Informed consent: Protection or obstacle? Some emerging issues

Controlled Clinical Trials

Volumn 18, Issue 6, 1997, Pages 628-636

  Ellenberg, Susan S ^a,b  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^b HFM 210 ^*  (United States)

Author keywords

Bioethics; Deferred consent; Emergency treatment; HHS regulations; Informed consent; Placebo controls; Randomized consent design

Indexed keywords

PLACEBO;

CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; EMERGENCY TREATMENT; ETHICS; HUMAN; INFORMED CONSENT; RANDOMIZED CONTROLLED TRIAL;

EMERGENCY TREATMENT; ETHICS, MEDICAL; HUMANS; INFORMED CONSENT; RANDOMIZED CONTROLLED TRIALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030684073     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(96)00130-4     Document Type: Conference Paper

References (41)

1. Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. 1949;2:181-182.
2. World Medical Association, 41st World Medical Assembly. Declaration of Helsinki IV, Hong Kong. September 1989.
3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Government Printing Office; 1978.
4. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: 1993, pp 13-29.
5. Zelen M. A new design for randomized clinical trials. N Engl J Med 1979;300: 1242-1245.
6. Tobias, JS, Souhami RL. Fully informed consent can be needlessly cruel. Brit Med J 1993;307:1199-1201.
7. Tobias JS, Houghton J. Is informed consent essential for all chemotherapy studies? Eur J Cancer 1994;30:897-899.
8. Your baby is in a trial. Lancet 1995;345:805-806. Editorial.
9. Annas GJ, Glantz LH, Katz BF. Informed Consent to Human Experimentation: The Subject's Dilemma. Cambridge, MA: Ballinger Publishing Co; 1977.
10. Final rule-final regulations amending basic HHS policy for the protection of human research subjects (45 CFR Part 46). Federal Register. January 26, 1981;46:8366-8391.
11. Final rule-protection of human subjects; informed consent (21 CFR Parts 50, 71, 171, 180, 310, 312, 314, 320, 330, 361, 430, 431, 601, 630, 812, 813, 1003, 1010). Federal Register. January 17, 1981;46:8942-8958.
12. Taylor KM, Margolese RG, Soskolne CL. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med 1984;310:1363-1367.
13. Epstein LC, Lasagna LL. Obtaining informed consent: form or substance. Arch Intern Med 1969;123:682-689.
14. Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent: why are its goals imperfectly realized? N Engl J Med 1980;302:896-900.
15. Robinson, G, Merav A. Informed consent: recall by patients tested postoperatively. Ann Thorac Surg 1976;22:209-212.
16. Zelen M. Statistical options in clinical trials. Semin Oncol 1977;4:441-446.
17. Protection of human subjects. Federal Register. May 30, 1974;39:18914-18920.
18. Fost N. Consent as a barrier to research. N Engl J Med 1979;300:1242-1245.
19. Cox EB. A new design for randomized trials. N Engl J Med 1979;301:786. Letter to the editor.
20. Stuart RK. A new design for randomized trials. N Engl J Med 1979;301:786. Letter to the editor.
21. Vawter DE. A new design for randomized trials. N Engl J Med 1979;301:787. Letter to the editor.
22. Capron AM. A new design for randomized trials. N Engl J Med 1979;301:787.
23. Ellenberg SS. Randomization designs in comparative clinical trials. N Engl J Med 1984;310:1404-1408.
24. Ellenberg SS. Pre-randomization: a preliminary assessment. Adj Therapy of Cancer IV 1984:71-78.
25. Ellenberg SS. Randomized consent designs for clinical trials: an update. Stat Med 1992;11:131-132.
26. Abramson NS, Meisel A, Safaf P. Deferred consent: a new approach for resuscitation research on comatose patients. JAMA 1986;255:2466-2471.
27. Fost N, Robertson J. Deferring consent with incompetent patients in an intensive care unit. IRB August/September 1980:5-6.
28. Levine RJ. Deferred consent. Controlled Clin Trials 1991;12:546-550.
29. OPRR Reports, Human Subjects Protections. Informed Consent - Legally Effective and Prospectively Obtained. 1993;93:9.
30. Kessler DA. Response to letters from researchers. September 14, 1993.
31. Biros MH, Lewis RJ, Olson CM, Runge JE, Cummins RO, Fost N. Informed consent in emergency research: consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA 1995;273:1283-1287.
32. Report of the Public Forum on Informed Consent in Clinical Research Conducted in Emergency Circumstances. Washington, DC: FDA and NIH; May 1995.
33. Notice of proposed rule-protection of human subjects; informed consent (21 CFR Parts 50, 56, 312, 314, 601, 812, 814). Federal Register. September 21, 1995;60: 49086-49103.
34. ACT UP Treatment and Data Committee. A national AIDS treatment research agenda (Pamphlet circulated at the 5th International Conference on AIDS, Montreal, Canada, June 1989.)
35. Ellenberg SS, Cooper E, Eigo J, et al. Studying treatments for AIDS: new challenges for clinical trials. A panel discussion at the 1990 annual meeting of the Society for Clinical Trials. Controlled Clin Trials 1992;13:272-292.
36. Green SB, Ellenberg SS, Finkelstein D, et al. Issues in the design of drug trials for AIDS. Controlled Clin Trials 1990;11:80-87.
37. Byar DP, Schoenfeld DA, Green SB, et al. Design consideration for AIDS trials. N Engl J Med 1990;323:1343-1348.
38. Ellenberg SS, Finkelstein DM, Schoenfeld DA. Statistical issues arising in AIDS clinical trials. JASA 1992;87:562-583.
39. Kessler DA, Feiden KL. Faster evaluation of vital drugs: traditional clinical trials may delay the availability of lifesaving therapies. Regulators now attempt to balance speed against the risk of errors. Scientific Am 1995;272:26-32.
40. Applications for FDA approval to market a new drug or an antibiotic drug. Federal Register. April 28, 1992;57:17981-18001.
41. Final rule-investigational new drug, antibiotic, and biological product applications; clinical hold and termination (21 CFR Part 312). Federal Register. April 15, 1992;57: 13244-13249.