what is random assignment of participants

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!

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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.

Table of Contents

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.

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6.2 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 what a control condition is, explain its purpose in research on treatment effectiveness, and describe some alternative types of control conditions.
• 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 college 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 assign 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 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 6.2 “Block Randomization Sequence for Assigning Nine Participants to Three Conditions” 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.

Table 6.2 Block Randomization Sequence for Assigning Nine Participants to Three Conditions

Random assignment 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 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 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.

Treatment and Control Conditions

Between-subjects experiments are often used to determine whether a treatment works. In psychological research, a treatment is any intervention meant to change people’s behavior for the better. This includes psychotherapies and medical treatments for psychological disorders but also interventions designed to improve learning, promote conservation, reduce prejudice, and so on. To determine whether a treatment works, participants are randomly assigned to either a treatment condition , in which they receive the treatment, or a control condition , in which they do not receive the treatment. If participants in the treatment condition end up better off than participants in the control condition—for example, they are less depressed, learn faster, conserve more, express less prejudice—then the researcher can conclude that the treatment works. In research on the effectiveness of psychotherapies and medical treatments, this type of experiment is often called a randomized clinical trial .

There are different types of control conditions. In a no-treatment control condition , participants receive no treatment whatsoever. One problem with this approach, however, is the existence of placebo effects. A placebo is a simulated treatment that lacks any active ingredient or element that should make it effective, and a placebo effect is a positive effect of such a treatment. Many folk remedies that seem to work—such as eating chicken soup for a cold or placing soap under the bedsheets to stop nighttime leg cramps—are probably nothing more than placebos. Although placebo effects are not well understood, they are probably driven primarily by people’s expectations that they will improve. Having the expectation to improve can result in reduced stress, anxiety, and depression, which can alter perceptions and even improve immune system functioning (Price, Finniss, & Benedetti, 2008).

Placebo effects are interesting in their own right (see Note 6.28 “The Powerful Placebo” ), but they also pose a serious problem for researchers who want to determine whether a treatment works. Figure 6.2 “Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions” shows some hypothetical results in which participants in a treatment condition improved more on average than participants in a no-treatment control condition. If these conditions (the two leftmost bars in Figure 6.2 “Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions” ) were the only conditions in this experiment, however, one could not conclude that the treatment worked. It could be instead that participants in the treatment group improved more because they expected to improve, while those in the no-treatment control condition did not.

Figure 6.2 Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions

Fortunately, there are several solutions to this problem. One is to include a placebo control condition , in which participants receive a placebo that looks much like the treatment but lacks the active ingredient or element thought to be responsible for the treatment’s effectiveness. When participants in a treatment condition take a pill, for example, then those in a placebo control condition would take an identical-looking pill that lacks the active ingredient in the treatment (a “sugar pill”). In research on psychotherapy effectiveness, the placebo might involve going to a psychotherapist and talking in an unstructured way about one’s problems. The idea is that if participants in both the treatment and the placebo control groups expect to improve, then any improvement in the treatment group over and above that in the placebo control group must have been caused by the treatment and not by participants’ expectations. This is what is shown by a comparison of the two outer bars in Figure 6.2 “Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions” .

Of course, the principle of informed consent requires that participants be told that they will be assigned to either a treatment or a placebo control condition—even though they cannot be told which until the experiment ends. In many cases the participants who had been in the control condition are then offered an opportunity to have the real treatment. An alternative approach is to use a waitlist control condition , in which participants are told that they will receive the treatment but must wait until the participants in the treatment condition have already received it. This allows researchers to compare participants who have received the treatment with participants who are not currently receiving it but who still expect to improve (eventually). A final solution to the problem of placebo effects is to leave out the control condition completely and compare any new treatment with the best available alternative treatment. For example, a new treatment for simple phobia could be compared with standard exposure therapy. Because participants in both conditions receive a treatment, their expectations about improvement should be similar. This approach also makes sense because once there is an effective treatment, the interesting question about a new treatment is not simply “Does it work?” but “Does it work better than what is already available?”

The Powerful Placebo

Many people are not surprised that placebos can have a positive effect on disorders that seem fundamentally psychological, including depression, anxiety, and insomnia. However, placebos can also have a positive effect on disorders that most people think of as fundamentally physiological. These include asthma, ulcers, and warts (Shapiro & Shapiro, 1999). There is even evidence that placebo surgery—also called “sham surgery”—can be as effective as actual surgery.

Medical researcher J. Bruce Moseley and his colleagues conducted a study on the effectiveness of two arthroscopic surgery procedures for osteoarthritis of the knee (Moseley et al., 2002). The control participants in this study were prepped for surgery, received a tranquilizer, and even received three small incisions in their knees. But they did not receive the actual arthroscopic surgical procedure. The surprising result was that all participants improved in terms of both knee pain and function, and the sham surgery group improved just as much as the treatment groups. According to the researchers, “This study provides strong evidence that arthroscopic lavage with or without débridement [the surgical procedures used] is not better than and appears to be equivalent to a placebo procedure in improving knee pain and self-reported function” (p. 85).

Research has shown that patients with osteoarthritis of the knee who receive a “sham surgery” experience reductions in pain and improvement in knee function similar to those of patients who receive a real surgery.

Army Medicine – Surgery – CC BY 2.0.

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.

Carryover Effects and Counterbalancing

The primary disadvantage of within-subjects designs is that they can result in carryover effects. 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 is called a context 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. This 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 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. For example, some participants would be tested in the attractive defendant condition followed by the unattractive defendant condition, and others 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 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.

