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HRPP Policy - IRB Meetings and Minutes
About This Policy
- Effective date:
- Last updated:
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IU Human Research Protection Program (HRPP)
IU has four (4) IRBs that are charged with understanding and applying their obligation to protect the rights and welfare of human research subjects recruited to participate in research activities and to ensure compliance with applicable institutional policies and federal and state regulations.
The IU IRBs meet multiple times per month, with the exception of IRB 07, which is an ad hoc IRB that meets only when called by the Chair. Meeting schedules are provided to IRB members well in advance of the meetings. The IRB Chair may, however, call additional meetings at any time if necessary.
Quorum must be present at the IRB meeting to conduct business, take action, or vote. Quorum is constituted of a majority of voting IRB members, or their designated alternates, present at the IRB meeting, including at least one member whose primary concerns are in nonscientific areas. ; Members who attend remotely, such as by phone or video conference, are counted toward quorum. Members who leave the meeting or are absent for discussion and voting on an item due to a conflict of interest, or for any other reason, do not count toward quorum.
A nonaffiliated member and a member who represents the general perspective of research subjects should be present at IRB meetings. These roles can be filled by the same person. Meetings may be held without the nonaffiliated and subject representative members, if necessary; however, frequent absences are not acceptable.
Prisoner representatives attend only as needed and only affect quorum when present at a meeting.
Committee decisions are made by a majority vote of the members present at the meeting. ; Voting occurs only after there has been a full, open discussion.
An IRB may, in its discretion, invite individuals with competence in special areas (e.g., consultants) to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB or be counted toward quorum. The IRB cannot delegate to consultants its responsibility to determine whether the criteria for approval are met.
When the IRB reviews research that affects the risk to pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates; children; or individuals lacking consent capacity, at least one individual (IRB member or consultant) who is knowledgeable about or experienced in working with such subjects must be present at the meeting or provide written comments. When the IRB reviews research involving prisoners as subjects, at least one individual (IRB member) who is knowledgeable about or experienced in working with prisoners must be present at the meeting.
Any IRB member or consultant present at a meeting who has a conflicting interest in a matter cannot vote on that matter and must be absent from the meeting during the deliberation and voting. He/she can, however, be in attendance to present information or answer questions as requested by the IRB. Conflicting interests include:
- Participation in the protocol
- PI of the protocol is an immediate family member
- Significant financial interest as defined by the IU Policy on Conflicts of Interest and Commitment
- Certain non-financial interests, including having supervision over the PI of the project or participating in a project that is in direct competition with the project
- Any other real or perceived conflict.
Meeting materials are made available to all members of the IRB in advance of the meeting. The following items are included at minimum, as applicable:
- Minutes from the most recent meeting for review and approval
IRB meetings are documented by the IRB minutes, which include the following:
- Attendance at the meeting
- Names of IRB members who leave the meeting, and if applicable, whether it was due to a conflict of interest
- Reviewers submitting written comments in lieu of attendance at the meeting
- Alternate member replaces an IRB member, including the name of the alternate member, if any
- Consultants serving as reviewers, if any
- Actions taken by the IRB, including votes for, against, or abstaining, and the names of IRB members who abstain, if any
- Description of the submission/event/circumstance
- Accounting of deliberations for each item, including a summary of the discussion of controverted issues and their resolution, the basis for requiring changes in research, and the basis for disapproving research
- The approval period (for initial approval and renewals)
- Determinations required by the regulations and research-specific findings justifying determinations for waiver or alteration of the consent process or documentation
- Determinations that the study has appropriate plans for research involving special populations, including children, prisoners, pregnant women, fetuses, neonates of uncertain viability or nonviable neonates, and individuals lacking consent capacity
- Determination as to whether a device is a significant or non-significant risk device, if any
- For determinations of unanticipated problem involving risks to subjects or others, or serious and/or continuing noncompliance, or if the IRB suspends or terminates approval of research:
- Reasons for the IRBs actions
- Plans for continued investigation and/or action
IRB minutes are approved on a regular basis by the IRB Chair or acting Chair who presided over the meeting. Once approved, administrative errors discovered during routine QA (e.g. errors that could be corroborated by other documentation) may be corrected with the approval of the University Director, HRPP. Other revisions should be reviewed and approved by the IRB Chair or acting Chair.
For meetings at which VA research was reviewed, approved minutes are provided to the VA Research and Development Committee in a timely manner.
IRB minutes and decisions may be made available, upon request, to relevant individuals or institutional officials at IU and/or its affiliates.
A primary reviewer system is used for items requiring review by the convened IRB. This includes amendments, renewals, and general information, including reportable events. For new studies which are greater than minimal risk requiring review by the convened IRB, at least two reviewers are assigned. Human Research Protection Program (HRPP) staff evaluate each study and assign a reviewer(s) with appropriate scientific expertise to conduct the in-depth review. A nonscientist or nonaffiliated member may be assigned as one of the reviewers.
If an IRB member feels the item they have been assigned to review is outside of their area of expertise and/or if they have, or believe they have, a conflict with the item, the IRB member should contact the HSO as soon as possible so the item may be reassigned to another IRB member to review and/or an additional reviewer can be identified.
Complete submission information is made available for review by any IRB member at the meeting, and any member may review the full research study.
A minimum of the following items, as applicable, are provided to all IRB members:
- IRB application form containing the relevant information to determine whether the proposed research fulfills the criteria for approval (this information may also be contained in the Protocol and/or consent document);
- Consent/assent document(s);
- Recruitment materials;
- Protocol and investigator's brochure;
Except for life-threatening emergencies that meet very specific requirements as outlined in the IU HRPP Policy on Emergency Use of Investigational Test Articles, review of all research that qualifies for full IRB review is performed at a convened IRB meeting.
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
- IRB Agenda Template
- IRB Minutes Template
- AAHRPP Standards
- Element I.5.D
- Standard II-1, Elements II.1.D, II.1.E
- Standard II-2, Elements II.2.D, II.2.E, II.2.G
- Element II.4.A
- Element II.5.B
- 21 CFR 56
- 45 CFR 46
- IU Policy on Conflicts of Interest and Commitment (UA-17)
- Memorandum of Understanding Between Richard L. Roudebush Veterans Affairs Medical Center and Indiana University Concerning Utilization of Indiana University’s Institutional Review Boards
- OHRP/FDA Guidance:
- VHA Directive 1200.05 – Requirements for the Protection of Human Subjects in Research, especially section 8
assent, continuing noncompliance, federally-funded, fetus, human subject, institutional review board (IRB), life-threatening, minimal risk, neonate, noncompliance, nonscientist, prisoner, recruitment, reportable event, research, serious noncompliance, significant financial interest, unanticipated problem involving risks to subjects or others (UPIRTSO)
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