Change%20to%20Procedures%20for%20Committee%20Review%20of%20Resubmissions%20of%20Grant%20Applications

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Change to Procedures for Committee Review of
Resubmissions of Grant Applications
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Agenda

• Institutional Obligations
• Regulations
• Old Process
• New Process

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Obligations to Match Protocols to the Grant
Proposal

• Regulations have always required that the
  institution certify that all funded proposals
  that involve human subjects and animals have a
  matched protocol which has been reviewed and
  approved prior to releasing the funds. The
  regulations do not advise institutions how to
  manage this comparison and subsequent
  certification. Follows are the regulations

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Regulations for Vertebrate Animals

• Public Health Service (PHS) requires that
  Applications or proposals (competing or
  non-competing) covered by this Policy from
  institutions that have an approved Assurance on
  file with OLAW shall include verification of
  approval (including the date of most recent
  approval) by the IACUC of those components
  related to the care and use of animals If
  verification of IACUC approved is submitted
  subsequent to the submission of the application
  or proposal, the verification shall state the
  modifications.

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Regulations for Human Subjects

• Department of Health and Human Services (HHS)
  regulations at 45 CFR 46.103(f) require that each
  application or proposal for HHS-supported human
  subject research be reviewed and approved by the
  Institutional Review Board.

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Regulations for Biosafety

• No specific regulations. NIH Guidelines For
  Research Involving Recombinant DNA Molecules (NIH
  Guidelines) state Section I-D.  As a condition
  for NIH funding of recombinant DNA research,
  institutions shall ensure that such research
  conducted at or sponsored by the institution,
  irrespective of the source of funding, shall
  comply with the NIH Guidelines.

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Old Process

• To meet these requirements, the Committees have
  required that a protocol and corresponding grant
  be submitted for review for each new competitive
  grant submission. The same logic was applied to
  resubmissions of these same grants. As funds
  became increasingly difficult to obtain,
  researchers have had to resubmit their grant
  proposals, in many cases, up to three times.
  This has resulted in multiple protocol
  submissions to allow the mandated review of grant
  to protocol.

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Old Process - Example

• For instance, a new competitive grant receives a
  just-in-time request. The PI submits the
  protocol and grant for review. The initial grant
  was not funded but, the PI resubmits to the
  sponsor with some changes to the grant. The PI
  receives a fundable score, so he/she submits
  another protocol which might or might not be
  identical. This second submission is not funded.
  The PI submits a second time and receives a
  just-in-time request and therefore submits a
  third protocol which may be identical to either
  of the first or with minor differences.
• So at this point the PI has submitted three
  protocols to the Committee for review and
  approval for one grant with none or minor
  differences. In some cases, it is not even the
  last submission that is funded and then it
  becomes difficult for the Committees and the PI
  to be sure which protocol to leave open.

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New Process

• At this time, we have changed the current
  requirements regarding submission of protocols to
  RPO Committees that correspond to resubmission of
  grant applications.
• Each new grant application and/or renewal to
  continue (competing renewals) will still require
  a new protocol for review. Supplements and
  resubmissions will now require only an amendment
  to the previously approved protocol. We have
  modified each of our amendment forms to provide
  for the resubmission, review of the resubmitted
  grant and any associated changes to the grant and
  protocol, and these will be handled under the
  amendment review mechanism. PIs will no longer
  need to submit a full protocol and new cover form
  for review!

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New Process
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Closing

• When in doubt about what is required for
  resubmissions, please contact the appropriate
  Research Review Administrator for the Committee
  you are working with at
• Research Protections Office
• 656-5040
• Thank you