Federal Constitution and IRB Composition

Constitution of the IRB:

Its Charter and Standard Operating Procedures establish and empower the Chaminade University (Chaminade) human subjects protection committee. Currently Chaminade has one committee, registered with the Federal Office for Human Research Protections (OHRP) as Institutional Review Board IORG00006607, IRB00007927.

The IRB functions administratively through the Office of Sponsored Programs. This structure provides for administrative coordination for the IRB with the various academic and administrative units at Chaminade.

The IRB advises and makes recommendations to the President and Provost, to policy and administrative bodies, and to any member of the Chaminade community on all matters related to the use of human subjects in research.

Composition of the IRB

A. Federal requirements

1. The IRB is composed of at least five voting members. Alternates and non-voting members may also be appointed, with alternates authorized to vote at convened meetings only in the absence of the member for whom they are the designated alternate. Although an alternate may be designated for more than one IRB member, each alternate may represent only one regular member at a convened meeting. All appointments are made in accordance with Section VII and reported to OHRP and the University’s President and Provost.
2. The IRB is composed of members with varying backgrounds and expertise in special areas to provide complete and adequate review of the research. Committee members should possess competence sufficient to comprehend the nature of the research, as well as other competencies necessary for judgments as to acceptability of the research in terms of Chaminade regulations, relevant law, ethical standards, and standards of professional practice. Consultants may be used to review proposals for which additional expertise is needed.
3. The IRB must include both men and women, at least one member whose primary concerns are in science areas, one whose primary concerns are nonscientific areas, and at least one member who is not otherwise affiliated (either directly or through immediate family) with No person shall be excluded from serving on the IRB based on sex, race, color or national origin. IRB members do not receive compensation for their service.

B. Current Membership

An updated roster may be obtained at any time from irb@chaminade.edu.

Conflicts of Interest for IRB Members

An IRB member is said to have a conflicting interest whenever that IRB member, or spouse, or dependent child of the member:

1. Is an investigator or sub-investigator on the protocol;
2. Has a “significant financial interest” in the sponsor or agent of the sponsor of a study being reviewed by the IRB, whereby the outcome of the study could influence the value of the financial interest (see the Chaminade Conflict of Interest Policy for the definition of “significant financial interest”);
3. Acts as an officer or a director of the sponsor or an agent of the sponsor of a study being reviewed by the IRB; or
4. Has identified him or her self for any other reason as having a conflicting.

It is the responsibility of each IRB member to identify and avoid any situations in which he or she, either personally or by virtue of their position, might have a conflict of interest, or may be perceived by others as having a conflict of interest, arising in connection with a matter before an IRB of which they are a member. If assigned as a reviewer for a matter with which the IRB member feels that he or she may have a conflict of interest, the IRB member must notify the IRB Chair immediately so the matter may be reassigned to another reviewer. In order not to delay the review process, it is essential that potential reviewers peruse the matters for which they are assigned reviewers immediately upon receipt to determine whether they may have a conflict.