When is an Institution Considered to Be Engaged in Research?
The Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP) has clarified in a revision to the frequently asked question regarding "engagement in research." Any institution which receives a direct award from the DHHS to carry out non-exempt human research is automatically considered to be "engaged." This applies even where all activities involving human subjects are carried out by a subcontractor or collaborator. In general, an institution is considered to be engaged in human subject's research when its employees or agents:
Employees and agents, including students, are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.
In general, simply informing potential subjects about a research study is not considered engagement in research. Also, providing written information about a research study, including how to contact the investigators for information and enrollment, and seeking and obtaining prospective subjects' permission for investigators to contact them are not considered engagement in research. On the other hand, if one is seeking informed consent from a research participant then this activity would be considered engagement in research. For specific details, go to DHHS OHRP’s guidance on this topic at: http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html
REMINDER: If the PI of a project is unavailable to conduct research, as when on extended leave, the responsibility to make arrangements for another investigator to assume all responsibilities for the study these modifications must be submitted as a change PI of the project and approved prior to implementation.