants. Thus one way to assign participants to two conditions would be to flip a coin for each one. If the coin lands heads, the participant is assigned to Condition A, and if it lands tails, the participant is assigned to Condition B. For three conditions, one could use a computer to generate a random integer from 1 to 3 for each participant. If the integer is 1, the participant is assigned to Condition A; if it is 2, the participant is assigned to Condition B; and if it is 3, the participant is assigned to Condition C. In practice, a full sequence of conditions—one for each participant expected to be in the experiment—is usually created ahead of time, and each new participant is assigned to the next condition in the sequence as he or she is tested. When the procedure is computerized, the computer program often handles the random assignment.

One problem with coin flipping and other strict procedures for random assignment is that they are likely to result in unequal sample sizes in the different conditions. Unequal sample sizes are generally not a serious problem, and you should never throw away data you have already collected to achieve equal sample sizes. However, for a fixed number of participants, it is statistically most efficient to divide them into equal-sized groups. It is standard practice, therefore, to use a kind of modified random assignment that keeps the number of participants in each group as similar as possible. One approach is block randomization . In block randomization, all the conditions occur once in the sequence before any of them is repeated. Then they all occur again before any of them is repeated again. Within each of these “blocks,” the conditions occur in a random order. Again, the sequence of conditions is usually generated before any participants are tested, and each new participant is assigned to the next condition in the sequence.  Table 5.2  shows such a sequence for assigning nine participants to three conditions. The Research Randomizer website ( http://www.randomizer.org ) will generate block randomization sequences for any number of participants and conditions. Again, when the procedure is computerized, the computer program often handles the block randomization.

Random assignment is not guaranteed to control all extraneous variables across conditions. The process is random, so it is always possible that just by chance, the participants in one condition might turn out to be substantially older, less tired, more motivated, or less depressed on average than the participants in another condition. However, there are some reasons that this possibility is not a major concern. One is that random assignment works better than one might expect, especially for large samples. Another is that the inferential statistics that researchers use to decide whether a difference between groups reflects a difference in the population takes the “fallibility” of random assignment into account. Yet another reason is that even if random assignment does result in a confounding variable and therefore produces misleading results, this confound is likely to be detected when the experiment is replicated. The upshot is that random assignment to conditions—although not infallible in terms of controlling extraneous variables—is always considered a strength of a research design.

Matched Groups

An alternative to simple random assignment of participants to conditions is the use of a matched-groups design . Using this design, participants in the various conditions are matched on the dependent variable or on some extraneous variable(s) prior the manipulation of the independent variable. This guarantees that these variables will not be confounded across the experimental conditions. For instance, if we want to determine whether expressive writing affects people’s health then we could start by measuring various health-related variables in our prospective research participants. We could then use that information to rank-order participants according to how healthy or unhealthy they are. Next, the two healthiest participants would be randomly assigned to complete different conditions (one would be randomly assigned to the traumatic experiences writing condition and the other to the neutral writing condition). The next two healthiest participants would then be randomly assigned to complete different conditions, and so on until the two least healthy participants. This method would ensure that participants in the traumatic experiences writing condition are matched to participants in the neutral writing condition with respect to health at the beginning of the study. If at the end of the experiment, a difference in health was detected across the two conditions, then we would know that it is due to the writing manipulation and not to pre-existing differences in health.

Within-Subjects Experiments

In a  within-subjects experiment , each participant is tested under all conditions. Consider an experiment on the effect of a defendant’s physical attractiveness on judgments of his guilt. Again, in a between-subjects experiment, one group of participants would be shown an attractive defendant and asked to judge his guilt, and another group of participants would be shown an unattractive defendant and asked to judge his guilt. In a within-subjects experiment, however, the same group of participants would judge the guilt of both an attractive  and  an unattractive defendant.

The primary advantage of this approach is that it provides maximum control of extraneous participant variables. Participants in all conditions have the same mean IQ, same socioeconomic status, same number of siblings, and so on—because they are the very same people. Within-subjects experiments also make it possible to use statistical procedures that remove the effect of these extraneous participant variables on the dependent variable and therefore make the data less “noisy” and the effect of the independent variable easier to detect. We will look more closely at this idea later in the book .  However, not all experiments can use a within-subjects design nor would it be desirable to do so.

One disadvantage of within-subjects experiments is that they make it easier for participants to guess the hypothesis. For example, a participant who is asked to judge the guilt of an attractive defendant and then is asked to judge the guilt of an unattractive defendant is likely to guess that the hypothesis is that defendant attractiveness affects judgments of guilt. This  knowledge could  lead the participant to judge the unattractive defendant more harshly because he thinks this is what he is expected to do. Or it could make participants judge the two defendants similarly in an effort to be “fair.”

Carryover Effects and Counterbalancing

The primary disadvantage of within-subjects designs is that they can result in order effects. An order effect  occurs when participants’ responses in the various conditions are affected by the order of conditions to which they were exposed. One type of order effect is a carryover effect. A  carryover effect  is an effect of being tested in one condition on participants’ behavior in later conditions. One type of carryover effect is a  practice effect , where participants perform a task better in later conditions because they have had a chance to practice it. Another type is a fatigue effect , where participants perform a task worse in later conditions because they become tired or bored. Being tested in one condition can also change how participants perceive stimuli or interpret their task in later conditions. This  type of effect is called a  context effect (or contrast effect) . For example, an average-looking defendant might be judged more harshly when participants have just judged an attractive defendant than when they have just judged an unattractive defendant. Within-subjects experiments also make it easier for participants to guess the hypothesis. For example, a participant who is asked to judge the guilt of an attractive defendant and then is asked to judge the guilt of an unattractive defendant is likely to guess that the hypothesis is that defendant attractiveness affects judgments of guilt. 

Carryover effects can be interesting in their own right. (Does the attractiveness of one person depend on the attractiveness of other people that we have seen recently?) But when they are not the focus of the research, carryover effects can be problematic. Imagine, for example, that participants judge the guilt of an attractive defendant and then judge the guilt of an unattractive defendant. If they judge the unattractive defendant more harshly, this might be because of his unattractiveness. But it could be instead that they judge him more harshly because they are becoming bored or tired. In other words, the order of the conditions is a confounding variable. The attractive condition is always the first condition and the unattractive condition the second. Thus any difference between the conditions in terms of the dependent variable could be caused by the order of the conditions and not the independent variable itself.

There is a solution to the problem of order effects, however, that can be used in many situations. It is  counterbalancing , which means testing different participants in different orders. The best method of counterbalancing is complete counterbalancing  in which an equal number of participants complete each possible order of conditions. For example, half of the participants would be tested in the attractive defendant condition followed by the unattractive defendant condition, and others half would be tested in the unattractive condition followed by the attractive condition. With three conditions, there would be six different orders (ABC, ACB, BAC, BCA, CAB, and CBA), so some participants would be tested in each of the six orders. With four conditions, there would be 24 different orders; with five conditions there would be 120 possible orders. With counterbalancing, participants are assigned to orders randomly, using the techniques we have already discussed. Thus, random assignment plays an important role in within-subjects designs just as in between-subjects designs. Here, instead of randomly assigning to conditions, they are randomly assigned to different orders of conditions. In fact, it can safely be said that if a study does not involve random assignment in one form or another, it is not an experiment.

A more efficient way of counterbalancing is through a Latin square design which randomizes through having equal rows and columns. For example, if you have four treatments, you must have four versions. Like a Sudoku puzzle, no treatment can repeat in a row or column. For four versions of four treatments, the Latin square design would look like:

You can see in the diagram above that the square has been constructed to ensure that each condition appears at each ordinal position (A appears first once, second once, third once, and fourth once) and each condition preceded and follows each other condition one time. A Latin square for an experiment with 6 conditions would by 6 x 6 in dimension, one for an experiment with 8 conditions would be 8 x 8 in dimension, and so on. So while complete counterbalancing of 6 conditions would require 720 orders, a Latin square would only require 6 orders.

Finally, when the number of conditions is large experiments can use  random counterbalancing  in which the order of the conditions is randomly determined for each participant. Using this technique every possible order of conditions is determined and then one of these orders is randomly selected for each participant. This is not as powerful a technique as complete counterbalancing or partial counterbalancing using a Latin squares design. Use of random counterbalancing will result in more random error, but if order effects are likely to be small and the number of conditions is large, this is an option available to researchers.

There are two ways to think about what counterbalancing accomplishes. One is that it controls the order of conditions so that it is no longer a confounding variable. Instead of the attractive condition always being first and the unattractive condition always being second, the attractive condition comes first for some participants and second for others. Likewise, the unattractive condition comes first for some participants and second for others. Thus any overall difference in the dependent variable between the two conditions cannot have been caused by the order of conditions. A second way to think about what counterbalancing accomplishes is that if there are carryover effects, it makes it possible to detect them. One can analyze the data separately for each order to see whether it had an effect.

