The merits of procedure-level risk-benefit assessment

IRB Ethics and Human Research

Volumn 33, Issue 5, 2011, Pages 7-13

  Westra, Anna E ^a   De Beaufort, Inez D ^b  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; ETHICS; HUMAN; HUMAN EXPERIMENT; METHODOLOGY; PROFESSIONAL STANDARD; RISK ASSESSMENT;

ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; RISK ASSESSMENT;

EID: 80054861738     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (22)

1. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;183:2701-2711.
2. Buiteiaar JK, Michelson D, Danckaerts M, et al. A randomized, double-blind study of continuation treatment for attention-deficit/hyperactivity disorder after 1 year. Biological Psychiatry 2007;61:694-699;
3. Michelson D, Buiteiaar JK, Danckaerts M, et al. Relapse prevention in pediatric patients with ADHD treated with atomoxetine: A randomized, double-blind, placebo-controlled study. Journal of the American Academy of Child and Adolescent Psychiatry 2004;43:896-904.
4. U. S. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46;
5. European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. European Journal of Health Law 2008;15:223-250;
6. Levine RJ. Ethics and Regulation of Clinical Research. Baltimore, MD, and Munich, Germany: Urban and Schwarzenberg, 1981;
7. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. 6th rev. Seoul, South Korea: World Medical Organization, 2008.
8. Weijer C. The ethical analysis of risk. Journal of Law, Medicine and Ethics 2000;28:344-361;
9. Weijer C, Miller PB. When are research risks reasonable in relation to anticipated benefits? Nature Medicine 2004;10:570-573;
10. Wendler D, Miller FG. Assessing research risks systematically: The net risks test. Journal of Medical Ethics 2007;33:481-486.
11. Joffe S, Miller FG. Bench to bedside: Mapping the moral terrain of clinical research. Hastings Center Report 2008;38:30-42;
12. Miller FG, Rosenstein DL. The therapeutic orientation to clinical trials. NEJM 2003;348:1383-1386;
13. Miller PB, Weijer C. Fiduciary obligation in clinical research. Journal of Law, Medicine and Ethics 2006;34:424-440;
14. Weijer C, Miller PB. Refuting the net risks test: A response to Wendler and Miller's "Assessing research risks systematically." Journal of Medical Ethics 2007;33:487-490.
15. Ackerman TF. The ethics of phase I pediatric oncology trials. IRB: A Review of Human Subjects Research 1995;17:1-5;
16. Appelbaum PS, Roth LH, Lidz CW, et al. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 1987;17:20-24;
17. Miller FG, Joffe S. Benefit in phase 1 oncology trials: Therapeutic misconception or reasonable treatment option? Clinical Trials 2008;5:617-623;
18. Oberman M, Frader J. Dying children and medical research: Access to clinical trials as benefit and burden. American Journal of Law and Medicine 2003;29:301-317;
19. Ross L. Phase I research and the meaning of direct benefit. Journal of Pediatrics 2006;149:S20-S24.
20. King NM. Defining and describing benefit appropriately in clinical trials. Journal of Law, Medicine and Ethics 2000;28:332-343.
21. Levine RJ. Clarifying the concepts of research ethics. Hastings Center Report 1979;9:21-26;
22. Levine RJ. The need to revise the declaration of Helsinki. NEJM 1999;341:531-534.