Approved by a vote of the full faculty Feb. 28, 2013

Abilene Christian University Institutional Review Board members will be appointed by the Provost. 

The chair shall be the director of the Office of Research and Sponsored Programs.

The term of service is normally five years, and a member is eligible for immediate reappointment for no more than 10 years of consecutive service. Once the extended term is complete, the member may not be nominated to be a voting member of the IRB for a period of three years.

Criteria for Membership
The Provost, considering advice from the Deans, will appoint IRB members using the following criteria, which were adapted in accordance with federal regulations 45 CFR 46 and 21 CFR 56 to safeguard the rights and welfare of human subjects in research:

1. Each IRB will consist of at least five and not more than seven voting members, with varying backgrounds to promote complete and adequate review of human research activities commonly conducted by the institution. 
2.  Each IRB will be sufficiently qualified through the experience, expertise, and 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. No IRB will consist entirely of men or entirely of women.  Qualified persons of both sexes will be considered so long as no selection is made to the IRB only on the basis of gender. 
4. Each IRB will consist of members of various professions including at least one scientist, one nonscientist, and 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 (community member). Members will be full-time tenured or tenure-track faculty members, which the exception of the individual representative who is not otherwise affiliated with ACU.

 

Replacing members
When a vacancy occurs on an IRB, the chair of the IRB shall contact the Dean of the appropriate university college/school/division and request a nomination to fill the vacancy. The name of the nominee and a current curriculum vita should be returned to the chair. Once the nomination has been returned, the Provost will review the credentials. 

The Office of Research and Sponsored Programs (ORSP) staff will review the functions and responsibilities with the nominee to ensure that the nominee realizes the time commitment needed for service on this committee. 

Once the nominee has agreed to participate as a member of the IRB, a recommendation for appointment may be sent to the Provost, indicating whether the appointment is as a full committee member or an alternate and the term of service with the IRB.

Once appointed, the IRB member will complete the following forms and submit them to the ORSP: 

1. Disclosure of Significant Financial Interest (annually)
2. Non-disclosure agreement (annually). 

 

Length of Term/Service and Description of Staggered Rotation
The length of service for an appointed IRB member will be five years. Usually, no more than one fifth of membership may be considered for renewal/replacement each year. If a member resigns prior to the end of their term, a nominee may be appointed to complete the original term. 

During the first year of the IRB member’s initial term, the IRB chair may assign a senior committee member to serve as a mentor for the new appointee. This mentor will assist the new member, when requested, in preparing for committee meetings, contacting investigators for additional information, and working through any problems noted with the IRB submission, before the scheduled IRB meeting.

Near the end of the five-year term, the ORSP staff will inquire as to whether or not the appointee wishes to continue to serve. If the IRB member wishes to continue to serve on the IRB, the ORSP staff will submit a request to the Provost for the member to remain on the committee. The ORSP staff, in consultation with the Provost, may extend an invitation for a committee member to remain for an additional five years for a total of no more than 10 years. Once the extended term is complete, the member may not be nominated to be a voting member of the IRB for a period of three years.

IRB Member Training and Continuing Education Requirement
All new members should complete training as directed by the chair of the IRB prior to beginning their work with the board. All new and continuing members should continue training through membership in designated national organizations and by attending related national and/or regional conferences. The ORSP will fund required training.

Functions and Responsibilities
The IRB member shall: 

1. Protect the rights and welfare of research subjects. 
2. Determine that subject risks are minimized. IRB members will ensure that the investigators: 
   1. use procedures which are consistent with sound research design and which do not expose subjects to risk, and 
   2. whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. 
3. Determine that risks to the subjects are reasonable in relation to the anticipated benefits to subjects, if any, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB member should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB member should not consider possible long-range effects of applying knowledge gained in the research. 
4. Determine that selection of subjects is equitable. In making this assessment, the following should be taken into account:
   1. the purpose(s) of the research and the setting in which it is conducted; and 
   2. should be particularly cognizant of special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, cognitively or mentally impaired persons, or economically or educationally disadvantaged persons. 
5. Determine whether the informed consent is adequate, and if not, request clarifications and changes in the consent form to adequately explain the purpose of the research, the risks and benefits entailed therein, and contains all other federally or locally mandated elements. 
6. Determine that the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects. 
7. Determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data. 
8. Ensure additional safeguards are in place to protect the rights and welfare of subjects that are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, cognitively or mentally impaired persons, or economically or educationally disadvantaged persons. 
9. Members may be asked to serve as Expedited Reviewers, if the IRB determines that a research request qualifies for an expedited review as defined by HHS.

 

Removal
When a committee member consistently fails to attend IRB meetings or fails to meet expectations, the ORSP staff and the Provost will meet with the committee member to determine the cause. If the IRB member indicates an inability to continue to function effectively as an IRB member, the ORSP staff or the Provost will request assistance from the Dean and/or department chair in obtaining a replacement member to serve on the IRB.