When 9 Is “Larger” Than 221

Researcher Michael Birnbaum has argued that the  lack  of context provided by between-subjects designs is often a bigger problem than the context effects created by within-subjects designs. To demonstrate this problem, he asked participants to rate two numbers on how large they were on a scale of 1-to-10 where 1 was “very very small” and 10 was “very very large”.  One group of participants were asked to rate the number 9 and another group was asked to rate the number 221 (Birnbaum, 1999) [1] . Participants in this between-subjects design gave the number 9 a mean rating of 5.13 and the number 221 a mean rating of 3.10. In other words, they rated 9 as larger than 221! According to Birnbaum, this  difference  is because participants spontaneously compared 9 with other one-digit numbers (in which case it is  relatively large) and compared 221 with other three-digit numbers (in which case it is relatively  small).

Simultaneous Within-Subjects Designs

So far, we have discussed an approach to within-subjects designs in which participants are tested in one condition at a time. There is another approach, however, that is often used when participants make multiple responses in each condition. Imagine, for example, that participants judge the guilt of 10 attractive defendants and 10 unattractive defendants. Instead of having people make judgments about all 10 defendants of one type followed by all 10 defendants of the other type, the researcher could present all 20 defendants in a sequence that mixed the two types. The researcher could then compute each participant’s mean rating for each type of defendant. Or imagine an experiment designed to see whether people with social anxiety disorder remember negative adjectives (e.g., “stupid,” “incompetent”) better than positive ones (e.g., “happy,” “productive”). The researcher could have participants study a single list that includes both kinds of words and then have them try to recall as many words as possible. The researcher could then count the number of each type of word that was recalled. 

Between-Subjects or Within-Subjects?

Almost every experiment can be conducted using either a between-subjects design or a within-subjects design. This possibility means that researchers must choose between the two approaches based on their relative merits for the particular situation.

Between-subjects experiments have the advantage of being conceptually simpler and requiring less testing time per participant. They also avoid carryover effects without the need for counterbalancing. Within-subjects experiments have the advantage of controlling extraneous participant variables, which generally reduces noise in the data and makes it easier to detect a relationship between the independent and dependent variables.

A good rule of thumb, then, is that if it is possible to conduct a within-subjects experiment (with proper counterbalancing) in the time that is available per participant—and you have no serious concerns about carryover effects—this design is probably the best option. If a within-subjects design would be difficult or impossible to carry out, then you should consider a between-subjects design instead. For example, if you were testing participants in a doctor’s waiting room or shoppers in line at a grocery store, you might not have enough time to test each participant in all conditions and therefore would opt for a between-subjects design. Or imagine you were trying to reduce people’s level of prejudice by having them interact with someone of another race. A within-subjects design with counterbalancing would require testing some participants in the treatment condition first and then in a control condition. But if the treatment works and reduces people’s level of prejudice, then they would no longer be suitable for testing in the control condition. This difficulty is true for many designs that involve a treatment meant to produce long-term change in participants’ behavior (e.g., studies testing the effectiveness of psychotherapy). Clearly, a between-subjects design would be necessary here.

Remember also that using one type of design does not preclude using the other type in a different study. There is no reason that a researcher could not use both a between-subjects design and a within-subjects design to answer the same research question. In fact, professional researchers often take exactly this type of mixed methods approach.

Key Takeaways

• Experiments can be conducted using either between-subjects or within-subjects designs. Deciding which to use in a particular situation requires careful consideration of the pros and cons of each approach.
• Random assignment to conditions in between-subjects experiments or counterbalancing of orders of conditions in within-subjects experiments is a fundamental element of experimental research. The purpose of these techniques is to control extraneous variables so that they do not become confounding variables.
• You want to test the relative effectiveness of two training programs for running a marathon.
• Using photographs of people as stimuli, you want to see if smiling people are perceived as more intelligent than people who are not smiling.
• In a field experiment, you want to see if the way a panhandler is dressed (neatly vs. sloppily) affects whether or not passersby give him any money.
• You want to see if concrete nouns (e.g.,  dog ) are recalled better than abstract nouns (e.g.,  truth).
• Birnbaum, M.H. (1999). How to show that 9>221: Collect judgments in a between-subjects design. Psychological Methods, 4 (3), 243-249. ↵

Share This Book

• Increase Font Size

What Is Random Assignment in Psychology?

Categories Research Methods

Random assignment means that every participant has the same chance of being chosen for the experimental or control group. It involves using procedures that rely on chance to assign participants to groups. Doing this means that every participant in a study has an equal opportunity to be assigned to any group.

For example, in a psychology experiment, participants might be assigned to either a control or experimental group. Some experiments might only have one experimental group, while others may have several treatment variations.

Using random assignment means that each participant has the same chance of being assigned to any of these groups.

How to Use Random Assignment

So what type of procedures might psychologists utilize for random assignment? Strategies can include:

• Flipping a coin
• Assigning random numbers
• Rolling dice
• Drawing names out of a hat

How Does Random Assignment Work?

A psychology experiment aims to determine if changes in one variable lead to changes in another variable. Researchers will first begin by coming up with a hypothesis. Once researchers have an idea of what they think they might find in a population, they will come up with an experimental design and then recruit participants for their study.

Once they have a pool of participants representative of the population they are interested in looking at, they will randomly assign the participants to their groups.

• Control group : Some participants will end up in the control group, which serves as a baseline and does not receive the independent variables.
• Experimental group : Other participants will end up in the experimental groups that receive some form of the independent variables.

By using random assignment, the researchers make it more likely that the groups are equal at the start of the experiment. Since the groups are the same on other variables, it can be assumed that any changes that occur are the result of varying the independent variables.

After a treatment has been administered, the researchers will then collect data in order to determine if the independent variable had any impact on the dependent variable.

Random Assignment vs. Random Selection

It is important to remember that random assignment is not the same thing as random selection , also known as random sampling.

Random selection instead involves how people are chosen to be in a study. Using random selection, every member of a population stands an equal chance of being chosen for a study or experiment.

So random sampling affects how participants are chosen for a study, while random assignment affects how participants are then assigned to groups.

Examples of Random Assignment

Imagine that a psychology researcher is conducting an experiment to determine if getting adequate sleep the night before an exam results in better test scores.

Forming a Hypothesis

They hypothesize that participants who get 8 hours of sleep will do better on a math exam than participants who only get 4 hours of sleep.

Obtaining Participants

The researcher starts by obtaining a pool of participants. They find 100 participants from a local university. Half of the participants are female, and half are male.

Randomly Assign Participants to Groups

The researcher then assigns random numbers to each participant and uses a random number generator to randomly assign each number to either the 4-hour or 8-hour sleep groups.

Conduct the Experiment

Those in the 8-hour sleep group agree to sleep for 8 hours that night, while those in the 4-hour group agree to wake up after only 4 hours. The following day, all of the participants meet in a classroom.

Collect and Analyze Data

Everyone takes the same math test. The test scores are then compared to see if the amount of sleep the night before had any impact on test scores.

Why Is Random Assignment Important in Psychology Research?

Random assignment is important in psychology research because it helps improve a study’s internal validity. This means that the researchers are sure that the study demonstrates a cause-and-effect relationship between an independent and dependent variable.

Random assignment improves the internal validity by minimizing the risk that there are systematic differences in the participants who are in each group.

Key Points to Remember About Random Assignment

• Random assignment in psychology involves each participant having an equal chance of being chosen for any of the groups, including the control and experimental groups.
• It helps control for potential confounding variables, reducing the likelihood of pre-existing differences between groups.
• This method enhances the internal validity of experiments, allowing researchers to draw more reliable conclusions about cause-and-effect relationships.
• Random assignment is crucial for creating comparable groups and increasing the scientific rigor of psychological studies.

Want to create or adapt books like this? Learn more about how Pressbooks supports open publishing practices.

14.1 What is experimental design and when should you use it?

Learning objectives.

Learners will be able to…

• Describe the purpose of experimental design research
• Describe nomethetic causality and the logic of experimental design
• Identify the characteristics of a basic experiment
• Discuss the relationship between dependent and independent variables in experiments
• Identify the three major types of experimental designs

Pre-awareness check (Knowledge)

What are your thoughts on the phrase ‘experiment’ in the realm of social sciences? In an experiment, what is the independent variable?

