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Charge: |
| The GCRC Advisory Committee (GAC)
provides oversight for the General Clinical Research Center, as required by
NIH/NCRR. The major charge to the GAC is to review all GCRC protocols for
scientific merit and suitability for utilization of GCRC resources. A
protocol must be approved by the GAC and given a scientific priority score
before any study-related procedures begins. Priority for utilization of the
GCRC is determined by the priority score and by any recommendations made by
the committee regarding use of particular GCRC resources.
The expectations of the GAC, according to NCRR
guidelines include the following:
- Evaluate projects for GCRC use, and prioritize them
in a manner that will assist the Program Director in allocating GCRC
resources
- Supervise and review all operations of the GCRC,
including its components, such as the Core Laboratory and the Informatics
and Imaging Cores.
- Assure that NIH policies on the inclusion of women,
minorities, and children as study subjects are followed
- Review and approve Data and Safety Monitoring Plans
for all GCRC protocols
- Designate each protocol as category A,B,C or D, or
a combination of these categories, as related to provision of specific
GCRC resources
- For industry-sponsored studies, the process of
protocol review must include review of research agreements and contracts
with the sponsor, the itemized study budget and any other correspondence
describing study drugs or devices, support to be provided for the study
and plans for analysis and use of the study data
- Review periodically all GCRC operations to ensure
that resources are used for the most scientifically justified and relevant
projects
- Work proactively with PD to address the following:
- Approve general policies of the GCRC
- Delineate common needs of the GCRC investigators
- Establish admission policies
- Address unmet needs of investigators for GCRC
resources
- Encourage junior faculty members to perform
clinical research and assist them in applying appropriate concepts and
methods
- Encourage GCRC use by investigators at the
institution who are not currently using
- Provide outreach to investigators from
institutions without a GCRC or comparable resources
- Provide oversight over the GCRC budget
- All requests to NCRR for funds shall be endorsed by
the GAC prior to submission of the request to NCRR
- Endorse all significant re-budgeting once funds are
awarded
- During the year, GCRC Program Director and
Administrator work closely with GAC and provide systematic updates on
financial matters. This should include comparisons of projected and actual
overall expenditures and projected and actual use of GCRC resources (days,
visits, ancillaries) by specific protocols
- The GCRC Program Director and Administrator should
report to GAC on apparent unmet needs of investigators, career development
efforts and other related activities at the GCRC and elsewhere at UTMB,
and other topics relevant to the clinical research interests of the host
institution
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Composition and
Membership: |
| Members of the GAC must hold UTMB faculty
positions. Efforts are made to include faculty from a variety of
disciplines, departments and schools, with an emphasis on clinical research
experience and expertise. Members of the GCRC administration and staff may
be ex officio members, but may not vote or serve as chairperson. The
members, chair and associate chair of the GAC are appointed by the Dean who
is also the Principal Investigator of the GCRC grant. |
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Meetings: |
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The GAC meets at least monthly, usually on the third
Wednesday of the month. Protocols must be submitted by the 23rd day of the
previous month, and are pre-reviewed to be sure all required documents are
included. If there are missing items, these must be submitted by the end of
the month. Additional meetings may be necessary if more than 3 protocols
must be reviewed in a given month or if there are urgent administrative
issues that must be reviewed and approved. |
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Agenda: |
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The agenda includes review of any new protocols submitted
to the GCRC, as detailed below. A report on GCRC activity and utilization
since the last meeting is provided by the Program Director. A separate
report is given by the Research Subject Advocate. The committee votes to
accept both reports. Additional reports may be given by other GCRC
administrative staff members, either at the request of the committee or the
Program Director. Reports from the Core Laboratory Director and the other
core directors are expected quarterly. |
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GCRC Application Packet: |
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The components of a GCRC application are listed and
described in detail on a separate web page
www.utmb.edu/gcrc. All or most
components must be submitted electronically. Material is submitted or
e-mailed to Elizabeth Ruiz in the GCRC Office. IRB approval may be sought
concurrently or prior to submission of a protocol to the GCRC. |
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Method of Review: |
| Every protocol is assigned to two members
of the GAC, who prepare detailed, written reviews. At least one reviewer
must be a voting member of the committee. The second reviewer may be an ex
officio member, or an invited reviewer with particular expertise. The
Biostatistician also prepares a written review of all protocols, emphasizing
data analysis and sample size considerations.
The two reviews and that of the Biostatistician are
read at the meeting. Each reviewer also recommends a priority score. This is
based on the NIH 1-5 scoring system. The Research Subject Advocate (RSA)
comments on all protocols, with special attention to human subjects
considerations and the data and safety monitoring plan. Other members of the
committee are encouraged to comment and contribute to the discussion. A
motion is then made to approve, defer or disapprove the protocol, with or
without stipulations. If the motion is for approval, it must state whether
the study is A, B or D. Any stipulations are part of the motion. Each voting
member records his/her vote (approve, defer, or disapprove) confidentially
on a sheet provided. |
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Summary Statement: |
| After the meeting, the GCRC Science
Writer prepares a summary statement that is based closely on the motion
passed at the meeting. The stipulations voted on by the committee are
included, and must be addressed by the PI by either changing the application
documents or justifying why no change should be made. The Summary Statement
may also list additional comments and suggestions, such as grammatical and
formatting considerations, which may be useful to the PI in revising the
protocol. The summary statement explicitly transmits to the applicant the
revisions that the GAC considers necessary to achieve final approval.
Conversations between the submitting investigator and the reviewer, the GAC
Chair, the PDs or GCRC staff often supplement the written review. |
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Revisions and Resubmissions: |
| Investigators are encouraged to revise
and resubmit their applications in a manner that addresses the concerns of
the GAC. The Chairperson, one or both reviewers and the Biostatistician
review this material if these individuals have asked for specific revisions.
The Chair may also request that other committee members, the PDs or GCRC
staff review revisions for adequacy, or may even require a re-review by the
full committee. When these individuals have approved the PI’s responses and
revisions, the Chair then prepares a memo giving final approval. Protocol
activity may then start on the GCRC, assuming the IRB has given final
approval, and after a GCRC Initiation Meeting has been held, and any
additional administrative requirements, such as identification of particular
resources, have been met. The whole committee must review all revised
protocols that were initially deferred or disapproved. |
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Absences and Conflicts of Interest: |
| Absences and Conflicts of Interest. A
quorum consists of six or more voting members. Voting members, if absent,
may not send substitutes to the meeting. Outside reviewers may be invited to
the meeting, if approved by the Chair, but may not vote.
In the past, investigators have not been permitted at
meetings. The GAC is currently testing a new procedure whereby investigators
may be invited to the monthly GAC meeting when this is important for
clarification of a presented protocol. This must be approved by the Chair of
the GAC. The purpose is to allow the investigator to respond to questions
from the committee. However the investigator must be absent from the room
during final discussion and voting.
Reviewers are asked to submit written reviews in
advance of the meeting. If a reviewer is absent, the chairperson reads his
or her review. Any member (voting or ex-officio) who is a co-investigators
on a protocol, or who otherwise has a real or perceived conflict of interest
may not review the protocol, and must be absent from the meeting during the
review of the protocol. If the Biostatistician has such a conflict, an
external biostatistician is asked to review the protocol and provide a
written review, and invited to attend the meeting. |
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