Compensation for subjects of medical research: The moral rights of patients and the power of research ethics committees

Journal of Medical Ethics

Volumn 23, Issue 3, 1997, Pages 181-185

  Guest, Stephen ^a,b  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b University College   (United Kingdom)

Author keywords

ABPI guidelines; Compensation; Drug research; Innovative therapy; LRECs; Negligence actions; NHS indemnity; Research on healthy volunteers; Research on patients

Indexed keywords

DRUG RESEARCH; HUMAN; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; NEGLIGENCE; PROFESSIONAL STANDARD; SHORT SURVEY; VOLUNTEER;

EID: 0030792488     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.23.3.181     Document Type: Short Survey

References (22)

1. Royal College of Physicians. Guidelines on the practice of ethics committees in medical research involving human subjects [3rd ed]. London: Royal College of Physicians, 1996: para. 6.4.
2. See reference 1: para. 6.5.
3. (1981) 124 DLR (3d) 215 (Alberta CA).
4. See R v Brown [1994] 1 AC 212: 282 and 266.
5. See reference: 1. Also see: Royal Commission on Civil Liability and Compensation for Personal Injury (the "Pearson report"), cmnd 7054 1978, para 1339; and see: Neuberger J. Ethics and health care. King's Fund Institute Research Report 13, 1992.
6. See reference 1: para 9.15.
7. See reference 5: para 1340.
8. See Lord Scarman in Sidaway v Board of Governors of the Bethlem Royal Hospital, etc [1985] 1 AC 871: 888-9.
9. Note the admirably expressed statement of principle in s 10 of the New Zealand Bill of Rights 1990: "Every person has the right not to be subjected to medical or scientific experimentation without that person's consent".
10. Department of Health. Local Research Ethics Committees. London, 1991. OHSG(91)5.
11. See reference 10: para 3.
12. See reference 10: para 2.11.
13. S4(1)(e) states that it is a defence ". . . that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question might be expected to have discovered the defect if it had existed under his products if they were under his control . . .".
14. Association of the British Pharmaceutical Industry. Guidelines for medical experiments in non-patient human volunteers. London: ABPI, 1990. (1988, revised 1990).
15. Association of the British Pharmaceutical Industry. Clinical trial compensation guidelines. London: ABPI, 1991.
16. In correspondence with the UCL Research Ethics Committee.
17. I am grateful to Professor Aubrey Diamond QC for this point.
18. Following an EC directive: EC (1991). Updated standards for the testing of medicines for human use. 91/507/EEC.
19. But see Marshall T, Moodie P. Scrutinising research ethics committees. British Medical Journal 1988; 297: 753. They say that there is no "absolute" requirement. In the sense that there is no statutory requirement, this is true, but there are duties of employment arising from DoH circulars, letters of intent and other evidence of established practices which are reasonably sufficient to impose the requisite legal duty. It is that those hospital administrators who are ultimately responsible for giving permission for medical experiments, especially in allocating resources, should first ensure that approval has been given by the local ethics committee.
20. See reference 1: para 9.3.
21. I thank my research student, Caroline Wilson, for this point.
22. See reference 1: para A1.15.