 The human subjects are in a lifethreatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebocontrolled investigations, is necessary...  Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent ... - Page 91by United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - 1997 - 228 pagesFull view - About this book
 | Administrative law - 1997 - 468 pages
...otherwise participating in the clinical investigation) finds and documents each of the following: (1) The human subjects are in a lifethreatening situation,...available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized... | |
 | Administrative law - 1999 - 508 pages
...otherwise participating in the clinical investigation) finds and documents each of the following: (1) The human subjects are in a lifethreatening situation,...available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized... | |
 | Administrative law - 2001 - 524 pages
...otherwise participating in the clinical investigation) finds and documents each of the following: (1) The human subjects are in a lifethreatening situation,...available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized... | |
 | United States. Congress. House. Committee on Government Reform and Oversight - Law - 1998 - 238 pages
...device exemption (IDE) application or investigations! new drug (IND) application. This will pemit rhe Agency to very carefully review each of these studies...administered before they could feasibly be reached, ind there is no reasonable way to identify prospectively the individuals likely to become eligible... | |
 | Baruch A. Brody - Medical - 1998 - 412 pages
...otherwise participating in the clinical investigation) finds and documents each of the following: (1) The human subjects are in a life-threatening situation,...available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized... | |
 | Jeffrey P. Kahn, Anna C. Mastroianni, Jeremy Sugarman - Medical - 1998 - 205 pages
...be satisfied before the waiver is authorized. Under the regulations, waivers may only be issued when "the human subjects are in a life-threatening situation,...available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence ... is necessary to determine the safety and effectiveness... | |
 | Nancy M. P. King, Gail Henderson, Jane Stein - Medical - 1999 - 300 pages
...order to permit a waiver of informed consent if the IRB finds and documents each of the following: 1. The human subjects are in a life-threatening situation,...available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized... | |
 | Jessica W. Berg, Paul S. Appelbaum, Charles W. Lidz, Lisa S. Parker - Medical - 2001 - 354 pages
...HHS, FDA issued new regulations, creating an exception from informed consent requirements when: 1. subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and a controlled investigation is necessary; 2. obtaining informed consent is not feasible; 3. the research... | |
 | John E. Steiner - Clinical trials - 2006 - 498 pages
...the general requirements for informed consent if it finds and documents each of the following: 1 . the human subjects are in a life-threatening situation,...available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence is necessary to determine safety and efficacy; 2. obtaining... | |
 | Daniel Farb, Bruce Gordon - Medical - 2005 - 337 pages
...otherwise participating in the clinical investigation) finds and documents each of the following: (1) The human subjects are in a life-threatening situation,...available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized... | |
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