The ethical imperative to treat NCDs during research in Africa
Authors: Majaliwa Mzombwe, Bernard Desderius, Saidi Kapiga, Luke Smart, Robert Peck
Journal: The Lancet Global Health (2019)

As the rising prevalence and life-threatening consequences of non-communicable diseases (NCDs) in Africa have become more obvious,1Naghavi M Forouzanfar MH Burden of non-communicable diseases in sub-Saharan Africa in 1990 and 2010: Global Burden of Diseases, Injuries, and Risk Factors Study 2010.Lancet. 2013; 381: S95Summary Full Text Full Text PDF PubMed Google Scholar so too has the fact that many African health systems are ill-equipped to meet the health-care needs of local communities affected by NCDs.2WHOA global brief on hypertension: silent killer, global public health crisis. World Health Day 2013. World Health Organization, Geneva2013Google Scholar Meanwhile, the quantity of clinical research done in Africa continues to increase,3World BankA decade of development in sub-Saharan African science, technology, engineering and mathematics research. World Bank Group, Washington, DC2014Google Scholar and carries with it unique ethical questions, especially relating to the amount of NCD medical care that ought to be provided for participants involved in this research. Many African research participants, whether enrolled in studies that investigate NCDs or other diseases, will inevitably have NCDs, but have little to no access to NCD health care in their communities. NCDs present a unique challenge because, contrary to acute infectious processes, the treatment of NCDs is not usually urgent and a lack of care will not lead to immediate morbidity or mortality. As such, do researchers in Africa have a responsibility to provide ancillary NCD services to research participants? In light of the third UN High-Level Meeting on NCDs, our aim is to provoke a dialogue regarding ancillary NCD services in the context of research in Africa. We believe that this dialogue can be guided by several lessons learned during the HIV epidemic and by a moral responsibility to provide ancillary care as articulated by Richardson.4Richardson HS Moral entanglements: the ancillary-care obligations of medical researchers. Oxford University Press, Oxford2012Crossref Scopus (41) Google Scholar First, researchers in Africa should strive for the "highest achievable standard" of ancillary care for NCDs diagnosed during the course of medical research.5Benatar SR Singer PA A new look at international research ethics.BMJ. 2000; 321: 824-826Crossref PubMed Scopus (199) Google Scholar Setting standards that are too high for ancillary NCD services will make the conduct of research too burdensome.6Dickert N Wendler D Ancillary care obligations of medical researchers.JAMA. 2009; 302: 424-428Crossref PubMed Scopus (35) Google Scholar, 7Dickert N DeRiemer K Duffy PE et al.Ancillary-care responsibilities in observational research: two cases, two issues.Lancet. 2007; 369: 874-877Summary Full Text Full Text PDF PubMed Scopus (22) Google Scholar By contrast, accepting health inequity as an unchangeable reality misses the opportunity for research to combat these inequities.5Benatar SR Singer PA A new look at international research ethics.BMJ. 2000; 321: 824-826Crossref PubMed Scopus (199) Google Scholar, 8Council for International Organizations of Medical SciencesInternational Ethical Guidelines for Health-related Research Involving Humans. Council for International Organizations of Medical Sciences, Geneva2016Crossref Google Scholar, 9Lurie P Sidney M Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries.N Engl J Med. 2000; 337: 853-856Crossref Scopus (536) Google Scholar, 10Brownsword R Cermak A Chaisson R et al.The ancillary-care obligations of medical researchers working in developing countries.PLoS Med. 2008; 5: 709-713Google Scholar, 11Slack CM Ancillary care in South African HIV vaccine trials: addressing needs, drafting protocols, and engaging community.J Empir Res Hum Res Ethics. 2014; 9: 83-95Crossref PubMed Scopus (18) Google Scholar Determining this "highest achievable standard" will require an in-depth understanding of the social, economic, and political contexts of the settings for each study.5Benatar SR Singer PA A new look at international research ethics.BMJ. 2000; 321: 824-826Crossref PubMed Scopus (199) Google Scholar Second, the "highest achievable standard" should be continuously reassessed and increased on the basis of improvements in the local health-care system and new scientific knowledge. During the initial decades (1995–2010) of HIV research in Africa, for example, the local capacity to provide antiretroviral treatment (ART) increased dramatically.12Fitzgerald DW Pape JW Wasserheit JN Counts GW Corey L Provision of treatment in HIV-1 vaccine trials in developing countries.Lancet. 2003; 362: 993-994Summary Full Text Full Text PDF PubMed Scopus (29) Google Scholar Therefore, the standard for ancillary HIV care in Africa also increased to the point of ART being provided for participants in HIV trials.8Council for International Organizations of Medical SciencesInternational Ethical Guidelines for Health-related Research Involving Humans. Council for International Organizations of Medical Sciences, Geneva2016Crossref Google Scholar, 12Fitzgerald DW Pape JW Wasserheit JN Counts GW Corey L Provision of treatment in HIV-1 vaccine trials in developing countries.Lancet. 