|
II.08
|
|
Continuing Review of Research
|
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 15th day of
the month prior to 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 Policy and Procedure II.7. In
addition to the information provided in the Continuing Review Submission, all
other information required by regulation to be provided to CPHS 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 Chairman or his/her
designee for assignment to a Primary Reviewer.
E. The Primary Reviewer will receive notification of research studies to
be reviewed. 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.
F. Continuing review must be substantive
and meaningful. Full information regarding the continuing review (application
and supplemental information) is provided to CPHS members within iRIS. 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 participantŐs 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. 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.
8.
Review the complete protocol including any protocol
modifications previously approved
9. 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.
10.
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 including a statement of no material changes to the protocol and will make
a recommendation. The discussion is open to all CPHS members.
1. One of the following determinations will be voted on
a. Approval of the proposal
b. Approval Pending Stipulations
c. Defer pending receipt of additional
information
d. Disapproval
a)
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 proposal. The investigator will receive a
written notice of approval via iRIS.
b)
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.
c)
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 research 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.
d)
Disapproval: Disapproval is given if the proposal
does not meet the criteria for approval as defined in 45 CFR 46.111. If the IRB decides to disapprove a
research activity, it shall include in its written notification a statement of
the reasons for its decision and give the investigator an opportunity to
respond in person or in writing.
e. Table: A protocol 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.
2. The CPHS shall determine if the research should undergo
continuing review sooner than one year, based on determination of risk.
H. The decisions and possible requirement
for changes are promptly conveyed to the PI in 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 decisions and possible requirements for changes
are promptly conveyed to the PI in 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.