Assessing the remedy: The case for contracts in clinical trials

American Journal of Bioethics

Volumn 11, Issue 4, 2011, Pages 3-12

  Edwards, Sarah J L ^a  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Biomedical research; IRB (institutional review board); Professional patient relationship; Research ethics

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); CONTRACT; DOCTOR PATIENT RELATION; ETHICS; FREEDOM; HUMAN; HUMAN RELATION; INFORMED CONSENT; LEGAL ASPECT; PATIENT; PATIENT RIGHT; PERSONNEL; PROFESSIONAL STANDARD; REPRODUCIBILITY; RESEARCH ETHICS; RESEARCH SUBJECT; VOLUNTARY WORKER;

CLINICAL TRIALS AS TOPIC; CONTRACTS; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; FREEDOM; HUMANS; INFORMED CONSENT; PATIENT DROPOUTS; PATIENT RIGHTS; PHYSICIAN-PATIENT RELATIONS; REPRODUCIBILITY OF RESULTS; RESEARCH PERSONNEL; RESEARCH SUBJECTS; RESEARCHER-SUBJECT RELATIONS; VOLUNTARY WORKERS;

EID: 79953904510     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265161.2011.560340     Document Type: Article

References (66)

1. Agosti, V., E. Nunes, and K. Ocepeck-Welikson. 1996. Patient factors related to early attrition from an outpatient cocaine research clinic. American Journal of Drug and Alcohol Abuse 22(1): 29-39.
2. Allchin, D. 2001. Error types. Perspectives on Science 9(1): 38-58.
3. Atiyah, P. S. 1985. The rise and fall of freedom of contract. Oxford: Oxford University Press.
4. Bagshaw, S. M., and R. Bellomo. 2008. The need to reform our assessment of evidence fromclinical trials:Acommentary. Philosophy, Ethics and Humanities in Medicine 3: 23.
5. Burch, D. 2001. Taking the medicine. London: Chatto and Windus, The Random House Group, Limited.
6. Church, A. H. 1993. Estimating the effect of incentives on mail survey response rates: A meta-analysis. Public Opinion Quarterly 57: 62-79.
7. Clarke, R. 1994. Ability and responsibility for omissions. Philosophical Studies: An International Journal for Philosophy in the Analytic Tradition, Papers Presented at the American Philosophical Association Pacific DivisionMeeting, March 1993, 73(2/3): 195-208.
8. Crouch, R. A., and J. D. Arras. 1998. AZT trials and tribulations. Hastings Center Report 28(6): 26-34.
9. Daar, A. S. 1997. Ethics of xenotransplantation: Animal issues, consent and likely transformation of transplant ethics. World Journal of Surgery 21: 975-982.
10. Dawson, A. J., and S. M. Yentis. Contesting the science/ethics distinction in the review of clinical research Journal of Medical Ethics 33: 165-167.
11. Department of Health. 2009. Guidance on the routine collection of Patient Reported Outcome Measures (PROMs). Her Majesty's Stationary Office. Available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH092647 (accessed October 2010).
12. De Vita, D.A., M.C. White, X. Zhao, Z. Kaidarova, and E. L. Murphy. 2009. Determinants of subject visit participation in a prospective cohort study of HTLV infection BMC Medical Research Methodology 9: 19.
13. Edwards, S. J. L. 2005. Research participation and the right to withdraw. Bioethics 19(2): 112-130.
14. Edwards, S. J. L. 2009. The rationale for ethics review of research by committee. Research Ethics Review 5(4): 147-150.
15. Edwards, S. J. L. 2010. Science and society: The scope of ethics review. Research Ethics Review 6(2): 53-56.
16. Edwards, S. J. L., R. J. Lilford, D. Braunholtz, and J. Jackson. 1997. Why "underpowered" trials are not necessarily unethical. Lancet 350: 804-807.
17. Epstein, R. A. 1975. Unconscionability:Acritical reappraisal. Journal of Law & Economics 18: 293.
18. Fabricatore, A. N., T. A. Wadden, R. H. Moore, M. L. Butryn, E.A. Gravallese, N. E. Erondu, S.B. Heymsfield, and A.M. Nguyen. 2009. Attrition from randomized controlled trials of pharmacological weight loss agents: A systematic review and analysis. Obesity Reviews 10(3): 333-341.
19. Farnsworth, A. E. 1998. Changing your mind: The law of regretted decisions. New Haven, CT: Yale University Press.