2003; 362: 993-994Summary Full Text Full Text PDF PubMed Scopus (29) Google Scholar, 13UNAIDSEthical considerations in HIV preventive vaccine research UNAIDS guidance document. UNAIDS, Geneva2000Google Scholar Members of one HIV trial network noted that, "One research organization cannot reverse global inequities in HIV[-1] care but researchers…have an obligation to try to narrow the equity gap."12Fitzgerald DW Pape JW Wasserheit JN Counts GW Corey L Provision of treatment in HIV-1 vaccine trials in developing countries.Lancet. 2003; 362: 993-994Summary Full Text Full Text PDF PubMed Scopus (29) Google Scholar Third, study-specific guidelines regarding ancillary care for NCDs should be guided by the "four Ps": positive duty, planning, partnership, and practical provisions.10Brownsword R Cermak A Chaisson R et al.The ancillary-care obligations of medical researchers working in developing countries.PLoS Med. 2008; 5: 709-713Google Scholar Researchers have a duty to assist study participants diagnosed with NCDs: careful planning is needed to anticipate the NCD burden in the study population; NCD care plans should be developed in partnership with the local community to prevent displacing or disrupting the local health-care system; and investigators should clearly state the planned NCD provisions. Fourth, study-specific ancillary care plans for NCDs should be guided by the nature of the relationships between the study participants, the investigators, and the community.4Richardson HS Moral entanglements: the ancillary-care obligations of medical researchers. Oxford University Press, Oxford2012Crossref Scopus (41) Google Scholar One working group suggested a series of questions helpful in evaluating ancillary care needs, including "how severe or acute are the likely ancillary care needs", is the identification of NCDs "integral or incidental to carrying out study procedures", and "how extensive are the proposed interactions between researchers and study participants".10Brownsword R Cermak A Chaisson R et al.The ancillary-care obligations of medical researchers working in developing countries.PLoS Med. 2008; 5: 709-713Google Scholar The final plan for ancillary NCD services should be the result of a moral negotiation between community members and the research study team.11Slack CM Ancillary care in South African HIV vaccine trials: addressing needs, drafting protocols, and engaging community.J Empir Res Hum Res Ethics. 2014; 9: 83-95Crossref PubMed Scopus (18) Google Scholar Finally, in our own research14Peck RN Shedafa R Kalluvya S et al.Hypertension, kidney disease, HIV and antiretroviral therapy among Tanzanian adults: a cross-sectional study.BMC Med. 2014; 12: 125Crossref PubMed Scopus (93) Google Scholar, 15Kayange NM Smart LR Downs JA Maskini M Fitzgerald DW Peck RN The influence of HIV and schistosomiasis on renal function: a cross-sectional study among children at a hospital in Tanzania.PLoS Negl Trop Dis. 2015; 9: e0003472Crossref PubMed Scopus (14) Google Scholar in east Africa, we have learned that high-quality ancillary services for common NCDs can be provided through the local health system at a reasonable cost. For example, in a cohort study of adults with HIV funded by the US National Institutes of Health, we raised modest private funds to provide free treatment for hypertension and diabetes. The HIV clinic used these funds to purchase high-quality generic drugs from a local pharmacy. Furthermore, we helped the HIV clinic's case manager to develop a system to track blood pressure, blood glucose control, and prescription refills. We also worked with HIV staff to incorporate hypertension and diabetes screening into routine clinic services and to develop locally relevant NCD health education. In conclusion, the medical research community in Africa has the opportunity and the moral responsibility to help combat the NCD epidemic in Africa through the provision of appropriate ancillary services for NCDs. Further dialogue is needed to help researchers and sponsors articulate the extent of this moral imperative. This online publication has been corrected. The corrected version first appeared at thelancet.com/lancetgh on October 15, 2020 This online publication has been corrected. The corrected version first appeared at thelancet.com/lancetgh on October 15, 2020 This work was supported by the National Institutes of Health Office of the Director, Fogarty International Center, Office of AIDS Research, National Cancer Center, National Eye Institute, National Heart, Blood, and Lung Institute, National Institute of Dental and Craniofacial Research, National Institute On Drug Abuse, National Institute of Mental Health, National Institute of Allergy and Infectious Diseases, and National Institutes of Health Office of Women's Health and Research through the Fogarty International Clinical Research Scholars and Fellows Program at Vanderbilt University (2D43 TW009337) and the American Recovery and Reinvestment Act. All authors declare no competing interests. We would like to thank Ellen Clayton and Doug Heimburger. Correction to Lancet Glob Health 2019; 7: e406–07Mzombwe M, Desderius B, Kapiga S, Smart L, Peck R. The ethical imperative to treat NCDs during research in Africa. Lancet Glob Health 2019; 7: e406–07—In the Declaration of interests section of this Comment, the grant number of the Fogarty International Clinical Research Scholars and Fellows Program at Vanderbilt University has been corrected to 2D43 TW009337. This correction has been made as of Oct 15, 2020. Full-Text PDF Open Access