A.
Investigational Review Board (IRB) Approval
All
biomedical research involving human subjects requires annual approval
by the IRB. For more information, please visit the IRB's website
or call Daniela Radu, Director of IRB, at 202-687-0328.
Protocols can be submitted to the IRB and the GAC simultaneously,
however, both approvals must be obtained PRIOR TO initiation
of any study on the GCRC. A copy of the IRB approval and annual
reviews MUST be forwarded to the GCRC Administrative offices.
B.
GCRC Scientific Advisory Committee (GAC) Review
The
GCRC Advisory Committee reviews protocols for scientific merit,
patient safety, statistical methodology, and study design. (Refer
to the GCRC Advisory Committee Membership.)
The protocol will be assigned a project number and two reviewers
selected by the committee chair from the advisory committee members.
The reviewers will familiarize themselves with the details of the
proposal and determine any need for additional information. The
principal investigator may be contacted by either of the reviewers
to clarify any problems. The principal investigator will be notified
of the committee meeting time and date at which his/her protocol
will be reviewed. At the meeting, the P.I. will be asked to present
a brief summary of the protocol to the committee and be available
for questions.
The protocol review will result in either "approval", "approval
pending response to committee concerns", or "deferral".
Definitions:
- Approved:
- Protocol
is acceptable for implementation on the GCRC. Please refer to
the implementation section of this booklet
-
- Approved
Pending Response to Committee Concerns:
-
If minor questions or concerns were raised by the committee.
they need to be addressed in writing with appropriate changes
made to the protocol prior to final approval. The written response
and protocol revision should be forwarded to the GCRC Administrative
Office. The information will be forwarded to a designated committee
member for approval; a return to full committee review is not
necessary. The protocol will be considered inactive until a
satisfactory response is received.
-
- Deferred:
- Major
concerns were raised by the committee which may require significant
revisions. The protocol must be resubmitted for full Committee
review.
The GCRC Advisory Committee assigns a priority score to the protocol
based on scientific merit. The score ranges from "Outstanding to
Acceptable" on a scale of 1.0 to 5.0. This score may be used to
prioritize scheduling on the GCRC as census warrants.
C.
Expedited Review
Expedited
review of a protocol may be requested by the investigator given
unusual circumstances. The GCRC Advisory Committee Chairman and
GCRC Program Director may provide temporary approval of the protocol
for a limited number of patients (10% of total population, but no
more than 3). The protocol must then be reviewed at the next GCRC
Scientific Advisory Committee Meeting and the full committee decision
is final.
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