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, he asked one group of participants to rate how large the number 9 was on a 1-to-10 rating scale and another group to rate how large the number 221 was on the same 1-to-10 rating scale (Birnbaum, 1999). 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 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. There are many ways to determine the order in which the stimuli are presented, but one common way is to generate a different random order for each participant.

Between-Subjects or Within-Subjects?

Almost every experiment can be conducted using either a between-subjects design or a within-subjects design. This 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 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 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 do exactly this.

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 to orders of conditions in within-subjects experiments is a fundamental element of experimental research. Its purpose is to control extraneous variables so that they do not become confounding variables.
• Experimental research on the effectiveness of a treatment requires both a treatment condition and a control condition, which can be a no-treatment control condition, a placebo control condition, or a waitlist control condition. Experimental treatments can also be compared with the best available alternative.

Discussion: For each of the following topics, list the pros and cons of a between-subjects and within-subjects design and decide which would be better.

• 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 ).
• Discussion: Imagine that an experiment shows that participants who receive psychodynamic therapy for a dog phobia improve more than participants in a no-treatment control group. Explain a fundamental problem with this research design and at least two ways that it might be corrected.

Birnbaum, M. H. (1999). How to show that 9 > 221: Collect judgments in a between-subjects design. Psychological Methods, 4 , 243–249.

Moseley, J. B., O’Malley, K., Petersen, N. J., Menke, T. J., Brody, B. A., Kuykendall, D. H., … Wray, N. P. (2002). A controlled trial of arthroscopic surgery for osteoarthritis of the knee. The New England Journal of Medicine, 347 , 81–88.

Price, D. D., Finniss, D. G., & Benedetti, F. (2008). A comprehensive review of the placebo effect: Recent advances and current thought. Annual Review of Psychology, 59 , 565–590.

Shapiro, A. K., & Shapiro, E. (1999). The powerful placebo: From ancient priest to modern physician . Baltimore, MD: Johns Hopkins University Press.

Research Methods in Psychology Copyright © 2016 by University of Minnesota is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

Random Assignment

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Random assignment defines the assignment of participants of a study to their respective group strictly by chance.

Introduction

Statistical inference is based on the theory of probability, and effects investigated in psychological studies are defined by measures that are treated as random variables. The inference about the probability of a given result with regard to an assumed population and the popular term “significance” are only meaningful and without bias if the measure of interest is really a random variable. To achieve the creation of a random variable in form of a measure derived from a sample of participants, these participants have to be randomly drawn. In an experimental study involving different groups of participants, these participants have to additionally be randomly assigned to one of the groups.

Why Is Random Assignment Crucial for Statistical Inference?

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Gigerenzer, G., Swijtink, Z., Porter, T., Daston, L., Beatty, J., & Kruger, L. (1989). The empire of chance: How probability changed science and everyday-life . Cambridge: New York.

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Random Assignment in Psychology (Intro for Students)

Random assignment is a research procedure used to randomly assign participants to different experimental conditions (or ‘groups’). This introduces the element of chance, ensuring that each participant has an equal likelihood of being placed in any condition group for the study.

It is absolutely essential that the treatment condition and the control condition are the same in all ways except for the variable being manipulated.

Using random assignment to place participants in different conditions helps to achieve this.

It ensures that those conditions are the same in regards to all potential confounding variables and extraneous factors .

Why Researchers Use Random Assignment

Researchers use random assignment to control for confounds in research.

Confounds refer to unwanted and often unaccounted-for variables that might affect the outcome of a study. These confounding variables can skew the results, rendering the experiment unreliable.

For example, below is a study with two groups. Note how there are more ‘red’ individuals in the first group than the second:

There is likely a confounding variable in this experiment explaining why more red people ended up in the treatment condition and less in the control condition. The red people might have self-selected, for example, leading to a skew of them in one group over the other.

Ideally, we’d want a more even distribution, like below:

To achieve better balance in our two conditions, we use randomized sampling.

Fact File: Experiments 101

Random assignment is used in the type of research called the experiment.

An experiment involves manipulating the level of one variable and examining how it affects another variable. These are the independent and dependent variables :

• Independent Variable: The variable manipulated is called the independent variable (IV)
• Dependent Variable: The variable that it is expected to affect is called the dependent variable (DV).

The most basic form of the experiment involves two conditions: the treatment and the control .

• The Treatment Condition: The treatment condition involves the participants being exposed to the IV.
• The Control Condition: The control condition involves the absence of the IV. Therefore, the IV has two levels: zero and some quantity.

Researchers utilize random assignment to determine which participants go into which conditions.

Methods of Random Assignment

There are several procedures that researchers can use to randomly assign participants to different conditions.

1. Random number generator

There are several websites that offer computer-generated random numbers. Simply indicate how many conditions are in the experiment and then click. If there are 4 conditions, the program will randomly generate a number between 1 and 4 each time it is clicked.

2. Flipping a coin

If there are two conditions in an experiment, then the simplest way to implement random assignment is to flip a coin for each participant. Heads means being assigned to the treatment and tails means being assigned to the control (or vice versa).

3. Rolling a die

Rolling a single die is another way to randomly assign participants. If the experiment has three conditions, then numbers 1 and 2 mean being assigned to the control; numbers 3 and 4 mean treatment condition one; and numbers 5 and 6 mean treatment condition two.

4. Condition names in a hat

In some studies, the researcher will write the name of the treatment condition(s) or control on slips of paper and place them in a hat. If there are 4 conditions and 1 control, then there are 5 slips of paper.

The researcher closes their eyes and selects one slip for each participant. That person is then assigned to one of the conditions in the study and that slip of paper is placed back in the hat. Repeat as necessary.

