IRB Membership

The membership of the IRB will conform to the requirements of [45 CFR Part 46.107(c)], and will be comprised, at a minimum, of one or more nonscientist member(s) of varying backgrounds and experience, one or more unaffiliated non-scientist community member(s), and one or more faculty with expertise in medicine, basic science, and behavioral science.

Non-scientist members may or may not be affiliated with SLUHN. Unaffiliated members may be non-scientists or scientists.

Unaffiliated members by definition may not be affiliated with SLUHN, nor have a family member (1st degree relative) who is affiliated with SLUHN. These members are tasked with representing the views and attitudes of the community at large. Such members may be assigned as primary reviewers depending on the nature of the protocol and their experience or training.

The IRB shall have a legal representative whose function is to be knowledgeable about federal and state regulations, standards of professional conduct and conflict of interest on the part of investigators, key personnel and IRB members. Counsel attending the IRBs are voting members and may count as either a scientist or non- scientist as per training or degrees.

The IRB Medical Director and Associate Directors shall be voting members of all IRBs. In the absence of the Chair of an IRB, the Vice Chair, or the Director/Associate Director will assume the Chair.

The primary duty of each IRB member is to review applications to conduct research involving human participants with the purpose of assessing whether they are ethically and scientifically sound with regard to human participation in said research. The IRB member is expected to be knowledgeable about regulations governing human participant protection, biomedical and behavioral research ethics and SLUHN policies governing research involving human participants. The individual IRB member, as well as the convened IRB, must be, and must be perceived to be, fair and impartial in its deliberations, and immune from pressure either by institutional administration, the investigator whose study is being reviewed, or from other professional and nonprofessional sources.