Engagement in Research Definition
The USC IRB defines engagement in research according to OHRP’s 2008 guidance on the Engagement of Institutions in Human Subjects Research and OHRP’s 2011 Correspondence on “Non- engaged Scenarios”.
USC becomes “engaged” in human subjects research when its employees or agents (all individuals performing institutionally-designated activities or exercising institutionally-delegated authority or responsibility, including faculty and students) for the purpose of the research project:
- Obtain information or biospecimens through intervention or interaction with the research participants; or
- Obtain, use, study, analyze, or generate identifiable private information or identifiable biospecimens; or
- Obtain informed consent of research participants.
Additionally, USC is automatically considered to be “engaged” in human subjects research whenever it receives a direct HHS award to support such research. In such cases the awardee’s Institution bears ultimate responsibility for protecting human participants under the award.
In general, USC Institutions are considered engaged in an HHS-conducted or -supported non- exempt human subjects research project (and, therefore, would need to hold or obtain OHRP-approved FWAs and certify IRB review and approval to HHS) when the involvement of their employees or agents in that project includes any of the following:
- USC Institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for the non-exempt human subjects research (awardee Institutions), even where all activities involving human participants are carried out by employees or agents of another Institution
- USC Institutions whose employees or agents intervene for research purposes with any human participants of the research by performing invasive or noninvasive procedures. Examples of invasive or noninvasive procedures include drawing blood; collecting buccal mucosa cells using a cotton swab; administering individual or group counseling or psychotherapy; administering drugs or other treatments; surgically implanting medical devices; utilizing physical sensors; and utilizing other measurement procedures
- USC Institutions whose employees or agents intervene for research purposes with any human participant of the research by manipulating the environment. Examples of manipulating the environment include controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions.
- USC Institutions whose employees or agents interact for research purposes with any human participant of the research. Examples of interacting include engaging in protocol dictated communication or interpersonal contact; asking someone to provide a specimen by voiding or spitting into a specimen container; and conducting research interviews or administering questionnaires.
- USC Institutions whose employees or agents obtain the informed consent from human participants for the research
- USC Institutions whose employees or agents obtain for research purposes identifiable private information or identifiable biological specimens from any source for the research. It is important to note that, in general, Institutions whose employees or agents obtain identifiable private information or identifiable biological 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 participant In general, obtaining identifiable private information or identifiable biological specimens includes, but is not limited to:
- observing or recording private behavior
- using, studying, or analyzing for research purposes identifiable private
information or identifiable biological specimens provided by another Institution - using, studying, or analyzing for research purposes identifiable private information or identifiable biological specimens already in the possession of the investigators
USC adheres to OHRP’s definition of identifiable private information and identifiable biospecimens in 45 CFR 46.102(e)(6) when the identity of the participant is or may readily be ascertained by the investigator or associated with the information or biospecimen.
USC Institutions would be considered not engaged in an HHS-conducted or -supported non- exempt human subjects research project (and, therefore, would not need to hold an OHRP-approved FWA or certify IRB review and approval to HHS) if the involvement of their employees or agents in that project is limited to one or more of the following examples.
