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NOTE: THIS GUIDANCE HAS BEEN REPLACED BY OHRP'S JULY 1, 2002, GUIDANCE ENTITLED, “GUIDANCE ON CONTINUING REVIEW.” CLICK HERE FOR THE JULY 11, 2002 GUIDANCE.

May 22, 2000

TO: Division of Human Subject Protections

FROM: Director, Division of Human Subject Protections

SUBJECT: Continuing Review of DSMB-Monitored Clinical Trials

As you know, OPRR guidance (see http://ohrp.osophs.dhhs.gov/references/findings.pdf) indicates that continuing review of research by the Institutional Review Board (IRB) should include consideration of adverse events, interim findings, and any recent literature that may be relevant to the research.

OPRR recognizes that such information may not be readily available to local investigators participating in multicenter clinical trials or to their local IRBs. However, OPRR notes that such trials are often subject to oversight by a Data and Safety Monitoring Board (DSMB) whose responsibilities include review of adverse events, interim findings, and relevant literature (e.g., DSMBs operating in accordance with the National Cancer Institute (NCI) Policy for Data and Safety Monitoring of Clinical Trials at http://grants.nih.gov/grants/policy/hs/data_safety.htm).

In such circumstances, IRBs conducting continuing review of research may rely on a current statement from the DSMB indicating that it has reviewed study-wide adverse events, interim findings, and any recent literature that may be relevant to the research, in lieu of requiring that this information be submitted directly to the IRB. Of course, the IRB must still receive and review reports of local, on-site unanticipated problems involving risks to subjects or others and any other information needed to ensure that its continuing review is substantive and meaningful.