Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 112
AAHRPP Elements: II.5.B.
- It is the policy of the UIC that OPRS staff must capture and document decisions at both convened review and in the expedited review process.
- For convened review, documentation is accomplished through IRB meeting minutes.
- For convened review, IRB meeting minutes incorporate all of the following documents: information as required by Section II of the Procedure section of this document, the written documentation signature sheet, the attendance sheet, the protocol voting record, and documentation of agenda approval.
- For expedited review, documentation is generally in the form of completed review guides, which are maintained with the protocol record.
- Assistant Directors/IRB Coordinators are responsible for creating and completing IRB meeting minutes and for ensuring that IRB members properly complete other required documentation, such as materials for expedited review.
- As a best practice, meeting minutes should allow a reader who was not present at the IRB meeting to understand how and why the convened IRB arrived at its determinations. Additionally, the meeting minutes should have sufficient detail to be able to reconstruct the IRBs discussions if necessary at a later time.
- Convened Board Minutes. OPRS staff maintains the anonymity of the IRB members and do not mention them by name in the meeting minutes and do not attribute their comments to them. An exception is that staff and IRB members are named in the minutes when they must recuse themselves due to a conflict of interest.
- During convened board meetings, the IRB Coordinator/Assistant Director captures the following information and documents it as part of the IRB meeting minutes to indicate that all of the applicable regulations and organizational requirements have been adequately addressed for each protocol under review:
- Actions taken by the IRB (refer to UIC HSPP policy Review of Research by the Convened IRB for a list of possible IRB actions);
- Specify the conditions required to secure approval and the reason the IRB is said conditions;
- when research is deferred, specify the changes, clarifications or further information to be addressed with the re-submission and the reason for the deferral;
- The level of risk involved in the research;
- The approval period for initial and continuing review ;
- Separate deliberations for each action, as applicable;
- Votes for each protocol as numbers for, against, abstaining, or recusals;
- Attendance at the meeting;
- When an alternate member replaced a primary member and whom the alternate is replacing;
- The basis for requiring changes in research;
- The basis for disapproving research;
- A written summary of the discussion of controverted issues and their resolution;
- If applicable, justification for any deletion or substantive revisions of information concerning risks or alternative procedures contained in the DHHS approved sample consent document.
- Initial Review, Amendment and Continuing Review Documentation:
- Criteria for approval at 45 CFR 46.111 (21 CFR 56.111 for FDA regulated research) are met.
- Criteria for obtaining and documenting informed consent at 45 CFR 46.116 & 117 (21CFR 50.25 & 27 for FDA regulated research) are met.
- OPRS staff must document the name of the IRB Members who left the meeting (recusal) due to a conflict of interest and an indication that a conflict of interest was the reason for their departure.
- Determinations required by the regulations and UIC policy and protocol-specific findings justifying those determinations (Refer to applicable policies and procedures for detailed requirements):
- Waiver or Alteration of the Consent process. (Refer to UIC HSPP policy Informed Consent Process and Documentation or the applicable Initial Review and/or Continuing Review review guides)
- Waiver of Documentation of Informed Consent. (Refer to UIC HSPP policy Informed Consent Process and Documentation or the applicable Initial Review and/or Continuing Review review guides)
- Research involving deception cannot be approved unless the IRB finds that waiver of the required elements of informed consent is warranted when applying the criteria in 45 CFR 46.116(d).
- Waiver or Alteration of HIPAA Authorization.
- HIPAA Preparatory to Research.
- Research Involving Pregnant Women, Fetuses, and Neonates. The meeting minutes must document that the IRB made findings in accordance with UIC HSPP policy Research Involving Pregnant Women, Human Fetuses and Neonates, and Fetal Tissue and the corresponding review guide.
- Short form requirements. (Refer to UIC HSPP policy Informed Consent Process and Documentation or the applicable Initial Review and/or Continuing Review review guides)
- Research Involving Prisoners. The meeting minutes must indicate that the research meets the findings required by 45 CFR 46.305(a) and represents one of the categories of research permissible under 45 CFR 46.306(a). In addition, the meeting minutes must document that at least one member of the IRB is a prisoner representative and present for the review of the applicable protocol. (Refer to UIC HSPP policy Research Involving Prisoners and the corresponding review guide)
- Research Involving Children (including Wards of the State). The minutes document IRB determination of additional safeguards, appropriate category of research, and make appropriate determinations as to permission from the parent or guardian and assent from the child. Additional determinations are required when research involves wards of the state. (Refer to UIC HSPP policy Research Involving Children (including Wards of the State) and the corresponding review guides)
- Research Involving Subjects without Capacity to Consent. IRB determinations per the applicable federal regulations and UIC policy are documented. (Refer to UIC HSPP policy Research Involving Decisionally and Cognitively Impaired Subjects and the corresponding review guide)
- Research involving subjects with diminished capacity to consent. Determination in accordance UIC HSPP policy Additional Protections for Vulnerable Populations are documented (refer to the applicable Initial Review and/or Continuing Review review guides).
