Ethical challenges in integrating patient-care with clinical research in a resource-limited setting: perspectives from Papua New Guinea

BMC Medical Ethics

Inoni Betuela²  Peter Siba¹  William Pomat¹  Moses Laman² 

[1] Papua New Guinea Institute of Medical Research, Goroka, Eastern Highlands Province, Papua New Guinea;Papua New Guinea Institute of Medical Research, Madang, Madang Province, Papua New Guinea

关键词: Inducement;    Therapeutic misconception;    Ethical challenges;    Papua New Guinea;    Resource-limited settings;    Developing countries;   

Others  :  799928
DOI  :  10.1186/1472-6939-14-29

 received in 2012-10-29, accepted in 2013-07-24,  发布年份 2013

【 摘 要 】

Background

In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea.

Discussion

Considering the difficulties of providing basic healthcare services in developing countries, it may be argued that integration of clinical research with patient-care is an effective, rational and ethical way of conducting research. However, blending patient-care with clinical research may increase the risk of subordinating patient-care in favour of scientific gains; therapeutic misconception and inappropriate inducement; and the risk of causing health system failures due to limited capacity in developing countries to sustain the level of healthcare services sponsored by the research. Nevertheless, these ethical and administrative implications can be minimised if patient-care takes precedence over research; the input of local ethics committees and institutions are considered; and funding agencies acknowledge their ethical obligation when sponsoring research in resource-limited settings.

Summary

Although integration of patient-care with clinical research in developing countries appears as an attractive way of conducting research when resources are limited, careful planning and consideration on the ethical implications of such approach must be considered.

