Ethics of Ancillary Care in Clinical Trials in Low Income Countries: A Nigerian Case Study

Bridget G. Haire, Olusegun Ogundokun

Abstract

The ethical conduct of HIV prevention researchers is subject to scrutiny. Many clinical trials take place in low and middle income countries where HIV incidence is high, but the benefits of research are often first enjoyed in high income countries. The provision of ancillary care – medical care provided to clinical trial participants during a trial, which is not related to the research question – is one way in which trial participants can receive direct benefits from their participation in research. We argue that such care is a legitimate benefit of research participation. This care does not constitute ‘undue inducement’ if the research study itself involves minimal risk and is subject to ethical and regulatory oversight. We also argue that research teams working with populations who have sub-optimal healthcare access have a duty to provide ancillary care within agreed limits. These limits should be negotiated to ensure that the research remains feasible and economically viable. (Afr J Reprod Health 2014; 18[3]: 135-142)

 

Keywords: Ancillary care; ethics, HIV prevention, undue inducement

 

Résumé 

La conduite éthique des chercheurs dans le domaine de la prévention du VIH est soumise au contrôle. De nombreux essais cliniques ont lieu dans les pays à faible et moyen revenu où l'incidence du VIH est élevée, mais les avantages de la recherche sont souvent d'abord appréciés dans les pays à revenu élevé. La prestation de soins auxiliaires – les soins médicaux fournis aux participants des essais cliniques au cours d'un procès, qui n'est pas liée à la question de la recherche - est une façon pour les participants à l'essai de recevoir des prestations directes pour leur participation à la recherche. Nous soutenons que ces soins constituent  un bénéfice légitime de participation à la recherche. Ce soin ne constitue pas «une incitation indue» si l'étude ellemême implique un risque minimal et elle est soumise à la surveillance éthique et réglementaire. Nous soutenons également qu’il incombe aux équipes de recherche qui travaillent avec les populations qui ont accès à des soins de santé sous-optimal  de leur fournir des soins auxiliaires dans les limites convenues. Ces limites doivent être négociées pour s'assurer que la recherche demeure réalisable et économiquement viable. (Afr J Reprod Health 2014; 18[3]: 135-142)

 

Mots-clés: Soins auxiliaires, éthique,  prévention du VIH,  incitations indues

Full Text:

PDF

References

Belsky L, Richardson HS. Medical researchers' ancillary clinical care responsibilities. BMJ. 2004; 328(7454):1494-6.

Merritt MW, Taylor HA,and Mullany, LC. Ancillary care in community-based public health intervention research. Am J Public Health. 2010;100 (2):211–6.

Richardson HS. Gradations of researchers' obligation to provide ancillary care for HIV/AIDS in developing countries. Am J Public Health. 2007; 97(11):1956-61.

Richardson HS. Comment on ‘a capacity-based approach for addressing ancillary-care needs: implications for research in resource limited settings’. Journal of Medical Ethics. 2012;38(11):677-8.

Richardson HS. Incidental findings and ancillary-care obligations. The Journal of Law, Medicine & Ethics. 2008; 36(2):256-70.

Bright PL, Nelson RM. A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings. Journal of Medical Ethics. 2012.

Hyder AA, Merritt MW. Ancillary care for public health research in developing countries. JAMA.

;302(4):429-31.

Pratt B, Zion D, Lwin KM, Cheah PY, Nosten F, Loff B. Ancillary care: From theory to practice in international clinical research. Public Health Ethics. 2013; 6(2):154-69.

Sagay AS. Current State of AIDS Epidemic in Nigeria: Role of ARVs on PMTCT. Biomedical HIV

Prevention Forum. 2013. Available at:www.nhvmasng.org/forum/confslides.php. Accessed 27 March 2014.

National Population Commission [Nigeria] and ICF Macro. Nigeria Demographic and Health Survey 2013 Preliminary Report. Abuja, Nigeria and Calverton, Maryland: National Population Commission and ICF Macro. October 2013.

Bankole A, Sedgh G, Okonofua F, Imarhiagbe C, Hussain R and Wulf D. 2009. Barriers to Safe Motherhood in Nigeria. New York: Guttmacher Institute. Available at: www.guttmacher.org Accessed 6 June 2014.

