Is informed consent always necessary for randomized, controlled trials?

New England Journal of Medicine

Volumn 340, Issue 10, 1999, Pages 804-807

  Truog, ^a  

^a BOSTON CHILDREN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTACID AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CEPHALOSPORIN DERIVATIVE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; HEPARIN;

ARTIFICIAL VENTILATION; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DRUG COST; HUMAN; INFORMED CONSENT; INTRAVASCULAR CATHETER; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; RISK ASSESSMENT; STOMACH PH; WOUND INFECTION;

ALTERNATIVES; AUTONOMY; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL APPROACH/SOURCE; CONTROL GROUPS; RESEARCH SUBJECTS; RISKS AND BENEFITS; STANDARDS; THERAPEUTIC RESEARCH; UNCERTAINTY; UNITED STATES;

CONTROL GROUPS; ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; PATIENT ADVOCACY; PERSONAL AUTONOMY; PROFESSIONAL STAFF COMMITTEES; RANDOMIZED CONTROLLED TRIALS; RESEARCH SUBJECTS; RISK; RISK ASSESSMENT; THERAPEUTIC HUMAN EXPERIMENTATION; UNCERTAINTY;

EID: 0033545528     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199903113401013     Document Type: Review

References (22)

1. Smithells R. Iatrogenic hazards and their effects. Postgrad Med J 1975; 51:Suppl 2:39-52.
2. Shuster E. Fifty years later: the significance of the Nuremberg Code. N Engl J Med 1997;337:1436-40.
3. World Medical Association. Declaration of Helsinki: recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997;277:925-6.
4. WMA's Declaration of Helsinki serves as a guide to physicians. JAMA 1964;189:33-4.
5. Beecher HK. Ethics and clinical research. N Engl J Med 1966;274: 1354-60.
6. Levine RJ. Research in emergency situations: the role of deferred consent. JAMA 1995;273:1300-2.
7. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5.
8. Beauchamp TL, Childress JF. Principles of biomedical ethics. 4th ed. New York: Oxford University Press, 1994:148-9.
9. Curran WJ. The Tuskegee syphilis study. N Engl J Med 1973;289:730-1.
10. Goldberg HI, McGough H. The ethics of ongoing randomization trials: investigation among intimates. Med Care 1991;29:Suppl:JS41-JS48.
11. Lantos J. Informed consent: the whole truth for patients? Cancer 1993;72:Suppl:2811-5.
12. Brewin TB. Consent to randomised treatment. Lancet 1982;2:919-21.
13. Tobias JD. BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 1997;314:1111-4.
14. Modi N. Informed consent difficult in paediatric intensive care. BMJ 1993;307:1495.
15. Jubelirer SJ. Level of reading difficulty in educational pamphlets and informed consent documents for cancer patients. W V Med J 1991;87:554-7.
16. Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ 1993;306:885-90.
17. Tarnowski KJ, Allen DM, Mayhall C, Kelly PA. Readability of pediatric biomedical research informed consent forms. Pediatrics 1990;85:58-62.
18. Snowdon C, Garcia J, Elbourne D. Making sense of randomization: responses of parents of critically ill babies to random allocation of treatment in a clinical trial. Soc Sci Med 1997;45:1337-55.
19. Appelbaum PS, Lidz CW, Meisel A. Informed consent: legal theory and clinical practice. New York: Oxford University Press, 1987.
20. Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Boston: Little, Brown, 1991.
21. Final Rule. Fed Regist 1996;61:51498-533.
22. Ellenberg SS. Informed consent: protection or obstacle? Some emerging issues. Control Clin Trials 1997;18:628-36.