Both the HHS regulations at 45 CFR 46.115(a)(2) and the FDA regulations at 21 CFR 56.115(a)(2) specifically require that an institution, or when appropriate, an IRB, prepare and maintain adequate documentation of IRB activities.

IRB Meeting Minutes (Expedited/Exempt Approval Form)

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 17
Effective Date: 10/8/2021

 

Policy

IRBs must comply with HHS and FDA regulations in 45 CFR part 46 and 21 CFR parts 50 and 56, respectively, when reviewing research subject to those regulations.  Both the HHS regulations at 45 CFR 46.115(a)(2) and the FDA regulations at 21 CFR 56.115(a)(2) specifically require that an institution, or when appropriate, an IRB, prepare and maintain adequate documentation of IRB activities, including minutes in sufficient detail to show:

1. Attendance at the meetings;
2. Actions taken by the IRB;
3. The vote on these actions, including the number of members voting for, against, and abstaining;
4. The basis for requiring changes in or disapproving research; and
5. A written summary of the discussion of controverted issues (See, CSS IRB SOP #28 Controverted Issues)  and their resolution.

These five items must be documented in the minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  When reviewing proposed research, the IRB must document the information required by 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2) in the minutes.  However, there are other findings and determinations the IRB must make to fulfill other regulatory requirements (e.g., the IRB must review research involving children as subjects that is covered by 45 CFR part 46, subpart D and/or 21 CFR part 50, subpart D (See, CSS IRB SOP #33 Research Involving Children and Investigator/Reviewer Checklist), and approve such research only if it satisfies the conditions of all applicable sections of those subparts). 

The College of St. Scholastica (CSS) IRB creates minutes for each convened IRB meeting that enable a reader who was not present at the meeting to determine how and with what justification the IRB arrived at its decision. They should also provide the IRB itself with sufficient detail to help it reconstruct its discussions at a later date, if necessary.  The minutes are written impersonally, without attributing opinions and votes to specific members.

• It is CSS policy that meeting minutes for each IRB full board meeting are prepared by following the IRB Minutes Template on IRBNet and then distributed to all members of the IRB one (1) week prior to the next scheduled convened IRB meeting, except for unusual and extraordinary circumstances.  Minutes are prepared by the CSS IRB Administrator.
• It is CSS IRB policy that meeting minutes are considered accepted at the end of the first IRB meeting after the prepared minutes have been distributed unless objections are raised by an IRB member. The IRB members do not vote to accept the minutes.
• It is CSS IRB policy that minutes are considered to be CSS archival records; that is, they are permanently retained.

The CSS IRB fulfills its federal regulatory requirement to advise its members of expedited review activities by providing each member, prior to the IRB full board meeting with a list of the research activities approved by expedited review.

The CSS IRB fulfills the federal regulatory requirement to notify the institution of its actions, as follows: ✔ The institution is represented by the individuals who are named on the CSS Federalwide Assurance as the CSS President and the VPAA.  A copy of the IRB meeting minutes is provided, if requested, to the Institutional Officials.

✔ It is CSS IRB policy to store the archival copy of meeting minutes as password protected electronic documents on IRBNet with limited access.

Purpose

The regulations for CSS IRB meeting minutes at 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2) provide institutions and IRBs with flexibility in choosing how to prepare minutes.  The CSS IRB has adopted standard operating procedures (SOP’s), follows OHRP guidance for preparation and maintenance of minutes, and acceptable CSS practice that allows the CSS IRB to efficiently accomplish its tasks.

Definitions

Agenda Document This document describes the agenda for the IRB meeting. It is prepared using the IRBNet template and distributed to all IRB members in advance of a meeting. It is then used as a template for the basic part of the meeting minutes.

Controverted Issues A controverted issue is an issue discussed at an IRB meeting for which there is a disagreement between some IRB members or there are opposing viewpoints among IRB members that are voiced during the IRB’s deliberations (CSS IRB SOP #28 Controverted Issues). In the absence of such disagreement or opposing viewpoints, it is unlikely that the discussion of an issue would be a discussion of a controverted issue. Federal regulations require a summary of controverted issues and their resolution to be included in IRB meeting minutes (45 CFR 46.115(a)(2)). Two statements are often sufficient to summarize a controverted issue:

• Statement #1: Description, discussion, and disagreement.
• Statement #2:  Resolution

Expedited Review Process Report (CSS IRB SOP #11 Expedited  Review  Procedure / Checklist) This document lists all items that were approved by an expedited review process for a specific period of time. It is distributed to the IRB members, in fulfillment of the federal regulatory requirement to advise all IRB members of items approved by expedited review.

