The Department of Health and Human Services Office of Human Research Protections (OHRP) last month issued guidance to assist institutional review boards (IRBs) in formulating various procedures set forth in the human research protection regulations.
"Because of the ever-more stringent enforcement environment and the trend toward naming IRBs and their members as defendants in research-related litigation, it is critically important that IRBs review and act on this guidance," warns health care attorney Bill Sarraille of Arent Fox, Washington, DC.
Given the recent emphasis on the conduct of research on human subjects, publication of the OHRP Guidance on Written IRB Procedures provides assistance to IRBs in developing written IRB procedures and policies, says Sarraille.
While the guidance is not all-encompassing, it does provide a basis and partial checklist for IRBs to develop policies and institute changes, if appropriate, regarding these activities, Sarraille notes.
According to the guidance, IRBs must have written procedures for:
- 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 the 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.
According to Sarraille, the guidance discusses the required elements in a written IRB policy and mandates that each written policy include a step-by-step description with operational elements for evaluations, reviews, processes, and/or tasks commonly utilized by IRBs. That includes, but is not limited to, the initial research review, review of protocol changes, meeting frequency, communication with investigators regarding IRB determinations, notification of institutional officials, and reporting requirements to the IRB by investigators of various unanticipated events.