Key to determining if research involves human beings as subjects are these definitions:
- The specimen/data/information must be collected from live subjects. Cadavers, autopsy specimens, or specimens/information from subjects now deceased in not human subjects.
- 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).
- An intervention includes physical/psychological procedures, manipulations of the human subject, or manipulations of the subject’s environment for research purposes.
- 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.
- 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)).
- 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).
By contrast, types of projects that do not require IRB approval include:
- Human subjects research generally does not include studies for internal management or assessment purposes (such as program evaluations, customer service surveys, marketing studies), journalism, or political polls. However, some of these activities may constitute research if there is a clear intent to contribute to generalizable knowledge.
- Information-gathering interviews where questions focus on things, products, or policies rather than about people or their thoughts regarding themselves are not human subjects research. For example, a canvass of librarians about rising journal costs.
- Course-related activities designed specifically for educational or teaching purposes where data is collected from and about human subjects as part of a class exercise or assignment, but are not intended for use outside of the classroom may not be human subjects research. Check with the IRB because some classroom projects (such as instruction on research methods and techniques) may require IRB review.
- Publicly available data do not require IRB review. For example, census data, labor statistics.
- Coded specimens and/or data sets that were not collected for the currently proposed projects do not need IRB review as long as the investigator cannot link the data/specimens back to the individual subjects. If the data provider can ascertain the identity of the subjects (names, addresses, etc.), the investigator must enter into an agreement with the data provider that states under no circumstances will the identity of the subjects be released to the investigator. These projects require verification from the IRB.
Investigators should choose to err on the side of caution and consult the IRB if there is uncertainty as to whether the study is considered human subject research.