What is the Scope of the IRBs Authority?
All research projects involving human subjects or human materials must be reviewed and approved by the Mount Carmel IRB prior to initiation of any research related activities, including recruitment and screening activities. Except for research in which the only involvement of humans is in one or more of the categories exempted or waived under 45 CFR 46 Section 101(b) (1-6) or 101(i), all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, are subject to IRB review if one or more of the following apply: • The research is sponsored by institutional authorities • The research is conducted by or under the direction of any physician, employee, faculty member, staff member, student, or agent of the Institution in connection with his or her institutional responsibilities • The research is conducted by or under the direction of any physician, employee, faculty member, staff member, student, or agent of the Institution
