OHRP issues IRB guidance

The Department of Health and Human Services’ Office of Human Research Protections (OHRP) in July issued guidance to assist institutional review boards (IRBs) in formulating various procedures set forth in the human research protection regulations. While the guidance is not all encompassing, it does provide a basis and partial checklist for IRBs to develop policies and institute changes if needed.

According to the guidance, IRBs must have written procedures for the following:

• conducting its initial and continuing reviews of research;
• reporting its findings and actions to the institution and investigators;
• determining which projects require more frequent review than once a year and need verification from sources other than the investigators that no material changes have occurred since previous IRB review;
• ensuring prompt reporting to the IRB of proposed changes in a research activity, including provisions that indicate that the IRB must approve any changes in previously approved research (except when necessary to eliminate apparent immediate hazards);
• ensuring prompt reporting to the IRB, appropriate institutional officials, and the appropriate federal department or agency heads of any unanticipated problems involving risks to subjects or others, any serious or continuing noncompliance with IRB policy or the requirements or determinations of the IRB, and any suspension or termination of IRB approval.