4 Documentation and Records
1 Documentation and Records
The IRB must prepare and maintain adequate documentation of the IRB’s activities including, copies of all items reviewed, including, but not limited to:
- research protocols
- investigators’ brochures, if any
- recruitment materials
- scientific evaluations (if any) that accompany the proposals
- approved consent documents, including DHHS-approved sample consent document and protocol, when they exist
- HIPAA Authorization documents if separate from the informed sample consent documents
records of continuing review activities, including progress reports submitted by investigators
- any proposed amendments and the IRB action on each amendment
- reports of injuries to participants and serious and unexpected adverse events
- documentation of protocol violations
- documentation of non-compliance with applicable regulations
- statements of significant new findings provided to participants
- IRB membership roster(s)
- IRB meeting minutes
- Copies of all correspondence between the IRB and the investigator
IRB records must also document any determinations required by the regulations and protocol-specific findings supporting those determinations, including:
- waiver or alteration of the consent process
- research involving pregnant women, fetuses, and neonates
- research involving prisoners
- research involving children
A membership list of IRB members must be maintained. It must identify members sufficiently to describe each member's chief anticipated contributions to IRB deliberations. The list must contain the following information about members:
- Earned degrees
- Affiliated or non-affiliated status (neither the member nor an immediate family member of the member may be affiliated with the university)
- Status as scientist (physician-scientist, other scientist, non-scientist or social behavioral scientist). For purposes of this roster, IRB members with research experience are designated as scientists (including the student member). Research experience includes training in research (e.g., doctoral degrees with a research-based thesis) and previous or current conduct of research. Students being trained in research fields will be designated as scientists.
- Indications of experience, such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IRB deliberations.
- Representative capacities of each IRB member; which IRB member is a prisoner representative (as required by Subpart C), and which IRB members are knowledgeable about or experienced in working with children, pregnant women, cognitively impaired individuals, and other vulnerable populations locally involved in research.
- Role on the IRB (Chair, Vice Chair, etc.)
- Voting status (Any ex officio members are non-voting members)
- Alternate status, including the member they alternate with
- Relationship (e.g., employment) between the individual IRB member and the organization
RPO must keep the IRB membership list current. The RPO Director, or designee, must promptly report changes in IRB membership to the Office for Human Research Protections, Departments of Health and Human Services.
Proceedings should be written and available for review by the next regularly scheduled IRB meeting date. Once approved by the members at a subsequent IRB meeting, the minutes must not be altered by anyone including a higher authority.
Minutes of IRB meetings must contain sufficient detail to show:
- names of members present
- names of members or alternate members who are participating through videoconference or teleconference and documentation that those attending through videoconferencing or teleconferencing received all pertinent material prior to the meeting and were able to actively and equally participate in all discussions
- names of absent members
- names of alternates attending in lieu of specified (named) absent members. (Alternates may substitute for specific absent members only as designated on the official IRB membership roster)
- names of consultants present
- name of investigators present
- names of guests present
Note: The initial attendance list shall include those members present at any point during the meeting. The minutes will indicate, by name, those members who enter or leave the meeting. The vote on each action will reflect the number of members present for the vote on that item.
- The presence of a quorum throughout the meeting, including the presence of one member whose primary concern is in a non-scientific area
- Business Items discussed
- Continuing Education
- Actions taken, including separate deliberations, actions, and votes for each protocol undergoing initial review, continuing review, or review of modifications by the convened IRB
- Votes on these actions (total number voting; number voting for; number voting against; number abstaining; number of those excused; number of those recused)
- Basis or justification for these actions including required changes in research
- Summary of controverted issues and their resolution
- Approval period for initial and continuing approved protocols, assumed to be 12 months unless otherwise indicated
- Risk level of initial and continuing approved protocols
- Review of interim reports, e.g. adverse event or safety reports, amendments, report of violation, etc.
- Review of Data and Safety Monitoring Board (DSMB) summary
- Applications that have met or not met requested stipulations
- Protocol-specific documentation that the research meets the required criteria [45 CFR 46.116(d)] 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 an informed consent
- Protocol-specific documentation that the research meets the required criteria [45 CFR 46.117(c)] when the requirements for documentation of consent are waived
- When approving research that involves populations covered by Subparts B, C, or D of 45 CFR 46, the minutes will document the IRB’s justifications and findings regarding the determinations stated in the Subparts or the IRB’s agreement with the findings and justifications as presented by the investigator on IRB forms.
- Determination of the risk level of investigational devices and the rationale for such determinations
- Determinations of conflict of interest.
- Identification of any research for which there is need for verification from sources other than the investigator that no material changes are made in the research (e.g., Cooperative Studies, or other collaborative research).
- Special protections warranted in specific research projects for groups of participants who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, regardless of source of support for the research.
- A list of research approved since the last meeting utilizing expedited review procedures and the specific citation for the category of expedited review of the individual protocol.
- Documentation of approval by the Chair or designee of research contingent on specific minor conditions in the minutes of the first IRB meeting that takes place after the date of the approval.
- An indication that, when an IRB member has a conflicting interest with the research under review, the IRB member was not present during the deliberations or voting on the proposal, and that the quorum was maintained.
- Key information provided by consultants will be documented in the minutes or in a report provided by the consultant.
A copy of the IRB-approved minutes for each IRB meeting will be distributed to the Institutional Official.
Documentation of verified exemptions consists of the reviewer’s citation of a specific exemption category and written concurrence that the activity described in the investigator’s request for satisfies the conditions of the cited exemption category.
IRB records for initial and continuing review by the expedited procedure must include: the specific permissible category, a description of action taken, if any, by the reviewer, and any determinations required by the regulations and protocol-specific findings supporting those determinations.
The above detailed records must be stored securely in RPO and must be retained for at least 3 years.
Records pertaining to research, which is conducted, must be stored securely in RPO and must be retained for at least three years after completion of the research. IRB records not associated with research or for protocols cancelled without participant enrollment will be retained at the facility for at least 3 years after closure.
After that time those records may be shredded or otherwise destroyed. All records must be accessible for inspection and copying by authorized representatives of the OHRP, sponsors, and other authorized entities at reasonable times and in a reasonable manner.
Records are maintained in locked file cabinets and/or locked offices within RPO and are available only to IRB members, RPO staff, and senior officers as necessary.