Overview
The GCRC is required by NIH to have a GCRC Advisory Committee (GAC)
that must review and approve all research protocols before they
use GCRC funds. Our GAC is chaired by Daniel E. Ford, M.D., M.P.H., Vice Dean
for Clinical Investigation and appointed by the dean’s office.
Because our GCRC averages 18 protocol reviews per month, the GAC
consists of three Protocol Review Subcommittees (PRS).
These subcommittees do the in-depth reviews, communicate with investigators,
and give final approval on behalf of the full GAC committee. Protocols
conducted primarily in the pediatric population are reviewed by
the Pediatric Protocol Review Sub-committee (Peds
PRS), chaired by Beth Laube, Ph.D..
Protocols conducted primarily in the adult population are reviewed
by the Adult Protocol Review Sub-committee (Adult PRS), chaired
by Simeon Margolis, M.D., Ph.D.. Protocols requiring
the expertise of the Neuro Behavioral Research Unit at the Kennedy
Krieger Institute are reviewed by the Neuro Behavioral Research
Unit Protocol Review Subcommittee (NBRU PRS), chaired by Dr. Michael
Johnston, M.D..
The purpose of the PRS is to provide a review that considers the
rigor of the science, analytic plan, inclusion
of women, minorities, and children, resources required, and logistics
of GCRC use. Human subjects’ issues and funding classification (A,
B, D) are also considered.
Steps in the Review Process:
1.
Application is submitted to the GCRC prior to the deadline and
assigned to the appropriate PRS.
2.
Application is placed on the agenda for the next PRS meeting and
primary, secondary, biostatistical, and human subjects reviewers are assigned.
3.
Application is discussed at the PRS meeting, culminating in a
vote.
4.
Committee chair sends letter to the investigator informing of the
committee’s decision, and including any relevant comments.
Possible Outcomes of Committee Vote
Approval: When a protocol is approved
by the PRS, it is fully approved on behalf of the entire GCRC Advisory
Committee. Members of the PRS also serve on the GAC.
Deferral:
Those applications deferred by the PRS are reconsidered after the
investigator responds to the committee’s comments. Safety issues,
concerns regarding the study design, lack of an analytic plan, or
significant human subjects’ issues would typically cause a protocol
approval to be deferred. A deferral letter including relevant comments
will be sent to the investigator. If the PRS is not satisfied with
the response and votes to defer again, the PI is usually invited to
attend the next PRS meeting.
Administrative Deferral:
Administrative Deferral is used when a protocol requires some relatively
minor clarifications or responses, but does not need to be re-reviewed
by the full committee. A deferral letter including relevant comments
will be sent to the investigator. Once a satisfactory response is received, full
approval is granted.
Common reasons for Administrative Deferral
- lack of IRB approval
- conflicts between consent form and study protocol
- incorrect Targeted/Planned Enrollment
Table
-
lack of acceptable Inclusion of Children statement
-
questions raised that do not require further discussion by the PRS
- “other sources of funding” budgets
not provided
- appearance of conflicts in funding
-
unsettled budget issues
- In some cases, the reviewers, as well
as the chair, will review the response prior to approval. However,
the protocol does not go back to the PRS for further review unless
the response raises some strong concerns that were not previously
apparent.
Disapprove: Those applications that are disapproved are
not reconsidered by the PRS unless they are resubmitted with major
revisions. Typically, a protocol is disapproved because the committee
feels there are serious design flaws or insufficient material to
judge the protocol fairly.
Once a study is fully approved an approval
letter from the GAC chair will be forwarded to the principal investigator.
To check on study approval status, contact Shernice Madison, Assistant
Administrative Manager, 4-2717, or Gerald Stacy, Administrative
Manager & GAC Secretary, 4-2717.
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