None of the funds appropriated by this Act or subsequent Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Acts shall be used to pay for any research program or project or any program, project, or course which is of an experimental nature, or any other activity involving human participants, which is determined by the Secretary or a court of competent jurisdiction to present a danger to the physical, mental, or emotional well-being of a participant or subject of such program, project, or course, without the written, informed consent of each participant or subject, or a participant’s parents or legal guardian, if such participant or subject is under eighteen years of age. The Secretary shall adopt appropriate regulations respecting this section.
Notes of Decisions
Cited in
8
cases, 1994–2011 · leading case:
Beno v. Shalala, 30 F.3d 1057 (9th Cir. 1994).
Beno v. Shalala, 30 F.3d 1057 (9th Cir. 1994).
· cites it 4× “and § 211 of the HHS Appropriations Act, 42 U.S.C. § 3515b, which prohibits HHS from spending federal money on experimental projects which pose a danger to human research subjects without their informed consent.”
Newton-Nations v. Betlach, 660 F.3d 370 (9th Cir. 2011).
· cites it 3× “§ 1315 and 1396o, and was arbitrary and capricious; (2) Defendant Secretary’s action failed to comport with the human participants protections required by 42 U.S.C. § 3515b, and was arbitrary and capricious; (3) Defendant Director’s imposition of copayments *377 violates the…”
C.K. v. Shalala, 883 F. Supp. 991 (D.N.J. 1995).
· cites it 3× “The Family Cap does not Violate the Human Subjects Protections of 42 U.S.C. § 3515b 42 U.S.C. § 3515b contains safeguards for human subjects in research projects or experiments conducted with funds appropriated to HHS.”
Newton-Nations v. Rogers, 221 F.R.D. 509 (D. Ariz. 2004).
· cites it 3× “§ 1315 and 1396o; (2) failed to comport to the protections required by 42 U.S.C. § 3515b; and (3) were done arbitrarily and capriciously.”
Newton-Nations v. Rogers, 316 F. Supp. 2d 883 (D. Ariz. 2004).
“§ 1315 and 1396o; (2) failed to comport to the human protections required by 42 U.S.C. § 3515b; and (3) that these actions were done in an arbitrary and capricious fashion.”
Newton-nations v. Betlach, 655 F.3d 1066 (9th Cir. 2011).
· cites it 3× “§ 1315 and 1396 o , and was arbitrary and capricious; (2) Defendant Secretary's action failed to comport with the human participants protections required by 42 U.S.C. § 3515b, and was arbitrary and capricious; (3) Defendant Director's imposition of copayments *377 violates the…”
C.K. v. New Jersey Dep't of Health & Human Servs., 92 F.3d 171 (3rd Cir. 1996).
· cites it 3× “THE HUMAN SUBJECTS PROTECTIONS OF 42 U.S.C. § 3515b 42 U.S.C. § 3515b contains safeguards for human subjects involved in research projects or experiments conducted with funds appropriated to HHS.”
Newton-nations v. Betlach, 655 F.3d 1066 (9th Cir. 2011).
· cites it 3× “§ 1315 and 1396 o , and was arbitrary and capricious; (2) Defendant Secretary's action failed to comport with the human participants protections required by 42 U.S.C. § 3515b, and was arbitrary and capricious; (3) Defendant Director's imposition of copayments violates the…”
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