The basics of experiments

In social work research, experimental design is used to test the effects of treatments, interventions, programs, or other conditions to which individuals, groups, organizations, or communities may be exposed to. There are a lot of experiments social work researchers can use to explore topics such as treatments for depression, impacts of school-based mental health on student outcomes, or prevention of abuse of people with disabilities. The American Psychological Association defines an experiment   as:

a series of observations conducted under controlled conditions to study a relationship with the purpose of drawing causal inferences about that relationship. An experiment involves the manipulation of an independent variable , the measurement of a dependent variable , and the exposure of various participants to one or more of the conditions being studied. Random selection of participants and their random assignment to conditions also are necessary in experiments .

In experimental design, the independent variable is the intervention, treatment, or condition that is being investigated as a potential cause of change (i.e., the experimental condition ). The effect, or outcome, of the experimental condition is the dependent variable. Trying out a new restaurant, dating a new person – we often call these things “experiments.” However, a true social science experiment would include recruitment of a large enough sample, random assignment to control and experimental groups, exposing those in the experimental group to an experimental condition, and collecting observations at the end of the experiment.

Social scientists use this level of rigor and control to maximize the internal validity of their research. Internal validity is the confidence researchers have about whether the independent variable (e.g, treatment) truly produces a change in the dependent, or outcome, variable. The logic and features of experimental design are intended to help establish causality and to reduce threats to internal validity , which we will discuss in Section 14.5 .

Experiments attempt to establish a nomothetic causal relationship between two variables—the treatment and its intended outcome.  We discussed the four criteria for establishing nomothetic causality in Section 4.3 :

• plausibility,
• covariation,
• temporality, and
• nonspuriousness.

Experiments should establish plausibility , having a plausible reason why their intervention would cause changes in the dependent variable. Usually, a theory framework or previous empirical evidence will indicate the plausibility of a causal relationship.

Covariation can be established for causal explanations by showing that the “cause” and the “effect” change together.  In experiments, the cause is an intervention, treatment, or other experimental condition. Whether or not a research participant is exposed to the experimental condition is the independent variable. The effect in an experiment is the outcome being assessed and is the dependent variable in the study. When the independent and dependent variables covary, they can have a positive association (e.g., those exposed to the intervention have increased self-esteem) or a negative association (e.g., those exposed to the intervention have reduced anxiety).

Since researcher controls when the intervention is administered, they can be assured that changes in the independent variable (the treatment) happens before changes in the dependent variable (the outcome). In this way, experiments assure temporality .

Finally, one of the most important features of experiments is that they allow researchers to eliminate spurious variables to support the criterion of nonspuriousness . True experiments are usually conducted under strictly controlled conditions. The intervention is given in the same way to each person, with a minimal number of other variables that might cause their post-test scores to change.

The logic of experimental design

How do we know that one phenomenon causes another? The complexity of the social world in which we practice and conduct research means that causes of social problems are rarely cut and dry. Uncovering explanations for social problems is key to helping clients address them, and experimental research designs are one road to finding answers.

Just because two phenomena are related in some way doesn’t mean that one causes the other. Ice cream sales increase in the summer, and so does the rate of violent crime; does that mean that eating ice cream is going to make me violent? Obviously not, because ice cream is great. The reality of that association is far more complex—it could be that hot weather makes people more irritable and, at times, violent, while also making people want ice cream. More likely, though, there are other social factors not accounted for in the way we just described this association.

As we have discussed, experimental designs can help clear up at least some of this fog by allowing researchers to isolate the effect of interventions on dependent variables by controlling extraneous variables . In true experimental design (discussed in the next section) and quasi-experimental design, researchers accomplish this w ith a control group or comparison group and the experimental group . The experimental group is sometimes called the treatment group because people in the experimental group receive the treatment or are exposed to the experimental condition (but we will call it the experimental group in this chapter.) The control/comparison group does not receive the treatment or intervention. Instead they may receive what is known as “treatment as usual” or perhaps no treatment at all.

In a well-designed experiment, the control group should look almost identical to the experimental group in terms of demographics and other relevant factors. What if we want to know the effect of CBT on social anxiety, but we have learned in prior research that men tend to have a more difficult time overcoming social anxiety? We would want our control and experimental groups to have a similar portions of men, since ostensibly, both groups’ results would be affected by the men in the group. If your control group has 5 women, 6 men, and 4 non-binary people, then your experimental group should be made up of roughly the same gender balance to help control for the influence of gender on the outcome of your intervention. (In reality, the groups should be similar along other dimensions, as well, and your group will likely be much larger.) The researcher will use the same outcome measures for both groups and compare them, and assuming the experiment was designed correctly, get a pretty good answer about whether the intervention had an effect on social anxiety.

Random assignment [/pb_glossary], also called randomization, entails using a random process to decide which participants are put into the control or experimental group (which participants receive an intervention and which do not). By randomly assigning participants to a group, you can reduce the effect of extraneous variables on your research because there won’t be a systematic difference between the groups.

Do not confuse random assignment with random sampling . Random sampling is a method for selecting a sample from a population and is rarely used in psychological research. Random assignment is a method for assigning participants in a sample to the different conditions, and it is an important element of all experimental research in psychology and other related fields. Random sampling helps a great deal with external validity, or generalizability , whereas random assignment increases internal validity .

Other Features of Experiments that Help Establish Causality

To control for spuriousness (as well as meeting the three other criteria for establishing causality), experiments try to control as many aspects of the research process as possible: using control groups, having large enough sample sizes, standardizing the treatment, etc. Researchers in large experiments often employ clinicians or other research staff to help them. Researchers train their staff members exhaustively, provide pre-scripted responses to common questions, and control the physical environment of the experiment so each person who participates receives the exact same treatment. Experimental researchers also document their procedures, so that others can review them and make changes in future research if they think it will improve on the ability to control for spurious variables.

An interesting example is Bruce Alexander’s (2010) Rat Park experiments. Much of the early research conducted on addictive drugs, like heroin and cocaine, was conducted on animals other than humans, usually mice or rats. The scientific consensus up until Alexander’s experiments was that cocaine and heroin were so addictive that rats, if offered the drugs, would consume them repeatedly until they perished. Researchers claimed this behavior explained how addiction worked in humans, but Alexander was not so sure. He knew rats were social animals and the experimental procedure from previous experiments did not allow them to socialize. Instead, rats were kept isolated in small cages with only food, water, and metal walls. To Alexander, social isolation was a spurious variable, causing changes in addictive behavior not due to the drug itself. Alexander created an experiment of his own, in which rats were allowed to run freely in an interesting environment, socialize and mate with other rats, and of course, drink from a solution that contained an addictive drug. In this environment, rats did not become hopelessly addicted to drugs. In fact, they had little interest in the substance. To Alexander, the results of his experiment demonstrated that social isolation was more of a causal factor for addiction than the drug itself.

One challenge with Alexander’s findings is that subsequent researchers have had mixed success replicating his findings (e.g., Petrie, 1996; Solinas, Thiriet, El Rawas, Lardeux, & Jaber, 2009). Replication involves conducting another researcher’s experiment in the same manner and seeing if it produces the same results. If the causal relationship is real, it should occur in all (or at least most) rigorous replications of the experiment.

Replicability

[INSERT A PARAGRAPH ABOUT REPLICATION/REPRODUCTION HERE. CAN USE/REFERENCE THIS   IF IT’S HELPFUL; include glossary definition as well as other general info]

To allow for easier replication, researchers should describe their experimental methods diligently. Researchers with the Open Science Collaboration (2015) [1] conducted the Reproducibility Project , which caused a significant controversy regarding the validity of psychological studies. The researchers with the project attempted to reproduce the results of 100 experiments published in major psychology journals since 2008. What they found was shocking. Although 97% of the original studies reported significant results, only 36% of the replicated studies had significant findings. The average effect size in the replication studies was half that of the original studies. The implications of the Reproducibility Project are potentially staggering, and encourage social scientists to carefully consider the validity of their reported findings and that the scientific community take steps to ensure researchers do not cherry-pick data or change their hypotheses simply to get published.

Generalizability

Let’s return to Alexander’s Rat Park study and consider the implications of his experiment for substance use professionals.  The conclusions he drew from his experiments on rats were meant to be generalized to the population. If this could be done, the experiment would have a high degree of external validity , which is the degree to which conclusions generalize to larger populations and different situations. Alexander argues his conclusions about addiction and social isolation help us understand why people living in deprived, isolated environments may become addicted to drugs more often than those in more enriching environments. Similarly, earlier rat researchers argued their results showed these drugs were instantly addictive to humans, often to the point of death.

Neither study’s results will match up perfectly with real life. There are clients in social work practice who may fit into Alexander’s social isolation model, but social isolation is complex. Clients can live in environments with other sociable humans, work jobs, and have romantic relationships; does this mean they are not socially isolated? On the other hand, clients may face structural racism, poverty, trauma, and other challenges that may contribute to their social environment. Alexander’s work helps understand clients’ experiences, but the explanation is incomplete. Human existence is more complicated than the experimental conditions in Rat Park.

