minor change

A minor change to a study approved by the 91̽»¨Institutional Review Board (IRB) neither materially increases risk, nor materially decreases benefit, when considered in light of any changes proposed to mitigate risk and improve benefit; does not materially decrease scientific merit; and does not adversely affect the assessment of the research with respect to the criteria for approval. For FDA-regulated research, any change that increases risk (whether materially or not) cannot be considered a minor change.

Minor changes to IRB-approved research may be approved by the expedited review process.

The 91̽»¨relies upon from the Secretary’s Advisory Council on Human Subjects Research Protections (SACHRP) about what constitutes a minor change.