40 CFR 26.1303 - Submission of information pertaining to ethical conduct of completed human research.

Regulations last checked for updates: Nov 25, 2024

Title 40 - Protection of Environment last revised: Nov 21, 2024

View all text of Subpart M [§ 26.1301 - § 26.1303]

§ 26.1303 - Submission of information pertaining to ethical conduct of completed human research.

Any person who submits to EPA data derived from human research covered by this subpart shall provide at the time of submission information concerning the ethical conduct of such research. To the extent available to the submitter and not previously provided to EPA, such information should include:

(a) Copies of all of the records relevant to the research specified by § 26.1115(a) to be prepared and maintained by an IRB.

(b) Copies of all of the records relevant to the information identified in § 26.1125(a) through (f).

(c) Copies of sample records used to document informed consent as specified by § 26.1117, but not identifying any subjects of the research.

(d) If any of the information listed in paragraphs (a) through (c) of this section is not provided, the person shall describe the efforts made to obtain the information.

authority: 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and 42 U.S.C. 300v-1(b)

source: 56 FR 28012, 28022, June 18, 1991, unless otherwise noted.

cite as: 40 CFR 26.1303