Patients' experiences and views of clinical trials

Medicine and Law

Volumn 20, Issue 1, 2001, Pages 143-152

  Ferguson, P R ^a  

^a UNIVERSITY OF DUNDEE   (United Kingdom)

Author keywords

Clinical trials; Experimental subject; Medical research; Patient perspectives

Indexed keywords

ARTICLE; CLINICAL TRIAL; DECISION MAKING; DRUG SCREENING; EXPERIENCE; EXPERIMENTAL MODEL; HUMAN; INTERVIEW; MAJOR CLINICAL STUDY; MEDICAL RESEARCH; MORALITY; PATIENT ATTITUDE; PATIENT SATISFACTION; RISK; VOLUNTEER;

EID: 0035010713     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (16)

1. Consumers for Ethics in Research (CERES) Medical Research and You 1994: London. Engelking has stated: "The demand for subjects is huge. Just one issue of the weekly medical journal the Lancet includes (I counted) experimental data on more than 31,500 volunteers." Engelking, C: Facilitating clinical trials: the expanding role of the nurse 1991 Cancer; 67:6, 1793-1797, at 1794.
2. Consumers for Ethics in Research (CERES) Medical Research and You 1994: London. Engelking has stated: "The demand for subjects is huge. Just one issue of the weekly medical journal the Lancet includes (I counted) experimental data on more than 31,500 volunteers." Engelking, C: Facilitating clinical trials: the expanding role of the nurse 1991 Cancer; 67:6, 1793-1797, at 1794.
3. See Hewlett, S: Consent to clinical research - adequately voluntary or substantially influenced? 1996 Journal of Medical Ethics; 22:232-237 at 233. According to Schafer: "Illness frequently makes a patient more-than-normally dependent upon and eager to please his doctor." Schafer, A. Experimentation with human subjects: a critique of the views of Hans Jonas 1983 Journal of Medical Ethics; 9: 76-79. Similarly, Tunkel: "Consent is not valid if it results from undue pressure. It is perhaps unavoidable that a patient in hospital will feel some physiological pressure to cooperate, especially if gravely ill." Tunkel, V: Legal aspects of clinical trials in the United Kingdom. Chapter 1 in Williams, C.J: Introducing New Treatments for Cancer 1992 Chichester: John Wiley and Sons, at 12.
4. See Hewlett, S: Consent to clinical research - adequately voluntary or substantially influenced? 1996 Journal of Medical Ethics; 22:232-237 at 233. According to Schafer: "Illness frequently makes a patient more-than-normally dependent upon and eager to please his doctor." Schafer, A. Experimentation with human subjects: a critique of the views of Hans Jonas 1983 Journal of Medical Ethics; 9: 76-79. Similarly, Tunkel: "Consent is not valid if it results from undue pressure. It is perhaps unavoidable that a patient in hospital will feel some physiological pressure to cooperate, especially if gravely ill." Tunkel, V: Legal aspects of clinical trials in the United Kingdom. Chapter 1 in Williams, C.J: Introducing New Treatments for Cancer 1992 Chichester: John Wiley and Sons, at 12.
5. See Hewlett, S: Consent to clinical research - adequately voluntary or substantially influenced? 1996 Journal of Medical Ethics; 22:232-237 at 233. According to Schafer: "Illness frequently makes a patient more-than-normally dependent upon and eager to please his doctor." Schafer, A. Experimentation with human subjects: a critique of the views of Hans Jonas 1983 Journal of Medical Ethics; 9: 76-79. Similarly, Tunkel: "Consent is not valid if it results from undue pressure. It is perhaps unavoidable that a patient in hospital will feel some physiological pressure to cooperate, especially if gravely ill." Tunkel, V: Legal aspects of clinical trials in the United Kingdom. Chapter 1 in Williams, C.J: Introducing New Treatments for Cancer 1992 Chichester: John Wiley and Sons, at 12.
6. Jonas, H: Philosophical reflections on experimenting with human subjects. In Beauchamp, T and Walters, L: (Editors) Contemporary Issues in Bioethics 1982 Belmont: Wadsworth, 2nd ed. 524-532.
7. Pfeffer, N: Consumers' viewpoint. Chapter 2 in Close, B. Combes, R. Hubbard, A. and Illingworth, J: (Editors). Volunteers in Research and Testing. 1997 Taylor & Francis: London, 23-31, at 25.
8. Chapter 8 in Medical Ethics Today: Its Practice and Philosophy. 1993 DMA Publishing Group: London, 195-229, at 208.
9. Hewlett, note 2, at 234. See also Royal College of Physicians: Research Involving Patients 1990 RCP: London, at 27, paragraph 7.78: "...patients may ... wish to please their doctor or they may be fearful of causing displeasure."
10. Marshall, S: (letter) Participants should be given feedback about the trial 1996 British Medical Journal; 312: 186.
11. Harth, S.C. and Thong, Y.H: Parental perceptions and attitudes about informed consent in clinical trials involving children 1995 Social Science & Medicine; 40:11, 1573-1577 at 1573.
12. Hewlett, S.E: Consent to research in rheumatoid arthritis: a difficult decision? 1994 British Journal_of Rheumatology; 33: 104, cited in Hewlett, op cit. at 233-234.
13. Medical Ethics Today: Its Practice and Philosophy. Op cit. at 196.
14. Baum, M: Clinical trials - a brave new partnership: a response to Mrs Thornton 1994 Journal of Medical Ethics; 20: 23-25, at 23.
15. Mackillop, W.J. and Johnston, P.A: Ethical problems in clinical research: the need for empirical studies of the clinical trials process. 1986 Journal of Chronic Diseases; 39:3; 177-188, at 178.
16. Pfeffer, N: Consumers' viewpoint. Chapter 2 in Close, B. Combes, R. Hubbard, A. and Illingworth, J (Editors) Volunteers in Research and Testing 1997 Taylor & Francis: London 23-31, at 23. The author also states: "Subjects are crucial to the research enterprise. Yet people who might be or who have been subjects of research are almost never asked about their motives or experiences "(ibid, at 24.)