Engaged in Research: Scenarios

Sample scenarios of institutions engaged in human subjects research:

  1. Institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (i.e. awardee institutions), even where all activities involving human subjects are carried out by employees or agents of another institution.
  2. Institutions whose employees or agents intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures.
  3. Institutions whose employees or agents intervene for research purposes with any human subject of the research by manipulating the environment.
  4. Institutions whose employees or agents interact for research purposes with any human subject of the research.
  5. Institutions whose employees or agents obtain the informed consent of human subjects for the research.
  6. Institutions whose employees or agents obtain for research purposes identifiable private information or identifiable biological specimens from any source for the research.

Sample scenarios of institutions NOT engaged in human subjects research:

  1. Institutions whose employees or agents perform commercial or other services for investigators provided that all of the following conditions also are met:
    1. the services performed do not merit professional recognition or publication privileges;
    2. the services performed are typically performed by those institutions for non-research purposes; and
    3. the institution’s employees or agents do not administer any study intervention being tested or evaluated under the protocol.
  2. 2. Institutions whose employees or agents:
    1. inform prospective subjects about the availability of the research;
    2. provide prospective subjects with information about the research (which may include a copy of the relevant informed consent document and other IRB approved materials) but do not obtain subjects’ consent for the research or act as representatives of the investigators;
    3. provide prospective subjects with information about contacting investigators for information or enrollment; and/or
    4. seek or obtain the prospective subjects’ permission for investigators to contact them.
  3. Institutions that permit use of their facilities for intervention or interaction with subjects by investigators from another institution.
  4. Institutions whose employees or agents release to investigators at another institution identifiable private information or identifiable biological specimens pertaining to the subjects of the research.
  5. Institutions whose employees or agents:
    1. obtain coded private information or human biological specimens from another institution involved in the research that retains a link to individually identifying information (such as name or social security number); and
    2. are unable to readily ascertain the identity of the subjects to whom the coded information or specimens pertain because, for example:
      • the institution’s employees or agents and the holder of the key enter into an agreement prohibiting the release of the key to the those employees or agents under any circumstances;
      • the releasing institution has IRB-approved written policies and operating procedures applicable to the research project that prohibit the release of the key to the institution’s employees or agents under any circumstances; or
      • there are other legal requirements prohibiting the release of the key to the institution’s employees or agents.

The above scenarios are not intended to be all-inclusive. Please see the full OHRP guidance on Engagement of Institutions in Human Subjects Research.