IRB Meeting Attendance Members, Alternates, Consultants, and Guests

The IRB minutes must be in sufficient detail to show attendance at the convened meeting (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  For ease of review, OHRP and FDA recommend that attendance information be listed at the beginning of the minutes and include the full name and representative capacity (e.g., scientist, nonscientist, unaffiliated) of each IRB member present at the convened meeting. IRB members may participate in a convened meeting of the IRB via telephone or video conferencing when those members have received in advance of the meeting a copy of the documents for research proposals that are to be reviewed at the meeting.  The minutes should make clear which members, if any, participated in the convened meeting via an alternative mechanism, such as telephone or video conferencing.

When an alternate member replaces a primary member at a convened meeting, the minutes must include the name of the alternate member in attendance.  When an alternate member substitutes for a primary member due to a conflicting interest, the minutes should identify the name of the primary member for whom the alternate member is substituting, and state that this is the reason for the substitution.

The CSS IRB may invite consultants to assist in the review of a particular study when expertise is required beyond or in addition to that available on the IRB.  If the IRB uses a consultant and the consultant is present at the convened meeting, the minutes must include the name of the consultant and should include a brief description of the consultant’s expertise.  The consultant may not vote with the IRB on the study.

If the IRB permits non-members and guests to attend a convened meeting (e.g., IRB support staff, the investigator whose study is being reviewed, study coordinator), then the minutes must record the name(s) of all such attendees (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

Quorum

A quorum is the minimum number and type of IRB members that must be present at a convened meeting.  In order to review proposed research at a convened meeting, a majority of the members of the

IRB must be present, including at least one member whose primary concerns are in nonscientific areas (45 CFR 46.108(b); 21 CFR 56.108(c)).  If a majority of the IRB membership is not present, or if a nonscientist is not present, then quorum has not been met. The attendance information in the minutes assists in determining whether enough IRB members were present to constitute a quorum, whether the nonscientist was present, and whether proposed research received enough votes (i.e., a majority of those present) to be approved.

A quorum must be maintained throughout the meeting.  If quorum is lost during a meeting, then the IRB may not vote on proposed research (45 CFR 46.108(b); 21 CFR 56.108(c)).  Because IRB members may occasionally enter or leave the room at various times during a convened meeting (e.g., arrive late, depart early, or leave the meeting temporarily), the minutes must provide sufficient information to indicate that a quorum is maintained.

Actions Taken by the IRB

The IRB minutes must provide sufficient information to identify the research activities being reviewed and voted on by the IRB at that meeting (e.g., initial review of protocol title/protocol number).  The minutes should serve as a central repository for IRB actions on proposed research activities.

1. Approve, Require Modifications to Secure Approval, Disapprove

Any IRB action to approve, require modifications in (to secure approval), or disapprove proposed research activities that occur at a convened meeting must be documented in the minutes (45 CFR

46.115(a)(2); 21 CFR 56.115(a)(2)).  Additionally, the CSS IRB may also approve with conditions and defer a decision until additional information can be obtained.

The minutes must be in sufficient detail to show the actions taken by the IRB at the convened meeting to approve research and show that the IRB determined that all of the criteria for IRB approval of research are satisfied. The CSS IRB minutes, or other IRB record (e.g., correspondence with the investigator), identify the effective date of approval and the approval period (continuing review interval) for any research approved by the IRB.  The CSS IRB will document its determination of which projects require review more often than annually.  Both OHRP and FDA have issued guidance on continuing review of research to assist the IRB in determining the effective date of the initial approval and the subsequent date of continuing review if continuing review is applicable.

