302: IRB meeting administration
The purpose of this policy is to provide the framework to ensure that IRB meetings are conducted and documented in a consistent manner in order to meet federal and institutional requirements.
Except when an expedited or exempt review procedure is used, the IRB will review proposed research at convened meetings at which a quorum and appropriate expertise is present. The IRB will meet monthly, or at some other frequency determined by the chairperson and the Office of Research Assurances (ORA) director.
3. Specific policies
- A quorum is defined as the majority of the voting members.
- A quorum consists of regular and/or their alternate members and includes at least one member whose primary concerns are in scientific areas, and one member whose primary concerns are in nonscientific areas.
- An alternate member may attend in the place of an absent regular member in order to meet the quorum requirements outlined above.
- IRB members who leave the room due to a conflict of interest cannot be counted towards quorum.
- When the IRB reviews research that involves subjects vulnerable to coercion or undue influence, at least one person (member or consultant) who is knowledgeable about or experienced in working with such subjects must be present at the convened meeting.
- At least one IRB member who is a licensed physician must be present at the convened meeting.
- For research to be approved, it must receive the approval of a majority of the members present at the meeting.
- If quorum is lost during a meeting, the IRB will not vote until quorum is restored even if that means deferring the vote to next month’s meeting.
- Consultants will not be used to establish a quorum and may not vote with the IRB.
- Each member has one vote.
- No proxy votes are allowed. Members may attend the IRB meeting by video conference or by telephone. It is the responsibility of the member to contact the IRB coordinator to ensure the necessary equipment will be available.
3.2 Primary and secondary reviewers (and tertiary, for full-board applications)
Prior to the meeting, the IRB coordinator with assistance from the ORA director and chairperson will designate primary and secondary reviewers (and tertiary, for full-board reviewed applications) for each research proposal, including continuations, and amendments, according to their scientific or scholarly expertise. If there is not a member with the appropriate expertise; an expert consultation will be arranged.
If there is not an appropriate scientific or scholarly reviewer (member or consultant) to conduct an in-depth review of the protocol, the protocol will be deferred to the next month’s IRB meeting.
3.3 Meeting materials sent prior to IRB meetings
All IRB members including those attending by conference call and alternates will have access to all required meeting materials at least ten (10) days in advance of the meeting to allow time for adequate review.
All members will have access to all the submission documents as well as the entire study file, via SharePoint.
Each member will receive an agenda. The agenda will list which members are assigned to be the primary and secondary reviewers (and tertiary, for full-board reviewed applications) for each study that is to be reviewed. The agenda also includes reporting of exempt and expedited studies and actions.
IRB meeting materials include, but are not limited to:
- IRB application with addendums
- Proposed informed consent document(s) and/or script as appropriate
- Copies of surveys, questionnaires, or videotapes
- Copies of letters of assurance or cooperation with research sites
- Recruitment/advertising intended to be seen or heard by potential subjects, including email solicitations and physician letters
- Reviewer’s comment sheet and informed consent checklist
- Translation, if appropriate
Continuing review materials
- Completed continuing/renewal form
- Current approved consent/assent document(s)
- A copy of the current HIPAA authorization document, if separate from the informed consent, if appropriate
- Any other relevant documents provided by the investigator
- Reviewers’ comment sheets
Amendments to the research
All IRB members are provided and are asked to review sufficient information about the proposed modifications to previously approved research to determine whether the modified research continues to fulfill the criteria for approval. The reviewer materials include:
- Revised application with highlighted changes
- Reviewers’ comment sheets
- Informed consent checklists, if appropriate
- The IRB coordinator or staff will take minutes of each meeting. Minutes will be written in sufficient detail to show the following:
- Attendance at the meeting including:
- Members or alternate members attending through teleconferencing and documenting that those members have received all IRB materials and can actively and equally participate in the discussion
- Status of each attendee (regular member, consultant, etc.)
- Alternate members and whom they are replacing
- Names of members who absent themselves due to conflicts of interest along with a notation that the member left due to a conflict
- Documentation of members leaving and re-entering
- Actions taken by the IRB on each agenda item requiring full IRB action
- Separate deliberations for each action.
