IRB Membership

Standard Operating Procedure, Institutional Review Board
Policy Number: #05
Effective Date: 9/14/23
Owner: Vice President of Academic Affairs
Author: CSS IRB

Policy

The CSS Institutional Review Board (IRB) functions independently. Attempts to coerce or otherwise unduly influence the actions of the IRB are forbidden by policy and are to be reported. Likewise, the CSS IRB must remain free from the influence of financial and other organizational interests. No individual with responsibility for the business and financial interests of the organization may serve on the IRB.

Research that has been reviewed and approved by the IRB may be subject to review and disapproval by the President of The College of St. Scholastica and the Vice President of Academic Affairs and legal counsel of the organization. However, those officials may NOT approve research if it has not been approved or has been disapproved by the IRB (CFR 45 §46.112). Reviewing officials may strengthen requirements and/or conditions or add other modifications before approval or may require approval by an additional ancillary committee. Previously approved research proposals and/or consent forms must be re-approved by the IRB before initiating any changes or modifications that result from such additional reviews/approvals.

Purpose

The CSS Institutional Review Board (IRB) shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The CSS IRB should also be able to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The management of the membership of the IRB and oversight of Member appointments, IRB related activities, communications, and other administrative details are the responsibility of The Vice President of Academic Affairs/CSS IRB Chairperson. The VPAA serves in an oversight role rather than a voting member of the IRB.

Board Composition

The IRB must have at least five (5) members with sufficiently diverse race, gender, and cultural backgrounds to promote adequate review of CSS sponsored or conducted research. Collectively, the IRB shall possess the competence and experience and diversity of its members’ backgrounds necessary to:

1. review research activities from the point of view of the subjects as well as the researchers; and 2) discern whether proposed research is consistent with CSS standards for professional conduct, and applicable law and regulations (45 CFR §46.107(a)). Consistent with these goals and the federal regulations, the composition of the IRB shall therefore consist of:
   • At least two faculty members from each School and up to six at large members representing schools or the community

• As committee vacancies occur, the IRB Chair will request names of potential members from the Dean(s) of the school representing the vacancy. The IRB Chair will review the candidate’s curriculum vitae and meet personally, if necessary, to determine a match with the IRB’s needs. Appointed new members will be notified of their IRB member status following a review by the IRB Chair, Administrator, and Vice President of Academic Affairs. New members are appointed to the IRB for a minimum of one three-year term.
• At least one person with advanced training and experience in conducting scientific investigations.
• At least one person whose primary work is not in the area of scientific investigations.
• At least one person who is not, and whose immediate family are not, affiliated with CSS.

FDA Guidance - Institutional Review Boards Frequently Asked Questions Guidance for Institutional Review Boards and Clinical Investigators. January 1998 (Content current as of 04/18/2019)

Which IRB members should be considered to be scientists and non-scientists?

21 CFR 56.107(c) requires at least one member of the IRB to have primary concerns in the scientific area and at least one to have primary concerns in the non-scientific area. Most IRBs include physicians and Ph.D. level physical or biological scientists. Such members satisfy the requirement for at least one scientist. When an IRB encounters studies involving science beyond the expertise of the members, the IRB may use a consultant to assist in the review, as provided by 21 CFR 56.107(f).

FDA believes the intent of the requirement for diversity of disciplines was to include members who had little or no scientific or medical training or experience. Therefore, nurses, pharmacists and other biomedical health professionals should not be regarded to have "primary concerns in the non-scientific area." In the past, lawyers, clergy and ethicists have been cited as examples of persons whose primary concerns would be in non-scientific areas.

Some members have training in both scientific and non-scientific disciplines, such as a J.D., R.N. While such members are of great value to an IRB, other members who are unambiguously non-scientific should be appointed to satisfy the non-scientist requirement.

Criteria for Members (CFR 45 § 46.107)

Individuals whose professional and cultural backgrounds satisfy the IRB composition requirements and complement the expertise and backgrounds of the existing members are eligible to serve on the IRB. Candidates must possess excellent communication and critical thinking skills to effectively apply the complex regulations and guidance for safeguarding the rights and welfare of human subjects. In addition, members are expected to be responsive, timely, and participate regularly.

Members must have an email address to receive IRB communications. Individuals who have been sanctioned for ethics violations or who are under investigation for ethics violations may not serve on the Board. The IRB will seek members with knowledge of the populations common to CSS research, particularly if these populations include groups who may be vulnerable to coercion or undue influence, such as children or persons disadvantaged educationally or economically.

The IRB will seek non-CSS members who are especially knowledgeable about their own local communities and are willing to review proposed research from that perspective. For example, ministers, teachers, attorneys, business persons, client advocates, and homemakers are possible candidates. (CFR 45 §46.107(c)).

Alternate members

The IRB may utilize designated alternate members either episodically or regularly. Episodic alternate members serve in place of primary members who are temporarily unavailable. Like job sharing, regular alternates share their role with another alternate, systematically trading responsibility for IRB activities to reduce individual burden. In either case, alternate members should have characteristics comparable to the IRB member replaced (e.g., both are unaffiliated members, or both are from the School of Nursing). Alternate members are counted for quorum only when present.

Non-member experts (§46.107(e))

When the IRB requires specific expertise that its members lack, such as knowledge or experience in working with a study’s targeted population, methodology, or techniques, it may invite experts with the necessary competence to supplement the IRB’s experience and assist with review. Such assistance can take various forms, but these non-member experts may not vote, and their presence at full board meetings must be noted in the meeting minutes.

