(a) Administrator means the Administrator of the Environmental Protection Agency (EPA) and any other officer or employee of EPA to whom authority has been delegated.
(b) Institution means any public or private entity or agency (including Federal, State, and other agencies).
(c) Pesticide means any substance or mixture of substances meeting the definition in 7 U.S.C. 136(u) (Federal Insecticide, Fungicide, and Rodenticide Act, section 2(u)).
(d) Research means a systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this subpart, whether or not they are considered research for other purposes. For example, some demonstration and service programs may include research activities.
(e) 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.
(3) “Intervention” includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. “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 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). 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.
(f) IRB means an institutional review board established in accord with and for the purposes expressed in this part.
(g) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.
(h) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
(i) Research involving intentional exposure of a human subject means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject's participation in the study.
(j) Person means any person, as that term is defined in FIFRA section 2(s) (7 U.S.C. 136), except:
(1) A federal agency that is subject to the provisions of the Federal Policy for the Protection of Human Subjects of Research, and
(2) A person when performing human research supported by a federal agency covered by paragraph (j)(1) of this section.
(k) Common Rule refers to the Federal Policy for the Protection of Human Subjects that was established in 1991 by the Office of Science and Technology Policy and codified in 1991 by EPA and 14 other Federal departments and agencies (see the Federal Register issue of June 18, 1991 (56 FR 28003)) and subsequently codified by other Federal departments and agencies. The Common Rule contains a widely accepted set of standards for conducting ethical research with human subjects, together with a set of procedures designed to ensure that the standards are met. Once codified by a Federal department or agency, the requirements of the Common Rule apply to research conducted or sponsored by that Federal department or agency. EPA's codification of the Common Rule appears in 40 CFR part 26, subpart A.
[71 FR 6168, Feb. 6, 2006, as amended at 78 FR 10543, Feb. 14, 2013]