Guidance on Engagement of Institutions in Human Subjects Research

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.

Before engaging in human subjects research that is not exempt, an institution must hold or obtain an OHRP-approved Federalwide Assurance and certify to the HHS agency conducting or supporting the research that the research has been reviewed and approved by an IRB.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. An institution is defined in 45 CFR 46.102(b) as any public or private entity or agency (including federal, state, and other agencies).

In other words, institutions are considered engaged in an HHS-conducted or -supported non-exempt (EXPEDITED OR FULL BOARD) human subjects research project when the involvement of their employees or agents in that project falls into various examples including:

Institutions whose employees or agents intervene for research purposes with any human subjects 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.

Institutions whose employees or agents intervene for research purposes with any human subject 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.

Institutions whose employees or agents interact for research purposes with any human subject 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.

For more information and other examples, go to http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.