Download GUIDELINE FOR INTERNAL REVIEW OF HUMAN GENE

GUIDELINE FOR INTERNAL REVIEW OF HUMAN GENE TRANSFER RESEARCH
This guideline describes the internal review activities that are required for all human gene transfer protocols.
The Institutional Biosafety Committee (IBC) may complete review of a human gene transfer protocol in
parallel to the Research Subjects Review Board (RSRB) conducting its review, when the RSRB is the
Reviewing IRB; however, IBC approval is required before RSRB approval will be granted. The Institutional
Biosafety Committee (IBC) will complete review of a human gene transfer protocol prior to submission to
the Reviewing IRB when the RSRB is the Relying IRB.
1. Institutional Biosafety Committee: Upon initial receipt of protocol materials, IBC will assess the study
to determine 1) whether UR is the initiating study site, and, if so, 2) whether the protocol meets NIH
criteria for RAC review in accordance with the NIH Guidelines for Research Involving Recombinant
or Synthetic Nucleic Acids. Once RAC review is completed, or if assessed as not required, the IBC
proceeds with review of the protocol to ensure that the Principal Investigator’s facilities, procedures,
practices, and personnel training and expertise are in compliance with the NIH Guidelines. The IBC is
required to have members who can assess the safety of recombinant or synthetic nucleic acid molecule
research and any potential risk to public health or the environment. For human gene transfer research,
the IBC is required to have adequate expertise in gene transfer research. The IBC complies with this
requirement through inclusion of standing IBC members with expertise in recombinant DNA, viral and
bacterial vector systems and other gene delivery methods. Additionally, ad hoc consultants will be
included as needed. IBC will upload documentation of its final review determination during the RSRB
application sign-off process. The notification will indicate whether RAC review was required.
Note: If IBC determines that RAC review is required, the Investigator will be notified and must
submit that written assessment to NIH for confirmation that RAC review is required.
Documentation of completed RAC review, or that RAC review is not required, must be forwarded
to IBC for continued review and approval of the protocol, regardless of whether UR is the initiating
study site.
2. RSRB Review – When the RSRB is the Reviewing IRB: Upon initial receipt of protocol materials, the
RSRB also may assess the study to determine whether the protocol meets NIH criteria for RAC review
in accordance with the NIH guideline. If RSRB determines RAC review is required, the RSRB will
communicate with IBC to ensure the PI is notified of the requirement. Once RAC review is complete,
or if not required, the RSRB will review the protocol in accordance with applicable regulations, as well
as NIH and FDA guidelines. The RSRB complies with the requirement to have appropriate expertise
during the review process either through the inclusion of standing members with expertise in gene
transfer research or through the use of outside consultants. In addition, the RSRB may involve an IBC
member for consultation during the RSRB review process.
The RSRB will conduct continuing review of gene transfer protocols every 6 months in accordance
with its standard review procedures, with particular emphasis on the following assessments based on
information provided in the continuing review report:
a) Whether the protocol needs to be modified (e.g., changes in eligibility criteria, changes in dose,
etc.); the Investigator Brochure needs to be updated; more frequent continuing review is
required, or other appropriate action needs to be taken in connection with the study.
Guideline for Gene Transfer Protocols
Final v. 05/08/2017
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b) Whether any changes are needed to the consent form to reflect new risks, benefits, or other
information that affects subject safety.
c) Whether any other issue need to be addressed that may affect the subject’s decision regarding
continued participation.
3. RSRB Review – When the RSRB is the Relying IRB: Upon initial receipt of protocol materials, the
RSRB will review whether or not the Reviewing IRB determined that the protocol meets NIH criteria
for RAC review in accordance with the NIH guideline. If the Reviewing IRB determined that RAC
review is required, the RSRB will communicate with IBC to ensure the PI is notified of the requirement.
Once RAC review is complete, or if not required, the RSRB will complete institutional review of the
protocol according to OHSP Policy 504 RSRB Reliance for Review.
4. Quality Improvement Review: An OHSP Quality Improvement review of gene transfer protocols will
be conducted once before the first subject is enrolled and at least once during the course of the study.
Guideline for Gene Transfer Protocols
Final v. 05/08/2017
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