DEFINING AND NEGOTIATING THE SOCIAL VALUE OF RESEARCH IN PUBLIC HEALTH FACILITIES: PERCEPTIONS OF STAKEHOLDERS IN A RESEARCH‐ACTIVE PROVINCE OF SOUTH AFRICA DEFINING AND NEGOTIATING THE SOCIAL VALUE...

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DEFINING AND NEGOTIATING THE SOCIAL VALUE OF RESEARCH IN PUBLIC HEALTH FACILITIES: PERCEPTIONS OF STAKEHOLDERS IN A RESEARCH‐ACTIVE PROVINCE OF SOUTH AFRICA DEFINING AND NEGOTIATING THE SOCIAL VALUE OF RESEARCH IN PUBLIC HEALTH FACILITIES: PERCEPTIONS OF STAKEHOLDERS IN A RESEARCH-ACTIVE PROVINCE OF SOUTH AFRICA ELIZABETH LUTGE, CATHERINE SLACK AND DOUGLAS WASSENAAR Keywords social value, collateral benefits, aspirational benefits, gatekeepers, researchers ABSTRACT This article reports on qualitative research conducted in KwaZulu-Natal, South Africa, among researchers and gate-keepers of health facilities in the province. Results suggest disparate but not irreconcilable perceptions of the social value of research in provincial health facilities. This study found that researchers tended to emphasize the contribution of research to the generation of knowledge and to the health of future patients while gate-keepers of health facilities tended to emphasize its contribution to the healthcare system and to current patients. Furthermore, relations between research stakeholders were perceived to be somewhat fragile, making it difficult for stakeholders to achieve consensus about the social value of research, as well as on ways to maximize value. Interventions to negotiate a shared perspective on the social value of research would appear to be warranted, and the findings of this study suggest some focus areas for such intervention. BACKGROUND The social value of research has emerged in recent deca- des as an important criterion for ethical research. In early guidelines the social value of research was only briefly alluded to and the reader was left to operational- ize the concept. Amongst earlier ethics guidelines, it is perhaps the Nuremberg Code (1947)1 which best identi- fies social value as desirable, and defines valuable research most clearly as that which yields �fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature�. Although not expressly identified as the standard of social value, this definition is echoed in the Interna- tional Ethics Guidelines for Biomedical Research involving Human Subjects (�CIOMS guidelines�) of 2002,2 as a requirement for ethical research, while the new draft (not yet finalized) explicitly lists social value as the first guidance point for ethical research.3 In recent years, the concept of social value has been more clearly articulated and elaborated upon as an ethical requirement of research in the frame- Address for correspondence: Elizabeth Lutge, KZN Department of Health – Epidemiology, Health Research and Knowledge Management, Natalia Building Langalibalele Street Pietermarizburg PIetermarizburg KwaZulu-Natal 3001, South Africa. Email: elizabethlutge@gmail.com 1 The Nuremberg Code 1947. BMJ 1996; 313: 1448. 2 Council for International Organizations of Medical Sciences (CIOMS) (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Available at http://www.cioms.ch/ publications/guidelines/guidelines_nov_2002_blurb.htm Accessed on 2 November 2016. 3 Council for International Organizations of Medical Sciences (CIOMS) (2015). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Available from http://www.cioms. ch/index.php/12-newsflash/394-the-public-consultation-on-ethical- guidelines-is-now-closed VC 2017 John Wiley & Sons Ltd Bioethics ISSN 0269-9702 (print); 1467-8519 (online) doi:10.1111/bioe.12323 Volume 31 Number 2 2017 pp 128–135 bs_bs_banner http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm http://www.cioms.ch/index.php/12-newsflash/394-the-public-consultation-on-ethical-guidelines-is-now-closed http://www.cioms.ch/index.php/12-newsflash/394-the-public-consultation-on-ethical-guidelines-is-now-closed http://www.cioms.ch/index.php/12-newsflash/394-the-public-consultation-on-ethical-guidelines-is-now-closed work provided by Emanuel and others.4 Within this framework, the concept has evolved over time. In the first