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II.09 |
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Committee for the
Protection of Human Subjects Meeting Process |
Objective
This
procedure describes the conduct of a convened meeting of The University of
Texas Health Science Center at Houston (UTHSC-H) Committee for the Protection
of Human Subjects (CPHS). The CPHS is UTHSC-HÕs Institutional Review Board
(IRB).
Policy/Procedure
I. A fully convened meeting of the CPHS must review research human subjects research that does not qualify for CPHS review under the exempt or expedited categories. The three IRB panels each meet monthly barring extenuating circumstances such as University closure, etc.
II. The Chairperson or designated chair pro-tem shall call the meeting to order.
A. Announcements shall be made, including but not limited to:
1. Reminder of the conflict of interest policy (COI) - CPHS members who are involved in research listed on the agenda may not be present during discussions or voting, unless the CPHS requests the member remain to provide information about the research;
a) The chairperson shall ask that any conflict of interest(s) be declared (as defined by HOOP 23.10).
2. Reminder that all discussion during the meeting is confidential.
B. It shall be determined if a quorum/other requirements have been met.
1. Quorum is defined as over one-half of the voting members (the Chair is considered a voting member).
2. At least one member whose primary concerns are in nonscientific areas must be present.
3. A prisoner representative must be in attendance for all protocols involving prisoner research.
C. No official actions may take place without a quorum.
1. Should the meeting lose quorum (e.g., those with conflicts of interest being excused, those leaving early, loss of non-scientist, stepping out of the meeting for any reason during the vote), it shall be closed for further votes until the quorum is re-established, and noted in the minutes which member(s) left or recused themselves.
2. Wherever possible, CPHS meetings shall take place with all participating CPHS members physically present. Circumstances sometimes warrant conducting meetings via a telephone conference call. A member who is unable to be present at the convened meeting may participate by videoconference or a conference telephone call, as long as the member has access to all of the documents in Internet Research Information Systems (iRIS), that are to be reviewed at the meeting. Such member(s) may vote and be counted as part of the quorum.
a) Minutes of such meetings must clearly document that the member(s)
(1) Has(ve) had access to all information; and
(2) Can actively and equally participate in the discussion of all protocols.
3. At the discretion of the CPHS Chairperson, an executive session may be called for discussion of sensitive and/or confidential issues. In this event, only voting members shall be allowed to stay in the room. At the discretion of the Chair, non-voting members, the panel coordinator and other staff members, and additional persons may also be invited to attend for specific testimony or tasks.
D. Substantive review of research shall include all materials submitted by the investigator (via iRIS), additional information and clarification obtained by the primary reviewer and subcommittee from the investigator, comments and recommendations of consultants, and discussion of issues by CPHS members. This information shall be available for all research issues brought before the CPHS (including but not limited to initial review, modifications, continuing review, as well as informational issues such as data safety monitoring reports, progress reports, etc). At the discretion of the panel Chairperson or his/her designee, protocol deviations and incidents of non-compliance may be included on the agenda.
1. The subcommittee Chairperson, or designee, shall present a report on the research, a summary of the consensus of the subcommittee, and make a motion as to the recommended action to be taken, when appropriate.
2. The Chairperson shall open the floor for discussion of the research as submitted.
3. The CPHS shall discuss the proposed research and review it according to the appropriate Policy and Procedure.
4. A vote is taken on each agenda item individually, as appropriate, and recorded.
E. Prior to the discussion of each protocol, any CPHS members who have a COI must excuse themselves from the room, unless the CPHS requests the member be present for any relevant questions. The member with the COI must leave the room during the voting. The meeting minutes shall specifically document any recusals.
F. The following are types of determinations/motions that may be taken by the CPHS
1. Approval – When the research meets the criteria for approval as defined in 21CFR 56.111, 38 CFR 16.111 or 45 CFR 46.111 and no changes to the submission are recommended. The investigator will receive a written notice via iRIS.
2. Approval pending – status of research that meets the criteria for approval as defined in 21CFR 56.111, 38 CFR 16.111 or 45 CFR 46.111, but with modifications and/or clarifications to be made before final approval. When the convened CPHS stipulates specific revisions requiring simple concurrence by the investigator, the research is approved if, on review, the modifications have been made by the Investigator and confirmed by the Chairperson or his/her designee. If any modifications have not been made, or additional modifications have been made that were not requested, the Chairperson or his/her designee refers the study to full CPHS review, unless the CPHS asked for correction of factual errors. The investigator will receive a written request for modifications via iRIS.
3. Deferral - When the convened CPHS requests substantive clarifications or modifications regarding the protocol or informed consent documents that are directly relevant to the determinations required by the CPHS under HHS regulations at 21CFR 56.111, 38 CFR 16.111 or 45 CFR 46.111. Subsequent review of any responsive material will return to the convened CPHS panel that performed the initial review. The investigator will receive a written request for specific or additional information via iRIS.
5. 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.
G. The Chairman shall entertain any other discussion(s).
H. The meeting shall be adjourned by the Chairperson.
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Applicable Regulations and Guidelines 21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html
) 21CFR 50 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html
) 38CFR 16 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html
) 45CFR 46 ( http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html
) ICH E6 ( http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB
) AAHRPP Evaluation
Instrument For Site Visitors ( http://www.aahrpp.org/Documents/D000043.PDF
) FDA Information Sheets
– Frequently Asked Questions
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Updated
10/2007, Report broken links |