【 授权许可】

   
2013 Laman et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Global forum for health research: Equitable access: research challenges fsor health in developing countries. Geneva: Global forum for health research; 2008.
• [2]Angell M: The ethics of clinical research in the Third World. N Engl J Med 1997, 337(12):847-849.
• [3]Council for International Organizations of Medical Sciences: International ethical guidelines for biomedical research involving human subjects. Bull Med Ethics 2002, (182):17-23.
• [4]Miller FG, Joffe S: Evaluating the therapeutic misconception. Kennedy Inst Ethics J 2006, 16(4):353-366.
• [5]Appelbaum PS, Roth LH, Lidz C: The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 1982, 5(3–4):319-329.
• [6]Miller FG, Brody H: A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials. Hastings Cent Rep 2003, 33(3):19-28.
• [7]Sundari TK: The untold story: how the health care systems in developing countries contribute to maternal mortality. International journal of health services: planning, administration, evaluation 1992, 22(3):513-528.
• [8]McClure EM, Saleem S, Pasha O, Goldenberg RL: Stillbirth in developing countries: a review of causes, risk factors and prevention strategies. The journal of maternal-fetal & neonatal medicine: the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstet 2009, 22(3):183-190.
• [9]Ribeiro CR, Zoboli EL: Poverty, bioethics and research. Rev Lat Am Enfermagem 2007, 15:843-849.
• [10]Angell M: Investigators’ responsibilities for human subjects in developing countries. N Engl J Med 2000, 342(13):967-969.
• [11]Lozano R, Wang H, Foreman KJ, Rajaratnam JK, Naghavi M, Marcus JR, Dwyer-Lindgren L, Lofgren KT, Phillips D, Atkinson C, et al.: Progress towards millennium development goals 4 and 5 on maternal and child mortality: an updated systematic analysis. Lancet 2011, 378(9797):1139-1165.
• [12]Pincock S: Papua New Guinea struggles to reverse health decline. Lancet 2006, 368(9530):107-108.
• [13]Bauze AE, Tran LN, Nguyen KH, Firth S, Jimenez-Soto E, Dwyer-Lindgren L, Hodge A, Lopez AD: Equity and geography: the case of child mortality in Papua New Guinea. PLoS One 2012, 7(5):e37861.
• [14]WHO: Trends in maternal mortality: 1990–2010. Geneva: World Health Organisation; 2012.
• [15]Duke T: Decline in child health in rural Papua New Guinea. Lancet 1999, 354(9186):1291-1294.
• [16]Manning L, Laman M, Edoni H, Mueller I, Karunajeewa HA, Smith D, Hwaiwhanje I, Siba PM, Davis TM: Subacute sclerosing panencephalitis in papua new guinean children: the cost of continuing inadequate measles vaccine coverage. PLoS Negl Trop Dis 2011, 5(1):e932.
• [17]Muller I, Bockarie M, Alpers M, Smith T: The epidemiology of malaria in Papua New Guinea. Trends Parasitol 2003, 19(6):253-259.
• [18]Laman M, Manning L, Hwaiwhange I, Vince J, Aipit S, Mare T, Warrel J, Karunajeewa H, Siba P, Mueller I, et al.: Lumbar puncture in children from an area of malaria endemicity who present with a febrile seizure. Clin Infect Dis 2010, 51(5):534-540.
• [19]Gratten M, Montgomery J: The bacteriology of acute pneumonia and meningitis in children in Papua New Guinea: assumptions, facts and technical strategies. 1991. P N G Med J 2005, 48(1–2):73-86.
• [20]Lehmann D, Yeka W, Rongap T, Javati A, Saleu G, Clegg A, Michael A, Lupiwa T, Omena M, Alpers MP: Aetiology and clinical signs of bacterial meningitis in children admitted to Goroka Base Hospital, Papua New Guinea, 1989–1992. Ann Trop Paediatr 1999, 19(1):21-32.
• [21]Laman M, Manning L, Greenhill AR, Mare T, Michael A, Shem S, Vince J, Lagani W, Hwaiwhanje I, Siba PM, et al.: Predictors of acute bacterial meningitis in children from a malaria-endemic area of Papua New Guinea. Am J Trop Med Hyg 2012, 86(2):240-245.
• [22]Papua New Guinea National Department of Health: The 2011 STI, HIV and AIDS Annual Surveillance Report. Port Moresby: PNG NDoH; 2012.
• [23]World Health Organization: Tuberculosis country profile. Papua New Guinea; 2011. http://www.who.int/countries/png/en/ webcite. Accessed September 2012
• [24]Kline K, McCarthy JS, Pearson M, Loukas A, Hotez PJ: Neglected tropical diseases of oceania: review of their prevalence, distribution, and opportunities for control. PLoS Negl Trop Dis 2013, 7(1):e1755.
• [25]World Health Organisation. World Health Statistics 2011. Geneva: WHO Press; 2012.
• [26]World Medical Association: Declaration of Helsinki. Helsinki, Finland: Adopted by the 18th World Medical Assembly, Hong Kong. France, Ferney-Voltaire: World Medical Association Inc.; 1989.
• [27]Caplan AL: Twenty years after. The legacy of the Tuskegee Syphilis Study. When evil intrudes. Hastings Cent Rep 1992, 22(6):29-32.
• [28]Wawer MJ, Sewankambo NK, Serwadda D, Quinn TC, Paxton LA, Kiwanuka N, Wabwire-Mangen F, Li C, Lutalo T, Nalugoda F, et al.: Control of sexually transmitted diseases for AIDS prevention in Uganda: a randomised community trial. Rakai project study group. Lancet 1999, 353(9152):525-535.
• [29]Science, ethics, and the future of research into maternal infant transmission of HIV-1. Perinatal HIV Intervention Research in developing countries workshop participants Lancet 1999, 353(9155):832-835.
• [30]Krogstad DJ, Diop S, Diallo A, Mzayek F, Keating J, Koita OA, Toure YT: Informed consent in international research: the rationale for different approaches. Am J Trop Med Hyg 2010, 83(4):743-747.
• [31]Douglas RM: Pneumonia in Papua New Guinea, from the past to the future. PNG Med J 2010, 53(3–4):99-105.
• [32]Shann F, Biddulph J, Vince J: Paediatrics for Doctors in Papua New Guinea. 2nd edition. PNG: Divine Word University Press; 2003.
• [33]Reeder JC, Taime J: Engaging the community in research: lessons learned from the malaria vaccine trial. Trends Parasitol 2003, 19(6):281-282.
• [34]Mfutso-Bengo J, Ndebele P, Jumbe V, Mkunthi M, Masiye F, Molyneux S, Molyneux M: Why do individuals agree to enrol in clinical trials? A qualitative study of health research participation in Blantyre. Malawi. Malawi Med J 2008, 20(2):37-41.
• [35]Reeder JC: John C Reeder–Director of the Papua New Guinea Institute of Medical Research. Interview by Pam Das. Lancet Infect Dis 2004, 4(6):376-380.
• [36]de Vries J, Bull SJ, Doumbo O, Ibrahim M, Mercereau-Puijalon O, Kwiatkowski D, Parker M: Ethical issues in human genomics research in developing countries. BMC Med Ethics 2011, 12:5. BioMed Central Full Text