5. CUHS Membership

5 CUHS Membership

5.1 Composition of the CUHS 

5.2 Appointment of Members to the CUHS

5.3 Use of Consultants (Outside Reviewers)

5.4 Duties of CUHS Members

5.5 Attendance Requirements

5.6 Training / Ongoing Education of Chair and CUHS Members in Regulations, Procedures

5.7 Review of CUHS Members’ Performance

5 CUHS Membership 

5.1 Composition of the CUHS 

1. The CUHS will have at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. 

2. The CUHS will be sufficiently qualified through the experience and expertise of its members, and the diversity of the 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. 

3. In addition to possessing the professional competence necessary to review specific research activities, the CUHS will be able to ascertain the acceptability of proposed research in terms of institutional policies and regulations, applicable law, and standards of professional conduct and practice. The CUHS will therefore include persons knowledgeable in these areas. Because much of the research that the CUHS regularly reviews is grounded in social, behavioral, or educational disciplines, and the protocols occasionally involve a vulnerable category of subjects (e.g., children, prisoners, pregnant women, or handicapped or mentally disabled persons), consideration will be given to the inclusion of one or more individuals on the CUHS who are knowledgeable about and experienced in working with these subject populations. 

4. Every nondiscriminatory effort will be made to ensure that the CUHS does not consist entirely of men or entirely of women, however, no membership selection shall be made to the CUHS solely on the basis of gender. 

5. The CUHS will always include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. The CUHS shall not consist entirely of members of one profession. 

6. The CUHS will always include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. 

7. One member may satisfy more than one membership category. 

8. The Officers of the CUHS may be voting IRB members, except that CUHS staff whose other University responsibilities include review and approval of sponsored proposals must serve as non-voting members. 

9. A doctoral-level graduate student may serve as a voting member of the CUHS. A prospective graduate student member must have written approval from his/her graduate advisor to serve as a CUHS member and may ordinarily serve on the CUHS only for a two-year term. 

5.2 Appointment of Members to the CUHS 

The CUHS Chair, in consultation with CUHS staff, identifies a need for a new or replacement member, or alternate member. Suggestions for potential new members may be made by CUHS staff, the CUHS Chair, the Dean of the relevant school, or the Provost. Department Chairs, Deans of University-Area institutions, and others may also forward suggestions for new members. 

The final decision to invite a new member is made by the CUHS Chair, the Executive Officer, and the Dean of FAS. An invitation to serve is forwarded by the Office of the Secretary of the Faculty of Arts and Sciences. The Provost and OHRP are advised of all changes to the membership. 

Appointments are made for a renewable annual period of service. Any change in appointment, including reappointment or removal, requires written notification. Members may resign by written notification to the Chair. 

On an annual basis, the CUHS Chair and Executive Officer review the membership and composition of the CUHS to determine if it continues to meet regulatory and institutional requirements. 

Alternate members. The CUHS may, at the election of the Chair, Executive Officer, and Institutional Official, have alternate members. The appointment and function of alternate members is the same as that for primary CUHS members, and the alternate's expertise and perspective are comparable to those of the primary member. The CUHS roster will identify the primary member(s) for whom each alternate member may substitute. The alternate member will not be counted as a voting member unless the primary member is absent. When an alternate member substitutes for a primary member, the alternate member will receive and review the same materials prior to the CUHS meeting that the primary member received or would have received. The CUHS minutes will document when an alternate member replaces a primary member. 

5.3 Use of Consultants (Outside Reviewers) 

The CUHS Chair or a CUHS Officer reviews agenda items in advance of the meeting and determines whether a consultant may be required for scientific or scholarly expertise, knowledge of the local context, representation of certain categories of subjects vulnerable to coercion or undue influence, or other expertise. If so, the CUHS Chair or a CUHS Officer will solicit individuals from the University or the community with competence in these special areas to assist in the review of issues or protocols that require scientific or scholarly expertise beyond or in addition to that available on the CUHS. The CUHS Officer will inform consultants of the CUHS conflict of interest policy (see 7.4.5) and consultants must confirm to the CUHS Officer that they do not have a conflict of interest prior to review. Individuals who have a conflicting interest or whose spouse or family members have a conflicting interest in the sponsor of the research will not be invited to provide consultation. 

