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IV.07
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Continuing Review of Research
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Objective
The
University of Texas Health Science Center at Houston (UTHSC-H) requires that protocols
approved by the Committee for Protection of Human Subjects (CPHS) undergo
continuing review. The CPHS conducts
continuing reviews of research covered by 21CFR,
45CFR 46, 38CFR 16 and ICH
E6 at intervals appropriate to the degree of risk, but not less than once per
year. This Policy/Procedure outlines the
requirements for conducting continuing reviews.
Policy/Procedure
I.
Protocols approved by the Committee for Protection of Human Subjects
(CPHS) undergo continuing review at least every 12 months, but the CPHS may
require more frequent reviews if it considers more oversight is necessary due
to the risks of the study. The PI will be informed in the approval letter of
the date of the next continuing review, and it will be in his/her study
information in iRIS. The PI will also be
reminded no less than 120 days prior to expiration of the approval date. However it is the responsibility of the PI to
ensure that his/her project is submitted for review on time.
II.
The PI shall be sent a Continuing Review Reminder via iRIS at 90, 60, and
30 days prior to the date the Continuing Review Submission is due.
III.
The PI shall submit a Continuing Review Submission via iRIS by the Due
Date which is the 1st day of the month in which the study is due to expire in
order to allow sufficient time for an adequate review by the CPHS.
IV.
Continuing Review is required in the following situations.
A. At intervals appropriate
to the degree of risk, but not less than once per year
B. As long as the research
remains active for long-term participant follow-up, even when permanently
closed to enrollment and participants have completed research-related
interventions
C. As long as activities include
analysis of identifiable data
D. Other requirements as
applicable
V.
Full CPHS Review
A. Research protocols
initially reviewed and approved by a full convened meeting of the CPHS will
undergo continuing review at a fully convened meeting unless the study
qualifies for expedited continuing review (See V. below).
B. Studies that were reviewed
and approved by an expedited process or were determined to be exempt may change
such that a CPHS full review and approval may be required for the continuing
review process.
C. All information required
to be submitted by the PI is listed in HRP PP VII.04. In addition to the
information provided in the Continuing Review Submission, all other information
required by regulation to be provided to the Continuing Review Committee to
assure adequate review (current protocol, serious adverse events, etc), is
recorded in iRIS and accessible to all members and consultants.
D. The IRB Coordinator will
assure that all Continuing Review Submissions are forwarded to the Continuing
Review Committee Chairman or his/her designee for assignment to a Primary
Reviewer.
E. The Primary Reviewer will
receive notification of research studies to be reviewed.
F.
Continuing review must be substantive and meaningful. The approval
criteria for continuing review are the same as that for initial review (see
Policy and Procedure II.2). Therefore it is the responsibility of the CPHS to
determine the following.
1. A current risk-benefit assessment is made based on
study results, including a review of all reported unanticipated problems and
serious adverse events. It shall be determined whether the level of risk has
changed from the last review.
2.
Selection of subjects continues
to be reasonable and impartial.
3.
When reviewing the current
informed consent document(s) the CPHS should ensure the following:
a) Whether
the currently approved informed consent document is still accurate and
complete;
b)
Any significant new findings that may relate to the
participant’s willingness to continue participation are provided to the participant
4. Adequate provisions to protect the privacy of
subjects and to maintain the confidentiality of data are provided, when
appropriate.
5. There continues to be adequate provision for
monitoring the data collected to ensure the continued safety of the participants,
when appropriate.
6.
Appropriate safeguards for
vulnerable populations are provided.
7.
Appropriate safeguards for
vulnerable populations are provided.
8. When the study is part of a multi-center trial and
is subject to oversight by a DSMB, the CPHS may rely on a current statement
from the DSMB or sponsor indicating that it has reviewed study-wide adverse
events, interim findings, and any recent literature that may be relevant to the
research, in lieu of requiring that this information be submitted directly to
the CPHS. The CPHS must still receive and review reports of local, on-site
adverse events and unanticipated problems involving risks to participants or
others and any other information needed to ensure that its continuing review is
substantive and meaningful.
9.
Review the complete protocol
including any protocol modifications previously approved
10. Any CPHS member shall have access to the CPHS
minutes from initial review and preceding continuing review of the protocol
prior to the convened CPHS meeting.
11. In addition, the CPHS may require additional
information for continuing review at its discretion
G. For each individual study
the Primary Reviewer will present his/her review of the information to the
members of the CPHS and will make a recommendation. The discussion is open to
all CPHS members.
1.
One of the following
determinations will be voted on
a) Disapproval
b) Deferral
c) Approval
pending specific criteria being met
d) Approval
e) Approval
with provisos
2. The CPHS shall determine if the research should
undergo continuing review sooner than one year, based on determination of risk.
H. The review outcome shall
be communicated to the PI via iRIS.
I.
The minutes of the convened meeting should document separate
deliberations, actions, and votes for each protocol undergoing continuing
review by the convened CPHS.
VI. Expedited Review
A. Research Protocols that
were originally reviewed using expedited review procedures may undergo
expedited continuing review unless previously met criteria have changed so the
study no longer meets the criteria for expedited review and approval.
B. Research Protocols that
were originally approved at a CPHS full board convened meeting may undergo expedited review by the
CPHS:
1. If the research is permanently closed to the
enrollment of new participants, all participants have completed all
research-related interventions, and the research remains active only for
long-term follow-up of participants; or
2. No participants have ever been enrolled at this site
and no additional risks have been identified (neither the investigator nor the
CPHS at this site has identified any additional risks from any site or other
relevant source); or
3.
Where the remaining research
activities are limited to data analysis.
C. The review outcome shall
be communicated to the PI via iRIS.
VII.
Expired Study
A. When the PI has not
submitted the Continuing Review Submission by the Due Date, he/she will be sent
a notification that the study will expire on the indicated expiration
date.
B. When continuing review of
a research protocol does not occur prior to the end of the approval period
specified by the CPHS, CPHS approval expires automatically. Such suspension of CPHS approval does not
need to be reported to OHRP as a suspension of CPHS approval.
C. On the date of expiration
a formal notice of termination of the study is sent to the PI, informing
him/her that:
1.
Enrollment must stop; and
2. All research activities must stop unless the PI
requests that the CPHS finds that there is an over-riding safety concern or
ethical issue such that it is in the best interests of individual subjects to
continue participating in the research interventions or interactions.