There are other ways of trying to ensure that the groups of participants are equal in all ways with the exception of the IV. However, random assignment is the most often used because it is so effective at reducing confounds.

Read About More Methods and Examples of Random Assignment Here

Potential Confounding Effects

Random assignment is all about minimizing confounding effects.

Here are six types of confounds that can be controlled for using random assignment:

• Individual Differences: Participants in a study will naturally vary in terms of personality, intelligence, mood, prior knowledge, and many other characteristics. If one group happens to have more people with a particular characteristic, this could affect the results. Random assignment ensures that these individual differences are spread out equally among the experimental groups, making it less likely that they will unduly influence the outcome.
• Temporal or Time-Related Confounds: Events or situations that occur at a particular time can influence the outcome of an experiment. For example, a participant might be tested after a stressful event, while another might be tested after a relaxing weekend. Random assignment ensures that such effects are equally distributed among groups, thus controlling for their potential influence.
• Order Effects: If participants are exposed to multiple treatments or tests, the order in which they experience them can influence their responses. Randomly assigning the order of treatments for different participants helps control for this.
• Location or Environmental Confounds: The environment in which the study is conducted can influence the results. One group might be tested in a noisy room, while another might be in a quiet room. Randomly assigning participants to different locations can control for these effects.
• Instrumentation Confounds: These occur when there are variations in the calibration or functioning of measurement instruments across conditions. If one group’s responses are being measured using a slightly different tool or scale, it can introduce a confound. Random assignment can ensure that any such potential inconsistencies in instrumentation are equally distributed among groups.
• Experimenter Effects: Sometimes, the behavior or expectations of the person administering the experiment can unintentionally influence the participants’ behavior or responses. For instance, if an experimenter believes one treatment is superior, they might unconsciously communicate this belief to participants. Randomly assigning experimenters or using a double-blind procedure (where neither the participant nor the experimenter knows the treatment being given) can help control for this.

Random assignment helps balance out these and other potential confounds across groups, ensuring that any observed differences are more likely due to the manipulated independent variable rather than some extraneous factor.

Limitations of the Random Assignment Procedure

Although random assignment is extremely effective at eliminating the presence of participant-related confounds, there are several scenarios in which it cannot be used.

• Ethics: The most obvious scenario is when it would be unethical. For example, if wanting to investigate the effects of emotional abuse on children, it would be unethical to randomly assign children to either received abuse or not.  Even if a researcher were to propose such a study, it would not receive approval from the Institutional Review Board (IRB) which oversees research by university faculty.
• Practicality: Other scenarios involve matters of practicality. For example, randomly assigning people to specific types of diet over a 10-year period would be interesting, but it would be highly unlikely that participants would be diligent enough to make the study valid. This is why examining these types of subjects has to be carried out through observational studies . The data is correlational, which is informative, but falls short of the scientist’s ultimate goal of identifying causality.
• Small Sample Size: The smaller the sample size being assigned to conditions, the more likely it is that the two groups will be unequal. For example, if you flip a coin many times in a row then you will notice that sometimes there will be a string of heads or tails that come up consecutively. This means that one condition may have a build-up of participants that share the same characteristics. However, if you continue flipping the coin, over the long-term, there will be a balance of heads and tails. Unfortunately, how large a sample size is necessary has been the subject of considerable debate (Bloom, 2006; Shadish et al., 2002).

“It is well known that larger sample sizes reduce the probability that random assignment will result in conditions that are unequal” (Goldberg, 2019, p. 2).

Applications of Random Assignment

The importance of random assignment has been recognized in a wide range of scientific and applied disciplines (Bloom, 2006).

Random assignment began as a tool in agricultural research by Fisher (1925, 1935). After WWII, it became extensively used in medical research to test the effectiveness of new treatments and pharmaceuticals (Marks, 1997).

Today it is widely used in industrial engineering (Box, Hunter, and Hunter, 2005), educational research (Lindquist, 1953; Ong-Dean et al., 2011)), psychology (Myers, 1972), and social policy studies (Boruch, 1998; Orr, 1999).

One of the biggest obstacles to the validity of an experiment is the confound. If the group of participants in the treatment condition are substantially different from the group in the control condition, then it is impossible to determine if the IV has an affect or if the confound has an effect.

Thankfully, random assignment is highly effective at eliminating confounds that are known and unknown. Because each participant has an equal chance of being placed in each condition, they are equally distributed.

There are several ways of implementing random assignment, including flipping a coin or using a random number generator.

Random assignment has become an essential procedure in research in a wide range of subjects such as psychology, education, and social policy.

Alferes, V. R. (2012). Methods of randomization in experimental design . Sage Publications.

Bloom, H. S. (2008). The core analytics of randomized experiments for social research. The SAGE Handbook of Social Research Methods , 115-133.

Boruch, R. F. (1998). Randomized controlled experiments for evaluation and planning. Handbook of applied social research methods , 161-191.

Box, G. E., Hunter, W. G., & Hunter, J. S. (2005). Design of experiments: Statistics for Experimenters: Design, Innovation and Discovery.

Dehue, T. (1997). Deception, efficiency, and random groups: Psychology and the gradual origination of the random group design. Isis , 88 (4), 653-673.

Fisher, R.A. (1925). Statistical methods for research workers (11th ed. rev.). Oliver and Boyd: Edinburgh.

Fisher, R. A. (1935). The Design of Experiments. Edinburgh: Oliver and Boyd.

Goldberg, M. H. (2019). How often does random assignment fail? Estimates and recommendations. Journal of Environmental Psychology , 66 , 101351.

Jamison, J. C. (2019). The entry of randomized assignment into the social sciences. Journal of Causal Inference , 7 (1), 20170025.

