IRB Analysis of Risks and Benefits of Research Guidance
Version Date: November 19, 2015
When UW-Madison IRBs review research they must determine whether the risks are reasonable in relation to the anticipated benefits. This risk/benefit assessment is dependent upon prevailing community standards and case-specific determinations of risk and benefit. To make this determination IRBs evaluate the following as appropriate:
- The expected benefits (direct benefits can take the form of therapy, education, information, resources, or empowerment).
- The importance of the research to society (especially if there are no expected benefits to participants).
- The potential risks (physical, social, economic, psychological and legal harms).
- The likelihood and magnitude of any potential benefits or risks.
In addition, UW-Madison IRBs determine whether the proposed research has been designed to minimize risks to participants. To make this determination IRBs evaluate the following as appropriate:
- The eligibility criteria to ensure they are equitable.
- The procedures used to ensure they are not unnecessary or excessive.
- The study design to ensure it is sound, such that participants are not unnecessarily exposed to risks and any risks participants assume will result in usable information.
- The probability or magnitude of risks to see if these can be reduced by using procedures already being performed for diagnostic or treatment purposes.
UW-Madison IRBs also ensure that risks to participants are minimized by considering whether there are resources necessary to protect participants. To make this determination IRBs evaluate the following as appropriate:
- The number of qualified staff or, in the case of student research, is the level of supervision to ensure it is adequate.
- The facilities and time available for the researchers to conduct and complete the research.
- The medical or psychosocial resources participants may need as a consequence of the research to ensure these will be available.
- The access to a population will allow recruitment of the necessary number of participants.