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.
Psychological harm
This is a common risk in social science research. Whenever you are asking participants about upsetting or disturbing events, there is a chance they will become upset or disturbed. Some research may involve asking about embarrassing subjects which can worry a participant. Other research may reveal something about their own reactions or prejudices which they find upsetting. Some research may deliberately deceive or startle a participant.
Although the potential for psychological harm is common in some research, it is important to accurately assess the level of harm. For most adults, a brief exposure to upsetting material will not cause long-lasting harm. Long-term effects can also be mitigated by having appropriate procedures in place such a debrief or mental health resources. The more serious the potential harm, the more detailed the mitigation procedures must be.
Physical harm
This type of harm is most common in medical research, but some non-medical research can still involve physical risks. One example could be, dizziness or nausea caused by a VR experiment.
Social harm
This is most common in situations where sensitive information is being collected about participants. If you are collecting information that is potentially stigmatizing in a participant's community (e.g. HIV status, past history of abuse, sexual practices), then privacy and confidentiality procedures will be scrutinized by the IRB.
Economic harm
Will participating in your research have costs for participants? These can include travel expenses and lost wages due to time off work. If so, how will they compensated?
Legal harm
Some research will need to collect information that will present a legal risk (e.g. immigration status, illegal drug use, participation in extra-legal work). Unlike a doctor or a lawyer, researchers are not able to protect their participant's information in a court of law.
If you plan to collect such information there are various steps you can take to minimize the risk to participants.
- If possible, do not collect identifiers (such as names and contact information). If a signed consent form would be the only identifier being collected, and the risk of being identified is the primary risk of the research, there is a special provision in the federal regulations to allow the IRB to waive the requirement for a signed consent (See Informed Consent for more information).
- For studies conducted in the U.S., you can also obtain a Certificate of Confidentiality (CoC), which permits researchers to refuse to disclose identifying information about their participants when subpoenaed by a court of law. These are issued by the NIH (and if your study is NIH funded, you will automatically be granted a CoC). Visit their website for more information.
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.