If the IRB takes an action to require modifications in the proposed research to secure approval, or disapproves the proposed research, the minutes must be in sufficient detail to show the action taken by the IRB, and the basis for requiring changes in, or for disapproving the proposed research (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

2. Suspension or Termination of IRB Approval

The CSS IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects (45 CFR 46.113; 21 CFR 56.113).  Any CSS IRB action to suspend or terminate IRB approval that occurs at a convened meeting must be documented in the minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  Any suspension or termination of approval must include a statement of the reasons for the IRB’s action (45 CFR 46.113; 21 CFR 56.113).  Any decision to suspend or terminate the study that occurs outside of a convened IRB meeting (e.g., as determined by the IRB Chair or Institutional Official for subject safety reasons) should be reported to the convened IRB and the discussion summarized in the minutes.  Any subsequent action taken by the convened IRB (e.g., to lift the suspension or to terminate the study) must be documented in the minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

3. Other IRB Regulatory Determinations and Review Responsibilities

In addition to the findings and determinations the CSS IRB must make and document in the minutes, there are other findings and determinations the IRB must make to fulfill other regulatory requirements. While the CSS IRB documents these additional findings and determinations in the minutes, these can be documented elsewhere in the IRB records to avoid redundancy (e.g., IRB reviewer form/checklist, database entries, other forms of physical or electronic records).  The CSS IRB must ensure that documentation includes relevant summary information when such information contributes to an understanding of the IRB’s findings and determinations.

Criteria for IRB Approval of Research

In order to approve research, the CSS IRB must determine that all of the criteria for IRB approval of research are satisfied (45 CFR 46.111; 21 CFR 56.111).  The process the IRB follows for considering the approval criteria is addressed in the IRB’s written procedures (CSS IRB SOP #12 Criteria for Approval of Research and Checklist).  The IRB’s consideration of these criteria applies to both initial review and continuing review of research and provides the framework for the IRB’s evaluation of research.  The minutes must document actions taken by the IRB (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

Informed Consent

In order to approve a study, the CSS IRB must determine that informed consent will be sought from each prospective subject or the subject’s legally authorized representative (LAR) in accordance with the regulations (45 CFR 46.111(a)(4); 21 CFR 56.111(a)(4)).  The IRB must also determine that informed consent will be appropriately documented in accordance with the regulations (45 CFR 46.111(a)(5); 21 CFR 56.111(a)(5)).  The minutes should indicate that, as part of its review and approval of a study, the IRB reviewed the informed consent form(s) and determined that the form(s) meet the applicable regulatory requirements.  (See, CSS IRB SOP #16 Informed Consent w/ Checklist and Templates.)

The IRB may require changes to the informed consent form(s).  The minutes of IRB meetings must be in sufficient detail to show the basis for requiring changes in (to secure approval) or disapproving research (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  The IRB may summarize any changes to the informed consent form(s) required by the IRB in the minutes, or other IRB record (e.g., an annotated informed consent form that includes IRB-required changes that gets appended to the minutes).

The CSS IRB may waive the requirement that the subject or the subject’s LAR sign a written consent form if the IRB determines that certain criteria are met (45 CFR 46.117(c); 21 CFR 56.109(c) and (d)). Any such waiver of documentation of informed consent must be documented in the minutes or other IRB record. (See, CSS IRB SOP #18 Waiver of Documentation Consent).

In addition, for HHS-conducted or -supported research, the regulations at 45 CFR 46.116(c) and (d) permit an IRB to approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent provided the IRB finds and documents that certain criteria are met (See, CSS IRB SOP #15 Waiver or Alteration of Consent). When the IRB approves a waiver or alteration of consent for research reviewed by the convened IRB, these findings must be documented (45 CFR 46.116(c) and (d) in the minutes or other IRB record.

Studies Involving Children

The CSS IRB’s review of studies involving children as subjects covered by 45 CFR part 46 subpart D and/or 21 CFR part 50 subpart D may approve only those studies that satisfy the conditions of all applicable sections of those subparts (45 CFR 46.403; 21 CFR 50.50).

The IRB must find that the research meets the conditions of 45 CFR 46.404 and/or 21 CFR 50.51

(research/clinical investigations not involving greater than minimal risk); 45 CFR 46.405 and/or 21 CFR 50.52 (research/clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects); or 45 CFR 46.406 and/or 21 CFR 50.53 (research/clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition).  If the IRB determines that the proposed research cannot be approved under these categories, then additional regulatory requirements under 45 CFR 46.407 and/or 21 CFR 50.54 (research/clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children) must be met.  Both OHRP and FDA have issued guidance to assist IRBs with handling clinical investigations that include children as subjects and that have been referred under 45 CFR 46.407 or 21 CFR 50.54.  (See, CSS IRB SOP #33 Research Involving Children and Investigator/Reviewer Checklist.)

