Office for Protection from Research Risks

Assurances for Performance Sites

September 1998

An Assurance is required when performance sites are engaged in human subjects research that is conducted or supported by the Department of Health and Human Services (DHHS). A performance site is usually considered engaged in research when its staff, facilities, or private records of identifiable individuals are utilized in the conduct of the research. Solicitation of consent by site staff would be considered engagement.

When performance sites are engaged in the research, Assurance and Institutional Review Board (IRB) options include the following:

(1) Each performance site provides an Assurance designating a local IRB.

(2) Each performance site provides an Assurance designating an IRB that can do equal justice to subjects at any of the engaged sites. This generally requires at least nonvoting consultant input to the IRB from the different sites to account for facility, population, and legal differences.

(3) A regional body (e.g., a school system) with authority over each local site provides an Assurance designating a central IRB or several local IRBs.

A performance site may be considered NOT engaged in a research activity if the only involvement of the site is to provide records information explicitly authorized by subjects AFTER they have consented to participate in the research.

Simple referral of potentially eligible subjects by sites to investigators for explanation of the research does not (in and of itself) constitute engagement in research. However, sites may not provide investigators with identifiable private information about potential subjects (e.g., names, addresses, or telephone numbers) without prior permission. Recruitment of subjects by sites that includes solicitation of consent would constitute engagement in research.