Lindquist, E. F. (1953). Design and analysis of experiments in psychology and education . Boston: Houghton Mifflin Company.

Marks, H. M. (1997). The progress of experiment: Science and therapeutic reform in the United States, 1900-1990 . Cambridge University Press.

Myers, J. L. (1972). Fundamentals of experimental design (2nd ed.). Allyn & Bacon.

Ong-Dean, C., Huie Hofstetter, C., & Strick, B. R. (2011). Challenges and dilemmas in implementing random assignment in educational research. American Journal of Evaluation , 32 (1), 29-49.

Orr, L. L. (1999). Social experiments: Evaluating public programs with experimental methods . Sage.

Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002). Quasi-experiments: interrupted time-series designs. Experimental and quasi-experimental designs for generalized causal inference , 171-205.

Stigler, S. M. (1992). A historical view of statistical concepts in psychology and educational research. American Journal of Education , 101 (1), 60-70.

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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

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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.

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What is a Randomized Control Trial (RCT)?

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.

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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

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A randomized control trial (RCT) is a type of study design that involves randomly assigning participants to either an experimental group or a control group to measure the effectiveness of an intervention or treatment.

Randomized Controlled Trials (RCTs) are considered the “gold standard” in medical and health research due to their rigorous design.

Control Group

A control group consists of participants who do not receive any treatment or intervention but a placebo or reference treatment. The control participants serve as a comparison group.

The control group is matched as closely as possible to the experimental group, including age, gender, social class, ethnicity, etc.

Because the participants are randomly assigned, the characteristics between the two groups should be balanced, enabling researchers to attribute any differences in outcome to the study intervention.

Since researchers can be confident that any differences between the control and treatment groups are due solely to the effects of the treatments, scientists view RCTs as the gold standard for clinical trials.

Random Allocation

Random allocation and random assignment are terms used interchangeably in the context of a randomized controlled trial (RCT).

Both refer to assigning participants to different groups in a study (such as a treatment group or a control group) in a way that is completely determined by chance.

The process of random assignment controls for confounding variables , ensuring differences between groups are due to chance alone.

Without randomization, researchers might consciously or subconsciously assign patients to a particular group for various reasons.

Several methods can be used for randomization in a Randomized Control Trial (RCT). Here are a few examples:

• Simple Randomization: This is the simplest method, like flipping a coin. Each participant has an equal chance of being assigned to any group. This can be achieved using random number tables, computerized random number generators, or drawing lots or envelopes.
• Block Randomization: In this method, participants are randomized within blocks, ensuring that each block has an equal number of participants in each group. This helps to balance the number of participants in each group at any given time during the study.
• Stratified Randomization: This method is used when researchers want to ensure that certain subgroups of participants are equally represented in each group. Participants are divided into strata, or subgroups, based on characteristics like age or disease severity, and then randomized within these strata.
• Cluster Randomization: In this method, groups of participants (like families or entire communities), rather than individuals, are randomized.
• Adaptive Randomization: In this method, the probability of being assigned to each group changes based on the participants already assigned to each group. For example, if more participants have been assigned to the control group, new participants will have a higher probability of being assigned to the experimental group.

Computer software can generate random numbers or sequences that can be used to assign participants to groups in a simple randomization process.

For more complex methods like block, stratified, or adaptive randomization, computer algorithms can be used to consider the additional parameters and ensure that participants are assigned to groups appropriately.

Using a computerized system can also help to maintain the integrity of the randomization process by preventing researchers from knowing in advance which group a participant will be assigned to (a principle known as allocation concealment). This can help to prevent selection bias and ensure the validity of the study results .

Allocation Concealment

Allocation concealment is a technique to ensure the random allocation process is truly random and unbiased.

RCTs use allocation concealment to decide which patients get the real medicine and which get a placebo (a fake medicine)

It involves keeping the sequence of group assignments (i.e., who gets assigned to the treatment group and who gets assigned to the control group next) hidden from the researchers before a participant has enrolled in the study.

This helps to prevent the researchers from consciously or unconsciously selecting certain participants for one group or the other based on their knowledge of which group is next in the sequence.

Allocation concealment ensures that the investigator does not know in advance which treatment the next person will get, thus maintaining the integrity of the randomization process.

Blinding (Masking)

Binding, or masking, refers to withholding information regarding the group assignments (who is in the treatment group and who is in the control group) from the participants, the researchers, or both during the study .

A blinded study prevents the participants from knowing about their treatment to avoid bias in the research. Any information that can influence the subjects is withheld until the completion of the research.

Blinding can be imposed on any participant in an experiment, including researchers, data collectors, evaluators, technicians, and data analysts.

Good blinding can eliminate experimental biases arising from the subjects’ expectations, observer bias, confirmation bias, researcher bias, observer’s effect on the participants, and other biases that may occur in a research test.

In a double-blind study , neither the participants nor the researchers know who is receiving the drug or the placebo. When a participant is enrolled, they are randomly assigned to one of the two groups. The medication they receive looks identical whether it’s the drug or the placebo.

Figure 1 . Evidence-based medicine pyramid. The levels of evidence are appropriately represented by a pyramid as each level, from bottom to top, reflects the quality of research designs (increasing) and quantity (decreasing) of each study design in the body of published literature. For example, randomized control trials are higher quality and more labor intensive to conduct, so there is a lower quantity published.

Prevents bias

In randomized control trials, participants must be randomly assigned to either the intervention group or the control group, such that each individual has an equal chance of being placed in either group.

This is meant to prevent selection bias and allocation bias and achieve control over any confounding variables to provide an accurate comparison of the treatment being studied.

