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II.13
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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) must receive approval from the CPHS before initiating any
changes, including those required by the sponsor, which would affect human
subjects, e.g. changes in methods or procedures, numbers or kinds of human
subjects, early termination of study, or revisions to the informed consent
document or procedures. The
addition of co-investigators must also receive approval from the CPHS. An investigator may not implement any
modifications/amendments to research without prior approval by the CPHS, except
to avert or minimize apparent immediate hazard to the participant. Such action
must be promptly reported to the CPHS for review and approval
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 participantŐs 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 Policy and Procedure 16.
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. A Reviewer must
declare any Conflict of Interest with the research assigned to him/her for
review. If there is a conflict,
the research study shall be reassigned to another Reviewer.
2. The
assigned Primary Reviewer and all members of the CPHS shall be provided the
request for modification and all supplemental information via iRIS. Members of
the CPHS are expected to have knowledge of the full protocol, consents, and
recruitment materials. All
previous information regarding the research is in iRIS for the members to
access to determine whether the modified research continues to fulfill the regulatory
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
participantŐs 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.
8. Changes made to a protocol in order to address an immediate
hazard to study participants must be reported to CPHS in a timely manner, via a
change request and a protocol deviation.
CPHS will then determine whether changes are consistent with continued
participation in the study.
F. The proposed modification shall have one of the
following actions taken.
1. Approval of the modification
2. Approval Pending Stipulations
3. Defer pending receipt of additional
information
4. Disapproval
1.
Approved: An
approval is grant if the research activity meets the criteria for approval as
defined in 45 CFR 46.111 and no changes are recommended to the modification.
The investigator will receive a written notice of approval via iRIS.
2.
Approval Pending Stipulations: An approved pending status
if given if the research meets the 45 CFR 46.111 criteria for research approval
and any modifications required by the IRB require simple concurrence by the
investigator. When the
modifications requiring simple concurrence are received from the investigator,
the Chair or his/her designee may then review and confirm the modifications
through an expedited procedure.
The proposal may be referred back to the full committee if deemed
necessary by the Chair or his/her designee. The investigator will receive a written request for
modifications via iRIS.
3.
Defer pending receipt of additional information: When the convened board requests
substantive modifications or clarifications directly relevant to the
determinations required at 45 CFR 46.111, IRB approval of the proposed modification
is deferred, pending subsequent review by the convened board of responsive
material. The investigator will
receive a written request for specific or additional information required via
iRIS.
4.
Disapproval:
Disapproval is given if the modification does not meet the criteria for
approval as defined in 45 CFR 46.111 (refer to section II above). If the IRB decides to disapprove a
research activity, it shall include in its written notification a statement of
the reasons for its decision via iRIS and give the investigator an opportunity
to respond in person or in writing.
5. Table: A modification may be tabled until another meeting due to lack
of review. In the event of a loss
of quorum, all incomplete agenda items shall be considered tabled until quorum
can be reconstituted in a convened meeting.
III.
The approval date of
the protocol modification is the date of the meeting at which the CPHS approved
the modification.
IV. The decisions and possible requirements for changes
requested by CPHS are promptly conveyed to the PI in iRIS.