OUSD(P&R) Human Research Protection Program (HRPP)
Relevant Terminology
The following statement provides an opportunity to define general terms relevant to human research.
- Assurance:
- Documents the institution’s commitment to comply with applicable laws, regulations, policies, and ethical guidelines.
- Describes the institution’s program for ensuring compliance with the above.
- Identifies the Institutional Review Board(s), IRBs, used by the institution.
- Engaged:
- Sponsored by the institution.
- Conducted or directed by employees or agents (including contractors and subcontractors).
- Conducted by or under direction of an institution facility.
- Institution releases non-public information to identify or recruit subjects or releases identifiable data for the research.
- Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains
- data through intervention or interaction with the individual, or
- identifiable private information
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
- Institution
- Any public or private entity or agency.
- An assurance holding entity.
- For P&R, institution means any component organization as defined by P&R.
- The head of the institution is required to sign the Assurance and to be acquainted with the basics of the protection program.
- Research: A systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
- Systematic means it is hypothesis driven with a research plan, data analysis, etc.
- Generalizable knowledge means new information that has relevance beyond the population or program from which it was collected, or information that is added to the scientific literature.