In addition to the findings and determinations described above, the CSS IRB must also determine that requirements for permission by parents or guardians and for assent by children are met (45 CFR 46.408; 21 CFR 50.55).  If the proposed research involves children who are wards of the State or other agency, institution or entity, then the IRB must ensure that additional requirements are met (45 CFR 46.409; 21 CFR 50.56).  In Minnesota, research with children who are wards of the state or other agency must first be approved by the Court. The CSS IRB’s findings and determinations for studies involving children must be documented in the minutes.

FDA-Regulated Medical Device Studies

Unless FDA has already made a risk determination for a device study (e.g., significant risk (SR), or nonsignificant risk (NSR)), or the study is exempt in accordance with 21 CFR 812.2(c), sponsors are responsible for making the initial risk determination and presenting it to the IRB.  In that case, the IRB must then make its own SR/NSR determination about the study, and either agree or disagree with the sponsor’s determination by reviewing relevant information provided by the sponsor at a convened meeting (21 CFR 56.108(a)(1); 21 CFR 812.66).  FDA considers this determination to be part of the IRB’s responsibilities for conducting its initial review of a study.  FDA recommends that the IRB document each

SR/NSR determination, along with the reason for the determination, in the minutes. (See, CSS IRB SOP #40 Research Studies Involving Investigational Medical Devices.)

Studies Involving Pregnant Women, Human Fetuses, and Neonates

The regulations for research conducted or supported by HHS require specific findings for research involving pregnant women, human fetuses, and neonates as subjects (45 CFR part 46, subpart B).  OHRP recommends that when such research is approved by the convened IRB, all required findings should be documented in the minutes or other IRB record.  (See, CSS IRB SOP #35 Research Involving Pregnant Women and Reviewer Checklist.)

The CSS IRB should be aware that FDA regulations do not require specific findings for research involving pregnant women, human fetuses, and neonates as subjects.  If the IRB reviews an FDA-regulated study that is not HHS-conducted or -supported research, and the study is expected to involve pregnant women, fetuses, or neonates as subjects, the IRB may find 45 CFR part 46, subpart B to be helpful.

Studies Involving Prisoners

The regulations for research conducted or supported by HHS require specific findings for research involving prisoners as subjects (45 CFR part 46, subpart C).  OHRP recommends that when such research is approved by the convened IRB, all required findings should be documented in the minutes or other IRB record. (See, CSS IRB SOP #34 Research Involving Prisoners.)

The CSS IRB should be aware that FDA regulations do not require specific findings for research involving prisoners as subjects.  If the IRB reviews an FDA-regulated study that is not HHS-conducted or -supported research, and the study is expected to involve prisoners as subjects, the IRB may find 45 CFR part 46, subpart C, and OHRP’s guidance on prisoners in research to be helpful.

Unanticipated Problems, Serious or Continuing Noncompliance, Suspension or Termination of IRB Approval

If at a convened meeting, the CSS IRB reviews an issue that requires prompt reporting to the IRB under 45 CFR 46.108(4)(i) or 21 CFR 56.108 (b) (e.g., an unanticipated problem involving risk to human subjects or others), the minutes should summarize the report and must document the IRB’s action, if any, resulting from that review (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  Any review of such information and any decisions made outside of a convened meeting (e.g., as determined by the IRB Chair or Institutional Official for subject safety reasons) should be reported to the convened IRB and the discussion summarized in the minutes.  Any subsequent action taken by the convened IRB (e.g., to lift suspension or to terminate the study) must be documented in the minutes (45 CFR 46.115(a)(2); 21 CFR

56.115(a)(2)). (See, CSS IRB SOP #24 Unanticipated Problems and Adverse Event Reporting / Including Report Form.)

Controverted Issues and Their Resolution

Controverted issues are those that cause controversy and dispute among the IRB membership during a convened meeting.  Controverted issues that arise during the convened meeting usually are the result of opposition to some aspect of the proposed research.  During the review of proposed research, IRB members may express a difference of opinion, or raise issues, questions or concerns that cause debate among the IRB members, or even result in disagreement.  Some research, by its very nature, is considered to be controversial (e.g., emergency research where informed consent may not be obtained for all subjects or some research involving vulnerable populations). (See, CSS IRB SOP #28 Controverted Issues.)

