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.

Minimizing 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.

See Also:




Keywords:risk benefit analysis reasonable relationship evaluation risk/benefit ratio minmize physical risks breach of confidentiality privacy   Doc ID:29478
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-16 10:45 CDTUpdated:2015-11-19 10:42 CDT
Sites:VCRGE and Graduate School
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