-
1
-
-
84882276566
-
21 CFR part 312. Human subject protection; foreign clinical studies not conducted under an investigational new drug application
-
and, 28 April, effective, October 27
-
DHHS Food and Drug Administration. 21 CFR part 312. Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule 28 April 2008, effective, October 27 2008., www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o= 0900006480537f08.
-
(2008)
Final rule
-
-
Food, D.H.H.S.1
-
2
-
-
15744371179
-
US exceptionalism comes to research ethics
-
CrossRef][Web of Science][Medline
-
Lurie P, Greco DB. US exceptionalism comes to research ethics. Lancet 2005;365:1117-9. [CrossRef][Web of Science][Medline]
-
(2005)
Lancet
, vol.365
, pp. 1117-1119
-
-
Lurie, P.1
Greco, D.B.2
-
3
-
-
84882245985
-
-
Trials on trial: the Food and Drug Administration should rethink its rejection of the Declaration of Helsinki [editorial]. Nature 2008;453:427-8.[Medline]
-
Trials on trial: the Food and Drug Administration should rethink its rejection of the Declaration of Helsinki [editorial]. Nature 2008;453:427-8.[Medline]
-
-
-
-
4
-
-
54949105799
-
-
Normile D. Ethics. Clinical trials guidelines at odds with US policy. Science 2008;322:516. [Abstract/Free Full Text]
-
Normile D. Ethics. Clinical trials guidelines at odds with US policy. Science 2008;322:516. [Abstract/Free Full Text]
-
-
-
-
5
-
-
35148823242
-
-
Goodyear MD, Krleza-Jeric K, Lemmens T. The Declaration of Helsinki. BMJ 2007;335:624-5.[Free Full Text]
-
Goodyear MD, Krleza-Jeric K, Lemmens T. The Declaration of Helsinki. BMJ 2007;335:624-5.[Free Full Text]
-
-
-
-
6
-
-
65349132487
-
The Declaration of Helsinki and the law: An international and comparative analysis
-
Frewer A, Schmidt U, eds, Stuttgart: Franz Steiner Verlag
-
Sprumont D, Girardin S, Lemmens T. The Declaration of Helsinki and the law: an international and comparative analysis. In: Frewer A, Schmidt U, eds. History and theory of human experimentation: the Declaration of Helsinki and modern medical ethics. Stuttgart: Franz Steiner Verlag, 2007:223-52.
-
(2007)
History and theory of human experimentation: The Declaration of Helsinki and modern medical ethics
, pp. 223-252
-
-
Sprumont, D.1
Girardin, S.2
Lemmens, T.3
-
7
-
-
58049151944
-
Helsinki discords: FDA, ethics, and international drug trials
-
CrossRef][Web of Science][Medline
-
Kimmelman J, Weijer C, Meslin EM. Helsinki discords: FDA, ethics, and international drug trials. Lancet 2009;373:13-4.[CrossRef][Web of Science][Medline]
-
(2009)
Lancet
, vol.373
, pp. 13-14
-
-
Kimmelman, J.1
Weijer, C.2
Meslin, E.M.3
-
8
-
-
55249097892
-
Moral imperialism and multi-centric clinical trials in peripheral countries
-
Web of Science][Medline
-
Garrafa V, Lorenzo C. Moral imperialism and multi-centric clinical trials in peripheral countries. Cad Saude Publica 2008;24:2219-26.[Web of Science][Medline]
-
(2008)
Cad Saude Publica
, vol.24
, pp. 2219-2226
-
-
Garrafa, V.1
Lorenzo, C.2
-
9
-
-
60849106348
-
Ethical and scientific implications of the globalization of clinical research
-
Free Full Text
-
Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009;360:816-23.[Free Full Text]
-
(2009)
N Engl J Med
, vol.360
, pp. 816-823
-
-
Glickman, S.W.1
McHutchison, J.G.2
Peterson, E.D.3
Cairns, C.B.4
Harrington, R.A.5
Califf, R.M.6
-
10
-
-
3442881628
-
CIOMS' placebo rule and the promotion of negligent medical practice
-
CrossRef][Medline
-
Lemmens T, Sprumont D, Nys H, Singh J, Glass KC. CIOMS' placebo rule and the promotion of negligent medical practice. Eur J Health Law 2004;11:153-74.[CrossRef][Medline]
-
(2004)
Eur J Health Law
, vol.11
, pp. 153-174
-
-
Lemmens, T.1
Sprumont, D.2
Nys, H.3
Singh, J.4
Glass, K.C.5
-
11
-
-
0004177252
-
-
World Medical Association. Declaration of Helsinki. 2008. www.wma.net/e/policy/pdf/17c.pdf.
-
(2008)
Declaration of Helsinki
-
-
-
12
-
-
55449107480
-
-
Goodyear MD, Eckenwiler LA, Ells C. Fresh thinking about the Declaration of Helsinki. BMJ 2008;337:a2128.[Free Full Text]
-
Goodyear MD, Eckenwiler LA, Ells C. Fresh thinking about the Declaration of Helsinki. BMJ 2008;337:a2128.[Free Full Text]
-
-
-
-
13
-
-
84882274697
-
-
Abdullahi v Pfizer. US Court of Appeals 2d Cir. 2009 US App LEXIS 1768, 30 Jan 2009.
-
Abdullahi v Pfizer. US Court of Appeals 2d Cir. 2009 US App LEXIS 1768, 30 Jan 2009.
-
-
-
|