- 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 which are comprised of the information as required by Section II of the Procedure section of this document.
- For expedited review, documentation is generally in the form of completed review guides, which are maintained with the protocol record.
- Assistant Directors/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.
- Convened Board Minutes. OPRS tries to maintain the anonymity of the IRB members and do not mention them by name in the meeting minutes with the following exceptions: when they must recuse themselves due to a conflict of interest, when they abstain from the vote, when they are an alternate member who is replacing the voting member, or when non-voting staff are assisting with the meeting.
- During convened board meetings, the Assistant Directors/Coordinators 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);
- The basis for requiring changes to the research;
- A written discussion of controverted issues and their resolution;
- The level of risk involved in the research;
- The approval period;
- Votes for each protocol as numbers for, against, abstaining, or recusals;
- Attendance at the meeting, including members/alternates who attended via video and/or teleconference, via the signature sheet;
- When an alternate member replaced a primary member and whom the alternate is replacing;
- The basis for disapproving research;
- 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 and/or 21 CFR 56.111 for FDA regulated research and/or 38 CFR 16.111 for VA research (limited to research reviewed by CHAIRb) are met.
- Criteria for obtaining and documenting informed consent at 45 CFR 46.116 & 117 and/or 21 CFR 50.25 & 27 for FDA regulated research and/or 38 CFR 16.116 & 117 for VA research (limited to research reviewed by CHAIRb) are met.
- Assistant Directors/Coordinators must document when a conflict of interest exists.
- Determinations required by the regulations and UIC policy (Refer to applicable policies and procedures for detailed requirements):
- Waiver or Alteration of the Consent process.
- Waiver of Documentation of Informed Consent.
- Research involving deception cannot be approved unless the IRB finds that an alteration of informed consent is warranted when applying the criteria in 45 CFR 46.116(d) and, for VA research reviewed by CHAIRb, 38 CFR 16.116(d).
- Short form requirements.
- Waiver or Alteration of HIPAA Authorization.
- HIPAA Preparatory to Research.
- Research Involving Pregnant Women, Human Fetuses and Neonates, and Fetal Tissue.
- Research Involving Prisoners.
- Research Involving Children (including Wards of the State).
- Research Involving Subjects without Capacity to Consent.
- Medical Devices. If applicable, the meeting minutes must state whether an IDEa medical device 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, AAdministrative Hold, Suspension or Termination of IRB Approval, or Unanticipated Problems and Other Events Requiring Prompt Reporting (refer to the corresponding review guides).
- 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 agenda and minutes of the first IRB meeting that takes place after the date of the approval.
- The Assistant Directors/Coordinators complete the draft minutes for the full board committee meeting.
- The Assistant Director or Coordinator (if designated) reviews and edits the meeting minutes.
- The Assistant Director 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 or Coordinator 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 designee;
- 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 IRB members are informed of the approval/acknowledgement statuses of expedited submissions for their specific IRB via the convened IRB agenda and corresponding meeting minutes. The following is a list of the types of the processed submissions that will appear on the agenda and corresponding meeting minutes:
- New expedited minimal risk protocols;
- Conditions required to secure approval of Initial Reviews, Amendments to Previously Approved Research, Continuing Reviews, and Final Reports;
- Amendments to Previously Approved Research of minimal risk studies;
- Continuing reviews of minimal risk studies;
- Final Reports;
- Adverse Events and Safety Reports;
- Protocol Deviation/Violation/Non-Compliance; and
- Notification of the emergency use of an FDA regulated product.
- Research reviewed by CHAIRb
- The minutes via signature sheet will document who was in attendance during the meeting. If a representative from a participating VA institution is not present for the discussion and vote of a protocol, then that specific VA site cannot participate until the representative reviews and comments on the protocol.
- As per the CHAIRb Operations SOP, the CHAIRb will notify organizational officers and officials in writing of IRB findings and actions by providing the participating site liaisons with the final, approved meeting minutes. Each participating site liaison is then responsible for ensuring the applicable official receives the minutes as per their institution’s policy.
- When applicable, the minutes will summarizes justification for inclusion of non-veterans in VA research.
- Expedited reviews are conducted and documented within the CHAIRb Portal. The following requirements are met and/or documented within the Portal:
- The reviews are conducted by either the Chair or an experienced and delegated IRB member;
- The study meets the definition of minimal risk; and
- Meets one of the specific categories which qualifies the review for the expedited procedure.
- Protocol Related Correspondence
- Protocol-related correspondence including approval, modification, or deferral notices; and notifications of impending expiration of IRB approval (90-60-30 Day Reminders, Expiration Notices) is sent to the investigator via email and are available via OPRS Live. Approved documents (informed consents, recruitment materials, etc.) are available via OPRS Live.
- 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
45 CFR 46.111
38 CFR 16.111
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.
Inclusion of language regarding CHAIRb and review of VA research. Removal of protocol voting record and attendance spreadsheet. Specifying the instances in which staff or an IRB member would
specifically be named in the minutes.
||Editorial revisions for clarity and consistency; Update in regards to distribution of protocol-related correspondence.
||Editorial revisions for clarity regarding the IRB of record reviewing the injury language.