Because the distribution of characteristics of patients that could influence the outcome is randomly assigned between groups, any differences in outcome can be explained only by the treatment.

High statistical power

Because the participants are randomized and the characteristics between the two groups are balanced, researchers can assume that if there are significant differences in the primary outcome between the two groups, the differences are likely to be due to the intervention.

This warrants researchers to be confident that randomized control trials will have high statistical power compared to other types of study designs.

Since the focus of conducting a randomized control trial is eliminating bias, blinded RCTs can help minimize any unconscious information bias.

In a blinded RCT, the participants do not know which group they are assigned to or which intervention is received. This blinding procedure should also apply to researchers, health care professionals, assessors, and investigators when possible.

“Single-blind” refers to an RCT where participants do not know the details of the treatment, but the researchers do.

“ Double-blind ” refers to an RCT where both participants and data collectors are masked of the assigned treatment.

Limitations

Costly and timely.

Some interventions require years or even decades to evaluate, rendering them expensive and time-consuming.

It might take an extended period of time before researchers can identify a drug’s effects or discover significant results.

Requires large sample size

There must be enough participants in each group of a randomized control trial so researchers can detect any true differences or effects in outcomes between the groups.

Researchers cannot detect clinically important results if the sample size is too small.

Change in population over time

Because randomized control trials are longitudinal in nature, it is almost inevitable that some participants will not complete the study, whether due to death, migration, non-compliance, or loss of interest in the study.

This tendency is known as selective attrition and can threaten the statistical power of an experiment.

Randomized control trials are not always practical or ethical, and such limitations can prevent researchers from conducting their studies.

For example, a treatment could be too invasive, or administering a placebo instead of an actual drug during a trial for treating a serious illness could deny a participant’s normal course of treatment. Without ethical approval, a randomized control trial cannot proceed.

Fictitious Example

An example of an RCT would be a clinical trial comparing a drug’s effect or a new treatment on a select population.

The researchers would randomly assign participants to either the experimental group or the control group and compare the differences in outcomes between those who receive the drug or treatment and those who do not.

Real-life Examples

• Preventing illicit drug use in adolescents: Long-term follow-up data from a randomized control trial of a school population (Botvin et al., 2000).
• A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure (Demetroulis et al., 2001).
• A randomized control trial to evaluate a paging system for people with traumatic brain injury (Wilson et al., 2009).
• Prehabilitation versus Rehabilitation: A Randomized Control Trial in Patients Undergoing Colorectal Resection for Cancer (Gillis et al., 2014).
• A Randomized Control Trial of Right-Heart Catheterization in Critically Ill Patients (Guyatt, 1991).
• Berry, R. B., Kryger, M. H., & Massie, C. A. (2011). A novel nasal excitatory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: A randomized controlled trial. Sleep , 34, 479–485.
• Gloy, V. L., Briel, M., Bhatt, D. L., Kashyap, S. R., Schauer, P. R., Mingrone, G., . . . Nordmann, A. J. (2013, October 22). Bariatric surgery versus non-surgical treatment for obesity: A systematic review and meta-analysis of randomized controlled trials. BMJ , 347.
• Streeton, C., & Whelan, G. (2001). Naltrexone, a relapse prevention maintenance treatment of alcohol dependence: A meta-analysis of randomized controlled trials. Alcohol and Alcoholism, 36 (6), 544–552.

How Should an RCT be Reported?

Reporting of a Randomized Controlled Trial (RCT) should be done in a clear, transparent, and comprehensive manner to allow readers to understand the design, conduct, analysis, and interpretation of the trial.

The Consolidated Standards of Reporting Trials ( CONSORT ) statement is a widely accepted guideline for reporting RCTs.

Further Information

• Cocks, K., & Torgerson, D. J. (2013). Sample size calculations for pilot randomized trials: a confidence interval approach. Journal of clinical epidemiology, 66(2), 197-201.
• Kendall, J. (2003). Designing a research project: randomised controlled trials and their principles. Emergency medicine journal: EMJ, 20(2), 164.

Akobeng, A.K., Understanding randomized controlled trials. Archives of Disease in Childhood , 2005; 90: 840-844.

Bell, C. C., Gibbons, R., & McKay, M. M. (2008). Building protective factors to offset sexually risky behaviors among black youths: a randomized control trial. Journal of the National Medical Association, 100 (8), 936-944.

Bhide, A., Shah, P. S., & Acharya, G. (2018). A simplified guide to randomized controlled trials. Acta obstetricia et gynecologica Scandinavica, 97 (4), 380-387.

Botvin, G. J., Griffin, K. W., Diaz, T., Scheier, L. M., Williams, C., & Epstein, J. A. (2000). Preventing illicit drug use in adolescents: Long-term follow-up data from a randomized control trial of a school population. Addictive Behaviors, 25 (5), 769-774.

Demetroulis, C., Saridogan, E., Kunde, D., & Naftalin, A. A. (2001). A prospective randomized control trial comparing medical and surgical treatment for early pregnancy failure. Human Reproduction, 16 (2), 365-369.

Gillis, C., Li, C., Lee, L., Awasthi, R., Augustin, B., Gamsa, A., … & Carli, F. (2014). Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology, 121 (5), 937-947.

Globas, C., Becker, C., Cerny, J., Lam, J. M., Lindemann, U., Forrester, L. W., … & Luft, A. R. (2012). Chronic stroke survivors benefit from high-intensity aerobic treadmill exercise: a randomized control trial. Neurorehabilitation and Neural Repair, 26 (1), 85-95.

Guyatt, G. (1991). A randomized control trial of right-heart catheterization in critically ill patients. Journal of Intensive Care Medicine, 6 (2), 91-95.