- Scientific design
- Subject selection and recruitment
- Additional safeguards for vulnerable subjects
- Privacy and confidentiality
- Minimization of risks to subjects
- Risk/benefit assessment
- Determination that all required elements of the consent document are present
- Controverted issues
- Voting results, including the number for, against, abstaining, and abstaining: due to a conflict of interest
- The basis for requiring changes in research
- The basis for disapproving of the research
- Written summary of the discussion of controverted issues and their resolution
- Determination of level of risk
- Summary of key information from consultant’s verbal in-person report if a written report was not provided
- Determination of approval period, whether protocols need to be reviewed more than annually (initial and continuing review)
- Determinations required by the regulations, and protocol-specific findings justifying those determinations, for:
- Waiver of alteration of informed consent
- Research involving pregnant women, human fetuses, and neonates
- Research involving prisoners
- Research involving children as subjects
- The rationale for significant risk/no significant risk device determinations
- Documentation of approval of research that was contingent on specific minor conditions reviewed and approved by the chair or designee. This documentation must take place at the first meeting after the date of approval
- Report on full board protocols approved in the interim
- Follow up on deferred protocols
- Expedited amendment/continuing review approvals for full board protocols
- Report of adverse event(s)
- A list of
- Expedited applications (new, amendment, and continuing review) approved since the last meeting and also for the fiscal year
- Expedited amendments/renewals for full-board applications approved since the last meeting.
A majority of members must vote in favor of an action for that category of action to be accepted by the IRB. Only regular and alternate members acting in place of absent regular members may vote. The vote will be recorded in the minutes. Members with a conflict of interest will absent themselves from the discussion and voting and such will be noted in the minutes.
3.5 Distribution of minutes
- Minutes must be written and available for review before the next meeting.
- Draft minutes will be distributed to members at the next IRB meeting for review.
- Corrections requested by the IRB will be made by the IRB coordinator and the minutes will be available in final form on request.
- The recorder will maintain copies of the minutes, as well as the agenda and pertinent materials on file.
- Once approved by the IRB members at a subsequent IRB meeting, the minutes may not be altered by anyone including a higher authority.
- A copy of the final minutes will be forwarded to the vice president for research.
3.6 Meeting conducted via conference calls and videoconferencing
Meetings may be convened via a telephone conference call and/or videoconference. A quorum (as defined above) must participate for the conference call meeting to be convened. To allow for appropriate discussion to take place, all members must be connected simultaneously for a conference call or videoconference to take place. “Telephone polling” (where members are contacted individually) will not be accepted.
Members not present at the convened meeting, nor participating in the conference call or videoconference may not vote on an issue discussed during a convened meeting. (No voting by proxy.)
Members of the IRB vote motions made and seconded according to the criteria for approval. Members also will determine level of risk, the frequency of review for each protocol, and that the criteria for approval have been met.
4. Applicable regulations and guidelines
6. Procedures employed to implement this policy & assignment of responsibility
|IRB coordinator||Complete agenda and ensure that everyone has one prior to start of meeting as well as a copy of the last meetings’ minutes|
|ORA director, chairperson, IRB coordinator||Evaluate each protocol prior to the meeting to ensure that at least one IRB member is knowledgeable about or experienced in working with subjects vulnerable to coercion or subjects who may be subject to undue influence. If no IRB member is available, obtain consultant.|
|IRB coordinator/staff||Assemble agenda and upload all applicable study files to secured website. Include in the agenda reporting of exempt reviews, expedited reviews and unanticipated problem reports received since the last IRB meeting. Also include other pertinent or applicable information needed to be reported to IRB members.
Record proceedings of the meeting.
Complete draft minutes in time to include in the reviewers' packets for the next meeting (within 3 weeks).
|Chairperson||Ensure that quorum is met, expertise is present and all business is addressed, that proceedings are recorded, and that any member who has a conflict of interest does not participate in the IRB’s consideration of the study for determination, except as requested by the IRB, or in voting.|