Dear Colleague,

The NIH recently implemented guidance on the reporting of adverse events to IRBs for multi-site clinical trials. That guidance was published on June 11, 1999 in the NIH Guide and was effective on July 1, 1999. To summarize, principal investigators involved in multi-site trials must forward to each IRB involved in the study the summary reports of the Data Safety Monitoring Board's (DSMB) discussion of adverse events. They should also identify the DSMB, but not the members' names. The new guidance does not supplant or replace any other reporting requirements in 45 CFR 46 or to the FDA.

The purpose of the guidance is to improve communication among the DSMBs, the PIs, and the IRBs. IRBs report that the format and content of reports of adverse events are often less than helpful. For example, information comes to IRBs from disparate sources as individual adverse event reports. It is difficult for IRBs to assess such reports and the magnitude of the problem since they lack numerators and denominators. The new guidance is intended to simplify this exchange of information over three stages of the research.

1. When submitting the initial protocol to the IRB for review, the investigators should describe the DSMB's plans for monitoring events.
2. During the course of the study, the principal investigators should send IRBs a written summary report after each DSMB review. These summary reports do not replace other reporting requirements to the IRBs.
3. Throughout the study, the PI should have in place a mechanism for distributing reports to all participating investigators for submission to their local IRBs as well as to their own IRB.

For additional information, see http://grants.nih.gov/grants/guide/notice-files/not99-107.html

Sincerely,