IRB Application Instructions - Subject Risks / Benefits

Help Information

A. Risks

  • Be sure to answer all aspects of this question; describe the potential risk and assess the likelihood of the risk occurring and the seriousness of the risk; the likelihood of the risk can be reduced through the procedures described in 21B; for example, a potential risk to subjects may be breach of confidentiality; the seriousness of the risk may be high based on the information collected (e.g. illegal behaviors), but the likelihood of the risk is low based on coding of the data, security measures in place for data storage, limited access to the data, etc.

  • See HRPP Manual 6-2, Minimization of Risks, and 6-3, Risk-Benefit Ratio for considerations

B. Minimization of Risks

C. Benefits (Expedited / Full Board Only)

  • Describe any potential benefits (if any) to the individual research subjects and to society in general (e.g. advancement of knowledge in the field); in some research, there may not be any individual benefit to the research subject

  • See HRPP Manual 6-3, Risk Benefit Ratio for considerations

Helpful HRPP Manual Sections

Question Number

  • Initial Application (Exempt) - Question 10 (Risks)

  • Initial Application (Expedited and Full Board) - Question 21