University of New Mexico Health Sciences Center
The HRRCs are comprised of regular voting members and alternate voting members. They may utilize, as they deem necessary, non-voting members and consultant reviewers as well.
Regular Voting members. The federal regulations and the UNMHSC FWA require each HRRC to have at least five regular voting members, including the Chair. At least one member on each HRRC must have primarily scientific concerns, one must have primarily nonscientific concerns ("community or lay member"), and one must be unaffiliated with both the University and the Albuquerque VA Medical Center 45 C.F.R. 46.107; 21 C.F.R. 56.107, VHA Handbook 1200.5. The UNMHSC HRRCs generally will have more than the minimum number of members to ensure adequate and efficient reviews, as the Sr. Associate Dean for Research, SOM, deems appropriate.
The Sr. Associate Dean for Research, SOM, will appoint members to each HRRC so that all HRRCs will be sufficiently qualified through the experience and expertise of its members, and the diversity of its members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. Further, each HRRC will 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. 45 C.F.R. 46.107; 21 C.F.R. 56.107; IRB Guidebook.
Scientific members. Scientific members of the HRRCs generally will have had experience in research involving human subjects, and will be recruited from among active members of the faculty of the SOM, the Colleges of Pharmacy and Nursing, or staff, as appropriate.
Nonscientific members. Nonscientific members will have as their primary focus a non-scientific area, such as law, ethics, human or patient rights, etc., and may be recruited from among others, active members of the faculty or the full-time staff of the UNMHSC or its clinical components.
Community members. The community members will be knowledgeable about the local community and willing to discuss issues and research from that perspective. They are chosen from Albuquerque and its vicinity. Neither they nor their immediate families may have an affiliation with UNM. Candidates for these positions include, among others, clergy, lawyers, teachers, and businesspersons.
Unaffiliated members. Unaffiliated members are those who are not otherwise affiliated with UNM or Albuquerque VA Medical Center and who are not part of the immediate family of a person who is affiliated with these institutions.
HRRC membership is reviewed periodically by the HRRC Executive Committee and recommendations are made to the Sr. Associate Dean for Research, SOM for recruitment, retention or dismissal of members. This review includes examination of attendance, specialty, expertise, education, affiliation and diversity.
The Sr. Associate Dean for Research, SOM, is responsible for ensuring the appropriate composition of the HRRCs. To determine what expertise is needed, and who might be recommended to be appointed, he/she solicits recommendations for appointments from the HRRC members as well as the Chairs of various departments within UNMHSC schools and colleges. In addition, as he/she deems appropriate, the Sr. Associate Dean for Research, SOM may solicit self-nominations from the faculty, full-time staff or others. Where a new community member is sought, the Sr. Associate Dean for Research, SOM, may receive recommendations from knowledgeable UNMHSC employees or may choose an alternative method of securing nominations, such as advertising in media. Solicitations for new members will highlight the desired qualifications based on gaps in the expertise of the HRRCs noted by the HRRCs and/or the Sr. Associate Dean for Research, SOM. The Sr. Associate Dean for Research, SOM, appoints new members at his or her discretion.
Each regular voting member of an HRRC generally will have an alternative member from the other HRRCs identified as his or her alternate, who may serve in his or her place. Such alternate members will have similar experience to the regular member. Alternate members may be called upon to serve where regular members will be absent from a meeting and there will be less than a quorum at an upcoming meeting. Alternate members will have voting rights and be counted in a quorum only when they replace their respective regular members.
Members of the UNMHSC staff or faculty may serve as non-voting members of the HRRCs should it be decided that such persons would be of assistance to the HRRCs in conducting their duties. A non-voting member cannot be counted in the quorum and cannot vote, but can participate in discussions and deliberations. The Associate Dean of Research, SOM, may appoint a non-voting member (or delegate this responsibility to the HRRC Chair), who will serve for only as long as requested.
The HRRCs may invite consultants to participate in discussions and deliberations on particular projects where they believe that additional expertise would assist it in reviewing a particular protocol. The HRRC Chair has the authority to invite such persons to participate. A consultant cannot be counted in a quorum, however, and cannot vote.
The HRRCs generally will have a Chair, Vice Chair, and Executive Chair. The Chair and Vice Chair each serve as Chair for two HRRCs. The Executive Chair is a member of all four committees and may serve as the Chair for any of the HRRCs if needed. Each of these will be chosen from the membership of the HRRCs, and will typically be filled by members of the faculty of UNM who are knowledgeable in human subject research, including the regulations, University and agency policies, and ethics relevant to such research. The Chair and Vice Chair generally are three-year positions (although the Sr. Associate Dean for Research, SOM, may in his/her discretion extend these terms). The Executive Chair may serve indefinitely, subject to the discretion of the Sr. Associate Dean for Research, SOM, as the Executive Chair undertakes additional administrative duties as discussed below.
