45 CFR 46.102 - Definitions

Cite as45 CFR 46.102
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66 practice notes
  • Federal Policy for the Protection of Human Subjects
    • United States
    • Federal Register September 08, 2015
    • September 8, 2015
    ...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR 46.102(i)). --------------------------------------------------------------------------- Eligibility for Expedited Review: The ANPRM suggested updatin......
  • Health and Human Services Acquisition Regulation
    • United States
    • Federal Register March 02, 2015
    • March 2, 2015
    ...370.300 Scope of subpart. This subpart applies to all research activities conducted under contracts involving human subjects. See 45 CFR 46.102(d) and 370.301 Policy. It is the Department of Health and Human Services (HHS) policy that the contracting officer shall not award a contract invol......
  • Health and Human Services Acquisition Regulations
    • United States
    • Federal Register November 18, 2015
    • November 18, 2015
    ...370.300 Scope of subpart. This subpart applies to all research activities conducted under contracts involving human subjects. See 45 CFR 46.102(d) and 370.301 Policy. It is the Department of Health and Human Services (HHS) policy that the contracting officer shall not award a contract invol......
  • Clinical Trials Registration and Results Submission
    • United States
    • Federal Register November 21, 2014
    • November 21, 2014
    ...review board is defined in Sec. 11.10 of this proposed rule to mean an ``institutional review board (IRB) as defined in 21 CFR 50.3 and 45 CFR 46.102 (or any successor regulation), as applicable, or equivalent independent ethics committee that is responsible for ensuring the protection of t......
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20 cases
  • Sherley v. Sebelius, No. 10–5287.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • April 29, 2011
    ...no such inquiry, the act of derivation can be deemed “research” only if it is part of a larger project. The plaintiffs refer us to 45 C.F.R. § 46.102(d), supra at 394 n. *; see also, e.g., Merriam–Webster Dictionary Online,,, http:// merriam- webster. com/ dictionary/ research (last visited......
  • Util. Solid Waste Activities Grp. v. Envtl. Prot. Agency, No. 15-1219
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • August 21, 2018
    ...research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Id. at 394 n.* (quoting 45 C.F.R. § 46.102(d) ). Notwithstanding this temporally broad definition, the majority declared that the "definition of research is flexible enough to descri......
  • CK v. Shalala, Civ. A. No. 93-5354 (NHP).
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • May 4, 1995
    ...is triggered, but they do not foreclose a finding of danger in a specific situation. See Beno, 853 F.Supp. at 1210 (citing 45 C.F.R. § 46.102(d)), rev'd on other grounds, 30 F.3d The Secretary argues that § 3515b by its terms contemplates an estimation in advance of the danger(s) posed by a......
  • United Tort Claimants v. Quorum Health Res., LLC (In re Otero Cnty. Hosp. Ass'n, Inc.), Case No. 11-11-13686 JL
    • United States
    • United States Bankruptcy Courts. Tenth Circuit. U.S. Bankruptcy Court — District of New Mexico
    • February 27, 2015
    ...investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." 45 C.F.R. § 46.102(d). The regulations define an IRB as "an institutional review board established in accord with and for the purposes expressed in this poli......
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17 firm's commentaries
  • Commercializing Stem Cell-Based Therapies: Meeting NIH and FDA Requirements by Kalah Auchincloss
    • United States
    • JD Supra United States
    • September 9, 2009
    ...are used for other than their normal function, are combined with non-tissue components, or are used for metabolic purposes.”19 15 45 C.F.R. § 46.102(f) (2008); see also HHS Office for Human Research Protections, Guidance for Investigators and Institutional Review Boards Regarding Research I......
  • What To Know About New FDA Informed Consent Guidance
    • United States
    • Mondaq United States
    • August 15, 2017
    ...examinations or tests" (21 C.F.R. §§ 50.3(k) and 56.102(i)). The Common Rule contains the same definition of "minimal risk" (45 C.F.R. § 46.102). The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific...
