Rethinking vulnerability and research: Defining the need for a post-research ethics audit

Asian Bioethics Review

Volumn 7, Issue 2, 2015, Pages 188-200

  Siriwardhana, Chesmal ^a,b,c  

^a ANGLIA RUSKIN UNIVERSITY   (United Kingdom)

^b KING'S COLLEGE LONDON   (United Kingdom)

^c Institute for Research and Development Sri Lanka   (Sri Lanka)

Author keywords

Ethics review; Humanitarian settings; Mental health research; Post research ethics audit; Vulnerable populations

Indexed keywords

EID: 85019050609     PISSN: 17938759     EISSN: 17939453     Source Type: Journal    
DOI: 10.1353/asb.2015.0015     Document Type: Article

References (40)

1. World Medical Association: Declaration of Helsinki, 2013. Available at http://www.wma.net/en/30publications/10policies/b3/[accessed 12 April 2013].
2. CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002. Available at http://www.cioms.ch/images/stories/CIOMS/guidelines/guidelines_nov_ 2002_blurb.htm[accessed 12 April 2013].
3. 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, DC: Department of Health, Education and Welfare, 1979), p. 12.
4. M.C. Ruof, “Vulnerability, Vulnerable Populations, and Policy”, Kennedy Inst Ethics J 14, 4 (2004): 411–25.
5. M.M. Lange, W. Rogers and S. Dodds, “Vulnerability in Research Ethics: A Way Forward”, Bioethics 27, 6 (2013): 333–40.
6. J.M. DuBois, L. Beskow, J. Campbell et al., “Restoring Balance: A Consensus Statement on the Protection of Vulnerable Research Participants”, Am J Public Health 102, 12 (2012): 2220–5.
7. A.V. Libin, M. Schladen, A. Pascalev et al., “Health Care Ethics in Vulnerable Populations: Clinical Research through the Patient’s Eyes”, Proceedings of World Academy of Science, Engineering and Technology 66 (2012): 767.
8. R. Macklin, “Bioethics, Vulnerability and Protection”, Bioethics 17 (2003): 472–86.
9. Nuremberg Code, 1947. Available at history.nih.gov/research/downloads/nuremberg.pdf [accessed 12 April 2013].
10. Nuffield Council on Bioethics and K. Calman, The Ethics of Research related to Healthcare in Developing Countries (London: Nuffield Council on Bioethics, 2002).
11. F. Luna, “Elucidating the Concept of Vulnerability: Layers not Labels”, Int J Fem Approaches Bioeth 2 (2009): 121–39.
12. S.A. Hurst, “Vulnerability in Research and Health Care: Describing the Elephant in the Room?”, Bioethics 22 (2008): 191–202.
13. R. Craven, “Protecting Research Participants with Impaired Decision-Making Capacity”, Lancet Neurol 9, 10 (2010): 952–3.
14. U. Schüklenk, “Protecting the Vulnerable: Testing Times for Clinical Research Ethics”, Soc Sci Med 51, 6 (2000): 969–77.
15. A. El-Khani, F. Ulph, A.D. Redmond et al., “Ethical Issues in Research into Conflict and Displacement”, Lancet 382, 9894 (2013): 764–5.
16. J. Leaning, “Ethics of Research in Refugee Populations”, Lancet 357, 9266 (2001): 1432–3.
17. D.P. O’Mathúna, “Conducting Research in the Aftermath of Disasters: Ethical Consid-erations”, J Evidence-Based Med 3, 2 (2010): 65–75.
18. A. Chiumento, M.N. Khan, A. Rahman and L. Frith, “Managing Ethical Challenges to Mental Health Research in Post-Conflict Settings”, Developing World Bioethics (2015). doi:10.1111/dewb.12076.
19. E. Newman, E. Risch and N. Kassam-Adams, “Ethical Issues in Trauma-Related Research: A Review”, J Empir Res Hum Res Ethics 1, 3 (2006): 29–46.
20. E. Newman and D.G. Kaloupek, “The Risks and Benefits of Participating in Trauma-Focused Research Studies”, J Trauma Stress 17, 5 (2004): 383–94.
21. K. Jacobsen and L.B. Landau, “The Dual Imperative in Refugee Research: Some Methodological and Ethical Considerations in Social Science Research on Forced Migration”, Disasters 27, 3 (2003): 185–206.
