Einstein IRB Newsletter
Table of Contents (click a link for more details):
Reportable Events Policy and Forms
- Additional New and Recently Revised Policies
- Additional New and Recently Revised Forms
- Human Research Seminar Series 2013-2014
- iRIS Update
- Newsletter Archive
- NEW! Reportable Events Policy
This new comprehensive policy replaces the Internal Adverse Event
Policy, External Adverse Event Policy and the Deviation Policy. The
reporting requirements have been simplified and now reflect the latest
federal guidance. New reportable event forms are also available (see
seminars are available (Mon 8/12 @ Einstein and Thu 8/15 @ Montefiore)
to review the changes associated with this new policy. For more
information about this policy (including answers to Frequently Asked
Questions), please visit the Reportable
Events Information page.
- Reportable Event Form – For filing an initial report
of a reportable event (except for Protocol Exception requests – see
separate form below).
- Reportable Event Follow-Up Report – For providing
additional outcome information related (not available at the time of the
- Protocol Exception Request Form – For requesting IRB
approval to of a temporary deviation from the protocol prior to
implementation, e.g., enrollment of a subject who does not meet the
- AE Log – This is a sample log that you may use to
record adverse events as required under the policy. Note: For greater
than minimal risk studies, the log must be submitted to the IRB as part
of the annual review of the protocol.
- Deviation Log – This is a sample log that you may use
to record deviations as required under the policy. Note: For greater than
minimal risk studies, the log must be submitted to the IRB as part of the
annual review of the protocol.
- Additional New and Recently
The following policies were recently revised as part of our ongoing behind
the scenes efforts to bring conformity to our policies and
procedures. Please take a few minutes to review the changes:
- Case Report Policy – This new policy describes
the requirements and applicability of IRB review and
consent/authorization for single- and multiple-case-reports. A new Authorization for Publication of Case Report is also
available (see below).
- HIV Guidelines – These guidelines were revised
to reflect recent changes to the NYS Public Health Law related to HIV
- Registration of Clinical Trials – This revision
updates the policy to more clearly explain the requirements (from FDA and
ICMJE) to register, and post results of, clinical trials at
- Additional New and Recently Revised
- Human Research Seminar Series
The IRB is in the final stages of planning this year’s
Human Research Seminar series. Watch your email for the announcement of
the seminar topics and the opening of registration. You’re also welcome to
review the handouts from the 2012-2013 seminars.
- iRIS Update
iRIS, the IRB’s online application software, has been in use for Exempt
and Expedited studies since January – hundreds of studies have already
been submitted. The IRB is currently completing the configuration of the
full board studies section – watch your email for an update this fall. In
the meantime, learn about iRIS, sign up for an iRIS Training, or review the iRIS Frequently Asked Questions (FAQ).
- Newsletter Archive
This and prior IRB Newsletters are available in the IRB Newsletter Archive.