The federal concept of “engagement” is important because it is a factor in determining whether research activities need IRB review.
In brief, an "engaged" institution is one whose agents (faculty, students, or staff) recruit and secure consent from subjects, conduct research procedures, or who receive or share private, identifiable information. This definition parallels the federal definition of research with human subjects. The activities listed need IRB review.
Institutions are not engaged if their employees:
- Inform prospective subjects about the availability of research
- Provide prospective subjects with written information about research, which may include a copy of the relevant informed consent document, and other IRB-approved materials) but do not obtain subjects' consent or act as authoritative representatives of the investigators;
- Provide prospective subjects with information about contacting investigators for information or enrollment; or
- Obtain and appropriately document prospective subjects' permission for investigators to contact them.
- Provide space for the US researcher to conduct their own research.
If a collaborating institution is not engaged in the research, the institution’s researchers do not need to secure IRB approval.
Applying the Definition
If a Duke researcher with limited travel funds wishes to expand a research study to clinics in new communities, and a colleague at another university agrees to help recruit subjects, the colleague may post flyers, make brochures available, or tell clients that there is a research opportunity that may interest them. Those activities do not constitute engagement. They must be described in the Duke researcher’s protocol, but they don’t need review by the collaborator’s institution. If colleagues decides that they would like to add questions to the survey for their own research, the colleague’s institution is now engaged and the colleague must secure IRB approval.
For the full policy see, Engagement of Institutions in Human Subjects Research (2008).