Risks and Benefits
Understanding the risks to research participants and how they are balanced (or not) by the potential benefits of the research, is the heart of the IRB process. Every part of the IRB process is designed to assess some element of this issue.
What is Risk?
Risk is the potential for harm. There are various types of potential harms that can be done by research.
Not all projects will involve all of these risks, and some may involve no significant risks beyond those experienced in everyday life. It is your job as the researcher to evaluate the risks of your project and to take measures to minimize them. It is the job of the IRB to evaluate whether risks have been appropriately recognized and minimized.
How does the IRB evaluate Risk?
The federal regulations use the threshold of minimal risk to determine what type of review is needed. Minimal risk exists when “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
This definition is flexible. For instance, whose "daily life" is being considered? When you fill out your application you will be ask to specify if certain risk sensitive populations are included (such as children, or prisoners). There are special regulatory protections for these populations.
How to Minimize Risk
Minimizing risk can be done in different ways, and will depend on the types of risk presented by the research design.
For some studies, providing resources to participants can be useful. For instance, when a project involves upsetting topics, the IRB may require a list of mental health resources to be offered to participants. For studies where there is deception, a debrief explaining the deception and the true purpose of the research is required. See our templates page for guidance.
For situations where the collection of sensitive information presents a risk, thinking carefully about your data privacy plans will be the first step of risk mitigation. See the privacy section for more information.
If the information has the potential to be legally damaging, then even more care must be taken. See the section above on legal harm for more information.
Benefits
It is important to understand the benefits of research as well as the harms. The IRB understands that some research projects will necessarily involve risk, but the risks must be outweighed or balanced by the benefits.
When you are discussing the benefits of your project, it is important not to overstate the benefits. For most non-medical research, direct benefits (as defined by the federal regulations), such as receiving proven diagnostic tests and therapy, are rare. Instead, you should discuss the potential or broader benefits of the research - such as contributions to scientific knowledge and technological advances.
Compensation is not considered a benefit in IRB terms (rather it is an incentive) and should never be discussed as a benefit in either the application or consent materials.
Understanding the risks to research participants and how they are balanced (or not) by the potential benefits of the research, is the heart of the IRB process. Every part of the IRB process is designed to assess some element of this issue.
What is Risk?
Risk is the potential for harm. There are various types of potential harms that can be done by research.
Not all projects will involve all of these risks, and some may involve no significant risks beyond those experienced in everyday life. It is your job as the researcher to evaluate the risks of your project and to take measures to minimize them. It is the job of the IRB to evaluate whether risks have been appropriately recognized and minimized.
How does the IRB evaluate Risk?
The federal regulations use the threshold of minimal risk to determine what type of review is needed. Minimal risk exists when “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
This definition is flexible. For instance, whose "daily life" is being considered? When you fill out your application you will be ask to specify if certain risk sensitive populations are included (such as children, or prisoners). There are special regulatory protections for these populations.
How to Minimize Risk
Minimizing risk can be done in different ways, and will depend on the types of risk presented by the research design.
For some studies, providing resources to participants can be useful. For instance, when a project involves upsetting topics, the IRB may require a list of mental health resources to be offered to participants. For studies where there is deception, a debrief explaining the deception and the true purpose of the research is required. See our templates page for guidance.
For situations where the collection of sensitive information presents a risk, thinking carefully about your data privacy plans will be the first step of risk mitigation. See the privacy section for more information.
If the information has the potential to be legally damaging, then even more care must be taken. See the section above on legal harm for more information.
Benefits
It is important to understand the benefits of research as well as the harms. The IRB understands that some research projects will necessarily involve risk, but the risks must be outweighed or balanced by the benefits.
When you are discussing the benefits of your project, it is important not to overstate the benefits. For most non-medical research, direct benefits (as defined by the federal regulations), such as receiving proven diagnostic tests and therapy, are rare. Instead, you should discuss the potential or broader benefits of the research - such as contributions to scientific knowledge and technological advances.
Compensation is not considered a benefit in IRB terms (rather it is an incentive) and should never be discussed as a benefit in either the application or consent materials.