Effectiveness versus Efficacy

Social workers are especially attentive to how social context shapes social life. This consideration points out a potential weakness of experiments. They can be rather artificial. When an experiment demonstrates causality under ideal, controlled circumstances, it establishes the efficacy of an intervention.

How often do real-world social interactions occur in the same way that they do in a controlled experiment? Experiments that are conducted in community settings by community practitioners are less easily controlled than those conducted in a lab or with researchers who adhere strictly to research protocols delivering the intervention. When an experiment demonstrates causality in a real-world setting that is not tightly controlled, it establishes the effectiveness of the intervention.

The distinction between efficacy and effectiveness demonstrates the tension between internal and external validity. Internal validity and external validity are conceptually linked. Internal validity refers to the degree to which the intervention causes its intended outcomes, and external validity refers to how well that relationship applies to different groups and circumstances than the experiment. However, the more researchers tightly control the environment to ensure internal validity, the more they may risk external validity for generalizing their results to different populations and circumstances. Correspondingly, researchers whose settings are just like the real world will be less able to ensure internal validity, as there are many factors that could pollute the research process. This is not to suggest that experimental research findings cannot have high levels of both internal and external validity, but that experimental researchers must always be aware of this potential weakness and clearly report limitations in their research reports.

Types of Experimental Designs

Experimental design is an umbrella term for a research method that is designed to test hypotheses related to causality under controlled conditions. Table 14.1 describes the three major types of experimental design (pre-experimental, quasi-experimental, and true experimental) and presents subtypes for each. As we will see in the coming sections, some types of experimental design are better at establishing causality than others. It’s also worth considering that true experiments, which most effectively establish causality , are often difficult and expensive to implement. Although the other experimental designs aren’t perfect, they still produce useful, valid evidence and may be more feasible to carry out.

Key Takeaways

• Experimental designs are useful for establishing causality, but some types of experimental design do this better than others.
• Experiments help researchers isolate the effect of the independent variable on the dependent variable by controlling for the effect of extraneous variables .
• Experiments use a control/comparison group and an experimental group to test the effects of interventions. These groups should be as similar to each other as possible in terms of demographics and other relevant factors.
• True experiments have control groups with randomly assigned participants; quasi-experimental types of experiments have comparison groups to which participants are not randomly assigned; pre-experimental designs do not have a comparison group.

TRACK 1 (IF YOU  ARE  CREATING A RESEARCH PROPOSAL FOR THIS CLASS):

• Think about the research project you’ve been designing so far. How might you use a basic experiment to answer your question? If your question isn’t explanatory, try to formulate a new explanatory question and consider the usefulness of an experiment.
• Why is establishing a simple relationship between two variables not indicative of one causing the other?

TRACK 2 (IF YOU  AREN’T  CREATING A RESEARCH PROPOSAL FOR THIS CLASS):

Imagine you are interested in studying child welfare practice. You are interested in learning more about community-based programs aimed to prevent child maltreatment and to prevent out-of-home placement for children.

• Think about the research project stated above. How might you use a basic experiment to look more into this research topic? Try to formulate an explanatory question and consider the usefulness of an experiment.
• Open Science Collaboration. (2015). Estimating the reproducibility of psychological science. Science, 349 (6251), aac4716. Doi: 10.1126/science.aac4716 ↵

an operation or procedure carried out under controlled conditions in order to discover an unknown effect or law, to test or establish a hypothesis, or to illustrate a known law.

treatment, intervention, or experience that is being tested in an experiment (the independent variable) that is received by the experimental group and not by the control group.

Ability to say that one variable "causes" something to happen to another variable. Very important to assess when thinking about studies that examine causation such as experimental or quasi-experimental designs.

circumstances or events that may affect the outcome of an experiment, resulting in changes in the research participants that are not a result of the intervention, treatment, or experimental condition being tested

causal explanations that can be universally applied to groups, such as scientific laws or universal truths

as a criteria for causal relationship, the relationship must make logical sense and seem possible

when the values of two variables change at the same time

as a criteria for causal relationship, the cause must come before the effect

an association between two variables that is NOT caused by a third variable

variables and characteristics that have an effect on your outcome, but aren't the primary variable whose influence you're interested in testing.

the group of participants in our study who do not receive the intervention we are researching in experiments with random assignment

the group of participants in our study who do not receive the intervention we are researching in experiments without random assignment

in experimental design, the group of participants in our study who do receive the intervention we are researching

The ability to apply research findings beyond the study sample to some broader population,

This is a synonymous term for generalizability - the ability to apply the findings of a study beyond the sample to a broader population.

performance of an intervention under ideal and controlled circumstances, such as in a lab or delivered by trained researcher-interventionists

The performance of an intervention under "real-world" conditions that are not closely controlled and ideal

the idea that one event, behavior, or belief will result in the occurrence of another, subsequent event, behavior, or belief

Doctoral Research Methods in Social Work Copyright © by Mavs Open Press. All Rights Reserved.

Share This Book

Behavioral Clinical Trials for Chronic Diseases pp 169–207 Cite as

Protection of Random Assignment

• Lynda H. Powell 4 ,
• Peter G. Kaufmann 5 &
• Kenneth E. Freedland 6  
• First Online: 14 October 2021

494 Accesses

Existence of an alternative explanation for the benefit of a treatment is a confounder. It is a nuisance “passenger” variable that rides along with treatment and undermines the ability to make causal inferences. This chapter focuses on why random assignment is so powerful and should be protected. It presents a history of attempts to answer the question of whether or not a treatment works, and the arrival at random assignment as the best way to make causal inferences about the benefits of a treatment. It defines confounding as an error of interpretation and the essential role of avoiding it by protecting the random assignment. It then goes on to illustrate ways to protect random assignment in the design, conduct, and analyses of a trial, with particular attention to the central role of identifying a patient-centered target population, recruiting it, retaining it, and insuring that all randomized participants are included in the evaluation of trial results.

• Confounding
• Random assignment
• Recruitment
• Intent-to-treat analyses
• Per-protocol analyses
• Post-randomization exclusions
• Target population
• Patient-centered target population
• pre-contemplators
• Inconclusive trial
• Responder-only analyses
• On-treatment analyses

“Daniel and his three companions were young Israelites who were taken to serve in the palace of the king of Babylon because they were of noble royal family, without physical defect, handsome, versed in wisdom, and competent. Daniel determined he would not defile himself with the King’s food or wine. He asked the overseer: ‘Please test us for 10 days and let us be given some vegetables to eat and water to drink. Then let our appearance be compared to the appearance of youths who are eating the King’s choice food.’ At the end of 10 days, their appearance seemed better and they were fatter than any of the youths who had been eating the King’s food. So the overseer let them continue to eat vegetables and drink water instead of what the king provided.” Bible, Old Testament, Book of Daniel 1:16

This is a preview of subscription content, log in via an institution .

Buying options

• Available as PDF
• Read on any device
• Instant download
• Own it forever
• Available as EPUB and PDF
• Durable hardcover edition
• Dispatched in 3 to 5 business days
• Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Bull JP (1959) The historical development of clinical therapeutic trials. J Chron Dis 10:218–248

PubMed   Google Scholar  

Armitage P (1982) The role of randomization in clinical trials. Stat Med 1:345–352

Van Helmont JB (1662) Oriatrike or Physik Refined. In Debus AG (1968) The chemical dream of the renaissance. Heffer, London

Google Scholar  

Peirce CS, Jastrow J (1884) Fifth memoir: on small differences of sensation. Ntl Acad Sci 3:73–83

Yule G (1924) The function of statistical method in scientific investigation. Industrial Health Research Board Report 28. His Majesty’s Stationery Office, London

Eliot MM (1925) The control of rickets: preliminary discussion of the demonstration in New Haven. JAMA 85:656–663

Hill AB (1952) The clinical trial. New Engl J Med 247:113–119

Hill AB (1953) Observation and experiment. New Engl J Med 248:995–1001

Sinclair HM (1951) Nutritional surveys of population groups. New Engl J Med 245:39–47

Mill JS (1843) A system of logic ratiocinative and inductive. Being a connected view of the principles of evidence and the methods of scientific investigation. Book I. In Robson JM (ed). The collected works of John Stuart Mill (1974). University of Toronto Press, Toronto

Hill AB (1965) The environment and disease: association or causation. Proc Roy Soc Med 58:295–300

Wang D, Bakhai A (2006) Clinical trials: a practical guide to design, analysis, and reporting. Remedica, London

Domanski M, McKinlay S (2009) Successful randomized trials. A handbook for the 21st century. Lippincott Williams & Wilkins, Philadelphia

