Association of British Pharmaceutical Industries, (1983): Guidelines: clinical trials—compensation for medically induced injury. London: ABPI, 1983.
2.
Association of British Pharmaceutical Industries, (1988a): Guidelines for medical experiments in non-patient volunteers. London: ABPI,1988 (updated 1990).
3.
Association of British Pharmaceutical Industries, (1988b): Guidelines on good clinical research practice. London: ABPI, 1988.
4.
Association of British Pharmaceutical Industries, (1988c): Relationships between the medical professions and the pharmaceutical industry. London: ABPI, 1988.
5.
ABPI, BMA, CSM and RGCP Joint Committee, (1988): “Guidelines on postmarketing surveillance”, BMJ, 296, p. 399.
6.
AllenM EVandenburgM J, (1991): “Good clinical practice: rules, regulations, and their impact on the investigator”, Br. J. clin. Pharmac. (1992), 33, pp. 463–5.
7.
(1991): “France legislates on medical research”, Bull. Med. Eth., 66, March 1991, pp. 8–11.
8.
(1992a): “2nd national conference of Local Research Ethics Committees”, Bull. Med. Eth., 83, August 1992, pp. 30–1.
9.
(1992b): “GP committee advises on reports and payments”, Bull. Med. Eth., 87, December 1992, pp. 29–31.
10.
(1992c): “News: EMRC panel on medical ethics”, Bull. Med. Eth., 83, August 1992, p. 31.
11.
(1992d): “Danish law on research ethics”, Bull. Med. Eth., 87, December 1992, pp. 24–7.
12.
BrockP., (1993): “A pharmaceutical company's approach to the threat of research fraud” in Lock and Wells (1993), pp. 25–41.
13.
BendallC, (1994): Standard Operating Procedures for Local Research Ethics Committees—Comments and Examples, London: McKenna & Co, 1994.
14.
BendallCRiddellJ, (1994): Using standards for local research ethics committees—A guide to using the framework of standards and the standard operating procedures, London: Department of Health, 1994.
15.
British Medical Association Central Ethics Committee, (1986): Improving the network of local ethical research committees and the establishment of a national ethical research committee, London: BMA, 1986.
16.
British Paediatric Association, (1980): “Working Party report on Ethics of Research in Children”, BMJ, 1980, 280, pp. 229–31 (guidelines issued and updated 1992).
17.
CMPM Working Party on Efficacy of Medicinal Products, (1990): “EEC Note for Guidance: Good Clinical Practice for Trials on Medicinal Products in the European Community”, Pharmacology & Toxicology, 1990, 67, pp. 361–72.
18.
Culyer (1994): Supporting research and development in the NHS: A Report to the Minister for Health by a Research and Development Task Force chaired by Professor Anthony Culyer, London: HMSO, September 1994.
19.
Department of Health, (1991), Local research ethics committees, London: HMSO, 1991. Referred to as the “Red Book”.
20.
Department of Health and Social Security, (1975), Supervision of the Ethics of clinical research investigations and foetal research, London: HMSO, 1975 (HSC(IS) 153).
21.
European Commission (1991a), Commission Directive of 19 July 1991 modifying the Annex to Council Directive 75/318/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (91/507/EEC), O.J., 26/9/91, L270, pp. 32–52.
22.
European Commission (1991b), Commission of the European Communities, Discussion paper on the need for a Directive on Clinical Trials, (111/3044/91).
23.
European Council (1993), Council Regulation (EEC) No. 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. O.J., 24/8/93, L214, pp. 1–21.
24.
GilbertCFulfordH W MParkerC, (1989), “Diversity in the practice of district ethics committees”, BMJ, 9 December 1989, 299, pp. 1437–9.
25.
Gilbert FosterC, (1993), “The development and future of research ethics committees in Britain”, in GrubbA, ed., Choices and Decisions in Health Care, London; John Wiley & Sons Ltd., 1993.
26.
GriffinJ P, (1991), “Clinical trials—paper trail or wild goose chase?”, Journal of the RCP, 1991, 25, p. 330.
27.