  • Controversial U.S. Medical Study Raises Informed Consent Questions
    • United States
    • Mondaq United States
    • May 10, 2013
    ...consent requirements, as these were the regulations at issue in the newborn study. When Do the Regulations Apply (45 CFR 46.101 and 45 CFR 46.102) According to the regulations, human subject protection rules apply to "all research involving human subjects conducted, supported or otherwise s......
  • Controversial U.S. Medical Study Raises Informed Consent Questions
    • United States
    • JD Supra United States
    • May 10, 2013
    ...consent requirements, as these were the regulations at issue in the newborn study. When Do the Regulations Apply (45 CFR 46.101 and 45 CFR 46.102) According to the regulations, human subject protection rules apply to "all research involving human subjects conducted, supported or otherwise s......
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4 books & journal articles
  • Creating clones, kids & chimera: liberal democratic compromise at the crossroads.
    • United States
    • Issues in Law & Medicine Vol. 20 Nbr. 1, June 2004
    • June 22, 2004
    ...Id. [section] 46.111(a)(2). (294) Id. [section] 46.111(b). (295) Id. [section] 46.102(d). (296) Id. [section] 46.116(a)(1)-(8). (297) 45 C.F.R. 46.102; see also id. [section] 46.401-09 (stating that children may be subject only to a minor increase over minimal (298) See generally 45 C.F.R. ......
  • Regulating Clinical Research: Informed Consent, Privacy, and Irbs
    • United States
    • Capital University Law Review Nbr. 31-1, January 2003
    • January 1, 2003
    ...research institutions to review, approve, and periodically monitor biomedical research studies. 21 C.F.R § 56.102(g) (2002); See also 45 C.F.R. § 46.102(g) (2001). [11] Rick Weiss & Deborah Nelson, Teen Dies Undergoing Experimental Gene Therapy, WASH. POST, Sept. 29, 1999, at A1; Gelsin......
  • Correlates of Intimate Partner Homicide in the Rural United States: Findings From a National Sample of Rural Counties, 2009–2016
    • United States
    • Homicide Studies Nbr. 24-4, November 2020
    • November 1, 2020
    ...private information belonging to human subjects as defined by the U.S. Code of Federal Regulations governing human subjects research (45 CFR § 46.102, item e), no ethics review was required for this study (U.S. Department of Health and Human Services, 2018).ResultsDescriptive Characteristic......
  • Institutional Review Board mission creep: the common rule, social science, and the nanny state.
    • United States
    • Independent Review Vol. 11 Nbr. 4, March 2007
    • March 22, 2007
    ...than those encountered in daily life or during the performance of routine physical or psychological examinations or tests" (1991, 45 CFR 46.102 I). The standard to be applied refers to the kinds of risks we all encounter in our daily lives, such as driving to work, crossing the street, or a......
23 provisions
  • Health and Human Services Acquisition Regulation
    • United States
    • Federal Register March 02, 2015
    • March 2, 2015
    ...370.300 Scope of subpart. This subpart applies to all research activities conducted under contracts involving human subjects. See 45 CFR 46.102(d) and 370.301 Policy. It is the Department of Health and Human Services (HHS) policy that the contracting officer shall not award a contract invol......
  • Health and Human Services Acquisition Regulations
    • United States
    • Federal Register November 18, 2015
    • November 18, 2015
    ...370.300 Scope of subpart. This subpart applies to all research activities conducted under contracts involving human subjects. See 45 CFR 46.102(d) and 370.301 Policy. It is the Department of Health and Human Services (HHS) policy that the contracting officer shall not award a contract invol......
  • Clinical Trials Registration and Results Submission
    • United States
    • Federal Register November 21, 2014
    • November 21, 2014
    ...review board is defined in Sec. 11.10 of this proposed rule to mean an ``institutional review board (IRB) as defined in 21 CFR 50.3 and 45 CFR 46.102 (or any successor regulation), as applicable, or equivalent independent ethics committee that is responsible for ensuring the protection of t......
  • Federal Policy for the Protection of Human Subjects
    • United States
    • Federal Register September 08, 2015
    • September 8, 2015
    ...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR 46.102(i)). --------------------------------------------------------------------------- Eligibility for Expedited Review: The ANPRM suggested updatin......
  • Request a trial to view additional results

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