IRB members may resolve controverted issues and concerns with continued discussion and deliberation, decide to seek further clarification from the investigator or sponsor of the proposed research, or decide to settle the issue by vote.  The minutes must summarize the IRB’s discussion and resolution of any controverted issues (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

The controverted issue should be recorded in the IRB meeting minutes in such a way that anyone who later reads the IRB minutes (perhaps even years later) should be able to recreate the history of the review and know what decisions were made and why. For example, why were pregnant women included or excluded from a clinical trial or why the specific age range was approved for the treadmill study. These may become important issues to know at continuing review. In the future these decisions may be reconsidered due to changing information or circumstances, but the knowledge of the original decisions is an important part of that discussion. Thus, the documentation of controverted issues in the IRB minutes is of vital importance, both because the regulations require it and the knowledge related to the decisions must be recorded. The IRB minutes should include:

1. A description of the controverted issue that is being debated.
2. A description of the various sides or points of view related to the controverted issue.
3. A summary of the essence of the discussion of the issues.
4. Documentation of the specific final resolution of the controverted issue including the vote, iftaken.

Requiring Changes or Disapproving Research

If the CSS IRB requires that the investigator make specified changes to the research protocol or informed consent document(s) and resubmit such documents to the convened IRB for subsequent review, the IRB’s action, along with the basis for requiring changes must be documented in the minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

If the CSS IRB disapproves a research activity, the IRB must include a statement of the reasons for its decision in the written notification to the investigator and the CSS Vice President of Academic Affairs (VPAA), and provide the investigator an opportunity to respond in person or in writing (45 CFR 46.109(d); 21 CFR 56.109(e)).  The minutes must document the IRB’s action along with the basis for disapproving the research (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

The Vote on IRB Actions

The minutes of IRB meetings must be in sufficient detail to show the vote on IRB actions as determined during the convened meeting, including the number of members voting for, against, and abstaining (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).  Individual voting records by name are not required.  The following are examples of acceptable formats for documenting the votes on actions taken by the IRB in the minutes.  Each example assumes that 15 members are attending the meeting:

The minutes should identify any member who has a conflicting interest in a research study, and as such, is excluded (recused) from participation in the IRB’s review of that particular research including the reason for the recusal.  As shown in the examples above, the minutes of the meeting must reflect a vote count (i.e., for, against, and abstaining) that is consistent with the number of non-conflicted IRB members present (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

Members who are recused from voting on a specific study because of conflicting interests may not be counted toward the quorum.  That is, their recusal may not be recorded as an abstention.

IRB members who participate in a convened meeting via telephone or video conferencing may vote and be counted towards the quorum.  The IRB must ensure that the votes of such members are recorded in the minutes (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)).

IRB members may not vote on proposed research outside of the convened meeting (e.g., via email prior to the convened meeting).  IRB members who cannot attend a convened meeting may not send someone (e.g., from their department or office) to vote in their place.  Opinions of absent members that are transmitted prior to the convened meeting by mail, telephone, telefax, or email may be considered by the attending IRB members but must not be counted as votes or towards the quorum for convened meetings (45 CFR 46.108(b); 21 CFR 56.108(c)).

Responsibilities

The CSS IRB administrator and the CSS IRB Chairperson are responsible for these procedures.

Procedures: Preparation and Distribution of Meeting Minutes

Federal regulations and guidance, and CSS policies, require significant information to be provided in the meeting minutes. The CSS IRB Minutes are created by using the IRBNet Minutes and Agenda templates that are available to the CSS IRB administrators.

Compilation of the minutes.

1. Taking notes during the IRB meeting. The CSS IRB Administrator takes the notes during the IRB meeting. Notes may be taken in any format or by any method as long as the method captures all required information in sufficient written detail to write review letters and prepare the meeting minutes.  Notes (whether paper-based or electronic) should not be retained after the minutes have been accepted and archived.  They are not an official IRB record.  Some tools that are available for computer-based note taking are found on IRBNet for administrators.
2. IRB acceptance of the minutes. The CSS IRBNet minutes are distributed to the IRB members with the agenda packet for an IRB meeting. The minutes are considered final at the end of the first IRB meeting held after the prepared minutes have been distributed, unless objections are raised by an IRB member or any inaccuracies or missing elements are identified. A vote tally is not taken.  If any revisions are necessary, they are made, and the revised minutes document is brought back to a subsequent IRB meeting.
3. Correction of accepted minutes. Mistakes may be discovered after minutes have been accepted. The CSS IRB administrator makes the corrections on the electronic copy of the minutes retained in IRBNet. The revised minutes are sent to the IRB, for consideration and acceptance at its next convened meeting. The reason for the correction is described in the administrative portion of the meeting agenda. The revised minutes are labeled as “corrected” and are then archived as described below.

