minor change

A minor change to a study approved by the UW 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 UW relies upon Guidance from the Secretary’s Advisory Council on Human Subjects Research Protections (SACHRP) about what constitutes a minor change.