Version
2.3
Date Updated
Thursday, May 31, 2012
Descripton

Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 173
AAHRPP Elements: I.5.D., II.2.F., II.2.G., III.2.D.


POLICY


  1. The UIC OPRS promptly reports to applicable institutional officials, funding sources,
    agency heads and regulatory agencies determinations by the IRB that an event
    represents:
    1. A reportable unanticipated problem involving risks to subjects or others as
      determined by the IRB;
    2. A serious or continuing non-compliance with federal regulations or the
      requirements or determinations of the IRB; or
    3. A suspension or termination of IRB approval.
  2. This policy fulfills DHHS, VA and FDA regulations for incident reporting at 45 CFR
    46.103(b)(5), 38 CFR 16.103(b)(5) and 21 CFR 56.108(b).
  3. UIC has reporting obligations under this policy for nonexempt human subjects
    research when UIC is engaged in the research or one of the UIC IRBs is the IRB of
    record or has oversight for the proposal.
  4. For multi-center trials, UIC has no reporting obligations for unanticipated problems,
    serious or continuing non-compliance or suspension or termination of approved
    research occurring at non-UIC or non JBVAMC sites, except when UIC/JBVAMC
    serves as the lead site, coordinating center or sponsor of the research.
  5. The reporting requirements in this policy are not necessarily applicable to
    administrative holds and lapses in IRB approval.
  6. The UIC has elected on its FWA not to apply the Common Rule and subparts B, C,
    and D to research which is not federally conducted or supported. UIC therefore does
    not report the events listed in Section I. to OHRP when the research is not federally
    conducted or supported.
  7. Responsibility for implementing and coordinating the procedures described in this
    policy lies with the Human Protections Administrator.

[accoridon title="REFERENCES"]

21 CFR 56.108(b)
38 CFR 16.103(b)(5)
45 CFR 46.103(b)(5)
OHRP, Guidance on Reporting Incidents to OHRP, May 27, 2005.
VHA Handbook 1200.5 (7)(d)
VHA Handbook 1058.1