Structure and Responsibilities
4.15 Institutional Review Board (From the Faculty Manual)
The McKendree University IRB shall have six faculty members and one outside member. This outside member will not otherwise be affiliated with the institution and will not be part of the immediate family of a person who is affiliated with the institution. The members will have varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall 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 participants. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall 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.
Every nondiscriminatory effort will be made to ensure that the McKendree IRB does not consist entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. The IRB may not consist entirely of members of one profession. The IRB shall 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 may not have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
The IRB may, in its discretion, invite individuals 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 individuals may not vote with the IRB.
The six faculty members are nominated by FAC and approved by the full faculty. Nominations to IRB may also be made by the faculty at large. Each serves a two year term. The elections are staggered; three members are elected each year. The six faculty members will solicit an outside member, bring this name to the FAC, and FAC will forward this name to the entire faculty. If any faculty member is unable to complete the two year term, then a new member will be chosen for the balance of the term via the standard election process.
The IRB shall act as a responsible overseer of research involving human participants that is conducted under the auspices of the University. Specifically, the IRB shall have responsibility for:
1. Approving proposals for research involving human participants. The IRB may deem a proposal unacceptable and fail to approve or ask for revisions and more information;
2. Determining which projects require review more often than annually; determining which projects need verification from sources other than the investigator(s); and determining that no material changes in the proposed research have occurred subsequent to an IRB review.
In case changes in a research activity involving humans become necessary, the IRB shall develop policy guidelines for
3. Ensuring prompt reporting to the IRB of proposed changes in approved research; and ensuring that proposed changes in approved research not be initiated without IRB review except when necessary to eliminate apparent immediate hazards to the participant(s).
The IRB shall further be responsible for
4. Ensuring the prompt reporting to the IRB and appropriate institutional officials of: a) any problems involving risk to participants or others not anticipated in the original proposal; b) any noncompliance with IRB guidelines or guidelines specific to the project;
5. Ensuring the timely notification of its findings and actions to the investigator.
The IRB shall review proposals for research involving human participants at regularly convened meetings. The presence of four (4) members shall constitute a quorum. For a proposal to be approved it shall require the approval of a majority of those present and voting. Whenever possible, a meeting of the IRB shall take place in person. Teleconference or on-line meetings may be convened provided members are in timely receipt of all pertinent material prior to the meeting and can actively participate in the discussion of all protocols.