6.4.6 Institutional Review Board (IRB) (A, S)
Approved by Provost and Academic Council on April 24, 2002
The University of the Pacific Institutional Review Board (IRB) is responsible for holding all research projects involving human subjects to the standards set out in the Code of Federal Regulations, 45 CFR 46.
The IRB committee reviews, examines and evaluates proposals for experimentation using human subjects in accordance with guidelines supplied by the Office for Human Research Protections (OHRP) of the Department of Health and Human Services.
The Committee is charged with determining:
- risks to human subjects;
- benefits to subjects and/or society;
- specific nature of subjects participation including;
- recruitment of subjects,
- voluntary nature of subject participation,
- informed consent,
- remuneration (if any) to subject,
- specific procedures to be followed.
The University composes the IRB committee in accordance with federal guidelines.
The IRB committee must have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
The Provost shall make appointment to the IRB committee.
The IRB can have as many members as necessary for it to perform its duties effectively. However, care should be taken to ensure that it does not become so large that its management becomes cumbersome.
The IRB committee shall schedule monthly meetings during the academic year.
The IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, including considerations of their racial and cultural heritage and their sensitivity to issues such as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
In addition to possessing the professional competence necessary to review specific research activities, the IRB must 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 IRB must therefore include persons knowledgeable in these areas.
The IRB may not consist entirely of members of one profession.
The IRB must 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 IRB committee must also 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.
The IRB must make every nondiscriminatory effort to ensure that it does not consist entirely of men or entirely of women. Selections must not, however, be made on the basis of gender.
An IRB may, in its discretion, invite individuals (adjunct members) with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These adjunct members may not vote.
The nonaffiliated member(s) of the IRB will be drawn from the local community-at-large. Ministers, teachers, attorneys, businesspersons, or homemakers are possible candidates.
The person(s) selected should be knowledgeable about the local community and be willing to discuss issues and research from that perspective.
Consideration will be given to the type of community from which the institution may draw its research subjects.
The nonaffiliated member(s) should not be vulnerable to intimidation by the professionals on the IRB, and their services should be fully utilized by the IRB.