Preparation and Distribution of Expedited/Exempt Approval Activities Report

In addition to the report of approved expedited activities recommended by OHRP, the CSS IRB includes all research proposals found to be exempt. The CSS IRB uses an expedited/exempt review procedure that includes keeping all members advised of research proposals which have been approved under the expedited/exempt review procedure (45 CFR 46.110(c); 21 CFR 56.110(c)).  The CSS IRB Chair will present a report of expedited/exempt actions during the convened meeting.  The IRB Agenda will note Expedited/Exempt Approval Activity Report as an agenda item.  The CSS IRB Minutes describe what was presented to the IRB, indicate that the IRB members had an opportunity to ask questions or raise concerns, and summarize questions or concerns, if any, raised by the IRB members.  This report requires acknowledgement by IRB members and does not require a vote. The report of expedited/exempt actions may also be appended to the minutes for reference.

The Expedited/Exempt Approval Activity Reports rely on the accuracy, timeliness and completeness of data entry associated with expedited reviews.  Expedited/Exempt Reports should establish and follow a process for ensuring that data entry is complete, accurate, and up to date before generating the

Expedited/Exempt Report. Failure to do so means that some expedited items will not appear on any Expedited Report, which is non-compliance with federal regulations. The Expedited/Exempt Report lists all items that received IRB approval by the expedited/exempt review process and that are associated with a specific IRB Agenda Date.

There are two types of Expedited Reports:

1. Minimal Risk Report. Minimal Risk reports include review of research studies that meet the criteria for expedited review, as well as all subsequent review activities for those studies (unless there is new information or a modification that disqualifies the study from subsequent expedited review).
2. Full Board Expedited Report. This report lists all approvals granted through the expedited review process, for studies that were initially reviewed by the full convened IRB. Any items (subsequent to initial review) that qualify for expedited review will be listed on the Expedited Report. This may include some modifications, some continuing reviews (Status Reports) and Problem Reports.

The timing and frequency of the Expedited Report are generated in synchrony with the full board convened IRB meetings.

 

Minutes Archiving         .

1. Location of accepted minutes. Within one week after an IRB meeting at which minutes are accepted, the CSS IRB Administrator moves the accepted minutes into IRBNet. If the minutes are a corrected version of already-accepted minutes, the title of the document should include the word “corrected.”
2. Archiving of accepted minutes.  The CSS IRB Administrator checks the IRBNet Minutes folder several times a month.  The IRB Administrator identifies tardy minutes and makes certain  that the minutes are appropriately documented in IRBNet.  On rare occasions, it is necessary to correct a set of IRB meeting minutes after they have been archived.  The original version is retained in the archives. The revised version is labeled as “corrected.”

Minutes Retention

The CSS IRB may maintain the records in printed form, or electronically (45 CFR 46.115(b); 21 CFR

56.115(b)).  IRB records required by the regulations, including meeting minutes, must be retained for at least 3 years after completion of the research that is the subject of the review and must be accessible for inspection and copying by authorized representatives from OHRP and/or FDA at reasonable times and in a reasonable manner (Id.).  Many sets of minutes will have records of review of multiple studies. Relevant portions of the minutes must be retained until the regulatory retention period for each study is satisfied.  The College of St. Scholastica and the CSS IRB can expect that representatives of OHRP conducting a compliance oversight assessment, or representatives of FDA conducting a Bioresearch Monitoring inspection, will review minutes and other appropriate IRB records to assess compliance with the regulations.

Resources

CFR 45 §46.115 (2)

21 CFR 56.115(a)(2)

University of Washington IRB Meeting Minutes

https://www.washington.edu/research/policies/sop-irb-meeting-minutes-2/

OHRP Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs https://www.hhs.gov/ohrp/regulations-and-policy/guidance/alphabetical-list/index.html Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs  (September

2017) https://www.fda.gov/media/94686/download

OHRP’s guidance on Prisoner Involvement in Research can be found

at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/prisoner-research-ohrp-guidance-2003/i ndex.html

OHRP’s Guidance Exempt Research and Research That May Undergo Expedited Review (May 5, 1995) https://www.hhs.gov/ohrp/regulations-and-policy/guidance/exempt-research-and-research-expedited-r eview/index.html

Prisoner Research FAQs can be found at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/prisoner-research/index.html.

IRB EasyEd. Controverted Issues Volume 2 Number 3. © 2017 Apex Ethical

This is a new policy per the 2018 Common Rule Requirements.