- USC Institutions whose employees or agents perform commercial or other services for investigators provided that all of the following conditions also are met:
- the services performed do not merit professional recognition or
publication privileges - the services performed are typically performed by those Institutions for
non-research purposes - the Institution’s employees or agents do not administer any study
intervention being tested or evaluated under the protocol
- the services performed do not merit professional recognition or
- USC Institutions whose employees or agents provide medical services that are dictated by the protocol and would typically be performed as part of routine clinical care and/or follow-up, are considered “not engaged” in research provided that all of the following conditions also are met:
- the USC Institution’s employees or agents do not administer the study interventions being tested or evaluated under the protocol
- the clinical trial-related medical services are typically provided by the Institution for clinical purposes
- the USC Institution’s employees or agents do not enroll participants or obtain the informed consent of any participant for participation in the research
- when appropriate, investigators from a USC Institution engaged in the research retain responsibility for:
- overseeing protocol-related activities
- ensuring appropriate arrangements are made for reporting
protocol-related data to investigators at an engaged Institution, including the reporting of safety monitoring data and adverse events as required under the IRB-approved protocol
Note that USC institutions (including private practices) not initially selected as research sites whose employees or agents administer the interventions being tested or evaluated in the study, such as administering either of two chemotherapy regimens as part of an oncology clinical trial evaluating the safety and effectiveness of the two regimens, generally would be engaged in human subjects research (see scenario B.(3) in OHRP guidance for a limited exception). If such an Institution does not have an FWA, its employees or agents may be covered by the FWA of another Institution that is engaged in the research through completion of an Individual Investigator Agreement and/or IRB Authorization Agreement
- USC Institutions (including private practices) not initially selected as a research site whose employees or agents administer the study interventions being tested or evaluated under the protocol limited to a one-time or short-term basis (an oncologist at the Institution administers chemotherapy to a research participant as part of a clinical trial because the participant unexpectedly goes out of town, or is unexpectedly hospitalized), provided that all of the following conditions also are met:
- an investigator from a USC Institution engaged in the research determines that it would be in the participant’s best interest to receive the study interventions being tested or evaluated under the protocol
- the USC Institution’s employees or agents do not enroll participants or obtain the informed consent of any participant for participation in the research
- investigators from the USC Institution engaged in the research retain responsibility for:
- overseeing protocol-related activities
- ensuring the study interventions are administered in accordance with the IRB-approved protocol and
- ensuring appropriate arrangements are made for reporting
protocol-related data to investigators at the engaged Institution, including the reporting of safety monitoring data and adverse events as required under the IRB-approved protocol and - an IRB designated on the engaged Institution’s FWA is informed that study interventions being tested or evaluated under the protocol have been administered at an Institution not selected as a research site
- USC Institutions whose employees or agents:
- inform prospective participants about the availability of the research
- provide prospective participants 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 participants’ consent for the research or act as representatives of the investigators - provide prospective participants with information about contacting investigators for information or enrollment and/or
- seek or obtain the prospective participants’ permission for investigators to contact them
- USC Institutions (schools, nursing homes, businesses) that permit use of their facilities for intervention or interaction with participants by investigators from another Institution. Example would be a school that permits investigators from another Institution to conduct or distribute a research survey in the classroom.
- USC Institutions whose employees or agents release to investigators identifiable private information or identifiable biological specimens pertaining to the participants of the research. Note that in some cases the Institution releasing identifiable private information or identifiable biological specimens may have institutional requirements that would need to be satisfied before the information or specimens may be released, and/or may need to comply with other applicable regulations or laws. In addition, if the identifiable private information or identifiable biological specimens to be released were collected for another research study covered by 45 CFR part 46, then the Institution releasing such information or specimens should:
- ensure that the release would not violate the informed consent provided by the participants to whom the information or biological specimens pertain (under 45 CFR 46.116), or
- if informed consent was waived by the IRB, ensure that the release would be consistent with the IRB’s determinations that permitted a waiver of informed consent under 45 CFR 46.116 (c) or (d)
Note that, in general, the USC Institutions whose employees or agents obtain the identifiable private information or identifiable biological specimens from the releasing Institution would be engaged in human subjects research.
- USC Institutions whose employees or agents:
- 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 - are unable to readily ascertain the identity of the participants 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 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
- here are other legal requirements prohibiting the release of the key to the Institution’s employees or agents
- obtain coded private information or human biological specimens from
For purposes of this document, coded means that:
- identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, and/or combination thereof (the code), and
- a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens
- USC Institutions whose employees or agents 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.
- USC Institutions whose employees or agents access or review identifiable private information for purposes of study auditing (a government agency or private company will have access to individually identifiable study data for auditing purposes).
- USC Institutions whose employees or agents receive identifiable private information for purposes of satisfying U.S. Food and Drug Administration reporting requirements.
- USC Institutions whose employees or agents author a paper, journal article, or presentation describing a human subjects research study.
For additional questions or further clarification, investigators should contact the IRB.