626. IRB Minutes
Updated July 1, 2019
Minutes of IRB meetings will be prepared in sufficient detail to demonstrate that IRB meetings were convened with a quorum of members and IRB deliberations reflecting appropriate regulatory or legal requirements. IRB Committee meeting minutes must accurately reflect the discussion and voting that took place at the meeting. RI staff will take notes during attendance and staff are responsible for preparing the minutes.
The Minutes will adequately document the following:
Attendance: A record of attendance of members, noting the key compositional requirements for Quorum and noting which members are eligible to vote, and a record of attendance of guests at the IRB Committee meeting
Attendance by Alternate Means: A record of those members or alternate members who participated in the meeting through videoconference or teleconference (speakerphone) and documentation that those attending via such means received all pertinent material prior to the meeting and were able to actively and equally participate in all discussions.
Quorum: A record of Quorum and/or loss of Quorum at each IRB meeting, including presence of one member whose primary concern is in a non-scientific area. Minutes shall specifically note changes in the voting members present during voting on each item throughout the meeting, in order to document the maintenance of Quorum. The minutes shall also note when departing members are replaced by other members during the meeting in order to maintain quorum.
Actions: A record of actions taken by the IRB. The minutes shall reflect separate deliberations, actions and votes for each protocol undergoing initial review, continuing review or review of modifications by the convened IRB. The IRB shall use the minutes and the meeting agenda to notify IRB members of actions taken through Expedited Review.
Votes: A record of votes taken by the IRB Committee on all actions, including the total number of votes, the number of votes for, against and abstaining. The vote on each action will reflect those members eligible to vote on that item.
Basis for Action: A description of the IRB Committee's rationale for requiring changes in or disapproving a protocol.
Discussion of Controverted Issues: A written summary of IRB Committee discussion of issues, including those involving opposing views, and their resolution.
Justification for Changes to HHS Approved Consent Documents: A record of the justification for any deletion or substantive modification of information concerning risks or alternative procedures contained in HHS-approved sample consent documents.
Conflict of Interest: For any IRB Committee meeting in which an IRB Chair, Vice Chair or IRB member recuses himself/herself due to a conflicting interest with the research under review, the minutes reflect that a conflicting interest has been disclosed. The member with the conflicting interest may provide information on the item under review if requested by the IRB Chair or members. The Minutes should reflect the member left the meeting and was not involved in any discussion regarding voting on the protocol in question and was not counted towards Quorum for the discussion. Minutes must reflect the reason for the recusal.
Vulnerable Populations: A record that reflects that the IRB reviewed additional safeguards to protect Vulnerable Populations if entered as study subjects, if this information is not otherwise documented in IRB records.
Review Period: For Initial and Continuing Review, a record of the duration of the approval granted to each protocol, as determined by the IRB.
Risk Level: The risk categories to be used are minimal risk or greater than minimal risk.
HIPAA: A record, as required by 45 CFR Section 164(i)(2), indicating the approval of a waiver or alteration of the HIPAA Authorization requirement. The presence of a HIPAA waiver/alternation worksheet within the electronic study submission, which describes how each criterion for a waiver/alteration is met, will suffice for a record of why the waiver/alteration was granted. Any additional discussion of how the study does or does not satisfy those criteria will be recorded in the minutes.
Consultants (and ad hoc Reviewers): A record of key information provided by Consultants if any.
Required Findings: Description of any required findings that IRB must make with regard to particular protocols along with the protocol-specific information justifying each IRB finding. In particular, documentation shall be included that:
- Establishes that the Research meets each of the required criteria of 45 CFR Section 116(d) along with protocol-specific information to justify why the IRB considers the Research to meet each criterion when approving a consent procedure that does not include or that alters some or all of the required elements of informed consent, or when waiving the requirement to obtain informed consent (unless excluded under the IRB Flexibility policy).
- Establishes that the Research meets each of the required criterion in 45 CFR 46.117 along with protocol specific information justifying why the IRB considers the Research to meet each criterion when the requirements for written documentation of consent are waived;
- When approving Research that involves populations covered by 45 CFR Subparts B, C, or D, the minutes shall set forth the protocol specific justifications and findings regarding the determination stated in the Subparts, or the IRB's agreement with the findings and justifications as presented by the Investigator on IRB forms
- When applicable under the FDA Regulations: rationale for significant risk/non-significant risk device determinations.
- Determinations under 45 CFR 46 Subpart B for research involving pregnant women, fetuses, or neonates
- Determinations under 45 CFR 46 Subpart C for research involving prisoners
- Determinations under 45 CFR 45 Subpart D for research involving children
Documentation for Full Committee Review
For each project/package reviewed by the IRB, the following will be available in IRBNet posted in Discussion and Remarks text box;
- IRB Actions/determinations
- Review type
- The vote on IRB actions, including the number of members voting for, against, and abstaining
- A written summary of the discussion and resolution of controversial issues
- Minor or substantive revisions required to secure approval and the basis for the revisions
- The basis for disapproving research
- The effective date, the initial approval date and expiration date;
Documentation of Actions Completed Outside of Convened Meetings
For projects/packages approved with specific minor conditions, the minutes of the first IRB meeting that takes place after approval was finalized will provide the date the conditions were met.
IRB minutes include sufficient information to notify IRB members of the following:
- Expedited reviews of new projects, including Expedited Review Category
- Expedited reviews of minor amendments to full board protocols, including a list of the amendments and confirmation the amendments met the criteria for Expedited Review (i.e., the amendments pose minimal risk and involve activities in one or more of the Research Categories eligible for Expedited Review)
- Expedited reviews of amendments to research initially approved by expedited procedures, including a list of the amendments and Expedited Review Category
- Expedited continuing reviews, including Expedited Review Category
NOTE: For research reviewed under expedited procedures, regulatory requirements for discussions, decisions and findings (including protocol-specific justifications) will be documented in IRBNet or via other records. This includes findings related to level of risk and waivers or alterations of informed consent.
Review and Approval of Minutes
The minutes of each IRB meeting are available for review by the Chair and members in IRBNet or upon request. RI staff will send an email within three weeks of the original meeting date with information to access the draft Minutes in IRBNet to all members, including those member unable to attend the meeting. All members are requested to review the Minutes and those members that did attend the meeting to send any changes or required revisions to RI staff. RI staff will make the changes or revisions to the draft Minutes and share with all members. Draft Minutes (revised as appropriate) will reviewed at the next IRB meeting. Generally, there should be two or three members that attend each meeting for purposes of continuity in IRB deliberations. In addition, at least two members of RI staff should attend each meeting. All members should engage in the review of the Minutes even if not in attendance to keep informed of IRB deliberations.
Once approved by the members at a subsequent IRB meeting, minutes cannot be altered by anyone including a higher authority. Minutes are available upon request by the Vice President for Research and Innovation, officials at Institutional Affiliates, federal agencies as applicable to the research, and sponsors. Approved minutes are retained in the Research Integrity for three years.