§97.102. Definitions for purposes of this policy. — Inbound Citations

The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this subpart:

(A) Beginning on the date of such documentation through January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:

(1) Section 97.102(l) of the 2018 Requirements (definition of research) (instead of § 97.102(d) of the pre-2018 Requirements);

(2) Section 97.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of § 97.103(f) of the pre-2018 Requirements); and

(3) Section 97.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of § 97.103(b), as related to the requirement for continuing review, and in addition to § 97.109, of the pre-2018 Requirements); and

In this section, research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (34 CFR 97.102(d)) Research is considered to involve human subjects when a researcher obtains information about a living individual through intervention or interaction with the individual or obtains personally identifiable private information about an individual. Some categories of research are exempt in accordance with 34 CFR part 97.

(A) Beginning on the date of such documentation through January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:

(1) Section 97.102(l) of the 2018 Requirements (definition of research) (instead of § 97.102(d) of the pre-2018 Requirements);

(2) Section 97.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of § 97.103(f) of the pre-2018 Requirements); and

(3) Section 97.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of § 97.103(b), as related to the requirement for continuing review, and in addition to § 97.109, of the pre-2018 Requirements); and