of Grant Applications
University of Florida IRBs are currently requesting that copies
of federal grant applications be submitted with IRB protocols.
The following questions and answers are provided to explain this
Why is the IRB requiring that a copy of the grant be submitted?
of Health and Human Services (DHHS) 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. The University of Florida is obliged, therefore,
to review these proposals.
What portion of the grant must be submitted?
must submit a copy of the entire proposal (exclusive of apendices).
If a grant is linked to multiple IRB protocols then the IRB needs
to know which protocols so that they can all be reviewed. Only
one copy of the grant proposal is required in the IRB office.
The IRB cannot review a protocol unless the entire grant application
has been submitted.
What exactly is the IRB looking for?
grant proposal must be found to be consistent with information
related to the protection of human subjects. Examples include
information about (i) the number and qualifications of collaborating
investigators and other members of the research team; (ii) cooperating
institutions or performance sites that may require separate or
additional IRB review or an Assurance of Compliance; (iii) characteristics
of proposed research facilities that may affect subject safety
or the confidentiality of data; (iv) the feasibility of financial
commitments made to subjects; and (v) the cost of proposed subject
protection measures, such as consent monitors or translators.
What will happen if the research protocol is found to be inconsistent
with the proposal?
IRB protocol must be consistent with the grant proposal. Any discrepancies
will require the PI to either amend the current protocol or to
submit a new protocol that is consistent with the grant application.
If the IRB and PI are unable to reconcile these differences then
the Division of Sponsored Research will freeze any funds in the
account until the IRB determines that the application and protocol