MediLexicon International. (n.d.). Randomized controlled trials: Overview, benefits, and limitations. Medical News Today. Retrieved from https://www.medicalnewstoday.com/articles/280574#what-is-a-randomized-controlled-trial

Wilson, B. A., Emslie, H., Quirk, K., Evans, J., & Watson, P. (2005). A randomized control trial to evaluate a paging system for people with traumatic brain injury. Brain Injury, 19 (11), 891-894.

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The Random Selection Experiment Method

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.

When researchers need to select a representative sample from a larger population, they often utilize a method known as random selection. In this selection process, each member of a group stands an equal chance of being chosen as a participant in the study.

Random Selection vs. Random Assignment

How does random selection differ from  random assignment ? Random selection refers to how the sample is drawn from the population as a whole, whereas random assignment refers to how the participants are then assigned to either the experimental or control groups.

It is possible to have both random selection and random assignment in an experiment.

Imagine that you use random selection to draw 500 people from a population to participate in your study. You then use random assignment to assign 250 of your participants to a control group (the group that does not receive the treatment or independent variable) and you assign 250 of the participants to the experimental group (the group that receives the treatment or independent variable).

Why do researchers utilize random selection? The purpose is to increase the generalizability of the results.

By drawing a random sample from a larger population, the goal is that the sample will be representative of the larger group and less likely to be subject to bias.

Factors Involved

Imagine a researcher is selecting people to participate in a study. To pick participants, they may choose people using a technique that is the statistical equivalent of a coin toss.

They may begin by using random selection to pick geographic regions from which to draw participants. They may then use the same selection process to pick cities, neighborhoods, households, age ranges, and individual participants.

Another important thing to remember is that larger sample sizes tend to be more representative. Even random selection can lead to a biased or limited sample if the sample size is small.

When the sample size is small, an unusual participant can have an undue influence over the sample as a whole. Using a larger sample size tends to dilute the effects of unusual participants and prevent them from skewing the results.

Lin L.  Bias caused by sampling error in meta-analysis with small sample sizes .  PLoS ONE . 2018;13(9):e0204056. doi:10.1371/journal.pone.0204056

Elmes DG, Kantowitz BH, Roediger HL.  Research Methods in Psychology. Belmont, CA: Wadsworth; 2012.

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

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How to Do Random Allocation (Randomization)

Jeehyoung kim.

Department of Orthopedic Surgery, Seoul Sacred Heart General Hospital, Seoul, Korea.

Wonshik Shin

To explain the concept and procedure of random allocation as used in a randomized controlled study.

We explain the general concept of random allocation and demonstrate how to perform the procedure easily and how to report it in a paper.

Randomized controlled trials (RCT) are known as the best method to prove causality in spite of various limitations. Random allocation is a technique that chooses individuals for treatment groups and control groups entirely by chance with no regard to the will of researchers or patients' condition and preference. This allows researchers to control all known and unknown factors that may affect results in treatment groups and control groups.

Allocation concealment is a technique used to prevent selection bias by concealing the allocation sequence from those assigning participants to intervention groups, until the moment of assignment. Allocation concealment prevents researchers from influencing which participants are assigned to a given intervention group. This process must be included in the experiment for the success of any RCT.

Blinding refers to keeping trial participants, health care providers, assessors or data collectors unaware of the assigned intervention, so that they will not be influenced by that knowledge. This process is conducted to minimize possible bias in implementation, dropouts, measurements, etc. Blinding is not always feasible for RCT but should be implemented if possible.

Randomization, allocation concealment and blinding should be well implemented and should be described in the paper.

On the other hand, many researchers are still unfamiliar with how to do randomization, and it has been shown that there are problems in many studies with the accurate performance of the randomization and that some studies are reporting incorrect results. So, we will introduce the recommended way of using statistical methods for a randomized controlled study and show how to report the results properly.

CATEGORIES OF RANDOMIZATION

Simple randomization.

The easiest method is simple randomization. If you assign subjects into two groups A and B, you assign subjects to each group purely randomly for every assignment. Even though this is the most basic way, if the total number of samples is small, sample numbers are likely to be assigned unequally. For this reason, we recommend you to use this method when the total number of samples is more than 100.

Block Randomization

We can create a block to assign sample numbers equally to each group and assign the block.

If we specify two in one block (the so-called block size is two), we can make two possible sequences of AB and BA. When we randomize them, the same sample numbers can be assigned to each group. If the block size is four, we can make six possible sequences; these are AABB, ABAB, ABBA, BAAB, BABA, BBAA, and we randomize them.

However, there is a disadvantage in that the executer can predict the next assignment. We can easily know the fact that B comes after A if the block size is two and if the block size is four; we can predict what every 4th sample is. This is discordant with the principle of randomization. To solve this problem, the allocator must hide the block size from the executer and use randomly mixed block sizes. For example, the block size can be two, four, and six.

Stratified Randomization

Randomization is important because it is almost the only way to assign all the other variables equally except for the factor (A and B) in which we are interested. However, some very important confounding variables can often be assigned unequally to the two groups. This possibility increases when the number of samples is smaller, and we can stratify the variables and assign the two groups equally in this case.

For example, if the smoking status is very important, what will you do? First, we have two methods of randomization that we learned previously. There are two randomly assigned separate sequences for smokers and non-smokers. Smokers are assigned to the smoker's sequences, and non-smokers are assigned to the non-smoker's sequences. Therefore, both smokers and non-smokers groups will be placed equally with the same numbers.

So we can use 'simple randomization with/without stratification' or 'block randomization with/without stratification.' However, if there are multiple stratified variables, it is difficult to place samples in both groups equally with the same numbers. Usually two or fewer stratified variables are recommended.