- Investigational Device Exemptions (IDE). If applicable, the meeting minutes must state whether an IDE is significant risk or non-significant risk and the rationale for this determination per 21 CFR 812.3.
- When an ad hoc consultant is present at the meeting, the IRB minutes must document both the consultant’s qualifications and any verbal advice. The consultant report along with his or her credentials must be kept within the protocol file.
- Review of unanticipated problems (adverse events), allegations of noncompliance, terminations, and suspensions. Minutes document the presentation of the report, discussion, recommended actions (including the need for immediate implementation of safeguards to prevent harm to subjects) and the determinations described in the UIC HSPP policies Handling Complaints and Allegations of Potential Non-Compliance with Human Subject Protection Regulations , Administrative Hold, Suspension or Termination of IRB Approval or Unanticipated Problems and Other Events Requiring Prompt Reporting (refer to the corresponding review guides).
- When the IRB serves as the IRB of Record, the Assistant Director/IRB Coordinator will assure that the Board discussion regarding the appropriateness of each site’s contact names/numbers, subject injury language, HIPAA language, conflict of interest, etc. is reflected in the IRB Minutes.
- Attendance of members or alternates who participated through videoconference or teleconference, and documentation that those members:
- Received all the pertinent material before the meeting; and
- Were able to actively and equally participate in all discussions.
- If the convened IRB approves research contingent on specific minor conditions, the subsequent approval by the Chair or Vice Chair will be documented in the minutes of the first IRB meeting (parallel to the agenda) that takes place after the date of the approval.
- The Assistant Director and IRB Coordinators complete the draft minutes for the full board committee meeting.
- The Assistant Director of the IRB reviews and edits the meeting minutes.
- The Assistant Director of the IRB gives the draft minutes to the IRB Chair for review and editing.
- Board# 2: The meeting minutes are reviewed and approved by the convened IRB, and the IRB Chair present at the meeting and Assistant Director for the IRB sign the approved version.
- Boards # 1 and 3: Following review and approval by the Chair, the Assistant Director and the IRB Chair sign the final approved minutes.
- The Assistant Director sends a copy of the approved minutes to the Executive Chair of the UIC IRBs and IO.
- Once approved by the IRB, minutes cannot be altered by anyone including institutional authorities, such as the Director of OPRS or the IO.
- Expedited Review.
- Expedited Review Requirements
- The IRB review guide and protocol file for expedited review contains the following documentation:
- Reviewer is either the IRB Chair or an experienced delegated IRB member;
- The study meets the definition of minimal risk;
- Meets one of the specific categories which qualifies the review for the expedited procedure (refer to UIC HSPP policy Expedited Review Process); and
- The protocol specific information justifying the action is documented in the review guide.
Expedited Reviews occurring in OPRS Live will not contain a signature; however, the review will be captured via a unique ID (assigned to each user) and an electronic date stamp. OPRS Live is an electronic submission system being beta tested by OPRS to help streamline the submission process and reduce waste by no longer requiring paper submissions.
- Expedited Review Documentation.
- The following information is provided to the IRB Members with the convened IRB agenda and also documented in the protocol file:
- New expedited minimal risk protocol determinations;
- Modifications of minimal risk studies;
- Minor modifications of greater than minimal risk studies;
- Continuing reviews of minimal risk studies; and
- Notification of the emergency use of an FDA regulated product.
- Protocol Related Correspondence (Effective February 8, 2016)
- Protocol-related correspondence including approval, modification or deferral notices; notifications of impending expiration of IRB approval (90-60-30 Day Reminders, Expiration Notices) and approved consent forms and recruitment materials is sent to the investigator via email.
- UIC OPRS does not provide handwritten (“wet”) signatures on protocol-related correspondence to investigators, research staff, and Department Heads generated through its RiSC database system. All protocol-related correspondence generated through RiSC are considered official UIC IRB business and are only sent by individuals who have been authorized by the UIC IRB.
- The OPRS RiSC system authenticates all users according to their assigned role within the UIC HSPP. In order to log-in, users must authenticate via their user ID and password. While the protocol-related correspondence may not display a visible signature, OPRS can validate the approval of any document that was submitted and reviewed.
21 CFR 56.111(a)(1), 21 CFR 56.111(a)(2)
45 CFR 46.111(a)(1), 45 CFR 46.111(a)(2)
Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, Frequently Asked Questions About Medical Devices, FDA Center for Devices and Radiological Health, dated January 2006
Significant Risk and NonSignificant Risk Medical Device Studies, FDA Information Sheet Guidance
|Version (#, date)
||Replaces (#, date)
||Summary of changes
||Included greater detail as to meeting minutes throughout the policy and procedure based on meeting minute audit findings.
||Updated listing of meeting minute contents, consolidated required documentation of determinations with other policies and review guides, and update VA requirements based on 1200.05, vs. 10/15/2010
||Removal of JBVAMC and IRB #4. Addition of explanation regarding lack of signatures on correspondence, effective February 8, 2016. Addition of explanation regarding beta testing of OPRS Live.