Friedman LM, Furberg CD, DeMets D, Reboussin DH, Granger CB (2015) Fundamentals of clinical trials, 5th edn. Springer, Cham

Rothman KJ, Greenland S, Lash TL (2008) Modern epidemiology, 3rd edn. Lippincott Williams & Wilkins, Philadelphia

Szklo M, Nieto FJ (2019) Epidemiology: beyond the basics, 4th edn. Jones & Bartlett Learning, Burlington

Hennekens CH, Buring JE, Mayrent SL (1987) Epidemiology in medicine. Little Brown, Boston

Susser M (1973) Causal thinking in the health sciences: Concepts and strategies of epidemiology. Oxford University Press, New York

Fisher RA (1951) The design of experiments, 6th edn. Hafner, New York

Shadish WR, Cook TD, Campbell DT (2002) Experimental and quasi-experimental designs for generalized causal inference. Houghton Mifflin, Boston

Byar DP, Simon RM, Friedewald WT, Schlesselman JJ, DeMets D, Ellenberg JH, Gail MH, Ware JH (1976) Randomized clinical trials--perspectives on some recent ideas. N Engl J Med 295:74–80

Moher D, Hopewell S, Schulz KF, Montori V, Gotzche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG (2010) CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 340:c869. https://doi.org/10.1136/bmj.c869

Mosteller F, Gilbert JP, McPeek B (1980) Reporting standards and research strategies for controlled trials. Control Clin Trials 1:37–58

Schulz KF, Chalmers I, Hayes RJ, Altman DG (1995) Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 273:408–412

CONSORT Group (2010) CONSORT checklist. www.consort-statement.org

Schulz KF, Altman DG, Moher D, CONSORT Group (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 152:726–732

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, and for the CONSORT and Pragmatic Trials in Healthcare (Practihc) groups (2008) Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 337:a2390. https://doi.org/10.1136/bmj.a2390

Schulz KF (1995) Subverting randomization in controlled trials. JAMA 274:1456–1458

Kraemer HC (2015) A source of false findings in published research studies: adjusting for covariates. JAMA Psychiatry 72:961–962

Pocock SJ, Assmann SE, Enos LE, Kasten LE (2002) Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med 21:2917–2930

Schulz KF, Grimes DA, Altman DG, Hayes RJ (1996) Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology. BMJ 312:742–744

PubMed   PubMed Central   Google Scholar  

Detry MA, Lewis RJ (2014) The intention-to-treat principle: how to assess the true effect of choosing a medical treatment. JAMA 312:85–86

Freedman B (1987) Equipoise and the ethics of clinical research. N Eng J Med 317:141–145

Green SB, Byar DP (1984) Using observational data from registries to compare treatments: the fallacy of omnimetrics. Stat Med 3:361–373

Hollon SD, Wampold BE (2009) Are randomized controlled trials relevant to clinical practice? Can J Psychiatry 54:637–643

Cook TD, Campbell DT (1979) Quasi-experimentation: Design and analysis issues for field settings. Houghton Mifflin, Boston

Glasgow RE, Lichtenstein E, Marcus AC (2003) Why don’t we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition. Am J Public Health 93:1261–1267

Areán PA, Kraemer HC (2013) High-quality psychotherapy research: From conception to piloting to national trials. Oxford University Press, New York

Brownell KD, Wadden TA (1992) Etiology and treatment of obesity: understanding a serious, prevalent, and refractory disorder. J Consult Clin Psychol 60:505–517

Prochaska JO, DiClemente CC, Norcross JC (1992) In search of how people change: Applications to addictive behaviors. Am Psychol 47:1102–1114

Hall SM, Tsoh JY, Prochaska JJ, Eisendrath S, Rossi JS, Redding CA, Rosen AB, Meisner M, Humfleet GL, Gorecki JA (2006) Treatment for cigarette smoking among depressed mental health outpatients: a randomized clinical trial. Am J Public Health 96:1808–1814

Prochaska JJ, Hall SE, Delucchi K, Hall SM (2014) Efficacy of initiating tobacco dependence treatment in inpatient psychiatry: a randomized controlled trial. Am J Public Health 104:1557–1565

Prochaska JJ, Hall SE, Hall SM (2009) Stage-tailored tobacco cessation treatment in inpatient psychiatry. Psychiatr Serv 60:848. https://doi:10.1176/appi.ps.60.6.848

Prochaska JJ, Velicer WF, Prochaska JO, Delucchi K, Hall SM (2006) Comparing intervention outcomes in smokers treated for single versus multiple behavioral risks. Health Psychol 25:380–388

The Steering Committee of the Physicians Health Study Research Group (1988) Preliminary report: findings from the aspirin component of the ongoing Physicians’ Health Study. N Engl J Med 318:262–264

Coronary Drug Project Research Group (1980) Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. N Engl J Med 303:1038–1041

Adamson J, Cockayne S, Puffer S, Torgerson DJ (2006) Review of randomised trials using the post-randomised consent (Zelen’s) design. Contemp Clin Trials 27:305–319

Fabricatore AN, Wadden TA, Moore RH, Butryn ML, Gravallese EA, Erondu NE, Heymsfield SB, Nguyen AM (2009) Attrition from randomized controlled trials of pharmacological weight loss agents: a systematic review and analysis. Obes Rev 10:333–341

Lang JM (1990) The use of a run-in to enhance compliance. Stat Med 9:87–93

Kong W, Langlois MF, Kamga-Ngandé C, Gagnon C, Brown C, Baillargeon JP (2010) Predictors of success to weight-loss intervention program in individuals at high risk for type 2 diabetes. Diabetes Res Clin Pract 90:147–153

Teixeira PJ, Going SB, Houtkooper LB, Cussler EC, Metcalfe LL, Blew RM, Sardinha LB, Lohman TG (2004) Pretreatment predictors of attrition and successful weight management in women. Int J Obes Relat Metab Disord 28:1124–1133

Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME (2015) From ideas to efficacy: the ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol 34:971–982

Bailey JV, Pavlou M, Copas A, McCarthy OL, Carswell K, Rait G, Hart G, Nazareth I, Free CJ, French R, Murray E (2013) The Sexunzipped trial: optimizing the design of online randomized controlled trials. J Med Internet Res 15:e278. https://doi.org/10.2196/jmir.2668

Boyd A, Tilling K, Cornish R, Davies A, Humphries K, Macleod J (2015) Professionally designed information materials and telephone reminders improved consent response rates: evidence from an RCT nested within a cohort study. J Clin Epidemiol 68:877–887

Dickson S, Logan J, Hagen S, Stark D, Glazener C, McDonald AM, McPherson G (2013) Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings. Trials 14:389. https://doi.org/10.1186/1745-6215-14-389

Gupta A, Calfas KJ, Marshall SJ, Robinson TN, Rock CL, Huang JS, Epstein-Corbin M, Servetas C, Donohue MC, Norman GJ, Raab F, Merchant G, Fowler JH, Griswold WG, Fogg BJ, Patrick K (2015) Clinical trial management of participant recruitment, enrollment, engagement, and retention in the SMART study using a Marketing and Information Technology (MARKIT) model. Contemp Clin Trials 42:185–195

Hadidi N, Buckwalter K, Lindquist R, Rangen C (2012) Lessons learned in recruitment and retention of stroke survivors. J Neurosci Nurs 44:105–110

Hartlieb KB, Jacques-Tiura AJ, Naar-King S, Ellis DA, Jen KL, Marshall S (2015) Recruitment strategies and the retention of obese urban racial/ethnic minority adolescents in clinical trials: the FIT families project, Michigan, 2010–2014. Prev Chronic Dis 12:E22. https://doi.org/10.5888/pcd12.140409

Johnson DA, Joosten YA, Wilkins CH, Shibao CA (2015) Case study. Community engagement and clinical trial success: outreach to African American women. Clin Transl Sci 8:388–390

Blake K, Holbrook JT, Antal H, Shade D, Bunnell HT, McCahan SM, Wise RA, Pennington C, Garfinkel P, Wysocki T (2015) Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: study design and rationale. Contemp Clin Trials 42:105–118

Cermak SA, Stein Duker LI, Williams ME, Lane CJ, Dawson ME, Borreson AE, Polido JC (2015) Feasibility of a sensory-adapted dental environment for children with autism. Am J Occup Ther 69:6903220020. https://doi.org/10.5014/ajot.2015.013714

Giuffrida A, Torgerson DJ (1997) Should we pay the patient? Review of financial incentives to enhance patient compliance. BMJ 315:703–707

Brown SD, Lee K, Schoffman DE, King AC, Crawley LM, Kiernan M (2012) Minority recruitment into clinical trials: experimental findings and practical implications. Contemp Clin Trials 33:620–623