22. A.B. Zwi et al., “Placing Ethics in the Center: Negotiating New Spaces for Ethical Research in Conflict Situations”, Global Public Health 1, 3 (2006): 264–77.
23. C. MacKenzie, C. McDowell and E. Pittaway, “Beyond ‘Do No Harm’: The Challenge of Constructing Ethical Relationships in Refugee Research”, Journal of Refugee Studies 20, 2 (2007): 299–319.
24. J. Sheather and T. Shah, “Ethical Dilemmas in Medical Humanitarian Practice: Cases for Reflection from Medecins Sans Frontieres”, Journal of Medical Ethics 37, 3 (2011): 162–5.
25. A. Sumathipala, A. Jafarey, L. De Castro et al., “Ethical Issues in Post-Disaster Clinical Interventions and Research: A Developing World Perspective. Key Findings from a Drafting and Consensus Generation Meeting of the Working Group on Disaster Research and Ethics (WGDRE) 2007”, Asian Bioethics Review 2, 2 (2010): 124–42.
26. C. Siriwardhana, A. Sumathipala, S.N. Hewage et al., “Psychosocial and Ethical Response to Disasters: A SWOT Analysis of Post-Tsunami Disaster Management in Sri Lanka”, Asian Bioethics Review 4, 3 (2012): 171–82.
27. World Medical Association, “World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research involving Human Subjects”, JAMA (2013). doi: 10.1001/jama.2013.281053.
28. C. Levine, R. Faden, C. Grady et al., “The Limitations of ‘Vulnerability’ as a Protection for Human Research Participants”, The American Journal of Bioethics 4, 3 (2004): 44–9.
29. C. Siriwardhana, A. Adikari, K. Jayaweera et al., “Ethical Challenges in Mental Health Research among Internally Displaced People: Ethical Theory and Research Implementation”, BMC Med Ethics 14 (2013): 13.
30. C. Siriwardhana and K. Wickramage, “Conflict, Forced Displacement and Health in Sri Lanka: A Review of the Research Landscape”, Conflict & Health 8 (2014): 22.
31. International Committee of Medical Journal Editors, Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals. Available at http://www.icmje.org/icmje-recommendations.pdf [accessed 17 Feb 2015].
32. COPE: Committee on Publication Ethics, International Standards for Authors. Available at http://publicationethics.org/international-standards-editors-and-authors [accessed 17 Feb 2015].
33. E.R. Cohen, H. Masum, K. Berndtson et al., “Public Engagement on Global Health Challenges”, BMC Public Health 8, 1 (2008): 168.
34. M.D. Mumford, S.T. Murphy, S. Connelly et al., “Environmental Influences on Ethical Decision Making: Climate and Environmental Predictors of Research Integrity”, Ethics & Behavior 17, 4 (2007): 337–66.
35. N.H. Steneck, “Fostering Integrity in Research: Definitions, Current Knowledge, and Future Directions”, Sci Eng Ethics 12 (2006): 53–74.
36. S.R. Benatar, “Reflections and Recommendations on Research Ethics in Developing Countries”, Soc Sci Med 54, 7 (2002): 1131–41.
37. D.R. Curry, R.J. Waldman and A.L. Caplan, An Ethical Framework for the Development and Review of Health Research Proposals involving Humanitarian Contexts, 2014. Available at http://www.elrha.org/uploads/FINAL%20R2HC%20Ethical%20Framework_Final%20Report_ 24%20January%202014_1.pdf [accessed 15 January 2015].
38. A. Sumathipala and S. Siribaddana, “Revisiting ‘Freely Given Informed Consent’ in Relation to the Developing World: Role of an Ombudsman”, Am J Bioeth 4, 3 (2004): w1–w7.
39. S. Kinn, “The Relationship between Clinical Audit and Ethics”, J Med Ethics 23, 4 (1997): 250–3.
40. M.R. Hunt, “Ethics beyond Borders: How Health Professionals Experience Ethics in Humanitarian Assistance and Development Work”, Dev World Bioethics 8, 2 (2008): 59–69.