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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).
56 FR 28012, 28022, June 18, 1991, unless otherwise noted.
84 FR 35318, July 23, 2019, unless otherwise noted.
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Any person or institution who intends to conduct or sponsor human research covered by § 26.1101(a) shall, after receiving approval from all appropriate IRBs, submit to EPA prior to initiating such research all information relevant to the proposed research specified by § 26.1115(a), and the following additional information, to the extent not already included:
(a) A discussion of:
(1) The potential risks to human subjects;
(2) The measures proposed to minimize risks to the human subjects;
(3) The nature and magnitude of all expected benefits of such research, and to whom they would accrue;
(4) Alternative means of obtaining information comparable to what would be collected through the proposed research; and
(5) The balance of risks and benefits of the proposed research.
(b) All information for subjects and written informed consent agreements as originally provided to the IRB, and as approved by the IRB.
(c) Information about how subjects will be recruited, including any advertisements proposed to be used.
(d) A description of the circumstances and methods proposed for presenting information to potential human subjects for the purpose of obtaining their informed consent.
(e) All correspondence between the IRB and the investigators or sponsors.
(f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that research involving human subjects has been reviewed and approved by an IRB.