Kiernan M, Phillips K, Fair JM, King AC (2000) Using direct mail to recruit Hispanic adults into a dietary intervention: an experimental study. Ann Behav Med 22:89–93

Batliner T, Fehringer KA, Tiwari T, Henderson WG, Wilson A, Brega AG, Albino J (2014) Motivational interviewing with American Indian mothers to prevent early childhood caries: study design and methodology of a randomized control trial. Trials 15:125. https://doi.org/10.1186/1745-6215-15-125

Article   PubMed   PubMed Central   Google Scholar  

Clark F, Pyatak EA, Carlson M, Blanche E, Vigen C, Hay J, Mallinson T, Blanchard J, Unger JB, Garber SL, Diaz J, Florindez L, Atkins M, Rubayi S, Azen SP, PUPS Study Group (2014) Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS). Clin Trials 11:218–229

Cruz TH, Davis SM, FitzGerald CA, Canaca GF, Keane PC (2014) Engagement, recruitment, and retention in a trans-community, randomized controlled trial for the prevention of obesity in rural American Indian and Hispanic children. J Prim Prev 35:135–149

Jimenez DE, Reynolds CF 3rd, Alegría M, Harvey P, Bartels SJ (2015) The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial. Trials 6:579. https://doi.org/10.1186/s13063-015-1113-3

Koziol-McLain J, Vandal AC, Nada-Raja S, Wilson D, Glass NE, Eden KB, McLean C, Dobbs T, Case J (2015) A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol. BMC Public Health 15:56. https://doi.org/10.1186/s12889-015-1395-0

Bakari M, Munseri P, Francis J, Aris E, Moshiro C, Siyame D, Janabi M, Ngatoluwa M, Aboud S, Lyamuya E, Sandström E, Mhalu F (2013) Experiences on recruitment and retention of volunteers in the first HIV vaccine trial in Dar es Salam, Tanzania - the phase I/II HIVIS 03 trial. BMC Public Health 13:1149. https://doi.org/10.1186/1471-2458-13-1149

Goldberg JH, Kiernan M (2005) Innovative techniques to address retention in a behavioral weight-loss trial. Health Educ Res 20:439–447

National Commission for the Protection of Human Subjects of Biomedical Behavioral Research (1978) The Belmont report: ethical principles and guidelines for the protection of human subjects of research. ERIC Clearinghouse, Bethesda

Moseley JB, O’Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP (2002) A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 347:81–88

Hays JL, Hunt JR, Hubbell FA, Anderson GL, Limacher MC, Allen C, Rossouw JE (2003) The Women’s Health Initiative recruitment methods and results. Ann Epidemiol 13:S18–S77

Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ (2010) Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One 5:e15591. https://doi.org/10.1371/journal.pone.0015591

Crichton GE, Howe PR, Buckley JD, Coates AM, Murphy KJ, Bryan J (2012) Long-term dietary intervention trials: critical issues and challenges. Trials 13:111. https://doi.org/10.1186/1745-6215-13-111

Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB (2013) Designing clinical research, 4th edn. Lippincott Williams & Wilkins, Philadelphia

Siddiqi AE, Sikorskii A, Given CW, Given B (2008) Early participant attrition from clinical trials: role of trial design and logistics. Clin Trials 5:328–335

Idoko OT, Owolabi OA, Odutola AA, Ogundare O, Worwui A, Saidu Y, Smith-Sanneh A, Tunkara A, Sey G, Sanyang A, Mendy P, Ota MO (2014) Lessons in participant retention in the course of a randomized controlled clinical trial. BMC Res Notes 7:706. https://doi.org/10.1186/1756-0500-7-706

Rucker-Whitaker C, Flynn KJ, Kravitz G, Eaton C, Calvin JE, Powell LH (2006) Understanding African-American participation in a behavioral intervention: results from focus groups. Contemp Clin Trials 27:274–286

Gross D, Fogg L (2004) A critical analysis of the intent-to-treat principle in prevention research. J Primary Prevention 25:475–489

Feinstein AR (1991) Intent-to-treat policy for analyzing randomized trials: statistical distortions and neglected clinical challenges. In: Cramer JA, Spilker B (eds) Patient compliance in medical practice and clinical trials. Raven, New York

Sheiner LB, Rubin DB (1995) Intention-to-treat analysis and the goals of clinical trials. Clin Pharmacol Ther 57:6–15

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM, Diabetes Prevention Program Research Group (2002) Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 346:393–403

Diabetes Prevention Program Research Group (1999) The Diabetes Prevention Program. Design and methods for a clinical trial in the prevention of type 2 diabetes. Diabetes Care 22:623–634

Diabetes Prevention Program Research Group (2000) The Diabetes Prevention Program: baseline characteristics of the randomized cohort. Diabetes Care 23:1619–1629

Frasure-Smith N, Prince R (1985) The Ischemic Heart Disease Life Stress Monitoring Program. Impact on mortality. Psychosom Med 47:431–445

Frasure-Smith N, Prince R (1989) Long-term follow-up of the Ischemic Heart Disease Life Stress Monitoring Program. Psychosom Med 51:485–513

Powell LH (1989) Unanswered questions in the Ischemic Heart Disease Life Stress Monitoring Program. Psychosom Med 51:479–484

Frasure-Smith N, Lespérance F, Prince RH, Verrier P, Garber RA, Juneau M, Wolfson C, Bourassa MG (1997) Randomised trial of home-based psychosocial nursing intervention for patients recovering from myocardial infarction. Lancet 350:473–479

O’Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Piña IL, HF-ACTION Investigators (2009) Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA 301:1439–1450

Keteyian SJ, Leifer ES, Houston-Miller N, Kraus WE, Brawner CA, O’Connor CM, Whellan DJ, Cooper LS, Fleg JL, Kitzman DW, Cohen-Solal A, Blumenthal JA, Rendall DS, Piña IL, HF-ACTION Investigators (2012) Relation between volume of exercise and clinical outcomes in patients with heart failure. J Am Coll Cardiol 60:1899–1905

Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL, American College of Cardiology Foundation, American Heart Association Task Force on Practice Guidelines (2013) 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 62:e147–e239

Centers for Medicare and Medicaid Services (2014) Decision memo for cardiac rehabilitation programs - chronic heart failure (CAG-00437N). US Department of Health & Human Services. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?

McCambridge J, Kypri K, Elbourne D (2014) In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials. J Clin Epidemiol 67:247–253

Ashley EA (2015) The precision medicine initiative: a new national effort. JAMA 313:2019–2020

Khoury MJ, Evans JP (2015) A public health perspective on a national precision medicine cohort: balancing long-term knowledge generation with early health benefit. JAMA 313:2117–2118

Ma J, Rosas LG, Lv N (2016) Precision lifestyle medicine: a new frontier in the science of behavior change and population health. Am J Prev Med 50:395–397

Brewin CR, Bradley C (1989) Patient preferences and randomised clinical trials. Br Med J 299:313–315

Download references

Author information

Authors and affiliations.

Department of Preventive Medicine, Rush University Medical Center, Chicago, IL, USA

Lynda H. Powell

College of Nursing, Villanova University, Villanova, PA, USA

Peter G. Kaufmann

Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA

Kenneth E. Freedland

You can also search for this author in PubMed   Google Scholar

Rights and permissions

Reprints and permissions

Copyright information

© 2021 Springer Nature Switzerland AG

About this chapter

Cite this chapter.

Powell, L.H., Kaufmann, P.G., Freedland, K.E. (2021). Protection of Random Assignment. In: Behavioral Clinical Trials for Chronic Diseases. Springer, Cham. https://doi.org/10.1007/978-3-030-39330-4_8

Download citation

DOI : https://doi.org/10.1007/978-3-030-39330-4_8

Published : 14 October 2021

Publisher Name : Springer, Cham

Print ISBN : 978-3-030-39328-1

Online ISBN : 978-3-030-39330-4

eBook Packages : Behavioral Science and Psychology Behavioral Science and Psychology (R0)

Share this chapter

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Publish with us

Policies and ethics

• Find a journal
• Track your research

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, automatically generate references for free.

• Knowledge Base
• Methodology
• Random Assignment in Experiments | Introduction & Examples

Random Assignment in Experiments | Introduction & Examples

Published on 6 May 2022 by Pritha Bhandari . Revised on 13 February 2023.

In experimental research, random assignment is a way of placing participants from your sample into different treatment groups using randomisation.

With simple random assignment, every member of the sample has a known or equal chance of being placed in a control group or an experimental group. Studies that use simple random assignment are also called completely randomised designs .

Random assignment is a key part of experimental design . It helps you ensure that all groups are comparable at the start of a study: any differences between them are due to random factors.

Table of contents

Why does random assignment matter, random sampling vs random assignment, how do you use random assignment, when is random assignment not used, frequently asked questions about random assignment.

