IRB: Review of Research With Potentially Hazardous Biological
Agents
Policy number:
504
References:
45CFR46.116
21CFR50.25, 21CFR312
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic
Acid Molecules, March 2013, 1-A-1 a
Date: 06/12/144
Policy Owner:
Executive Director, HRPP
Cross reference:
Activities involving Recombinant or Synthetic Nucleic Acid Molecules or
Other Potentially Hazardous Biological Agents
http://www1.umn.edu/regents/policies/academic/RecombinantDNA.pdf
Definitions:
None
1.0 Reason for Policy
This policy describes how the Institutional Review Board (IRB) will review research involving human
gene transfer (HGT) and other potentially hazardous biological agents in coordination with the
Institutional Biosafety Committee (IBC). It is essential that good communication exist between the IRB
and the IBC.
2.0 Scope of Policy
This policy applies to University or Minnesota research community and its healthcare components.
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3.0 Policy Statement
Potentially hazardous biological agents may include but is not limited to human gene transfer, the
deliberate transfer of recombinant DNA or RNA, infectious agents, including non-virulent and vaccine
strains and/or biologically derived toxins, including mutated, truncated, or inactivated toxins. Research
that involves human subjects and potentially hazardous biological agents must be reviewed by both the
IRB and the IBC.
For experiments involving the deliberate transfer of recombinant DNA (rDNA), or DNA or RNA
derived from rDNA, or synthetic nucleic acid molecules into human research participants (human gene
transfer(HGT)), no research participant shall be enrolled until the:
 Recombinant DNA Advisory Committee (RAC) review process has been completed (if
applicable)
 Institutional Biosafety Committee (IBC) approval (from the clinical trial site) has been
obtained
 Institutional Review Board (IRB) approval has been obtained
 All applicable regulatory authorization(s) have been obtained (1-A-1-a)
In addition to NIH Guidance and review, all HGT clinical trials are subject to FDA regulations as
biological products.
The consent form for human subjects must meet NIH Guidelines as well as the requirements of
45CFR46.116 and 21CFR50.25 for informed consent. The IRB and IBC will collaborate to revise the
consent form(s) to ensure that risks and benefits are clearly described.
Researchers may submit applications simultaneously to the IRB and IBC. HRPP staff may triage and pre
review the applications. But, according to the NIH Guidelines, the application must first be reviewed by
the IBC in order to inform the IRB in its review of the application. The IBC advises the IRB on risk
assessment and biosafety issues according to the NIH Guidelines.
IRB approval must not be granted until IBC grants final approval.
Both the IRB and IBC will review unanticipated problems, serious adverse events, changes in protocol,
informational items or updates submitted during the course of the research, if appropriate.
Both IRB and IBC will review and follow reporting requirements and communication with PI’s,
sponsor, NIH-OBA, FDA and OHRP.
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4.0 Required approvals for this document
Title
HRPP Executive Director
5.0 Revision History
Revision
06/12/14
04/25/14
03/16/12
11/02/09
08/21/09
08/6/09
Reason for change
Update
Policy update for AHRPP
Policy update
Update cross references
Revision
New Policy
Date of release
09/02/14
09/02/14
03/16/12
11/02/09
08/21/09
To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654
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