| Baruch A. Brody - Medical - 1998 - 412 pages
...short form written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's...subjects with a written statement regarding the research. §46. 7 18 Applications and Proposals Lacking Definite Plans for Involvement of Human Subjects Certain... | |
| Nancy M. P. King, Gail Henderson, Jane Stein - Medical - 1999 - 300 pages
...requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: breach of confidentiality. Each subject will be asked...statement regarding the research. (Approved by the Off1ce of Management and Budget under Control Number 9999-0020). APPENDIX C CIOMS Epidemiological Research... | |
| Administrative law - 2000 - 784 pages
...representative. When this method is used, there shall be a witness to the oral presentation. Also, the ERB shall approve a written summary of what is to be said...the research. (Approved by the Office of Management anc Budget under control number 9999-0020) {16.118 Applications and proposals lacking definite plans... | |
| Administrative law - 2001 - 608 pages
...for the investigator to obtain a signed consent form for some or all subjects if it finds either: (l) That the only record linking the subject and the research...research. (Approved by the Office of Management and Budget under control number 9999-0020) (Authority: 5 USC 301; 20 USC 1221e-3, 3474; and 42 USC 300v-1(b))... | |
| Leslie John Francis, Jeff Astley - Religion - 2001 - 410 pages
...requirement for the investigator to obtain a signed consent form for some or all subjects if it finds . . . that the research presents no more than minimal risk...normally required outside of the research context. Scientifically, a study design with complete blinding was preferred because it eliminated any possibility... | |
| Daniel Pollack - Jewish law - 2001 - 294 pages
...representative"). 806. See 45 CFR § 46.117(c) (2) (stating that the IRB may waive the signedconsent requirement if "the research presents no more than minimal risk of...normally required outside of the research context"); see also id. § 46.116(d) (1) (stating that the IRB may approve experimentation even if all the elements... | |
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