Standard Operating Procedures - Chapter 6

MEMBERSHIP OF THE IRB

6.1 Appointment of IRB Members

The IRB consists of faculty, staff, and community members appointed and selected by the institutional officials. IRB members serve three-year terms and may be re-appointed at the discretion of the institutional official and IRB Chair. IRB members who do not adequately fulfill their responsibilities, as judged by the IRB Chair or HPA may be asked to step down from IRB membership by the institutional official.

IRB members are appointed and selected with varying backgrounds of expertise and experience to reflect the diverse community UMASS represents. Accordingly, appointments are made to avoid potential biases that would create a board that is represented by one department or area of expertise, gender or ethnicity.

6.2 Chair

The IRB has a Chair appointed by the institutional official. The IRB Chair is a respected, active member of UMASS who is well informed of regulations relevant to the use of human participants in research. The term of service is at the discretion of the institutional official. Whenever the Chair is not available to conduct IRB business, the Chair may assign the Vice Chair (or another designee) to assume his/her responsibilities during the period of his/her absence. In the Vice Chair’s absence, the IRB may designate a chair pro temp from among the members for that meeting.

Responsibilities of the Chair include: overseeing the conduct of meetings, conducting or appointing designees to conduct expedited reviews, reviewing research compliance reports, reviewing serious adverse event reports, and assessing conflicts of interest reported by IRB members. In addition, the IRB Chair serves as a resource for investigators and IRB members regarding issues related to UMASS policies, and federal and state regulations. The Chair is a voting member of the IRB.

To assist with these responsibilities, the Chair may designate individuals who are voting members of the IRB to carryout specific procedures including:

• Determining the type of review (exempt, expedited, full board) required

• Assigning IRB reviewers

• Reviewing specific revisions to consent/consent documents that are required as conditions of approval

• Signing approval memos

• Conducting review of expedited and exempt applications.

6.3 Vice-Chair

In the absence of the IRB Chair, in the case of a Chair’s potential conflict of interest, or at the discretion of the Chair, the Vice-Chair or an experienced IRB member as appropriate, fulfills the Chair’s duties for the UMASS IRB.

The IRB Vice-Chair is a respected, active member of UMASS or the local community who is well informed of regulations relevant to the use of human participants in research. The term of service is at the discretion of the institutional official.

6.4 Full IRB Members

The IRB is composed of: (1) at least one community member serving on the board who is not employed or affiliated with UMASS and does not have an immediate family member employed or affiliated with UMASS; (2) at least one member whose primary concerns are in scientific areas and (3) at least one member whose primary concerns are in non-scientific areas. In addition, each IRB that reviews FDA-regulated products (drugs, biologics, and devices) includes at least one member who is a physician. Each September, members are asked to review and sign a Non Disclosure Agreement Form and a Conflict of Interest Disclosure Agreement Form.

Full IRB members are required to attend all scheduled IRB meetings. If a member cannot attend a meeting they are required to notify the HRPO. The HRPO will contact the designated alternate(s), where applicable, to ensure the voting position is filled.

6.5 Alternate IRB Members

Alternate IRB members consist of faculty, staff, and community members selected and appointed by the institutional official. Alternate IRB members serve three-year terms and may be re-appointed at the discretion of the institutional official, IRB Chair, and HPA. Alternate members who do not adequately fulfill their responsibilities, as determined by the IRB Chair or HPA, may be asked to resign from IRB membership by the institutional official. Alternate members, while encouraged to attend all committee meetings, are not required to attend unless they are: (1) assigned to discuss an agenda item, or (2) requested to attend in place of a regular member for whom they are listed as the designated alternate. If both the alternate and the regular member attend the same meeting, only one may vote. The vote defaults to the regular member unless notice is given to the IRB Chair prior to the meeting. The minutes reflect who is in attendance as a voting member.

6.6 Membership Diversity

The IRB contains members with varying backgrounds, and sufficient experience and expertise to promote an adequate review of research involving human participants (45 CFR 46.107(a)). IRB membership is reviewed and adjusted on an annual basis to ensure that it meets regulatory and organizational requirements, and that the board has members with the appropriate knowledge and experience necessary to provide an adequate review of the research study.

