KEY TERMS
Human Research Protocol Application (Protocol):
Description of human research activity to be conducted by a University
investigator and submitted to the IRB for review. The protocol is saved in
the IRB files.
Proposal/Application:
A request for financial support of a research project or activity submitted to
a sponsor via Grants & Contracts Administration. The proposal is saved
in the GCA database and when awarded, is administered by Grants &
Contracts Financial Administration (GCFA).
Congruency:
A determination by the IRB that the research described in a protocol is
consistent with that described in any associated proposal/application.
Determination is stated in IRB approval letter and recorded in protocol
database (Coeus) both for IRB purposes and for GCA to search on and
record in their certification to the funding agency.
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PROTOCOL-PROPOSAL CONGRUENCY INITIATIVE
In 2008, the University formalized the proposal-protocol congruency
process between IRBs – GCA/GCFA:
•Strengthened communication channels between these departments and
research community
•Improved upon information sharing via access to GCA proposal and IRB
protocol databases (IRES and Coeus), and eRA Commons
•Increased efforts to educate research community and departmental
business offices on congruency requirements
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PROTOCOL SUBMISSION/REVIEW PROCESS
PI submits protocol
application to IRB
IRB reviews
protocol
1.
Federal funding?
2.
The IRB ensures that the research described in
the protocol and any associated sponsored project
proposals are consistent (congruency)
Congruency noted in
IRB protocol approval
letter and database
(Coeus)
IRB approves
protocol
Human
research
can begin!
Yes?
Note: If an additional/new funding
source is associated with or later
removed from the protocol, the PI
must submit a protocol amendment
to the IRB
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REGULATIONS, GUIDANCE AND POLICY
Protocol review and approval:
IRB must review and approve all human research protocols prior to
the undertaking of the activities.
Office for Human Research Protections (OHRP) - 45 CFR Part
46.103(f): Certification is required when the research is supported
by a federal department or agency and not otherwise exempted or
waived under §46.101(b) or (i). An institution with an approved
assurance shall certify that each application or proposal for
research covered by the assurance and by §46.103 of this Policy
has been reviewed and approved by the IRB. Such certification
must be submitted with the application or proposal or by such
later date as may be prescribed by the department or agency to
which the application or proposal is submitted. Under no condition
shall research covered by §46.103 of the Policy be supported
prior to receipt of the certification that the research has been
reviewed and approved by the IRB.
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REGULATIONS, GUIDANCE AND POLICY
OHRP's 5/31/2000 memo IRB Review of Applications for HHS Support
(http://www.hhs.gov/ohrp/policy/aplrev.html) recommends that IRBs
ensure that all research described in the application or proposal is entirely
consistent with any corresponding protocol(s) submitted to the IRB.
National Institutes of Health (NIH) Policy - Grantees must provide a
certification to NIH that the research application has been approved by an
appropriate IRB, consistent with 45 CFR part 46. IRB approval must have
been granted within 12 months before the budget period start date to be
valid.
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CHALLENGES
Regulatory language
Proposal is often quite expansive and contains sections that are relevant
to research, but not intended for IRB approval, such as animal research
and budget requirements.
IRBs approve research protocols; detailed requirements of protocol review
and approval criteria set forth in the IRB application are not specified
sufficiently in the proposal.
OHRP Guidance contemplates a 1:1 match between the proposal and the
IRB protocol; reality is that several protocols may be supported by 1
proposal, or several proposals may support 1 protocol; multi-phased
research problematic with this expectation.
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CHALLENGES - CONTINUED
“IRB Holds “on Award Set-up
Holds are put on releasing funding by Grants & Contracts Financial
Administration (GCFA). Most holds are due to investigator delay in either
submitting the protocol to the IRB for review, or submitting an amendment
request to add the funding source/proposal to an existing protocol for the
IRB to review. Responsibility is on investigator to associate ALL appropriate
proposal(s) with protocol(s) and to ensure that substantive changes to one
are reflected in the other and reviewed/approved by the IRB. GCFA won't
release funding to the investigator without confirming that we have done
congruency on the award, so if the investigator hasn't associated the
award with a protocol, it becomes a rather urgent request of us to review
the proposal and protocol to release the funding.
Changes to protocol funding source not communicated to the IRB
Our records won’t be updated in a timely manner and reports that we run
from our records at any given time will be inaccurate in these cases.
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PROCESS IMPROVEMENTS
•We are working toward getting an electronic protocol system – a fully
integrated database that allows for data sharing and automatic feeds to
and from GCA and IRB records, rather than the current system that relies
on human interface
•Increasing IRB education and outreach to departmental business
managers, as well as investigators and research coordinators
•Continue communication and collaboration with GCA colleagues and
researchers to identify areas for improvement and to facilitate the timely
approval of research.
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