Defining Research with Human Subjects – Research Course

Question 1: According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:

Answer: Obtains, uses, studies, analyzes, or generates identifiable private information.
In order to meet the definition of research with human subjects a researcher must obtain data about a living individual through interaction or intervention or, alternatively, obtain individually identifiable private information. If a researcher obtains public information or de-identified information about individuals, and has not interacted or intervened with the individuals, those individuals are not considered human subjects for the purposes of the research.

Question 2: A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates’ friends, family members, and business acquaintances. The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB?

Answer: The IRB will not review this study because it is not research as defined by the federal regulations.

This proposal is obtaining data from human subjects, but this project is not research since it is not “a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This project will not be reviewed by the IRB.

Question 3: According to the federal regulations, which of the following studies meets the definition of research with human subjects?

Answer: An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.
In the study of the effects of evoking stereotypes on subsequent performance, the researcher has a research question and will be manipulating the behavior of individuals. An in-house study conducted with the intention of improving a department’s mentoring programs is not research with human subjects, but rather program improvement. Receiving data with no identifiers is not research with human subjects because there is no interaction or intervention with a living human being and no collection of private identifiable data. In addition, creating a report for a membership organization does not involve a research question, as defined by the federal regulations, so it too is not research with human subjects.

Question 4: A medical record is an example of:

Answer: Private information

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 that has been provided for specific purposes by an individual and that 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. 45 CFR 46.102(e).

A medical record is considered private because it includes identifiable information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public. A medical record is not considered public information, nor is it considered a behavior.

Question 5: According to the federal regulations, which of the following studies meets the definition of research with human subjects?

Answer: A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.

A cognitive scientist studying the effect of moods on problem-solving behaviors is asking aresearch question and is interacting with living individuals. Questioning a superintendent of schools to acquire data about the ethnic composition of a school system is asking “about what” questions rather than “about whom” questions. (If a study proposed interviewing the superintendent of public schools about his or her experience in the field of education or about his or her perceptions about the current problems within the school system and possible solutions, the questions would become “about whom.”) Analyses of public behavior such as writing for a blog or a newspaper do not meet the definition because there is no interaction or intervention with a human subject and no collection of private information. Finally, in the class exercise described, the intention is pedagogical (to learn how to conduct and interview) rather than to answer a research question.