federal agencies should harmonize their guidelines about safety monitoring at various risk levels and share information with the research community and the public regarding the results of federalwide monitoring. High-risk NIH studies (intramural or extramural) should be monitored with the same scrutiny as FDA-regulated trials, and for certain high-risk studies, DSMB/ DMCs are essential. NIH should therefore take the lead in developing and funding more DSMB/DMCs. Federal agencies also need to standardize their adverse event definitions and reporting requirements so that these reports can be more effectively used by Research ERBs to ensure participant safety.

To protect research participants as fully as possible, it is essential that the relevant program mechanisms communicate with one another effectively. To this end, the DSMB/DMC should advise the Research ERB regarding whether new information affects participant safety and, as appropriate, this information should in turn be communicated to participants.



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