EXAMPLES OF RANDOMIZATION

Although there are websites or common programs for randomization, let us use an Excel file. Download the attached file in http://cafe.naver.com/easy2know/6427 . It is in a 'Read-only' state, but there is no limit in function; it is in the 'Read-only' state only to prevent accidental modification.

Due to the nature of Excel, if there is a change, it creates a new random number accordingly. If we input any number instead of '2' in the orange-colored cell and click the 'enter key,' it creates new random sequences ( Fig. 1 ). The sequences are the result of simple randomization. The numbers in the right column show the numbers of the total sample. Basically the numbers are up to 1,000, but if you need to, you can extend the numbers with the AutoFill function in Excel.

Simple randomization sheet.

Fig. 2 shows an example of randomization when the block size is four. Also, there are numbers of the total samples in the right column.

An example of randomization when the block size is four.

Fig. 3 shows an example of block randomization when the block size is two and four. Total eight kinds of blocks inside of the red-dotted line are assigned at random. The left column is for allocation and the right column is for the total sample size.

Block randomization when the block size is two and four. Total eight blocks in the red-dotted line are assigned at random. The left column is for allocation and the right column is for the total sample size.

By the way, www.randomization.com can do block randomization for up to four kinds of block sizes and it is very easy to perform as well. Fig. 4 shows the general features and an example.

www.randomization.com can do block randomization more easily. In this figure, the block size is 2, 4, and 6 when the total samples are 88.

THE REALITY OF THE RANDOMIZATION PROCEDURE

How to implement these techniques can vary by each trial. The following is only one of the examples of how these can be implemented in real trial. You may change the details of the example for your experiment. Figures of randomization and allocation concealment can also be adjusted to your needs ( Fig. 5 ).

The reality of the randomization procedure.

Random Allocation

An independent researcher makes random allocation cards using computer-generated random numbers. He keeps the original random allocation sequences in an inaccessible third place and works with a copy. Since the executers can get confused with the original coding of A and B later, the allocator should record exactly what these codes mean to avoid further confusion.

When the purpose of the study is a surgical procedure, instead of using A and B, different names that distinguish exactly between the surgical procedures should be used (for example, 'the anterior approach' and 'the posterior approach'). It is convenient to reproduce the contents of the Excel file to a Word file, and enlarge the text font after replacing A with 'the anterior approach' (page break) and B with 'the posterior approach' (page break). Next, you print it out and put each of the sheets one by one into each envelope ( Fig. 6 ).

MS word can replace A and B with a specific treatment name easily.

Here in Fig. 6 , '^m' is a special character for manual page break. After setting it as shown, you click 'all change' and print it out. Then we can get it printed per sheet. The inside of the envelope should not be visible from the outside, and it has to be printed out for each one and put in an envelope after being folded several times. In some papers, even aluminum foil was used to hide the print to prevent it from being read with a flash of light.

There are serial numbers on the outside of the envelopes. Input date, time, patient ID, results after the procedure, etc. usually will be recorded on the envelope or another sheet inside of the envelope, also.

Drug Preparation

An independent nurse (researcher) prepares syringes with "drug A" and "drug B" and puts them into envelopes according to the allocation orders. These syringes cannot be distinguished because they contain the same colored liquid with the same volume. Or pills or tablets with the same color and shape (placebo) will be put into the envelopes according to the allocation orders.

In the case of surgical treatment, an independent researcher prepares the envelopes, including writing the treatment name on a sheet of paper inside it. In the operation room, another independent nurse (researcher) opens the envelope and informs the doctor to do the treatment that is written on the paper in the envelope.

Another independent nurse injects the drug or the doctor performs the operation according to the order. The patient's ID, date, time and other information are recorded on each envelope. The nurse and the patient would not know what drugs are injected (double blinded). The doctor knows the treatment and the patient does not know it (one blinded). The preparer retrieves the envelopes and checks to see if the operation (and injection) was done as planned.

In the case of broken or lost syringes, the preparer figures out what the number of the envelope it is and replaces the envelope with the same drug according to the allocation.

The envelopes should be opened just before the injection or operation. For example, when a patient comes, an envelope is opened; however, if this does not meet the criteria for the performance of the study, this can be cancelled. Also, if the operator finds out before an operation the tool that is to be inserted, it is impossible to get the operation as planned. For example, even though plate A was assigned to be used, if the patient was indicated to have some other surgery because of infection or severe osteoporosis, you will waste an envelope and it will cause confusion as well as violate the randomization. All these cases should be mentioned as inclusion criteria and exclusion criteria in advance. To avoid this, the envelopes should be opened just before the operation or injection if possible.

However, in cases where the operation tool is so big that two tools cannot be prepared at the same time, or the preparation takes a lot of money (robotic surgery, etc.) or time (liver transplantation, etc.), the envelopes can be opened in advance.

Also, although you open an envelope and choose the procedure that you see, other conditions that affect the outcome can occur. For example, the patient could be admitted to the intensive care unit for medical problems after treatment, or may not get enough rehabilitation treatment for some other reasons.

In this case, it is an important issue whether to consider this as a follow-up loss or exclude this case from the study. We can deal with this issue by focusing on intention-to-treat analysis and per-protocol analysis. We will study this later when we get a chance.

Survey Results

After a period of time, another independent researcher measures the patient's outcome. He does not know the allocation. That is another blinding, so triple blinding is recommended if possible.

Another independent researcher who was not involved in any stage of these procedures will do the statistical analysis (sometimes a statistician). He even does not know the treatment name because the treatment name is hidden, as in A and B.

