What we worry about when we worry about the ethics of clinical research

Theoretical Medicine and Bioethics

Volumn 32, Issue 3, 2011, Pages 161-180

  Wendler, David ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Clinical research; Exploitation; Informed consent; Risks

Indexed keywords

ARTICLE; ETHICS; HUMAN; HUMAN EXPERIMENT; INDUSTRY; INFORMED CONSENT; MEDICAL RESEARCH; METHODOLOGY; PEDIATRICS; PERSONNEL; RESEARCH ETHICS; VULNERABLE POPULATION;

BIOMEDICAL RESEARCH; ETHICS, RESEARCH; HUMANS; INDUSTRY; INFORMED CONSENT; NONTHERAPEUTIC HUMAN EXPERIMENTATION; PEDIATRICS; RESEARCH DESIGN; RESEARCH PERSONNEL; VULNERABLE POPULATIONS;

EID: 79956150058     PISSN: 13867415     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11017-011-9176-y     Document Type: Article

References (32)

1. Ferri, Cleusa P., Martin Prince, Carol Brayne, et al. Alzheimer's Disease International. 2005. Global prevalence of dementia: A Delphi consensus study. Lancet 366: 2112-2117.
2. 1-42 and increased tau levels in cerebrospinal fluid of patients with Alzheimer disease JAMA 289 2094 2103 10.1001/jama.289.16.2094 (Pubitemid 37430211)
3. James Wilson David Hunter 2010 Research exceptionalism American Journal of Bioethics 10 45 54
4. Wartofsky, Marx. 1976. Doing it for the money. In Research involving prisoners: Report and recommendations, DHEW publication No. (OS) 76-132, National Commission for the Protection of Human Subjects, Appendix. Washington, DC.
5. Paul McNeill 1997 A response to Wilkinson and Moore Bioethics 11 390 396 10.1111/1467-8519.00079
6. Ben Sachs 2010 The exceptional ethics of the investigator-subject relationship Journal of Medicine and Philosophy 35 64 80 10.1093/jmp/jhp055
7. Paul M Stewart Anna Stears Jeremy W Tomlinson Morris J Brown 2008 Regulation-the real threat to clinical research British Medical Journal 337 1085 1087
8. Richard Sullivan 2008 The good the bad and the ugly: Effect of regulation on cancer research Lancet Oncology 9 2 3 10.1016/S1470-2045(07)70388-1
9. Neal Dickert Christine Grady 1999 What's the price of a research subject? Approaches to payment for research participation New England Journal of Medicine 34 198 203 10.1056/NEJM199907153410312 (Pubitemid 29325751)
10. Wertheimer, Alan. 1996. Exploitation. Princeton: Princeton University press.
11. Martin Wilkinson Andrew Moore 1997 Inducements in research Bioethics 11 373 389 10.1111/1467-8519.00078
12. Richard Ashcroft 2001 Money, consent, and exploitation in research American Journal of Bioethics 1 62 63
13. Ezekiel J Emanuel 2004 Ending concerns about undue inducement Journal of Law Medicine and Ethics 32 100 105 10.1111/j.1748-720X.2004.tb00453.x
14. International Conference on Harmonization. 1996. Guidance for industry. E6 good clinical practice: Consolidated guidance. http://www.fda.gov/downloads/ drugs/guidancecomplianceregulatoryinformation/guidances/ucm073122.pdf. Accessed 24 Jan 2011.
15. Council for International Organizations of Medical Sciences. 2002. International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS. http://www.cioms.ch/publications/layout-guide2002.pdf. Accessed 8 Dec 2010.
16. World Medical Association. 2008. Declaration of Helsinki: Ethical principles for medical research involving human subjects. http://www.wma.net/en/ 30publications/10policies/b3/index.html. Accessed 8 Dec 2010.
17. Global Youth Service Day. http://gysd.org. Accessed 30 Oct 2010.
18. Youth Service America. http://www.ysa.org/node. Accessed 28 Oct 2010.
19. Warren E Berger 1968 Reflections on law and experimental medicine UCLA Law Review 15 436
20. Doraine L Coleman 2007 The legal ethics of pediatric research Duke Law Journal 57 517 624
21. Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807 (Md. Ct. of App. 2001, reconsideration denied, Oct. 11, 2001).
22. Elaine R Peskind Robert Riekse Joseph Quinn, et al. 2005 Safety and acceptability of the research lumbar puncture Alzheimer Disease and Associated Disorders 19 220 225 10.1097/01.wad.0000194014.43575.fd (Pubitemid 44366623)
23. Henry K Beecher 1966 Ethics and clinical research New England Journal of Medicine 274 1354 1360 10.1056/NEJM196606162742405
24. Paul S Appelbaum Charles W Lidz Thomas Grisso 2004 Therapeutic misconception in clinical research: Frequency and risk factors IRB 26 1 8 10.2307/3564231
25. Franklin G Miller Alan Wertheimer 2007 Facing up to paternalism in research ethics Hastings Center Report 37 24 34 10.1353/hcr.2007.0044
26. Hans Jonas 1969 Philosophical reflections on experimenting with human subjects Daedalus 98 219 247
27. Elliott, Carl. 2008. Guinea-pigging; healthy human subjects for drug-safety trials are in demand. But is it a living? New Yorker January 7. http://www.newyorker.com/reporting/2008/01/07/080107fa-fact-elliott. Accessed 28 Oct 2010.
28. David Wendler Leonard Glantz 2007 A new standard for assessing the risks of pediatric research: Pro and con Journal of Pediatrics 150 579 582 10.1016/j.jpeds.2007.02.018 (Pubitemid 46755810)
29. National Bioethics Advisory Commission. 1998. Research involving persons with mental disorders that may affect decisionmaking capacity. Washington, DC: US Government Printing Office.
30. Jason Karlawish Jonathan Rubright David Casarett Mark Cary Thomas ten Have Pamela Sankar 2009 Older adults' attitudes toward enrollment of non-competent subjects participating in Alzheimer's research American Journal of Psychiatry 166 182 188 10.1176/appi.ajp.2008.08050645
31. US Code of Federal Regulations. 2009. Protection of human subjects. 45 CFR 46.116 d. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed 15 Dec 2010.
32. David Wendler Tammara Jenkins 2008 Children's and their parents' views on facing research risks for the benefit of others Archives of Pediatrics and Adolescent Medicine 162 9 14 10.1001/archpediatrics.2007.3