Observers

Only Individuals who have an affiliation with the application (investigator, invited expert) being reviewed at a full board meeting will be allowed to be present when the application is being reviewed. Observers not affiliated with the application can attend full board meetings when applications are not under review and by invitation.

Member Responsibilities

IRB Members are expected to complete the CITI (Collaborative Institutional Training Initiative) training every 3 years (See, CSS IRB SOP #37 IRB Human Subjects Research Required Education). IRB members are expected to keep up to date on IRB related education. IRB members are expected to be familiar with the Belmont Report and the federal regulations that govern the Board and human subject protections, in general. Specific responsibilities include:

• Review IRB members review research projects primarily to assess human subjects’ burdens to ensure that their rights and safety are properly protected. IRB members are appointed as “primary and secondary reviewers” from time to time to thoroughly analyze research projects and report in detail. Reviews are expected to be completed within 7 – 10 days from receipt of the review request. For studies that qualify for expedited review, at least one IRB member will be assigned to review and recommend approval and/or any stipulations to the IRB Chair. For studies that require full Board review, primary reviewers lead the Board’s deliberations about the project’s use of human research subjects.
• Deliberate IRB members evaluate and discuss research proposals and continuing reviews presented at meetings. As needed, IRB members also discuss and approve IRB policies.
• Attend IRB members are expected to attend meetings as their busy professional schedules allow. If members cannot participate at meetings in person, CSS Zoom technology is available to appear remotely. Members who miss at least two meetings in one year will be asked to explain their absences and reconsider their time commitments to the IRB. The IRB Chair has the discretion to remove non-attending members.
• Maintain Confidentiality Members are expected to respect and maintain the confidentiality of the research studies reviewed and the IRB deliberations thereon.
• Declare Conflict of Interest (See, CSS IRB SOP # 36 Conflict of Interest.) Members are expected to disclose a real or perceived conflict with any study under review by the IRB, and not participate in the IRB review of such studies.

IRB Chair

The CSS IRB Chair reports to the VPAA, including on matters concerning compliance with 45 CFR §46 and IRB Standards of Operating Procedures. The VPAA has delegated responsibility for the daily operation of the IRB to the IRB Chair. The VPAA serves in an oversight role rather than a voting member of the IRB. (CFR 45 §46.112; §46.113 and §46.108(4).) See also, (§46.103(a)) and CSS IRB SOP # 04 CSS IRB Meeting Management, Function and Operations).

During the budget review period the IRB Chair meets with the VPAA to discuss allocation of resources in comparison to the volume of research and other administrative functions, for example maintenance of IRB Standard Operating Procedures.

The IRB Chair’s term of service is 3 years with the possibility of serving additional terms.

The duties of the IRB Chair include conducting IRB meetings, management of protocol review process, review of protocols, development of Standard Operating Procedures, creation and criteria revision of IRB forms, recruitment and training of new members, continuing education of members and investigators, and review of member performance. The Chair responds to issues of compliance, adverse events and serious problems. The Chair serves as a resource for investigators and IRB members regarding issues related to CSS and federal policies. The IRB Chair is responsible for ensuring the appropriateness of all IRB decisions and actions.

The management of the membership of the IRB and oversight of member appointments, IRB related activities, communications, and other administrative details are the responsibility of the IRB Chair/IRB Administrator.

Vice Chair

If the IRB Chair designates an IRB member to serve as IRB Vice Chair, the IRB Vice Chair will work closely with the IRB Chair. The IRB Vice Chair may be primarily involved in reviewing protocols as needed, adverse events and IRB serious problems, and chair the IRB meeting when necessary.

The Vice Chair may also review expedited reviews and changes in protocol and some full board continuing reviews and changes. This individual is selected by the IRB Chair.

Resignations and Removals

If a Member resigns before the conclusion of his or her term, the vacancy will be filled as quickly as possible by the IRB Chair. With reasonable cause, the IRB Chair may recommend and confer with the IRB Administrator the removal of an IRB Member at any time. Acting upon the recommendations of the IRB Chair and the IRB Administrator, the CSS VPAA has the authority to remove a Member.

The CSS IRB Committee may recommend to the CSS IRB Administrator the removal of an IRB Chair at any time. Each voting member of the IRB Committee has the authority to convene a meeting with or without the presence of the IRB Chair. Acting upon the recommendation of the IRB Committee, the IRB Administrator has the authority to recommend to the Vice President of Academic Affairs the removal of the IRB Chair.

Compensation

Participation by CSS faculty, staff, or students is considered a component of their job responsibilities as established by their supervisors and not typically compensated. However, there may be situations where non-CSS affiliated voting members may be modestly compensated for the expenses incurred for IRB-related activities (e.g. parking and meals).

Liability Insurance

Regular, alternate and community members acting consistently with their charge as CSS IRB members have liability insurance coverage under The College of St. Scholastica Insurance - Errors and Omissions clause.

Records

The CSS IRB Administrator and IRB Chair shall maintain a current list of IRB Members, along with each Member’s CV or qualifications and CITI Training certification. (See, CSS IRB SOP #37 Human Subjects Research Required Education.)

CSS IRB Resource Responsibility

The VPAA (IRB Human Subjects Contact Person) is responsible for ensuring the IRB has adequate resources to identify and recruit qualified potential members. The VPAA is responsible for arranging for compensation as needed for consultants and non-affiliated members. The IRB Chair is responsible for recruiting and training new IRB Members.

References

45 CFR 46.107

45 CFR 46.108

FDA Institutional Review Boards Frequently Asked Questions - Information Sheet https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-b oards-frequently-asked-questions#IRBMember