Vulnerability in research ethics: A way forward

Bioethics

Volumn 27, Issue 6, 2013, Pages 333-340

  Lange, Margaret Meek ^a   Rogers, Wendy ^b   Dodds, Susan ^c  

^a MACQUARIE UNIVERSITY   (Australia)

^b MACQUARIE UNIVERSITY   (Australia)

^c UNIVERSITY OF TASMANIA   (Australia)

Author keywords

Alzheimer's Disease; Research ethics; Tenofovir case; Vulnerability

Indexed keywords

ADENINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; DRUG DERIVATIVE; PHOSPHONIC ACID DERIVATIVE; TENOFOVIR;

ALZHEIMER DISEASE; ARTICLE; CAMBODIA; ETHICS; HUMAN; HUMAN EXPERIMENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMED CONSENT; METHODOLOGY; MORALITY; PARTICIPATORY RESEARCH; PERSONNEL; PRIMARY PREVENTION; PROFESSIONAL STANDARD; PROSTITUTION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH ETHICS; RESEARCH SUBJECT; VULNERABLE POPULATION;

ADENINE; ALZHEIMER DISEASE; ANTI-HIV AGENTS; CAMBODIA; COMMUNITY-BASED PARTICIPATORY RESEARCH; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HIV INFECTIONS; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MORAL OBLIGATIONS; ORGANOPHOSPHONATES; PRIMARY PREVENTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH PERSONNEL; RESEARCH SUBJECTS; SEX WORKERS; VULNERABLE POPULATIONS;

EID: 84880156096     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/bioe.12032     Document Type: Article

References (37)