20. Food and Drug Administration. 2008. Guidance for sponsors, clinical investigators, and IRBs data retention when subjectswithdraw from FDAregulated clinical trials. Washington, DC: U.S. Department of Health and Human Services.
21. Fried, C. 1981. Contract as promise: A theory of contractual obligation. Cambridge, MA: Harvard University Press.
22. Kleinig, J. 1983. John Stuart Mill and voluntary slavery contracts. Australian Journal of Political Science 18(2):76-83.
23. Goldman, A. I., R. Holcomb, M. H. Perry, Jr., H. W. Schnaper, A. E. Fitz, and E. D. Frohlich. 1982. Can dropout and other noncompliance be minimized in a clinical trial? Report from the Veterans Administration National Heart, Lung and Blood Institute cooperative study on antihypertensive therapy: Mild hypertension. Controlled Clinical Trials 3(2): 75-89.
24. Groeneveld, I. F., K. I. Proper, A. J. Van Der Beek, V. H. Hildebrandt, and W. van Mechelen. 2009. Factors associated with non-participation and drop-out in a lifestyle intervention for workers with an elevated risk of cardiovascular disease. International Journal of Behavioral Nutrition and Physical Activity 6: 80.
25. Hollis, S., and F. Campbell. 1999. What is meant by intention to treat analysis? Survey of published randomised controlled trials. British Medical Journal 319: 670-674.
26. Hellard, M. E., M. I. Sinclair, A. B. Forbes, and C. K. Fairley. 2001. Methods used to maintain a high level of participant involvement in a clinical trial. Journal of Epidemiology and Community Health 55: 348-351.
27. Honoŕe, A. M. 1971. Causation and remoteness of damage. In International Encyclopedia of Comparative Law, vol. xi, chap. 7, The Hague: M. Nijhoff.
28. Kimel, D. 2005. From promise to contract: Towards a liberal theory of contract. Oxford: Hart.
29. Jansen, V. A., N. Stollenwerk, H. J. Jensen, M. E. Ramsay, W. J. Edmunds, and C. J. Rhodes. 2003. Measles outbreaks in a population with declining vaccine uptake. Science 301: 804.
30. Laurence, D. R. 2005. Participants in research: Patients in clinical trials are protected by consumer regulation. British Medical Journal 331: 110.
31. El-Khorazaty, M. N., A. A. Johnson, M. Kiely, A. A. El-Mohandes, S. Subramanian, H. A. Laryea, K. B. Murray, J. S. Thornberry, and J. G. Joseph. 2007. Recruitment and retention of low-incomeminority women in a behavioural intervention to reduce smoking, depression, and intimate partner violence during pregnancy. BMC Public Health 7: 233.
32. Langford, A. T., K. Resnicow, R. E. Davis, G. L. Alexander, J. Calvi, C. Weise, and D. Tolsma. 2010. Ethnic Identity predicts loss-tofollow-up in a health promotion trial. Contemporary Clinical Trials 31(5): 414-418.
33. Larson, E. L., E. G. Cohn, D. D. Meyer, and B. Boden-Albala. 2009. Consent administrator training to reduce disparities in research participation. Journal of Nursing Scholarship 41(1): 95-103.
34. Lemmens, T., and C. Elliott. 1999. Guinea pigs on the payroll: The ethics of paying research subjects. Accountability in Research 7(1): 3-20.
35. Liu-Seifert, H., S. Zhang, D. D'Souza, and V. Skljarevski. 2010. A closer look at the baseline-observation-carried-forward (BOCF). Patient Preference and Adherence 4: 11-16.
36. McKendrick, E. 2003. Contract law, 5th ed. Basingstoke, UK: Palgrave.
37. McCarthy, K. D., S. Nurudeen, A. Armstrong, E. Levens, and L. K. Nieman. 2010. Recruitment and retention of women for clinical leiomyoma trials. Contemporary Clinical Trials 31(1): 44-48.
38. Mallinckrodt, C., W. S. Clark, and S. R. David. 2001. Type I error rates from mixed effects model repeated measures versus fixed effects ANOVA with missing values imputed via last observation carried forward. Drug Information Journal 35: 1215-1225.
39. Martin, K. A., D. J. Bowen, J. Dunbar-Jacob, and M. G. Perri. 2000. Who will adhere? Key issues in the study and prediction of adherence in randomized controlled trials. Controlled Clinical Trials 21(5): S195-S199.
40. Miller, D. 1991. Introduction. In Liberty, ed. D. Miller. New York: Oxford University Press.
41. Miller, F., and A. Wertheimer, eds. 2009. The ethics of consent. New York: Oxford University Press.
