Federal
regulations and existing PHRC/IRB policies require the
reporting of adverse events in clinical trials to various
entities inside and outside the Partners system. These
entities include the PHRC/IRB (and certain institutional
officials) at the relevant Partners institutions, the
FDA, the NIH or other federal agencies funding the research,
the sponsor, and in some circumstances the Office for
Human Research Protections. When a Data Safety Monitoring
Board (DSMB) is involved in the trial, the researcher
must report adverse events to the DSMB as well. The
researcher may also under certain circumstances report
adverse events to non-Partners' investigators who would
in turn report them to their site responsible IRBs (e.g.,
if the Partners' site is a coordinating center for a
multicenter study).
Beginning
on April 14, 2003, internal review and external disclosure
of identifiable health information in adverse events
will also be subject to the requirements of the HIPAA
Privacy Rule. Accordingly, Partners will require the
following: