II.03

 

 

CPHS Meetings and Minutes

 

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PURPOSE

1. The purpose of this policy and procedure is to describe the conduct of a convened meeting of CPHS and the minutes of the meeting.

SCOPE

2. This policy and procedure is applicable to CPHS Members and ORSC Staff.

POLICY

3. A fully convened meeting of the CPHS must review human subjects research that does not qualify for exempt or expedited review. CPHS has 3 IRB Panels. Each IRB Panel meets monthly and reviews all types of research protocols.

4. Actions at the meeting may be taken only when a quorum is present. A quorum is considered over one-half of the voting members. The quorum must include at least one member whose primary concerns are in nonscientific areas. Should the meeting lose quorum, it shall be closed for further votes until the quorum is re-established.

PROCEDURE

5. Meeting Agenda - The ORSC Staff will prepare the meeting agenda and distribute to CPHS members prior to each meeting. The agenda and meetings materials are maintained in iRIS. All CPHS members have access to meeting materials in iRIS to allow them to perform a substantive review.

6. Meeting Process: When quorum is met, the Chairperson shall call the meeting to order. The Chairperson shall announce that members who are involved in research listed on the agenda may not be present during discussions or voting, except to provide information about that research. The Chairperson shall ask that any conflict of interest(s) be declared. The Chairperson will also remind members that all discussions during the meeting are confidential.

6.1. Prior to the discussion of each item on the agenda, 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 voting. The meeting minutes shall specifically documents the names of members who left the room due to a conflict of interest.

6.2. For each item on the agenda, the subcommittee Chairperson, or designee, shall present a summary of the research submission with emphasis on the ethical issues and identified concerns. The subcommittee Chairperson will make a motion to approve, approve pending, defer or disapprove the submission and the motion is seconded. The IRB Chairperson shall then open the item for discussion by the Committee. Following discussion, the IRB Chairperson calls for a vote for all in favor of the motion, all opposed and any abstentions. The ORSC Staff records the vote.

6.3. After all the items on the agenda are discussed, the Chairman shall open the meeting for any other discussion(s). The meeting shall be adjourned by the Chairperson.

7. Special Circumstances:

7.1. Teleconferencing: Whenever 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. Member(s) participating through teleconferencing may vote and will be counted as part of the quorum.

7.2. Executive Sessions: At the discretion of the Executive Chairperson or IRB Panel 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 Chairperson, non-voting members, the panel coordinator and other staff members, and additional persons may also be invited to attend. The discussion and outcome of the Executive Session are recorded in the minutes.

7.3. Principal Investigator: The Principal Investigator and/or any member of the study team may be invited to attend the meeting to provide information on any aspect of a research project submitted to CPHS for review and approval. The PI and/or any member of the study team however, shall not participate in the deliberation, decision-making and voting.

8. Minutes: The ORSC Staff will prepare the meeting minutes.

8.1. The minutes will include the following general information:

  1. Date and time the meeting begins and ends.
  2. Members present at the meeting.
  3. Any alternate members present that are voting and for whom they are voting.
  4. Guests, staff, and ex-officio members that are present.
  5. Any announcements made by those present.
  6. Any old business discussed.
  7. Any informational/educational documents provided to the CPHS Members.

8.2. For each protocol undergoing initial review, continuing review, and review of change requests, protocol deviation, data and safety monitoring reports and other miscellaneous items on the agenda, the minutes shall include the following details:

  1. Summary of discussions of controverted issues and their resolution, even when the resolution of the issue is to accept the protocol as submitted.
  2. Action taken.
  3. The basis for requiring modifications to the research as presented including but not limited to, application, informed consent document, advertisements, etc.
  4. The basis for disapproving research.
  5. For initial and continuing reviews, the decision for the period of approval.

8.3. For NIH-supported multi-center trials, the minutes shall include justification of any deletion or substantive modifications of information concerning risks or alternative procedures contained in the DHHS-approved sample ICF, as required and approved by the CPHS.

8.4. When reviewing emergency research requesting exception from informed consent requirements, the minutes shall specifically record the licensed physician memberÕs affirmative vote and document that the research meets FDA criteria for approval of exception from informed consent requirements for emergency research.

8.5. When CPHS makes specific determinations, these findings shall be fully documented in the minutes and shall include protocol-specific information justifying each determination. Examples of specific determinations include the following:

  1. Alteration or waiver of informed consent
  2. Waiver of documentation of informed consent
  3. Research involving children as participants
  4. Research involving prisoners
  5. Research involving pregnant women, fetuses and neonates,
  6. Documentation of the rationale for significant risk / non significant risk determinations for research involving devices

8.6. Voting: The ORSC Staff shall include summary of the voting results for each protocol item discussed. The minutes shall document votes on each action taken including the number of members voting for, against, and abstaining. The names of those members not present for vote due to conflict of interest shall be documented. Votes shall be recorded in the minutes using the following format:


Total = 16,
Vote: For-13,
Opposed-0,
Abstained-1
Not Present for Vote Š 2 (Name of person with COI)

9. Dissemination and Approval: Copies of the draft minutes shall be distributed to all CPHS members and the Executive Vice President for Research for review and comment. Following review and comment, the ORSC Staff will forward the finalized minutes to the IRB Chairperson for approval and signature. ORSC Staff will file the signed minutes in the ORSC office.

RESPONSIBILITY

10. The ORSC Staff are responsible for logistical arrangements of the meeting.

11. IRB Chairperson is responsible for the overall conduct of the meeting and members are responsible for conducting substantive review of research items on the agenda.

12. The ORSC Staff are responsible for preparing minutes of the meeting.

 

 

Applicable Regulations and Guidelines

1. 45 CFR 46
2. 21 CFR 56
3. 21 CFR 50

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Updated 2/2009, Report broken links