1. World Medical Association. 2008. Declaration of Helsinki. Available at[Accessed 15 Oct 2012]; http://www.wma.net/en/30publications/10policies/b3/
2. CIOMS. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Available at www.cioms.ch/publications/layout_guide2002.pdf2002
3. Canadian Institutes of Health Research. 2010. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humanswww.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf
4. National Health and Medical Research Council. 2007. National Statement on the Ethical Conduct in Human Researchwww.nhmrc.gov.au/guidelines/publications/e35
5. We take these to include Institutional Review Boards (IRBs), Human Research Ethics Committees (HRECs), and Institutional Ethics Committees (IECs).
6. M.A. Fineman. The Vulnerable Subject: Anchoring Equality in the Human Condition. Yale J Law Fem 2008; 20: 1-23
7. J. Butler. 2010. Frames of War: When is Life Grievable? London: Verso;
8. A. MacIntyre. 1999. Dependent Rational Animals. Chicago and La Salle, Illinois: Open Court;
9. B.S. Turner. 2006. Vulnerability and Human Rights. University Park, PA: Penn State University Press.
10. R. Goodin. 1985. Protecting the Vulnerable: A Reanalysis of Our Social Responsibilities. Chicago, IL: The University of Chicago Press
11. R. Macklin. Bioethics, Vulnerability, and Protection. Bioethics 2003; 17: 472-486
12. F. Luna. Elucidating the Concept of Vulnerability: Layers not Labels. Int J Fem Approaches Bioeth 2009; 2: 121-139
13. S.A. Hurst. Vulnerability in Research and Health Care; Describing the Elephant in the Room? Bioethics 2008; 22: 191-202
14. Nuremberg Code. 1947. Available at history.nih.gov/research/downloads/nuremberg.pdf2012
15. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: Department of Health, Education, and Welfare: 12.1979
16. P.J. Nickel. Vulnerable Populations in Research: The Case of the Seriously Ill. Theor Med Bioeth 2006; 27: 245-264
17. C. Levine, R. Faden, C. Grady, et al. The Limitations of 'Vulnerability' as a Protection for Human Research Participants. Am J Bioethic 2004; 4: 44-49
18. D. Schroeder & E. Gefenas. Vulnerability: Too Vague and Too Broad? Camb Q Healthc Ethics 2009; 18: 113-121
19. R. Macklin. 2003. Bioethics, Vulnerability and Protection. Bioethics 17: 472-486
20. A.D. Lyerly et?al. Risk and the Pregnant Body. Hastings Cent Rep 2009; 39: 34-42
21. W. Rogers & A. Ballantyne. Justice in Health Research: What is the Role of Evidence-based Medicine? Perspect Biol Med 2009; 52: 188-202
22. W. Rogers, C. Mackenzie & S. Dodds. Why Bioethics Needs a Theory of Vulnerability. Int J Fem Approaches Bioeth 2012; 5: 11-38
23. W. Rogers & A. Ballantyne. When Is Sex-Specific Research Appropriate? Int J Fem Approaches Bioeth 2008; 1: 38-57
24. S. Dodds. Inclusion and Exclusion in Women's Access to Health and Medicine. Int J Fem Approaches Bioeth 2008; 1: 58-79
25. V.J. Palmer, J.S. Yelland & A.J. Taft. Ethical Complexities for Screening for Depression and Intimate Partner Violence (IPV) in Intervention Studies BMC Public Health 2011; 11(Suppl 5): http://www.biomedcentral.com/1471-2458/11/S5/S3
26. M. Smiley. Paternalism and Democracy. J Value Inq 1989; 23: 299-318
27. K. Page-Shafer, et?al. HIV Prevention Research in a Resource-limited Setting: the Experience of Planning a Trial in Cambodia. Lancet 2005; 366: 1499-1503
28. Women's Network for Unity. 2004. Background to WNU Press Conference on Tenofovir Trials in Cambodia on March 29, 2004. Phnom Penh, Cambodia: Women's Network for Unity.http://swgpp.pbworks.com/f/Background+to+WNU+Press+Conference+on+Tenofovir+Trials+in+Cambodia+on.pdf
29. The Global Campaign for Microbicides reports that 'NIH policy prohibits the use of its funds to provide post-trial treatment or financial compensation for long-term injury'. Global Campaign for Microbicides. Preventing Prevention Trial Failures: A Case Study and Lessons for Future Trails from the 2004 Tenofovir Trials in Cambodia. Washington, D.C.: Global Campaign for Microbicides at [Accessed 22 May 2012]. This policy agrees with general practice in the United States: 'In the United States ... sponsors and institutions are not required to provide either free medical care or compensation [for injured research subjects]'. PATH.http://www.global-campaign.org/clientfiles/Cambodia.pdf2009
30. R. Steinbrook. Compensation for injured research subjects. N Engl J Med 2006; 354: 1871-1873
31. However, 'US policy in this area has been described by some ethicists as contravening accepted ethical guidelines'. Global Campaign for Microbicides, p. 24
32. Human Rights Watch. Off the Streets: Arbitrary Detention and Other Abuses against Sex Workers in Cambodia. New York: Human Rights Watch. Available at: http://www.hrw.org/sites/default/files/reports/cambodia0710webwcover_2.pdf15-16.2010
33. G.W. Small, et al. Diagnosis and Treatment of Alzheimer Disease and Related Disorders. JAMA 1997; 278: 1363-1371
34. R. Brookmeyer, et al. Forecasting the Global Burden of Alzheimer's Disease. Alzheimers Dement 2007; 3: 186-191
35. Lorenzo M. Refolo et?al. Common Alzheimer's Disease Research Ontology: National Institute on Aging and Alzheimer's Association Collaborative Project. Alzheimers Dement 2012; 8: 372-375
36. J. Arboleda-Flórez & D.N. Weisstub. 1998. Ethical Research With Vulnerable Populations: The Mentally Disordered. In Research on Human Subjects: Ethics, Law and Social Policy. D.N. Weisstub, ed. Oxford: Pergammon Press, 433-450
37. World Medical Association. 2008. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.http://www.wma.net/en/30publications/10policies/b3/