IRB Minimal Risk Research & Exemptions
Minimal Risk Research
Minimal risk research includes research activities where the probability and magnitude of anticipated harm or discomfort to human subjects is not greater than that ordinarily encountered in daily life, or during the performance of routine physical or psychological examinations or tests.
Salus IRB provides initial review of minimal risk research in accordance with 21 CFR 56.110 and 45 CFR 46.110. The research must meet the 21 CFR 56.111 and 45 CFR 46.111 criteria for IRB approval. The review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the IRB chairperson. To determine if your research is minimal risk, refer to Salus Form 100.C Supplemental for Expedited Review of Minimal Risk Research.
IRB Exempt Determinations
Some minimal risk human subject research may be exempt from review. However, this does not always mean that a submission is exempt from all the requirements of 45 CFR 46. It is still considered human subject research but must fit the description of the exempt category and not include nonexempt research activities. Some exempt categories identify specific criteria that must be met (e.g., limited IRB review and broad consent) as conditions of being exempt from other regulatory requirements.
Salus IRB provides review of proposed research to determine if a project is exempt from IRB review (i.e., research activities in which the only involvement of human subjects falls within one or more of the categories outlined in 45 CFR 46.104(d)).
If the board determines your research to be exempt, Salus requires submission of any modification to the research for prospective review and determination of continued exemption status prior to the implementation of the change. In some circumstances, changes to the protocol may disqualify the research from exempt status. A written notification to Salus that the research is completed or terminated is also required within 30 days of completion or termination of all research activity.
To determine if your research is exempt from IRB review, refer to Salus Form 100.D Supplemental for Exempt Research