What should investigators do when considering changes to an exempt study that could make it nonexempt?

Investigators should consult with the appropriate institutional authority whenever questions arise about whether planned changes to an exempt study might make that study nonexempt human subjects research. OHRP recommends that institutions have policies in place to define how proposed changes to exempt research will be evaluated. The person(s) authorized to make this determination should have access to sufficient information to make a correct determination. In addition, the institution should ensure the appropriate communication of such a policy to all investigators.

Last Reviewed: 12/01/2010

• Who may determine that research is exempt?
• Must there be review by someone other than the investigator before a research study is determined to be exempt?

• Exempt Research Determination