42. Miller, F., and A. Wertheimer. 2008. Payment for research participation: A coercive offer? Medical Ethics 34: 389-392.
43. Mintzer, M. Z., K. B. Stoller, and R. R. Griffiths. 1999. A controlled study of flumazenil-precipitated withdrawal in chronic low-dose benzodiazepine users. Psychopharmacology (Berlin) 147(2): 200-209.
44. Molnar, F. J., M. Man-Son-Hing, B. Hutton, and F. Fergusson. 1999. Have last-observation-carried-forward analyses caused us to favour more toxic dementia therapies over less toxic alternatives? A systematic review. Open Medicine 3(2): 31-50.
45. Moore, M. 1999. Causation and responsibility, Social Philosophy & Policy 16(2): 1-51.
46. Myers, W. R. 2000. Handling missing data in clinical trials: An overview. Drug Information Journal 34: 525-533.
47. Narveson, J. 2002. Collective responsibility. Journal of Ethics 6: 179-198.
48. NHS Act. The National Health Service Act. 2006. Her Majesty's Stationary Office and Queen's Printer Acts of Parliament, London. Available at: http://www.legislation.gov.uk/ukpga/2006/41/contents.
49. Newell, D. J. 1978. Type II errors and ethics. British Medical Journal iv: 1789.
50. Parfit, D. 1986. Reasons and persons. New York: Oxford University Press.
51. Parrish, R. K. 2006. The European Glaucoma Prevention Study and the Ocular Hypertension Treatment Study: Why do two studies have different results? Current Opinion in Ophthalmology 17(2): 138-141.
52. Peppercorn, J., I. Shapira, D. Collyar, T. Deshields, N. Lin, I. Krop, H. Grunwald, P. Friedman, A. H. Partridge, R. L. Schilsky, and M. M. Bertagnolli. 2010. Ethics of mandatory research biopsy for correlative end points within clinical trials in oncology. Journal of Clinical Oncology 28(15): 2635-2640.
53. Raboud, J.M., J. S. G. Montaner, A. Thorne, J. Singer, M.T. Schechter, the Canadian HIV Trials Network A002 Study Group. 1996. Impact of missing data due to dropouts on estimates of the treatment effect in a randomized trial of antiretroviral therapy for HIV-infected individuals. Journal of Acquired Immune Deficiency Syndromes&Human Retrovirology 12(1): 46-55.
54. Rabinowitz, J., and O. Davidov. 2008. The association of dropout and outcome in trials of antipsychotic medication and its implications for dealing with missing data. Schizophrenia Bulletin 34(2): 286-291.
55. Shih, W. J., and H. Quan. 1997. Testing for treatment differences with dropouts present in clinical trials-A composite approach. Statistics in Medicine 16: 1225-1239.
56. Salk, J. E. 1953. Studies in human subjects on active immunization against poliomyelitis. Journal of the American Medical Association 151: 1081-1098.
57. Sprague, S., P. Leece, M. Bhandari, P. Tornetta, E. Schemitsch, and M. F. Swiontkowski. 2003. Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery. Controlled Clinical Trials 24(6): 719-725.
58. Siddiqui, F., T. F. Pajak, D. Watkins-Bruner, et al. 2008. Pretreatment quality of life predicts for locoregional control in head and neck cancer patients: A radiation therapy oncology group analysis. International Journal of Radiation Oncology Biology Physics 70: 353-360.
59. Stone, R. 2003. The modern law of contract, 5th ed. London: Cavendish.
60. Trebilcock, M. J. 1992. The limits of freedom of contract. Cambridge, MA: Harvard University Press.
61. Ulmer, M., D. Robinaugh, J. P. Friedberg, S. R. Lipsitz, and S. Natarajan. 2008. Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention. Contemporary Clinical Trials 29(5): 705-710.
62. Vanderpool, H. Y. 1998. Critical ethical issues in clinical trials with xenotransplants. Lancet 351:1347-1350.
63. Wilkinson, M., and A. Moore. 1997. Inducement in research. Bioethics 11: 373-389.
64. Williams, G. 1961. The risk principle. Law Quarterly Review 77: 179-212.
65. Williams, H. C. 2008. Evidence based dermatology. New York: Wiley.
66. Wright, R. W. 1988. Causation, responsibility, risk, probability, naked statistics, and proof: Pruning the bramble bush by clarifying the concepts. Iowa Law Review 73: 1001-1077.