Human Subjects

Key to determining if research involves human beings as subjects are these definitions:

 What is a “living individual?”

•  The specimen/data/information must be collected from live subjects.  Cadavers, autopsy specimens, or specimens/information from subjects now deceased in not human subjects.

 What does “about whom” mean?

•  A human subject research project requires that the data received from the living individual is about the person—not about something else (such as a product or service).

 What is an “intervention?”

• An intervention includes physical/psychological procedures, manipulations of the human subject, or manipulations of the subject’s environment for research purposes.

 What is “interaction?”

• An interaction includes communication between the investigator and the subject.  This includes face-to-face, mail, phone, e-mail as well as any other mode of communication.

 What is “identifiable private information?”

• Federal regulation defines identifiable private information as “information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place,” (such as a public restroom) and “information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (such as a health care record)” (45 CFR 46. 102(f)(2)).

 What is “identifiable?”

•  Identifiable means the information contains one or more data elements that can be combined with other information to identify an individual (such as a Social Security number).

Under changes to the Common Rule effective January 21, 2019, the following activities are not considered to be research involving human subjects and do not need IRB approval or oversight:

1. Scholarly and journalistic activities such as oral history, journalism, biography, literary criticism, legal research, historical scholarship, etc. that focus on specific individuals for legal or historical purposes;
2. Public health surveillance:  the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority;
3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law court order solely for criminal justice or criminal investigative purposes;
4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense or other national security missions;
5. Program improvement activities – collection and analysis of data, including biospecimens, for the purpose of an institution’s internal evaluation, monitoring or program improvement; and
6. Quality assurance and quality improvement – the implementation of an accepted practice to improve the quality of care, or the analysis of data or biospecimens to evaluate the effectiveness of an accepted practice.