When the project is scheduled for full board review, the consultant’s findings will be presented to the CUHS either in person or in summary by the CUHS staff. Consultants may attend the relevant portion of CUHS meetings to provide advice or to answer members’ questions but may not participate in or observe the vote. 

Ad hoc or informal consultations requested by individual members (rather than the full board) will be requested in a manner that respects the researcher’s confidentiality and is in compliance with the CUHS conflict of interest policy (unless the question raised is generic enough to protect the identity of the particular PI and research protocol). 

Summaries of information provided by consultants are maintained in the protocol application records and information provided by consultants at convened meetings is summarized in the minutes. 

5.4 Duties of CUHS Members 

The agenda, submission materials, protocols, proposed informed consent forms and other appropriate documents are distributed to members prior to the convened meetings at which the research is scheduled to be discussed. Members receive the materials at least five days before each meeting, to allow full participation in the review of each proposed project. CUHS members will treat the research proposals, protocols, and supporting data confidentially. All copies of the protocols and supporting documents provided to members are returned at the conclusion of the review for destruction by CUHS staff or a professional shredding service. 

5.5 Attendance Requirements 

Members are expected to attend all scheduled CUHS meetings. A member who is unable to attend a scheduled meeting should inform the CUHS Chair or a CUHS Office staff member. If the inability to attend will be prolonged, a request for an alternate to be assigned may be submitted to the Chair or the Executive Officer. 

5.6 Training / Ongoing Education of Chair and CUHS Members in Regulations, Procedures 

A vital component of a comprehensive human research protection program is an education program for the CUHS Chair and the CUHS members. Harvard University is committed to providing training and an ongoing educational process for CUHS members and the staff of the CUHS Office, related to ethical concerns and regulatory and institutional requirements for the protection of human subjects. 

Orientation 

New CUHS members, including alternate members, will meet with the Chair, Executive Officer, and selected staff for an orientation session. At or before the session, the new member will be given a copy of the “CUHS Members’ Toolkit” (binder) that includes: 

• Belmont Report; 

• Federal regulations relevant to the business of the CUHS; 

• University Area Policies and Procedures for Human Research Protection [this document]; 

• Institutional Review Board Member Handbook, Amdur; 

• Other reference and supporting materials. 

New members must complete the Initial Education requirement for CUHS members before they may serve as Primary Reviewer/Presenter. 

Initial Education 

CUHS members and Office staff must complete “HETHR – Harvard Ethics Training in Human Research,” Harvard University’s online training program developed specifically for training both investigators and IRB personnel. 

In addition, CUHS Office staff will attend relevant professional development programs at the earliest opportunity, such as programs presented by PRIM&R. As part of their ongoing education, CUHS members will also be invited to attend PRIM&R conferences, or other educational opportunities. 

Continuing Education 

To ensure that oversight of human research is ethically grounded and the decisions made by the CUHS are consistent with current regulatory and policy requirements, training is continuous for CUHS members throughout their service on the CUHS. Educational activities include, but are not limited to; 

• In-service training at CUHS meetings; 

• Distribution of copies of IRB: Ethics and Human Research

• Identification and dissemination to CUHS members by the Executive Officer and CUHS staff (by mail, email, or during convened meetings) of new information that might affect the human research protection program, including laws, regulations, policies, procedures, and emerging ethical and scientific issues; 

• Unlimited access to the CUHS Office resource library. 

The University will provide support for the Chair, CUHS staff, and as many members of the CUHS as possible to attend annual PRIM&R conferences on human research protections. 

The CUHS professional staff will be encouraged to apply for the Certificate for IRB Professionals (CIP) and sit for the CIP qualifying examination. 

5.7 Review of CUHS Members’ Performance 

The CUHS Members’ performance will be reviewed on an annual basis by the Executive Officer, in consultation with the Chair and CUHS staff. Members who are not acting in accordance with the CUHS mission or policies and procedures or who have an undue number of absences will not be invited to continue their service on the Committee, and appropriate substitutes will be recommended for appointment by the Dean.