Ethical Review of Health Systems Research in Low- and Middle-Income Countries: A Conceptual Exploration

American Journal of Bioethics

Volumn 14, Issue 2, 2014, Pages 28-37

  Hyder, Adnan A ^a   Rattani, Abbas ^a   Krubiner, Carleigh ^a   Bachani, Abdulgafoor M ^a   Tran, Nhan T ^b  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

developing world; ethical review; health systems; health systems research; implementation research; research ethics

Indexed keywords

ARTICLE; DEVELOPING COUNTRY; ETHICS; HEALTH SERVICES RESEARCH; HUMAN; INFORMED CONSENT; PROFESSIONAL STANDARD; RESEARCH SUBJECT; VULNERABLE POPULATION;

DEVELOPING COUNTRIES; ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; HEALTH SERVICES RESEARCH; HUMANS; INFORMED CONSENT; RESEARCH SUBJECTS; VULNERABLE POPULATIONS;

EID: 84893941601     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265161.2013.868950     Document Type: Article

References (44)

1. Alliance for Health Policy and Systems Research. 2012a. Health policy and system research: A methodology reader, Edited by: Gilson, L. Geneva, Switzerland: World Health Organization. Available at: http://www.who.int/alliance-hpsr/alliancehpsr_reader.pdf
2. Alliance for Health Policy and Systems Research. 2012b. Global Symposium on Health Systems Research. World Health Organization. Available at: http://www.who.int/alliance-hpsr/hsr-symposium/en/
3. Baum, N. M., Gollust, S. E., Goold, S. D. and Jacobson, P. D. 2007. Looking ahead: Addressing ethical challenges in public health practice. Journal of Law, Medicine, and Ethics, 35 (4): 657 - 667.
4. Brown, C. A. and Lilford, R. J. 2006. The stepped wedge trial design: A systematic review. BioMed Centeral Medical Research Methodology, 6: 54
5. Cassell, J. and Young, A. 2002. Why we should not seek individual informed consent for participation in health services research. Journal of Medical Ethics, 28: 313 - 317.
6. Council for International Organizations of Medical Sciences. 2002. International ethical guidelines for biomedical research involving human subjects Geneva, Switzerland Available at: http://www.cioms.ch/publications/layout_guide2002.pdf
7. Daniels, N. 2006. Toward ethical review of health system transformations. American Journal of Public Health, 96 (3): 447 - 451.
8. Davis, D. S. 2000. Groups, communities, and contested identities in genetic research. Hastings Center Report, 30 (6): 38 - 45.
9. Diallo, D. A., Doumbo, O. K., Plowe, C. V., Wellems, T. E., Emanuel, E. J. and Hurst, S. A. 2005. Community permission for medical research in developing countries. Clinical Infectious Diseases, 41 (2): 255 - 259.
10. Emanuel, E. J., Wendler, D. and Grady, C. 2000. What makes clinical research ethical?. Journal of the American Medical Association, 283 (20): 2701 - 2711.
11. Emanuel, E. J. and Miller, F. G. 2001. The ethics of placebo-controlled trials-A middle ground. New England Journal of Medicine, 345 (12): 915 - 919.
12. Emanuel, E. J., Wendler, D., Killen, J. and Grady, C. 2004. What makes clinical research in developing countries ethical? The benchmarks of ethical research. Journal of Infectious Diseases, 189 (5): 930 - 937.
13. Freedman, B. 1990. Placebo-controlled trials and the logic of clinical purpose. IRB: Ethics and Human Research, 12 (6): 1 - 6.
14. Gilson, L., Hanson, K., Sheikh, K., Agyepong, I. A., Ssengooba, F. and Bennett, S. 2011. Building the field of health policy and systems research: Social science matters. PLoS Medicine, 8 (8): e1001079
15. Global Forum for Health Research. 2004. Strengthening health systems: The role and promise of policy and systems research, Geneva, Switzerland: Alliance for Health Policy and Systems Research.
16. Grady, C. 2005. The challenge of assuring continued post-trial access to beneficial treatment. Yale Journal of Health Policy, Law, and Ethics, 5 (1): 425 - 435.
17. Heiby, J. 1993. Project officer's perspective: Quality assurance as a management tool. Quality Assurance Brief, 2 (1): 1 - 4.
18. Heiby, J. 1998. Quality assurance and supervision systems. Quality Assurance Brief, 7 (1): 1 - 3.
19. Hutton, J. L., Eccles, M. P. and Grimshaw, J. M. 2008. Ethical issues in implementation research: A discussion of the problems in achieving informed consent. Implementation Science, 3: 52
20. Hyder, A. A. and Dawson, L. 2005. Defining standard of care in the developing world: The intersection of international research ethics and health systems analysis. Developing World Bioethics Journal, 5 (2): 142 - 152.