The Chair, Vice Chair and Executive Chair are responsible for oversight of physician emergency or "compassionate" uses of investigational products (Sections 9.1 - 9.3), expedited reviews (Section 5.2), initial reviews of adverse event reports (Section 8.2), and reviews of requests for exemption (Section 5.1). The Chair, Vice Chair and Executive Chair are also responsible for ensuring that the HRRC members are adequately informed about the requirements of the regulations and that they conduct appropriate reviews. The Executive Chair and Director of Research Protections are responsible for overseeing the day-to-day administrative operations and compliance activities of the HRRCs. Among other things, the Executive Chair and Director of Research Protections are responsible for answering investigator questions on regulatory issues and HRRC policies, and coordinating, obtaining and disseminating legal advice on issues that arise at HRRC meetings, and informing the HRRCs on regulations and policies.
Whenever the Chair or Vice Chair is not available, the Executive Chair will assume the responsibilities of the Chair during the period of his or her absence.
Serving on an HRRC is considered to be an important role of faculty and staff, as well as an honor. It is recognized and appreciated that members serve in addition to their regular UNMHSC duties. Therefore, it is understood that on occasion a member may need to miss a scheduled HRRC meeting. However, it is very important for continuity, scheduling, and well-rounded reviews that members attend HRRC meetings. Membership is chosen based on the unique expertise that each member brings to an HRRC. If a member cannot make a meeting, he/she should notify the HRRC Support Office well enough in advance (two weeks before meeting in writing or by telephone) that his/her alternate may be secured as necessary. Because members serve at the pleasure of UNMHSC, failing to regularly attend meetings or the lack of diligence in performing duties could result in removal of a member from an HRRC.
The HRRC Support Office, as overseen by the Executive Chair and Director of Research Protections, will promptly notify OHRP in writing of any changes in HRRC membership.
An institution may have a conflict of interest in human subject research whenever the financial interests or other conflicts of interest of the institution, or of an institutional official acting within his or her authority on behalf of the institution, might affect or reasonably appear to affect institutional processes for the conduct, review, or oversight of human subjects research.
Conflict of interest means a situation associated with an individual’s participation in review of a proposal where it reasonably appears, on an actual or potential basis, that:
Some individuals may feel that they have a conflict of interest due to other circumstances in their lives or professional careers. Examples may include being in the same department as an investigator on the research being considered or being in a subordinate or supervisory (or advisory) role to an investigator on the research. If it is felt by the individual that their objectivity may be in question, they should respond as though they do have a conflict of interest.
Currently IRB members are already required by federal regulation to recuse themselves from voting upon or participating in any deliberations concerning protocols in which they have conflicting interests. In order to proactively deal with HRRC Member Conflicts of Interest, the HRRC institutes the following:
For all new full review studies to be reviewed at a convened HRRC meeting, the sponsoring company is identified and included in the review materials that members receive prior to the meeting.
HRRC Members will be requested to notify the HRRC Support Office as soon as they become aware that there is a project scheduled for HRRC review for which they have a potentially conflicting significant financial interest[i] or any other conflict of interest that might affect or reasonably appear to affect their review of a study.
In an effort to avoid potentially losing quorum at the HRRC meeting and to avoid assigning a primary reviewer who has a potential conflict of interest, the HRRC asks members to inform the HRRC Support Office of any potential conflicts related to sponsors, investigators or other situations to help guide the HRRC Support Office in assigning reviews and projecting quorum.
The HRRC Chairperson will poll the HRRC about any potential conflicts of interest at the start of each meeting and the members' responses will be documented in the meeting minutes.
Any member who has a potential conflict of interest will recuse himself or herself from voting upon or participating in any deliberations concerning those protocols and the recusal will be documented in the meeting minutes.
All consultant or expert reviewers will be asked if they have a potential conflict of interest at such time they are contacted to provide guidance to the HRRC. If they do, other individuals without the conflict will be considered to provide the review. In such cases where a potentially conflicted individual is needed to provide guidance to the HRRC and no other reasonable alternatives exist, the circumstances regarding the conflict will documented in the HRRC record and disclosed to the HRRC prior to any final approval of the research.
i Significant Financial Interest (based on UNM's Conflict of Interest Policy Adopted 4/11/2000: UNM Handbook; UNM COI Research Policies)