CHA News Article

Draft Guidance Released on Preparing IRB Meeting Minutes
HHS seeks comments by Jan. 4, 2016

The Department of Health and Human Services this month released draft guidance on preparing meeting minutes for institutional review boards (IRBs). Federal regulations require IRBs that are responsible for review and oversight of human subject research to prepare and maintain adequate documentation of IRB activities, including meeting minutes. The draft guidance is intended to assist institutions and IRBs in preparing IRB meeting minutes that comply with regulatory requirements. Guidance documents do not establish legally enforceable standards separate from federal regulations, but rather explain an agency’s current rationale on a particular topic and provide insight into areas where an agency may focus future compliance efforts. HHS encourages comments on the new guidance; comments should be submitted by Jan. 4, 2016 at www.regulations.gov/

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