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Results: 1 to 20 of 189

1.

Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE.

Wiedermann CJ, Almici M, Mangione S, Giarratano A, Mayr O.

Intensive Care Med. 2007 Feb;33(2):316-8. Epub 2006 Nov 30. No abstract available.

PMID:
17136516
[PubMed - indexed for MEDLINE]
2.

New data on clinical trials directive in Europe show few favorable outcomes.

Rice M.

J Natl Cancer Inst. 2006 Feb 1;98(3):159-60. No abstract available.

PMID:
16449673
[PubMed - indexed for MEDLINE]
Free Article
3.

The regulation of gene therapy research in competent adult patients, today and tomorrow: implications of EU Directive 2001/20/EC.

Kong WM.

Med Law Rev. 2004 Summer;12(2):164-80. No abstract available.

PMID:
16610146
[PubMed - indexed for MEDLINE]
4.

[American and European legislation on bioethics evaluation of clinical experimentation].

Scuderi G.

Ann Ist Super Sanita. 1998;34(2):179-85. Italian.

PMID:
9810739
[PubMed - indexed for MEDLINE]
5.

[Research ethics and revised law regarding the Danish Central Scientific Ethical Committee].

Kamper-Jørgensen F.

Ugeskr Laeger. 2004 Jun 7;166(24):2337-40. Review. Danish. No abstract available.

PMID:
15281571
[PubMed - indexed for MEDLINE]
6.

Regulating clinical research: informed consent, privacy, and IRBs.

Hoffman S.

Cap Univ Law Rev. 2003;31(1):71-91. No abstract available.

PMID:
15295833
[PubMed - indexed for MEDLINE]
7.

[The scientific committee system].

Kamper-Jørgensen F.

Ugeskr Laeger. 2003 Apr 14;165(16):1680-2. Danish.

PMID:
12756830
[PubMed - indexed for MEDLINE]
9.

European Union clinical trials directive.

[No authors listed]

Bull Med Ethics. 2001 Jul;(169):13-24. No abstract available.

PMID:
11878337
[PubMed - indexed for MEDLINE]
10.

[Ethics committees bear a responsibility for patient information. Informed consent implies that the patient understands what he has consented to].

Werkö L.

Lakartidningen. 2002 Mar 19;99(14):1552-5. Review. Swedish.

PMID:
12025208
[PubMed - indexed for MEDLINE]
11.

Medical research involving incapacitated adults: implications of the EU Clinical Trials Directive 2001/20/EC.

Liddell K, Bion J, Chamberlain D, Druml C, Kompanje E, Lemaire F, Menon D, Vrhovac B, Wiedermann CJ.

Med Law Rev. 2006 Autumn;14(3):367-417. Epub 2006 Aug 23. No abstract available.

PMID:
16928731
[PubMed - indexed for MEDLINE]
12.

European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population.

[No authors listed]

Eur J Health Law. 2008 Jul;15(2):223-50.

PMID:
18988606
[PubMed - indexed for MEDLINE]
13.

Re-engineering the European Union Clinical Trials Directive.

Kenter MJ, Cohen AF.

Lancet. 2012 May 12;379(9828):1765-7. doi: 10.1016/S0140-6736(12)60430-9. No abstract available.

PMID:
22579309
[PubMed - indexed for MEDLINE]
14.

[The system of scientific ethical committees].

Larsen NA.

Ugeskr Laeger. 2003 Jun 2;165(23):2412-3. Danish. No abstract available.

PMID:
12841005
[PubMed - indexed for MEDLINE]
15.

A European consistency for functioning of RECs? We just lost our chance.

Waligora M.

J Med Ethics. 2013 Jun;39(6):408-9. doi: 10.1136/medethics-2012-101228. Epub 2012 Dec 8.

PMID:
23222144
[PubMed - indexed for MEDLINE]
16.

[Harmonisation of regulatory requirements for clinical trials on medicinal products for human use in the Directive 2001/20/EC and complementary guidance. Implementation of the 12th Law Amending the German Drug Law].

Geisler I, Hofmann HP, Nickel L.

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005 Feb;48(2):141-6. German.

PMID:
15726454
[PubMed - indexed for MEDLINE]
17.

Reforming the EU Clinical Trials Directive: streamlining processes or a radical "new" agenda?.

McHale JV.

Eur J Health Law. 2013 Sep;20(4):363-81.

PMID:
23977734
[PubMed - indexed for MEDLINE]
18.
19.

Are US informed consent requirements driving resuscitation research overseas?

Cone DC, O'Connor RE.

Resuscitation. 2005 Aug;66(2):141-8. Review.

PMID:
15955611
[PubMed - indexed for MEDLINE]
20.

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