REPORTING OF RANDOMIZATION METHODS

From 1988 to 2000, 72 of 2,468 papers (2.9%) in the Journal of Born and Joint Surgery were RCTs. 1) It has been suggested that in some of the papers, randomization was not completely done or the result was not properly reported. According to the analysis of RCTs using painkillers from the January issue in 1966 to the June issue in 2006, 23.9% of the papers were inadequate in terms of the randomization. 2) It would be helpful to see a CONSORT checklist and examples. The following were used in the actual papers and extracted from examples in the CONSORT ( http://www.consort-statement.org ).

Sequence Generation

"Independent pharmacists dispensed either active or placebo inhalers according to a computer generated randomization list."

"For allocation of the participants, a computer-generated list of random numbers was used."

Type of Randomization

"Randomization sequence was created using Stata 9.0 (StataCorp, College Station, TX, USA) statistical software and was stratified by center with a 1:1 allocation using random block sizes of 2, 4, and 6."

"Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups."

We can apply the above examples to our case as follows: Randomization sequence was created using Excel 2007 (Microsoft, Redmond, WA, USA) with a 1:1 allocation using random block sizes of 2 and 4 by an independent doctor. In this way, sequence generation and type of randomization can be expressed at the same time.

Allocation Concealment Mechanism

"The doxycycline and placebo were in capsule form and identical in appearance. They were pre-packed in bottles and consecutively numbered for each woman according to the randomization schedule. Each woman was assigned an order number and received the capsules in the corresponding pre-packed bottle."

"The allocation sequence was concealed from the researcher (JR) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Aluminum foil inside the envelope was used to render the envelope impermeable to intense light. To prevent subversion of the allocation sequence, the name and date of birth of the participant was written on the envelope and a video tape made of the sealed envelope with participant details visible. Carbon paper inside the envelope transferred the information onto the allocation card inside the envelope and a second researcher (CC) later viewed video tapes to ensure envelopes were still sealed when participants' names were written on them. Corresponding envelopes were opened only after the enrolled participants completed all baseline assessments and it was time to allocate the intervention."

The second example was described in great detail, and we can guess how important the randomization and concealment were.

Who Generated the Allocation Sequence, Who Enrolled Participants, and Who Assigned Participants to Interventions?

"Determination of whether a patient would be treated by streptomycin and bed-rest (S case) or by bed-rest alone (C case) was made by reference to a statistical series based on random sampling numbers drawn up for each sex at each center by Professor Bradford Hill (this means that the stratification was done by sex and center); the details of the series were unknown to any of the investigators or to the coordinator. After acceptance of a patient by the panel, and before admission to the streptomycin center, the appropriate numbered envelope was opened at the central office; the card inside told, if the patient was to be an S or a C case, and this information was then given to the medical officer of the center."

"Details of the allocated group were given on colored cards contained in sequentially numbered, opaque, sealed envelopes. These were prepared at the NPEU and kept in an agreed location on each ward. Randomization took place at the end of the 2nd stage of labor when the midwife considered a vaginal birth was imminent. To enter a woman into the study, the midwife opened the next consecutively numbered envelope."

"Block randomization was by a computer generated random number list prepared by an investigator with no clinical involvement in the trial. We stratified by admission for an oncology related procedure. After the research nurse had obtained the patient's consent, she telephoned a contact who was independent of the recruitment process for allocation consignment."

If Done, Who Was Blinded after Assignment to Interventions and How

"Whereas patients and physicians allocated to the intervention group were aware of the allocated arm, outcome assessors and data analysts were kept blinded to the allocation."

"Blinding and equipoise were strictly maintained by emphasizing to intervention staff and participants that each diet adheres to healthy principles, and each of them is advocated by certain experts to be superior for long-term weight-loss. Except for the interventionists (dieticians and behavioral psychologists), investigators and staff were kept blind to diet assignment of the participants. The trial adhered to established procedures to maintain separation between staff that take outcome measurements and staff that deliver the intervention. Staffs who obtained outcome measurements were not informed of the diet group assignment. Intervention staffs, dieticians and behavioral psychologists who delivered the intervention did not take outcome measurements. All investigators, staffs, and participants were kept masked to outcome measurements and trial results."

In short, in a paper, we have to report who was kept blinded. In the case of physical therapy or surgery, keeping the surgeon blinded would be difficult or even impossible; however, blinding is possible for the person who measures the outcome. Anyhow, all individuals who were kept blinded must be described in the report.

WEBSITES AND SYSTEMS HELPING THESE PROCEDURES

To help with all the procedures of a fully qualified RCT, the following systems including electronic case report forms (eCRFs) are available for researchers.

iCReaT (clinical research and trial management system) in Korea Centers for Disease Control & Prevention (KCDC; http://icreat.nih.go.kr ): free for pre-educated and qualified researchers; there are regular education programs once a month, and some hospitals (for example, Severance Hospital) have their own educational programs. An English version will be available soon for non-Korean researchers.

MRCC ( https://mrcc.snuh.org ): for Seoul National University Hospital only. It is relatively inexpensive and includes statistical counseling.

Velos ( http://eresearch.ncc.re.kr ): a world-famous system and very expensive; it is available at National Cancer Center in Korea ( http://ncc.re.kr/crcc/ ).

eCRFs are very convenient as well as helpful to improve the quality of research and their advantages are summarized in the table ( Table 1 ).

Comparisons between Paper CRFs and e-CRFs of Web-based Clinical Research Management System

CRF: case report form.

In RCT, random assignment is important and performing it is easy if you know how to do it. Besides the practice of randomization, correct reporting of the randomization process is also important and it should be done very accurately.

No potential conflict of interest relevant to this article was reported.