21. Hyder, A. A., Bachani, A. and Rattani, A. 2012a. Ethics of health systems research-A scoping study. Geneva: Alliance for Health Policy & Systems Research. Working paper (available from authors)
22. Hyder, A. A., Krubiner, C. B., Bloom, G. and Bhuiya, A. 2012b. Exploring the ethics of long-term research engagement with communities in low- and middle-income countries. Public Health Ethics, 5 (3): 252 - 262.
23. Ijsselmuiden, C. B. and Faden, R. R. 1992. Research and informed consent in Africa: Another look. New England Journal of Medicine, 326 (12): 830 - 833.
24. Lairumbi, G. M., Michael, P., Fitzpatrick, R. and English, M. C. 2011. Ethics in practice: The state of the debate on promoting the social value of global health research in resource poor settings particularly Africa. BioMed Central Medical Ethics, 12: 22
25. Lavery, J. V. 2004. Putting international research ethics guidelines to work for the benefit of developing countries. Yale Journal of Health Policy, Law, and Ethics, 4 (2): 319 - 336.
26. Lee, L. M. and Thacker, S. B. 2011. Public health surveillance and knowing about health in the context of growing sources of health data. American Journal of Preventative Medicine, 41 (6): 636 - 640.
27. Lee, L. M., Heilig, C. M. and White, A. 2012. Ethical justification for conducting public health surveillance without patient consent. American Journal of Public Health, 102 (1): 38 - 44.
28. London, A. J. 2000. The ambiguity and the exigency: Clarifying 'standard of care' arguments in international research. Journal of Medicine and Philosophy, 25 (4): 379 - 397.
29. London, A. J., Borasky, D. A. Jr., Bhan, A. and Ethics Working Group of the HIV Prevention Trials Network. 2012. Improving ethical review of research involving incentives for health promotion. PLoS Medicine, 9 (3): e1001193
30. Miller, F. G. and Brody, H. 2002. What makes placebo-controlled trials unethical?. American Journal of Bioethics, 2 (2): 3 - 9.
31. Peters, D. H., El-Saharty, S., Siadat, B., Janovsky, K. and Vujicic, M. 2009. Improving health service delivery in developing countries, Washington, DC: International Bank for Reconstruction and Development/The World Bank.
32. Protection of Human Subjects Research. 2009. Title 45 Code of Federal Regulations Part 46.
33. Reinke, W. A. 1995. Quality management in managed care. Health Care Manager, 2 (1): 79 - 88.
34. Sim, J. and Dawson, A. 2012. Informed consent and cluster-randomized trials. American Journal of Public Health, 102 (3): 480 - 485.
35. Swain, G. R., Burns, K. A. and Etkind, P. 2008. Preparedness: Medical ethics versus public health ethics. Journal of Public Health Management and Practice, 14 (4): 354 - 357.
36. Taljaard, M., Weijer, C., Grimshaw, J. M., Belle Brown, J., Binik, A., Boruch, R., Brehaut, J. C., Chaudhry, S. H., Eccles, M. P., McRae, A., Saginur, R., Zwarenstein, M. and Donner, A. 2009. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. Trials, 10: 61
37. Thompson, A. K., Faith, K., Gibson, J. L. and Upshur, R. E. G. 2006. Pandemic influenza preparedness: an ethical framework to guide decision-making. BioMed Central Medical Ethics, 7: E12
38. Upshur, R. E. G. Principles for the justification of public health intervention. Canadian Journal of Public Health, 93 (2) 101 - 103.
39. Viola Fry, C., Marjanovic, S., Yaqub, O. and Chataway, J. 2011. Health Innovation Transfer from South to North. Santa Monica: RAND Corporation. Available at: http://www.rand.org/pubs/documented_briefings/DB616.html
40. Wallwork, E. 2008. Ethical analysis of research partnerships with communities. Kennedy Institute of Ethics Journal, 18 (1): 57 - 85.
41. Weijer, C. and Emanuel, E. J. 2000. Ethics: Protecting communities in biomedical research. Science, 289 (5482): 1142 - 1144.
42. Weijer, C., Grimshaw, J. M., Taljaard, M., Binik, A., Boruch, R., Brehaut, J. C., Donner, A., Eccles, M. P., Gallo, A., McRae, A. D., Saginur, R. and Zwarenstein, M. 2011. Ethical issues posed by cluster randomized trials in health research. Trials, 12: 100
43. World Health Organization. 2009. Scaling up research and learning for health systems: Now is the time Report of a High Level Task Force (presented and endorsed at the Global Ministerial Forum on Research for Health 2008), Bamako, Mali. Available at: http://www.who.int/rpc/publications/scaling_up_research/en/index.html
44. Zeitz, P. S., Salami, C. G., Burnham, G., Goings, S. A., Tijani, K. and Morrow, R. H. 1993. Quality assurance management methods applied to a local-level primary health care system in rural Nigeria. International Journal of Health Planning and Management, 8 (3): 235 - 244.