Random assignment is an important part of control in experimental research, because it helps strengthen the internal validity of an experiment.

In experiments, researchers manipulate an independent variable to assess its effect on a dependent variable, while controlling for other variables. To do so, they often use different levels of an independent variable for different groups of participants.

This is called a between-groups or independent measures design.

You use three groups of participants that are each given a different level of the independent variable:

• A control group that’s given a placebo (no dosage)
• An experimental group that’s given a low dosage
• A second experimental group that’s given a high dosage

Random assignment to helps you make sure that the treatment groups don’t differ in systematic or biased ways at the start of the experiment.

If you don’t use random assignment, you may not be able to rule out alternative explanations for your results.

• Participants recruited from pubs are placed in the control group
• Participants recruited from local community centres are placed in the low-dosage experimental group
• Participants recruited from gyms are placed in the high-dosage group

With this type of assignment, it’s hard to tell whether the participant characteristics are the same across all groups at the start of the study. Gym users may tend to engage in more healthy behaviours than people who frequent pubs or community centres, and this would introduce a healthy user bias in your study.

Although random assignment helps even out baseline differences between groups, it doesn’t always make them completely equivalent. There may still be extraneous variables that differ between groups, and there will always be some group differences that arise from chance.

Most of the time, the random variation between groups is low, and, therefore, it’s acceptable for further analysis. This is especially true when you have a large sample. In general, you should always use random assignment in experiments when it is ethically possible and makes sense for your study topic.

Prevent plagiarism, run a free check.

Random sampling and random assignment are both important concepts in research, but it’s important to understand the difference between them.

Random sampling (also called probability sampling or random selection) is a way of selecting members of a population to be included in your study. In contrast, random assignment is a way of sorting the sample participants into control and experimental groups.

While random sampling is used in many types of studies, random assignment is only used in between-subjects experimental designs.

Some studies use both random sampling and random assignment, while others use only one or the other.

Random sampling enhances the external validity or generalisability of your results, because it helps to ensure that your sample is unbiased and representative of the whole population. This allows you to make stronger statistical inferences .

You use a simple random sample to collect data. Because you have access to the whole population (all employees), you can assign all 8,000 employees a number and use a random number generator to select 300 employees. These 300 employees are your full sample.

Random assignment enhances the internal validity of the study, because it ensures that there are no systematic differences between the participants in each group. This helps you conclude that the outcomes can be attributed to the independent variable .

• A control group that receives no intervention
• An experimental group that has a remote team-building intervention every week for a month

You use random assignment to place participants into the control or experimental group. To do so, you take your list of participants and assign each participant a number. Again, you use a random number generator to place each participant in one of the two groups.

To use simple random assignment, you start by giving every member of the sample a unique number. Then, you can use computer programs or manual methods to randomly assign each participant to a group.

• Random number generator: Use a computer program to generate random numbers from the list for each group.
• Lottery method: Place all numbers individually into a hat or a bucket, and draw numbers at random for each group.
• Flip a coin: When you only have two groups, for each number on the list, flip a coin to decide if they’ll be in the control or the experimental group.
• Use a dice: When you have three groups, for each number on the list, roll a die to decide which of the groups they will be in. For example, assume that rolling 1 or 2 lands them in a control group; 3 or 4 in an experimental group; and 5 or 6 in a second control or experimental group.

This type of random assignment is the most powerful method of placing participants in conditions, because each individual has an equal chance of being placed in any one of your treatment groups.

Random assignment in block designs

In more complicated experimental designs, random assignment is only used after participants are grouped into blocks based on some characteristic (e.g., test score or demographic variable). These groupings mean that you need a larger sample to achieve high statistical power .

For example, a randomised block design involves placing participants into blocks based on a shared characteristic (e.g., college students vs graduates), and then using random assignment within each block to assign participants to every treatment condition. This helps you assess whether the characteristic affects the outcomes of your treatment.

In an experimental matched design , you use blocking and then match up individual participants from each block based on specific characteristics. Within each matched pair or group, you randomly assign each participant to one of the conditions in the experiment and compare their outcomes.

Sometimes, it’s not relevant or ethical to use simple random assignment, so groups are assigned in a different way.

When comparing different groups

Sometimes, differences between participants are the main focus of a study, for example, when comparing children and adults or people with and without health conditions. Participants are not randomly assigned to different groups, but instead assigned based on their characteristics.

In this type of study, the characteristic of interest (e.g., gender) is an independent variable, and the groups differ based on the different levels (e.g., men, women). All participants are tested the same way, and then their group-level outcomes are compared.

When it’s not ethically permissible

When studying unhealthy or dangerous behaviours, it’s not possible to use random assignment. For example, if you’re studying heavy drinkers and social drinkers, it’s unethical to randomly assign participants to one of the two groups and ask them to drink large amounts of alcohol for your experiment.

When you can’t assign participants to groups, you can also conduct a quasi-experimental study . In a quasi-experiment, you study the outcomes of pre-existing groups who receive treatments that you may not have any control over (e.g., heavy drinkers and social drinkers).

These groups aren’t randomly assigned, but may be considered comparable when some other variables (e.g., age or socioeconomic status) are controlled for.

In experimental research, random assignment is a way of placing participants from your sample into different groups using randomisation. With this method, every member of the sample has a known or equal chance of being placed in a control group or an experimental group.

Random selection, or random sampling , is a way of selecting members of a population for your study’s sample.

In contrast, random assignment is a way of sorting the sample into control and experimental groups.

Random sampling enhances the external validity or generalisability of your results, while random assignment improves the internal validity of your study.

Random assignment is used in experiments with a between-groups or independent measures design. In this research design, there’s usually a control group and one or more experimental groups. Random assignment helps ensure that the groups are comparable.

In general, you should always use random assignment in this type of experimental design when it is ethically possible and makes sense for your study topic.

To implement random assignment , assign a unique number to every member of your study’s sample .

Then, you can use a random number generator or a lottery method to randomly assign each number to a control or experimental group. You can also do so manually, by flipping a coin or rolling a die to randomly assign participants to groups.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the ‘Cite this Scribbr article’ button to automatically add the citation to our free Reference Generator.

Bhandari, P. (2023, February 13). Random Assignment in Experiments | Introduction & Examples. Scribbr. Retrieved 21 March 2024, from https://www.scribbr.co.uk/research-methods/random-assignment-experiments/

Is this article helpful?

Pritha Bhandari

Other students also liked, a quick guide to experimental design | 5 steps & examples, controlled experiments | methods & examples of control, control groups and treatment groups | uses & examples.

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• J Hum Reprod Sci
• v.4(1); Jan-Apr 2011

This article has been retracted.

An overview of randomization techniques: an unbiased assessment of outcome in clinical research.

Department of Biostatics, National Institute of Animal Nutrition & Physiology (NIANP), Adugodi, Bangalore, India

Randomization as a method of experimental control has been extensively used in human clinical trials and other biological experiments. It prevents the selection bias and insures against the accidental bias. It produces the comparable groups and eliminates the source of bias in treatment assignments. Finally, it permits the use of probability theory to express the likelihood of chance as a source for the difference of end outcome. This paper discusses the different methods of randomization and use of online statistical computing web programming ( www.graphpad.com /quickcalcs or www.randomization.com ) to generate the randomization schedule. Issues related to randomization are also discussed in this paper.

INTRODUCTION

A good experiment or trial minimizes the variability of the evaluation and provides unbiased evaluation of the intervention by avoiding confounding from other factors, which are known and unknown. Randomization ensures that each patient has an equal chance of receiving any of the treatments under study, generate comparable intervention groups, which are alike in all the important aspects except for the intervention each groups receives. It also provides a basis for the statistical methods used in analyzing the data. The basic benefits of randomization are as follows: it eliminates the selection bias, balances the groups with respect to many known and unknown confounding or prognostic variables, and forms the basis for statistical tests, a basis for an assumption of free statistical test of the equality of treatments. In general, a randomized experiment is an essential tool for testing the efficacy of the treatment.

