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IV.12
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Review of Modifications/Amendments to
Previously Approved Research
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Objective
The
Committee for the Protection of Human Subjects (CPHS) reviews all requests for modification/amendments
to previously approved research, and this Policy/Procedure describes the
process by which the CPHS reviews modification/amendments submitted for
approval.
Policy/Procedure
I.
The Principal Investigator (PI) may not implement any modifications/amendments
to research without approval by the CPHS, except to avert or minimize apparent
immediate hazard to the participant. Such action must be promptly reported to
the CPHS.
II. The PI must submit the
modification/amendment via the Internet Research Information System (iRIS).
A. The exact text changes of
an amendment may be incorporated into a revised version of the protocol or
other document.
1. Modifications to the informed consent form (ICF)
should take into account both prospective research participants and research
participants already enrolled in the study.
New findings developed during the course of the research which may
affect a participant’s willingness to continue participation must be provided to
the participant in a letter of notification, an addendum to the initial consent
document, or by re-consenting the participant using
the modified ICF. All such revised
documents must be approved by the CPHS.
B. Modification/amendment to research
involving prisoners must go to the full committee for review.
C. For research that was
initially determined to be exempt, any proposed or anticipated changes must be
submitted to the CPHS for approval prior to initiation of the change. The
research proposal will then be evaluated for appropriate IRB review, as defined
in HRP PP IV.06.
D. For those modifications to
research that are identified as qualifying for expedited review:
1. The IRB coordinator shall assign the requested
modification to an Expedited Reviewer (Reviewer). All previous information
regarding the research is in iRIS for the Reviewer to
access.
2. If the Reviewer determines that the modification
does not qualify for expedited review, the request shall be returned to the IRB
Coordinator to be assigned to the full committee to review and take action on.
3. The Reviewer shall review the modification/amendment
4. The Reviewer will take the following actions on the
requested modification/amendment:
a)
Approve
b)
Approve pending modifications
c)
The reviewer may not disapprove the change, but
instead return the request to the IRB coordinator to be assigned to a full
committee for review.
5. All modifications approved by expedited review
(minor changes) must be reported to CPHS
#1 & #2 by placing them on the next agenda.
E. For those modifications
that must go to a full convened meeting:
1. The IRB coordinator shall determine the chairman of
the subcommittee that initially reviewed the study and assign it to that person
(or to one of the other subcommittee members if possible, if the chairman is
not available) as the Primary Reviewer.
2. The assigned Primary Reviewer and all members of the
CPHS shall be provided the request for modification via iRIS.
All previous information regarding the research is in iRIS
for the members to access to determine whether the modified research continues
to fulfill the criteria for approval.
3. The Primary Reviewer shall review the requested
modifications/amendments and shall indicate any issues/clarification and make a
recommendation to the committee..
4. After receiving the information and recommendation
the CPHS shall review and discuss the request.
5. Should the ICF require revision the CPHS may request
that participants currently in the study be reconsented. Should this
request be made it shall be included as a provision in the approval letter to
the PI.
6. The CPHS shall determine whether participants who
have completed research involvement might be affected, and/ or might need to be
recontacted and provided with additional information.
This determination should be based on new information regarding a change to the
risk/benefit ratio that would possibly affect the participant’s welfare. Should
it be determined that the participants must be recontacted,
it shall be a provision in the approval letter to the PI.
7. When the CPHS reviews a modification request that
involves prisoners, at least one voting member must be present at the CPHS
meeting who is a prisoner, or a prisoner representative with appropriate
background and experience to serve in that capacity.
F. The proposed modification
shall have one of the following actions taken.
1. Approved
2. Approved Pending
3. Disapproved
III.The outcome of the review shall be provided to the PI via iRIS.