Overview
When Pitt faculty, students and staff collaborate with individuals conducting human subjects research at off-campus sites, it is important – from a regulatory perspective – to determine whether those sites are actually ‘engaged in research’. If the study is federally funded, and the other site (or institution) is ‘engaged’, a Federal Wide Assurance (FWA) is required for that site [45 CFR 46.103(a)], and the site must certify to the HHS agency conducting or supporting the research that the research has been reviewed and approved by an IRB designated in the FWA, and will be subject to continuing review by an IRB [45 CFR 46.103(b)]. For example, if a Pitt researcher with federal funding conducts a study at a local clinic not affiliated with UPMC or Pitt, that clinic will have to obtain an FWA if its employees are ‘engaged’ in research activities.
Determining whether or not an institution is ‘engaged’ can be challenging, and it is critically important to consult with the Pitt HRP early on when developing research projects that use facilities that may not be covered by existing Pitt/UPMC FWAs.
Description
The Office for Human Research Protections (OHRP) provides a Guidance on Engagement of Institutions in Human Subjects Research. This guidance document applies to research involving human subjects that is conducted or supported by the Department of Health and Human Services (HHS). When an institution is engaged in non-exempt human subjects research that is conducted or supported by HHS, it must satisfy HHS regulatory requirements related to holding an assurance of compliance and certifying institutional review board (IRB) review and approval. This guidance document describes:
- Scenarios that, in general, would result in an institution being considered engaged in a human subjects research project
- Scenarios that would result in an institution being considered not engaged in a human subjects research project, and
- IRB review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project.
Examples of when an institution/individual is engaged in human subjects research include:
- Receiving direct federal funding for research (i.e., Primary Awardee of the grant)
- Obtaining data about research subjects through intervention/interaction
- Obtaining identifiable private information about research subjects
- Obtaining informed consent
- Implementing/administering research intervention
Definitions
Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. [45 CFR 46.102(l)]
Human subject: A living individual about whom an investigator (whether professional or student) conducting research obtains [45 CFR 46.102(e)(1)]:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyses the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Intervention: Includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. [45 CFR 46.102(e)(2)]
Interaction: Includes communication or interpersonal contact between investigator and subject. [45 CFR 46.102(e)(3)]
Private information: includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record). [45 CFR 46.102(e)(4)]
Identifiable private information: Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(5)]
Identifiable biospecimen: A biospecimen for which the identify of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(6)]
Institution: Any public or private entity or agency (including federal, state, and other agencies). [45 CFR 46.102(f)]
For purposes of this document, an institution’s employees or agents refers to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. “Employees and agents” can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation
Considerations
You cannot make this determination alone. It is important that you consult with the Pitt HRP to assist in making the final determination as to whether the collaborating individual (institution) is engaged in research involving human subjects. Please contact askirb@pitt.edu for assistance.
NOTE: It is inappropriate for a collaborating institution to list the University of Pittsburgh as their IRB of record on the FWA without first discussing this with the Director or Associate Director of the University of Pittsburgh HRP
Additional Information
US Department of Health & Human Services Guidance on Engagement of Institutions in Human Subject Research
v.4/20/2021