National Population Commission [Nigeria] and ICF Macro. Nigeria Demographic and Health Survey 2008 Preliminary Report. Abuja, Nigeria and Calverton, Maryland: National Population Commission and ICF Macro, 2009.

New HIV Vaccine and Microbicide and Advocacy Society (NHVMAS). Nigeria- A Haven for Clinical trials. Sept 15, 2012. Available at: http://www.nhvmas-ng.org/news.php?news_id=66 Accessed 27 March 2014.

Ogundokun O. Monitoring – A gradual process. 4 December 2013. Available at: http:// globalhealthtrials.tghn.org/articles. Accessed 27 March 2014.

Goldstein S. Bioethics takes root in Nigeria. Global Health Matters Newsletter/ November / December 2011. 10 (6) 2011.Available at: http://www.fic.nih. gov/News/GlobalHealthMatters/nov-dec-2011/ Pages /bioethics-nigeria.aspx Accessed 27 March 2014.

Ogundele S, Falade, C.O. Good clinical practice in Nigeria - the way forward. Annals of Ibadan Post Graduate Medicine. 2006;4(1):28-32

WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects

Available at www.wma.net. Accessed 27 March 2014

International Conference on Harmonization Guideline for Good Clinical Practice. (ICH-GCP). Available at: www.ema.europa.eu/docs/en_GB/document_libtrary/s cientific_guideline/2009/09/WC00002874.pdf Accessed 27 March 2014.

Emanuel EJ. Undue inducement: Nonsense on stilts? The American Journal of Bioethics. 2005; 5(5):9 - 13.

Van Damme L, Ramjee G, Alary M, Vuylsteke B,

Chandeying V, Rees H, et al. Effectiveness of COL1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial. The Lancet. 2002; 360(9338):971-7.

UNAIDS. Ethical considerations in biomedical HIV prevention trials [Additional guidance point added in 2012]. Joint United Nations Programme on HIV/AIDS (UNAIDS). 2012.

Beauchamp T, Childress J. Principles of Biomedical Ethics. 4th ed. New York, Oxford: Oxford University Press; 1994.

Miller PB, Weijer C. Fiduciary obligation in clinical research. The Journal of Law, Medicine & Ethics. 2006; 34(2):424-40.

Hooper CR. Ancillary care duties: the demands of justice. Journal of Medical Ethics. 2010; 36(11):708-11.

Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? Jama. 2000; 283(20):2701-11.

Hyder AA, Merritt MW. Ancillary care for public health research in developing countries. JAMA. 2009;302(4):429-31.

Benatar S, Singer P. A new look at international research ethics. BMJ. 2000; 321: 824 - 6.

Vallely A, Shagi C, Kasindi S, Desmond N, Lees S, Chiduo B, et al. The benefits of participatory methodologies to develop effective community dialogue in the context of a microbicide trial feasibility study in Mwanza, Tanzania. BMC Public Health. 2007;7:133

Haire BG. Ethics of medical care and clinical research: a qualitative study of principal investigators in biomedical HIV prevention research. Journal of Medical Ethics. 2013;39(4):231-5.

Ukpong M, Falobi, O. The oral Tenofovir controversy: Report of a dialogue between community advocates and researchers on the Phase II Oral Tenofovir (TDF) trial in Nigeria. Nigeria HIV Vaccine and Microbicide Advocacy Group. Lagos, Nigeria. 2005.

Ukpong M, Peterson K. Oral Tenofovir Controversy II: Voices from the field. A series of reports of the oral Tenofovir trials with perspectives of community voices from Cambodia, Cameroon, Nigeria, Thailand and Malawi. New HIV Vaccine and Microbicides Advocacy Society (NHVMAS). Lagos, Nigeria. 2009.

Page-Shafer K, Saphonn V, Sun LP, Vun MC, Cooper DA, Kaldor JM. HIV prevention research in a resource-limited setting: the experience of planning a trial in Cambodia. The Lancet. 2005;366(9495):1499503.

Haire BG. Because we can: Clashes of perspective over researcher obligation in the failed PrEP Trials. Developing World Bioethics. 2011; 11(2):63-74.

Refbacks

  • There are currently no refbacks.