HUMAN SUBJECTS RESEARCH -
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As you know, the Institutions have long
had a policy requiring investigators to report adverse events
to the IRB. We have been examining this policy over the last year
to provide clearer guidance to investigators and their staff,
as well as bring it into line with current OHRP and FDA guidance
for reporting events to an IRB. An updated Event Reporting policy
has been developed by the JHM IRBs and is now posted on the IRB
website (http://irb.jhmi.edu).
Please note that the policy has been expanded to cover reporting
requirements for adverse events, unanticipated events, and protocol
deviations. The new policy also deals explicitly with reporting
requirements in observational studies.
If you have any questions about the new
policy or its implementation, please contact a member of the IRB
regulatory team at Ext. 5-3008. We will accumulate comments and
questions and evaluate what changes may be needed as we go forward.
Thank you for your help in developing the best possible policies
to guide clinical research.
