Engagement of Institutions in Human Subjects Research (HSR)

For many clinical studies, the role of some members of the investigative team might not meet the definition of human subjects research (HSR). For example, if a laboratory technician receives a blood specimen that is coded and they have no way to re-identify the individual from whom the specimen was obtained, the technician is not engaged in HSR.

OHRP Guidance on Engagement of Institutions

If there is uncertainty about whether or not CHOP or an investigator at CHOP is engaged in the research, the Office of Human Research Protections (OHRP) provides a Guidance on Engagement of Institutions in Human Subjects Research. The FAQs for this section provide examples of when IRB Review is needed and when it is not.

Based on OHRP's Guidance, under some circumstances CHOP and its agents are not engaged in HSR, even though investigators elsewhere are. For example, blood specimens are sent to CHOP without identifiers for analysis. If CHOP does not enroll subjects in the study, then CHOP is not engaged in HSR. There is one exception; when the study is funded by the DHHS and the PI is from CHOP, the IRB is required to review the study under the Common Rule at 45 CFR 46.122. This is true even when the PI is not personally engaged in the conduct of HSR. The rationale is that PI is responsible for the oversight of the HSR that is being conducted on at the sub-contracted site(s).

Summary of OHRP's Guidance

Institutions are engaged in HSR if their agents or employees:

  1. receive an award through a grant, contract, or cooperative agreement directly from HHS
  2. intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures (see limited exceptions in column to right);
  3. intervene by manipulating the environment;
  4. interact with subjects for research purposes;
  5. obtain consent of subjects;
  6. obtain for research purposes identifiable private information or identifiable biological specimens from any source

It is important to note that, in general, institutions whose employees or agents obtain identifiable private information or identifiable specimens for non-exempt human subjects research are considered engaged in the research, even if the institution’s employees or agents do not directly interact or intervene with human subjects.

 

Institutions are not engaged in HSR (NHSR) if their agents or employees:

  1. perform commercial or other services for investigators (somewhere else) provided that all of the following are also 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. provide clinical trial-related medical services that are dictated by the protocol and would typically be performed as part of routine clinical monitoring and/or follow-up of subjects enrolled at a study site by clinical trial investigators;
  3. administer the study interventions being tested or evaluated under the protocol limited to a one-time or short-term basis;
  4. provides patients with literature about a research study at another institution, including a copy of the informed consent document, and obtains permission from the patient to provide the patient's name and telephone number to the investigators;
  5. access or utilize individually identifiable private information only while visiting an institution that is engaged in the research, provided their research activities are overseen by the IRB of the institution that is engaged in the research;
  6. release to investigators at another institution identifiable private information or identifiable biological specimens pertaining to the subjects of the research. NOTE: the subjects would need to provide informed consent at the institution to which the data will be released.

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