Human subject research determinations

The following definitions are used to consider what projects constitute research activities at Children's Wisconsin.

2018 Common rule definitions

Research: The common rule defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge.

Systematic investigation: An activity that involves a prospective study plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a study question. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.

Human subject: A human subject as defined by the Common Rule is a living individual about whom an investigator conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)]

Intervention: Both physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. [45 CFR 46.102(e)(2)]

Interaction: Communication or interpersonal contact between investigator and subject. Please note that per OHRP interaction includes indirect means of communication such as via completion of a web-based survey.

Private information: 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).

Identifiable private information: Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(e)(5)].

Identifiable biospecimen: A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(6)]

Coded: (1) Identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

U.S. Food and Drug Administration (FDA) definitions

Research: The FDA has defined "research" as being synonymous with the term "clinical investigation." A clinical investigation, as defined by FDA regulations, means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]

Human subject: Human subject means an individual who is or becomes a participant in a clinical investigation, either as a recipient of the test article or as a control. A subject might be either a healthy individual or a patient. For research involving medical devices a human subject is also an individual on whose specimen an investigational device is used or tested or used as a control (regardless of whether the specimens are identifiable). [21 CFR 50.3(g), 21 CFR 312.3(b), 21 CFR 812.3(p)]

The Children's IRB has provided several tools to help investigators determine if their research project warrants a non-human research determination.

• Human subject research (HSR) determination form
• IRB operations vs. research algorithm
• IRB operations vs. research guidance
• Nursing research review process