Restricted treatments, inducements, and research participation

Bioethics

Volumn 20, Issue 2, 2006, Pages 77-91

  Edwards, Sarah J L ^a,b,c  

^a UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c University and the NHS Hospitals Trust   (United Kingdom)

Author keywords

Choice; Clinical trials; Consent; Evidence based medicine; Paternalism; Regulation; Research

Indexed keywords

ANTINEOPLASTIC AGENT; PENTOSAN POLYSULFATE;

ARTICLE; BRAIN TUMOR; COST; CREUTZFELDT JAKOB DISEASE; CYSTITIS; DEATH; DRUG INDUSTRY; DRUG USE; ECONOMICS; ENTERITIS; FINANCE; FOOD AND DRUG ADMINISTRATION; GEOGRAPHY; HEALTH PRACTITIONER; HUMAN; INSURANCE; JUSTICE; MEDICAL RESEARCH; MEDULLOBLASTOMA; NONHUMAN; PATIENT; PATIENT PARTICIPATION; RESEARCH;

ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH; PHILOSOPHICAL APPROACH;

CLINICAL TRIALS; COERCION; DOUBLE EFFECT; DRUG APPROVAL; DRUG INDUSTRY; DRUGS, INVESTIGATIONAL; ETHICAL ANALYSIS; FREEDOM; GOVERNMENT REGULATION; HEALTH SERVICES ACCESSIBILITY; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; INSURANCE COVERAGE; INTERNATIONALITY; MOTIVATION; PATERNALISM; PATIENTS; PHILOSOPHY; RESEARCH SUBJECTS; RISK ASSESSMENT; SOCIAL JUSTICE; VULNERABLE POPULATIONS;

EID: 33644932150     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2006.00479.x     Document Type: Article

References (45)

1. Udo Shüklenk explores the balance of individual freedoms, forms of paternalism, and public harm in his book. Udo Schüklenk. 1998. Access to Experimental Drugs in Terminal Illness. New York. Pharmaceutical Products Press. For an historical account of the regulation of research in the wake of thalidomide and other disasters see Harry M. Marks. 1997. The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900-1990. Cambridge History of Medicine. Cambridge. Cambridge University Press.
2. For example, the European Union Directive on Good Clinical Practice for Clinical Trials covers only clinical trial research and only trials of 'medicinal products' which are mainly drugs. Note that there are no restrictions on surgical innovations or new instruments in the UK, despite growing political pressure to make them similarly restricted to research protocols. See. At the same time, some practitioners use available medicinal products in ways outside the terms of their licence to treat an individual in the best way they can. For a recent and high profile example, see that of the Indian doctor who was severely criticised for using the anti-impotence drug, Viagra, to treat newborn babies with pulmonary hypertension, despite a clear physiological rationale, a catalogue of failed alternatives, and desperate emergency conditions. The doctor claims he saved the lives of these babies by the unconventional use of the drug. At.
3. P.P. Koopman Clinical endpoints in trials of dugs for cancer: time for a rethink Br Med J 2002 324 1389 1391
4. R.J. Levine FDA's New Rule on Treatment Use and Sale of Investigational New Drugs IRB: A Review of Human Subjects Research 1987 9 4 1 4
5. Ibid.
6. J. Menikoff The hidden alternative: getting investigational treatments off-study Lancet 2003 361 63 67
7. A.M. Reitsma J.D. Moreno Ethical Regulations for Innovative Surgery: The Last Frontier J Am Coll Surg 2002 194 6 792 801
8. For a full history of FDA 1962 amendments see.
9. Global Harmonisation Task Force (GHTF). See details of the progress of their work at.
10. M. Wilkinson A. Moore Inducement and Research Bioethics 1997 11 4 373 389
11. S.J.L. Edwards S. Kirchin Rationing, randomising, and researching in health care provision J Med Ethics 2002 28 1 20 3
12. C. Weijer The ethical analysis of risk J Law Med Ethics 2000 28 344 61
13. World Medical Association. Declaration of Helsinki. Fifth amendment. 52nd General Assembly, Edinburgh, Scotland, 2001.
14. R.J. Levine The need to revise the Declaration of Helsinki N Engl J Med 1999 341 7 531 34
15. J.D. Moreno Goodbye to all that: the end of moderate protectionism in human subjects research Hastings Cent Rep 2001 31 3 15
16. C. Kerr Do people think new means better Patient Educ Couns 2004 53 107 113
17. P.S. Appelbaum Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception Am J Bioeth 2002 2 22 23
18. C.R. Freed Transplantation of embryonic dopamine neurons for severe Parkinson's disease N Engl J Med 2001 344 10 710 19
19. S.J.L. Edwards S. Kirchin R. Huxtable Research ethics committees and paternalism J Med Ethics 2004 30 88 91
20. See BBC News website at:.
21. Ibid.
22. Moreno, op. cit. note 15.
23. See details of his case at:.
24. A. Rixon Performance League Tables Br Med J 1995 311 209 210
25. R.J. Levine FDA's New Rule on Treatment Use and Sale of Investigational New Drugs IRB: A Review of Human Subjects Research 1987 9 4 1 4
26. N. Daniels J. Sabin Last-chance therapies and managed care: pluralism, fair procedures, and legitimacy Hastings Cent Rep 1998 28 2 27 41
27. Minogue Individual autonomy and the double-blind controlled experiment: the case of desperate volunteers J Med Philos 1995 20 1 43 55
28. Royal College of Physicians Research on Healthy Volunteers, a report of the Royal College of Physicians J R Coll Physicians Lond 1986 Oct 20 4 3 17
29. M.L. Russell D.G. Moralejo E.D. Burgess Paying research subjects: participants' perspectives J Med Ethics 2000 26 126 30
30. C. Grady Money for Research Participation: Does it Jeopardize Informed Consent Am J Bioeth 2001 2 40 44
31. Wilkinson & Moore, op. cit. note 10.
32. I. Berlin. 1958. Two Concepts of Liberty. London. Oxford University Press: 7.
33. Ibid. p.15.
34. Ibid. p. 7.
35. Ibid. p.16.
36. Ibid. pp. 21-22 (italics added).
37. Ibid. p.14.
38. A. Wertheimer. 1996. Exploitation. Princeton, NJ. Princeton University Press.
39. Ibid.
40. H. Sidgwick. 1962. The Methods of Ethics. 7th ed. Chicago. Chicago University Press: 288.
41. Wertheimer, op. cit. note 36, p. 232.
42. Wilkinson & Moore, op. cit. note 10.
43. Wertheimer, op. cit. note 36.
44. M. Kuczewski Is Informed Consent Enough? Monetary Incentives for Research Participation and the Integrity of Biomedicine Am J Bioeth 2001 2 49 50
45. J. Harris. 1985. The Value of Life. London & Boston. Routledge.