-
1
-
-
0003177157
-
On the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
-
Directive 2001/20/EC of the European Parliament and of the Council of 2001 April 4
-
Directive 2001/20/EC of the European Parliament and of the Council of 2001 April 4. On the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities 2001;L121:34-41.
-
(2001)
Official Journal of the European Communities
, vol.121 L
, pp. 34-41
-
-
-
2
-
-
0003898510
-
Governance arrangements for NHS research ethics committees
-
Central Office for Research Ethics Committees. London: Department of Health
-
Central Office for Research Ethics Committees. Governance arrangements for NHS research ethics committees. London: Department of Health, 2001.
-
(2001)
-
-
-
3
-
-
0003767164
-
Research governance framework for health and social care
-
Department of Health. London: Department of Health
-
Department of Health. Research governance framework for health and social care. London: Department of Health, 2001.
-
(2001)
-
-
-
4
-
-
0003898507
-
Local research ethics committees
-
Department of Health. London: Department of Health (HSG(91)5.)
-
Department of Health. Local research ethics committees. London: Department of Health, 1991. (HSG(91)5.)
-
(1991)
-
-
-
6
-
-
0029153787
-
Cross district comparison of applications of research ethics committees
-
Garfield P. Cross district comparison of applications of research ethics committees. British Medical Journal 1995;311:660-1;
-
(1995)
British Medical Journal
, vol.311
, pp. 660-661
-
-
Garfield, P.1
-
9
-
-
0003898509
-
Ethics committee review of multi-centre research
-
Department of Health. London: Department of Health (HSG(97)23.)
-
Department of Health. Ethics committee review of multi-centre research. London: Department of Health, 1997. (HSG(97)23.)
-
(1997)
-
-
-
10
-
-
0034728858
-
The new system of review by multicentre research ethics committees: Prospective study
-
Tully J, Ninis N, Booy R, et al. The new system of review by multicentre research ethics committees: prospective study. British Medical Journal 2000;320:1179-82.
-
(2000)
British Medical Journal
, vol.320
, pp. 1179-1182
-
-
Tully, J.1
Ninis, N.2
Booy, R.3
-
11
-
-
0003854612
-
How should an LREC handle an MREC approved application: Interim guidance
-
[circular letter to all LRECs and MRECs] Sept 28
-
Stacey TE. How should an LREC handle an MREC approved application: interim guidance [circular letter to all LRECs and MRECs]. 1998 Sept 28: 1-3.
-
1998
, pp. 1-3
-
-
Stacey, T.E.1
-
12
-
-
0034728855
-
Multicentre research ethics committees: Has the cure been worse than the disease?
-
Alberti KGMM. Multicentre research ethics committees: has the cure been worse than the disease? British Medical Journal 2000;320: 1157-8.
-
(2000)
British Medical Journal
, vol.320
, pp. 1157-1158
-
-
Alberti, K.G.M.M.1
-
14
-
-
0029116130
-
Ethics committees: Impediments to research or guardians of ethical standards?
-
See
-
See While A. Ethics committees: impediments to research or guardians of ethical standards? British Medical Journal 1995;311:661.
-
(1995)
British Medical Journal
, vol.311
, pp. 661
-
-
While, A.1
-
15
-
-
0003871544
-
World Medical Association Declaration of Helsinki-ethical principles for medical research involving human subjects
-
World Medical Association. Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General ssembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996, and the 52nd WMA General Assembly, Edinburgh, Scotland, October article 5
-
World Medical Association. World Medical Association Declaration of Helsinki-ethical principles for medical research involving human subjects. Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General ssembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996, and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000: article 5.
-
(2000)
-
-
-
16
-
-
0010712273
-
Ethics committees do not understand research methods
-
See [letter]
-
See Mossman J. Ethics committees do not understand research methods [letter]. British Medical Journal 2000;317:1217.
-
(2000)
British Medical Journal
, vol.317
, pp. 1217
-
-
Mossman, J.1
-
17
-
-
0028248866
-
Multicenter trials and subject eligibility: Should local IRBs play a role?
-
Freedman B. Multicenter trials and subject eligibility: should local IRBs play a role? IRB: Review of Human Subjects Research 1994;16:1-6.
-
(1994)
IRB: Review of Human Subjects Research
, vol.16
, pp. 1-6
-
-
Freedman, B.1
-
20
-
-
0029083970
-
Local research ethics committees
-
Alberti KGMM. Local research ethics committees. British Medical Journal 1995;311:639-40;
-
(1995)
British Medical Journal
, vol.311
, pp. 639-640
-
-
Alberti, K.G.M.M.1
-
21
-
-
0028971669
-
Hazards of misguided ethics committees
-
Eichler H-G. Hazards of misguided ethics committees. Lancet 1995;346:1115-16;
-
(1995)
Lancet
, vol.346
, pp. 1115-1116
-
-
Eichler, H.-G.1
-
24
-
-
26344463981
-
Tripartite guideline for good clinical practice
-
International Conference on Harmonisation of Technical Requirements for Regulation of Pharmaceuticals for Human Use. Geneva: International Federation of Pharmaceutical Manufacturers Association
-
International Conference on Harmonisation of Technical Requirements for Regulation of Pharmaceuticals for Human Use. Tripartite guideline for good clinical practice. Geneva: International Federation of Pharmaceutical Manufacturers Association, 1996.
-
(1996)
-
-
-
25
-
-
0010713923
-
-
See reference 1: article 7. This reads: "For multi-centre clinical trials limited to the territory of a single Member State, Member States shall establish a procedure providing, notwithstanding the number of Ethics Committees, for the adoption of a single opinion for that Member State. In the case of multi-centre clinical trials carried out in more than one Member State simultaneously, a single opinion shall be given for each Member State concerned by the clinical trial"
-
See reference 1: article 7. This reads: "For multi-centre clinical trials limited to the territory of a single Member State, Member States shall establish a procedure providing, notwithstanding the number of Ethics Committees, for the adoption of a single opinion for that Member State. In the case of multi-centre clinical trials carried out in more than one Member State simultaneously, a single opinion shall be given for each Member State concerned by the clinical trial".
-
-
-
-
26
-
-
0000580092
-
Positivism and the separation of law and morals
-
Hart HLA. Positivism and the separation of law and morals. Harvard Law Review 1958;71:606-15.
-
(1958)
Harvard Law Review
, vol.71
, pp. 606-615
-
-
Hart, H.L.A.1
-
27
-
-
0034079052
-
Ethical ethics committees?
-
For example
-
For example, Barber SG. Ethical ethics committees? Journal of Medical Ethics 2000;26:142.
-
(2000)
Journal of Medical Ethics
, vol.26
, pp. 142
-
-
Barber, S.G.1
|