In practice, randomization requires generating randomization schedules, which should be reproducible. Generation of a randomization schedule usually includes obtaining the random numbers and assigning random numbers to each subject or treatment conditions. Random numbers can be generated by computers or can come from random number tables found in the most statistical text books. For simple experiments with small number of subjects, randomization can be performed easily by assigning the random numbers from random number tables to the treatment conditions. However, in the large sample size situation or if restricted randomization or stratified randomization to be performed for an experiment or if an unbalanced allocation ratio will be used, it is better to use the computer programming to do the randomization such as SAS, R environment etc.[ 1 – 6 ]

REASON FOR RANDOMIZATION

Researchers in life science research demand randomization for several reasons. First, subjects in various groups should not differ in any systematic way. In a clinical research, if treatment groups are systematically different, research results will be biased. Suppose that subjects are assigned to control and treatment groups in a study examining the efficacy of a surgical intervention. If a greater proportion of older subjects are assigned to the treatment group, then the outcome of the surgical intervention may be influenced by this imbalance. The effects of the treatment would be indistinguishable from the influence of the imbalance of covariates, thereby requiring the researcher to control for the covariates in the analysis to obtain an unbiased result.[ 7 , 8 ]

Second, proper randomization ensures no a priori knowledge of group assignment (i.e., allocation concealment). That is, researchers, subject or patients or participants, and others should not know to which group the subject will be assigned. Knowledge of group assignment creates a layer of potential selection bias that may taint the data.[ 9 ] Schul and Grimes stated that trials with inadequate or unclear randomization tended to overestimate treatment effects up to 40% compared with those that used proper randomization. The outcome of the research can be negatively influenced by this inadequate randomization.

Statistical techniques such as analysis of covariance (ANCOVA), multivariate ANCOVA, or both, are often used to adjust for covariate imbalance in the analysis stage of the clinical research. However, the interpretation of this post adjustment approach is often difficult because imbalance of covariates frequently leads to unanticipated interaction effects, such as unequal slopes among subgroups of covariates.[ 1 ] One of the critical assumptions in ANCOVA is that the slopes of regression lines are the same for each group of covariates. The adjustment needed for each covariate group may vary, which is problematic because ANCOVA uses the average slope across the groups to adjust the outcome variable. Thus, the ideal way of balancing covariates among groups is to apply sound randomization in the design stage of a clinical research (before the adjustment procedure) instead of post data collection. In such instances, random assignment is necessary and guarantees validity for statistical tests of significance that are used to compare treatments.

TYPES OF RANDOMIZATION

Many procedures have been proposed for the random assignment of participants to treatment groups in clinical trials. In this article, common randomization techniques, including simple randomization, block randomization, stratified randomization, and covariate adaptive randomization, are reviewed. Each method is described along with its advantages and disadvantages. It is very important to select a method that will produce interpretable and valid results for your study. Use of online software to generate randomization code using block randomization procedure will be presented.

Simple randomization

Randomization based on a single sequence of random assignments is known as simple randomization.[ 3 ] This technique maintains complete randomness of the assignment of a subject to a particular group. The most common and basic method of simple randomization is flipping a coin. For example, with two treatment groups (control versus treatment), the side of the coin (i.e., heads - control, tails - treatment) determines the assignment of each subject. Other methods include using a shuffled deck of cards (e.g., even - control, odd - treatment) or throwing a dice (e.g., below and equal to 3 - control, over 3 - treatment). A random number table found in a statistics book or computer-generated random numbers can also be used for simple randomization of subjects.

This randomization approach is simple and easy to implement in a clinical research. In large clinical research, simple randomization can be trusted to generate similar numbers of subjects among groups. However, randomization results could be problematic in relatively small sample size clinical research, resulting in an unequal number of participants among groups.

Block randomization

The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. Blocks are small and balanced with predetermined group assignments, which keeps the numbers of subjects in each group similar at all times.[ 1 , 2 ] The block size is determined by the researcher and should be a multiple of the number of groups (i.e., with two treatment groups, block size of either 4, 6, or 8). Blocks are best used in smaller increments as researchers can more easily control balance.[ 10 ]

After block size has been determined, all possible balanced combinations of assignment within the block (i.e., equal number for all groups within the block) must be calculated. Blocks are then randomly chosen to determine the patients’ assignment into the groups.

Although balance in sample size may be achieved with this method, groups may be generated that are rarely comparable in terms of certain covariates. For example, one group may have more participants with secondary diseases (e.g., diabetes, multiple sclerosis, cancer, hypertension, etc.) that could confound the data and may negatively influence the results of the clinical trial.[ 11 ] Pocock and Simon stressed the importance of controlling for these covariates because of serious consequences to the interpretation of the results. Such an imbalance could introduce bias in the statistical analysis and reduce the power of the study. Hence, sample size and covariates must be balanced in clinical research.

Stratified randomization

The stratified randomization method addresses the need to control and balance the influence of covariates. This method can be used to achieve balance among groups in terms of subjects’ baseline characteristics (covariates). Specific covariates must be identified by the researcher who understands the potential influence each covariate has on the dependent variable. Stratified randomization is achieved by generating a separate block for each combination of covariates, and subjects are assigned to the appropriate block of covariates. After all subjects have been identified and assigned into blocks, simple randomization is performed within each block to assign subjects to one of the groups.

The stratified randomization method controls for the possible influence of covariates that would jeopardize the conclusions of the clinical research. For example, a clinical research of different rehabilitation techniques after a surgical procedure will have a number of covariates. It is well known that the age of the subject affects the rate of prognosis. Thus, age could be a confounding variable and influence the outcome of the clinical research. Stratified randomization can balance the control and treatment groups for age or other identified covariates. Although stratified randomization is a relatively simple and useful technique, especially for smaller clinical trials, it becomes complicated to implement if many covariates must be controlled.[ 12 ] Stratified randomization has another limitation; it works only when all subjects have been identified before group assignment. However, this method is rarely applicable because clinical research subjects are often enrolled one at a time on a continuous basis. When baseline characteristics of all subjects are not available before assignment, using stratified randomization is difficult.[ 10 ]

Covariate adaptive randomization

One potential problem with small to moderate size clinical research is that simple randomization (with or without taking stratification of prognostic variables into account) may result in imbalance of important covariates among treatment groups. Imbalance of covariates is important because of its potential to influence the interpretation of a research results. Covariate adaptive randomization has been recommended by many researchers as a valid alternative randomization method for clinical research.[ 8 , 13 ] In covariate adaptive randomization, a new participant is sequentially assigned to a particular treatment group by taking into account the specific covariates and previous assignments of participants.[ 7 ] Covariate adaptive randomization uses the method of minimization by assessing the imbalance of sample size among several covariates.

Using the online randomization http://www.graphpad.com/quickcalcs/index.cfm , researcher can generate randomization plan for treatment assignment to patients. This online software is very simple and easy to implement. Up to 10 treatments can be allocated to patients and the replication of treatment can also be performed up to 9 times. The major limitations of this software is that once the randomization plan is generated, same randomization plan cannot be generated as this uses the seed point of local computer clock and is not displayed for further use. Other limitation of this online software Maximum of only 10 treatments can be assigned to patients. Entering the web address http://www.graphpad.com/quickcalcs/index.cfm on address bar of any browser, the page of graphpad appears with number of options. Select the option of “Random Numbers” and then press continue, Random Number Calculator with three options appears. Select the tab “Randomly assign subjects to groups” and press continue. In the next page, enter the number of subjects in each group in the tab “Assign” and select the number of groups from the tab “Subjects to each group” and keep number 1 in repeat tab if there is no replication in the study. For example, the total number of patients in a three group experimental study is 30 and each group will assigned to 10 patients. Type 10 in the “Assign” tab and select 3 in the tab “Subjects to each group” and then press “do it” button. The results is obtained as shown as below (partial output is presented)

Another randomization online software, which can be used to generate randomization plan is http://www.randomization.com . The seed for the random number generator[ 14 , 15 ] (Wichmann and Hill, 1982, as modified by McLeod, 1985) is obtained from the clock of the local computer and is printed at the bottom of the randomization plan. If a seed is included in the request, it overrides the value obtained from the clock and can be used to reproduce or verify a particular plan. Up to 20 treatments can be specified. The randomization plan is not affected by the order in which the treatments are entered or the particular boxes left blank if not all are needed. The program begins by sorting treatment names internally. The sorting is case sensitive, however, so the same capitalization should be used when recreating an earlier plan. Example of 10 patients allocating to two groups (each with 5 patients), first the enter the treatment labels in the boxes, and enter the total number of patients that is 10 in the tab “Number of subjects per block” and enter the 1 in the tab “Number of blocks” for simple randomization or more than one for Block randomization. The output of this online software is presented as follows.

The benefits of randomization are numerous. It ensures against the accidental bias in the experiment and produces comparable groups in all the respect except the intervention each group received. The purpose of this paper is to introduce the randomization, including concept and significance and to review several randomization techniques to guide the researchers and practitioners to better design their randomized clinical trials. Use of online randomization was effectively demonstrated in this article for benefit of researchers. Simple randomization works well for the large clinical trails ( n >100) and for small to moderate clinical trials ( n <100) without covariates, use of block randomization helps to achieve the balance. For small to moderate size clinical trials with several prognostic factors or covariates, the adaptive randomization method could be more useful in providing a means to achieve treatment balance.

Source of Support: Nil

Conflict of Interest: None declared.