HodgesC, (1993), “Investigating, reporting and pursuing fraud in clinical research: legal aspects and options in England and Wales”; in Lock and Wells (1993), pp. 91–107.
28.
HosieJ, (1993), “Fraud in general practice research: intention to cheat” in Lock and Wells (1993), pp. 42–9.
29.
KennedyI, (1992), “Research Ethics Committees and the Law”, in C Gilbert Foster, compiler, Manual for Research Ethics Committees, London: Centre for Medical Law and Ethics, King's College, London.
30.
LockS, (1991), “Monitoring research ethical committees”, BMJ, 1990, 300, pp. 61–2.
31.
LockS, (1993), “Research misconduct: a resume of recent events”; in Lock and Wells (1993), pp. 5–24.
32.
LockSWellsF, (1993), eds., Fraud and misconduct in medical research, London: BMA, 1993.
33.
MasonJ KMcCall-SmithR A, (1994), Law and Medical Ethics, 4th ed., London: Butterworths, 1994
34.
Ministry of Health, (1968), Supervision of the ethics of clinical research, London: HMSO, 1968 (HM(68)33).
35.
MontgomeryJ, (1992), “New law not needed for better RECs”, Bull. Med. Eth., 80, May 1992, pp. 34–5.
36.
MoodieP C EMarshallT, (1992), “Guidance for local research ethics committees”, BMJ, 1992, 304, pp. 1293–5.
37.
MoriceA, (1991), “Good clinical practice and the clinical pharmacologist”, Br. J. clin. Pharmac., 1991, 32, pp. 529–30.
38.
Medical Research Council, (1964), Responsibility in investigations in human subjects: Report of the MRC for the year 1962–3, London: HMSO, 1964 (Cmnd 2382).
39.
NeubergerJ, (1992), Ethics and Health Care: The role of research ethics committees in the United Kingdom (Research Report 13), London: King's Fund Institute, 1992.
40.
NHS Management Executive, (1991), Local Research Ethics Committees: Health Service Guidelines, London: HMSO, 19 August 1991 (HSG(91)5).
41.
NHS Training Division/Leigh & Barron Consulting Ltd. and Christie Associates, (1994), Standards for Local Research Ethics Committees—A Framework for Ethical Review, London: Department of Health, 1994.
42.
Royal College of Physicians, (1967), Supervision of the ethics of clinical research investigations in institutions, London: HMSO, 1967 (updated 1973).
43.
Royal College of Physicians, (1984), Guidelines on the practice of ethics committees in medical research, London: HMSO, 1984 (updated 1990).
44.
Royal College of Physicians, (1986), Research on Healthy Volunteers, London: RCP,? (reprinted from The Journal of the Royal College of Physicians of London, Vol. 20, No.4, October 1986).
45.
Royal College of Physicians, (1990a), Guidelines on the practice of ethics committees in medical research involving human subjects, 2nd ed., London: RCP, 1990.
46.
Royal College of Physicians, (1990b), Research involving patients, London: RCP, 1990.
47.
Royal College of Physicians, (1991), Fraud and misconduct in medical research—Causes, investigation and prevention, London: RCP, 1991.
48.
Royal College of Psychiatrists, (1990), “Guidelines for Research Ethics Committees on psychiatric research involving human subjects”, Psychiatric Bulletin, 1990, 14, pp. 48–61.
49.
ShenfieldG MHirshornJ E, (1991), “Good clinical practice in the investigation of pharmaceutical products”, The Medical Journal of Australia, 1991, 154, pp. 631–6.
50.
SmithR, (1989), “Doctors, unethical treatments, and turning a blind eye”, BMJ, 1989, 298, pp. 1125–6.
51.
VandenburgMDavisMNealH, (1993), “The pharmaceutical industry and contract research organisations”, in Lock and Wells (1993), pp. 5060.
52.
WarnockM, (1988), “A national ethics committee: To meet the growing public demand for candour”, BMJ, 1988, 297, pp. 1626–7.
53.
WellsF, (1993), “The British pharmaceutical industry's response”, in Lock and Wells (1993), pp. 75–90.