Overview

Schulman can serve as an institution's IRB when there is no local IRB with jurisdiction or where the local IRB defers, in writing, to Schulman. "Institutions" includes, but is not limited to, academic medical centers, hospital systems, community hospitals, etc., that may or may not have local IRBs. Schulman meets the requirements of the federal regulations on human subject protection (45 CFR 46), is registered (#00000971) with the Office for Human Research Protections (OHRP), and can review federally funded research that falls under the auspices of OHRP.

If an institution conducting research under a Federal Wide Assurance ("FWA") prefers to use the services of Schulman, it must include Schulman as an IRB on its FWA. If Schulman is not currently named as an IRB on the institution's FWA, the institution must update its FWA to include Schulman and submit it to OHRP. In addition, the Institution must execute an IRB Authorization Agreement with Schulman.

An institution may have concerns related to local review when it has deferred to a central IRB, located in another state or region of the country. The Board, in addition to having members whose backgrounds are culturally, racially, ethnically and professionally diverse, is sensitive to issues regarding local review by a central IRB. When reviewing federally funded studies and/or studies conducted under an FWA, Schulman contacts local representatives and obtains verbal and written reports of community attitudes toward research. A visit to the site also may be performed, if needed.

For federally funded studies and/or studies conducted under an FWA, the
Research Site Submission Form must be completed, including, where applicable, the Federally Funded Research/FWA Supplement.

The Board also reviews protocols and informed consent documents submitted by facilities (such as hospitals, nursing homes, homeless shelters, etc.) that do not have local IRBs. In these situations, the Board requires written permission from the facility, deferring to Schulman as the reviewing IRB. The facility's IRB chairperson, CEO, or authorized person must submit a Hospital Deferral Letter authorizing the Board to review the study.