Membership is selected to ensure appropriate diversity, including representation by multiple professions, diverse ethnic backgrounds and both genders, and includes both scientific and non-scientific members.

6.7 Responsibilities of IRB Members

For full board studies, responsibilities of members include reviewing protocol materials in advance of meetings, arriving prepared to discuss issues related to human participant protections, serving as designated reviewers when requested, and having an understanding of the specific requirements of human participant regulations. When serving as a reviewer for expedited or exempt studies, IRB members are responsible for (1) determining that review criteria and required findings are met and (2) making a decision whether the research will be approved or forwarded for full board review.

6.8 IRB Member Liability

IRB members function as agents of UMASS while performing duties and activities required by their appointment to the IRB. When acting in accordance with UMASS IRB's policies, they are afforded coverage under applicable UMASS liability insurance policies .

6.9 Non-Voting Members

The IRB Chair or HPA may, at his/her discretion, recruit non-voting members from among the academic or administrative staff of UMASS whose presence at an IRB meeting would aid the IRB in conducting its duties. These members may take part in all meetings of the IRB, participate in the discussions, and make recommendations, but they may not vote on the decisions. Non-voting members are not included in determining or establishing a quorum at the meetings. IRB meeting minutes reflect the presence of non-voting members.

6.10 Consultants or Ad Hoc Reviewers

At the time of review, the IRB may invite scientists or non-scientists from within or outside UMASS, who have special expertise, to function as a consultant or ad hoc reviewer of an IRB application. This determination may be made based on the scientific design of the study, the ethical issues of the study, the potential risks or benefits of the study, specific privacy and confidentiality concerns, or considerations relative to a particular study population.

Upon identifying the need for a consultant review, the IRB Chair, HPA, and/or designated reviewers, in consultation with the Chair and HPA, will identify a consultant based on the particular issues to be addressed. For issues requiring only simple clarification, a written set of questions may be developed for submission to the consultant. The consultant’s written response to these questions will be provided to the IRB for review at the time of the full meeting. For issues requiring more than simple clarification, the consultant may also be invited to attend the board meeting during the review of that particular study. The consultant is not included in determining or establishing a quorum at the meetings. These individuals have access to all documents submitted to the IRB relevant to the specific study under review, participate in the deliberations and make recommendations on the study, but may not vote. Documentation including the attendance of and discussion with the consultant will be included in the meeting minutes as outlined above.

No person with a conflict of interest will serve as a consultant for the purposes described in this section.

6.11 Guests Attending Meetings

At their discretion, the IRB Chair or HPA may invite:

• Scientists or non-scientists from within or outside the UMASS who have special expertise to function as consultants and ad hoc reviewers of a study. These individuals have access to all documents submitted to the IRB relevant to the specific study under review, and participate in the deliberations and make recommendations on the study.

• Investigators and/or advisors for the purpose of additional clarification or discussion regarding their study. These individuals are required to leave the meeting for final discussion and voting.

• Guests from among the academic or administrative staff of the UMASS. Guests and the reason(s) for attendance are stated at the beginning of the meeting and in the minutes.

None of the guests, as outlined above, are included in determining or establishing a quorum at the meetings, and may not vote. All guests are required to read and sign a Non Disclosure Agreement Form. The IRB meeting minutes reflect the presence of all guests.

6.12 Conflict of Interest

Given the central role of IRBs in overseeing the ethical conduct of research involving human participants, it is critical that IRBs operate free from inappropriate influence and bias. The UMASS IRB interprets the regulations to prohibit IRB members from participating in the deliberative discussion or vote on any research in which they (i) participate in any way, including but not limited to study planning and design, conduct of the study, data analysis, subject recruitment, subject consent, and authorship; or (ii) have, or may appear to have, any personal, professional, or financial conflict. See Managing Conflicts of Interest, Chapter 18.2 for more information.

6.13 Education and Training

For the specific requirements see Chapter 19.2.

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