iteration,5 the social value of research was defined as being the �enhancements of health or knowledge. . . derived from the research� which reflects the implied definitions in major interna- tional guidelines such as the Nuremberg Code6 and CIOMS guidelines.7 In subsequent elaborations of Emanuel�s framework8 the essence of this first definition of social value was retained but important qualifications were introduced in the benchmarks (discussed in more detail later). These benchmarks recognize that social value is likely to be conceptualized and measured differently by different ben- eficiaries of research, and that value in research is not a constant – it can both be enhanced and undermined by factors within or external to the research process. The benchmarks are crucially important for specifying social value and reflect the complexity of applying any ethical standard in various socio-cultural contexts, including the standard of social value. It could be argued that there are objective indicators of whether research has social value, such as disability and quality adjusted life years, or whether it corresponds to national health priorities. Yet it is also possible, even likely, that various research stake- holders will judge the social value of a study differently, pointing to the elements of value that are subject to social context.9 Such differing judgements may reflect the interests of specific social groups that may have diverging perspectives, needs and priorities.10 There is much literature on the importance, and pro- cess, of eliciting such views from various stakeholders or �communities�, particularly in relation to HIV research.11 There have also been several studies investi- gating the related concept of research benefits.12 To date, however, much of the literature has tended to define the inherent value of research according to its contribution to new knowledge, and this has been the point of departure for empirical studies on this sub- ject.13 Our study underscores that this �traditional� defi- nition of value is not always shared by key research stakeholders, and interrogates the opinions of both researchers and non-researchers around this concept. 4 E.J. Emanuel, D. Wendler & C. Grady. What makes clinical research ethical? JAMA 2000; 283: 2701 – 2711; E.J. Emanuel et al. What makes clinical research in developing countries ethical? The benchmarks of eth- ical research. J Infect Dis 2004; 189: 930–937; E.J. Emanuel, D. Wendler & C. Grady. 2008. An ethical framework for biomedical research. In The Oxford Textbook of Clinical Research Ethics, E.J. Emanuel et al. New York: Oxford University Press. 5 Emanuel, Wendler & Grady. 2000, op. cit. note 4. 6 The Nuremberg Code 1947. BMJ 1996; 313: 1448. 7 Council for International Organizations of Medical Sciences (CIOMS) (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Available at http://www.cioms.ch/ publications/guidelines/guidelines_nov_2002_blurb.htm [accessed 2 November 2001]. 8 Emanuel et al. 2004, op. cit. note 4; Emanuel, Wendler & Grady 2008, op. cit. note 4. 9 P.W. Geissler 2011. Studying Trial Communities: Anthropological and Historical Inquiries into Ethos, Politics and Economy of Medical Research in Africa. In Evidence, Ethos and Experiment: the Anthropol- ogy and History of Medical Research in Africa. P.W. Geissler & C. Moly- neux, eds. New York: Berghahn Books; 2011. Available from: http:// www.ncbi.nlm.nih.gov/books/NBK184571/ 10 D.R. Wassenaar & N. Mamotte. 2012. Ethical issues and ethics reviews in social science research. In The Oxford handbook of interna- tional psychological ethics. M. Leach et al., eds. New York: Oxford Uni- versity Press: 268-282. 11 M.O. Folayan et al. Debating Ethics in HIV Research: Gaps between Policy and Practice in Nigeria. Dev World Bioeth 2015; 15(3): 214–225; M.O. Folayan, K.S. Oyedeji & O.A. Fatusi OA. Community Members� Engagement with and Involvement in Genomic Research: Lessons to Learn from the Field. Dev World Bioeth 2015; 15(1): 1–7; D. Allman, M.H. Ditmore & K. Kaplan. Improving Ethical and Participatory Prac- tice for Marginalized Populations in Biomedical HIV Prevention Trials: Lessons from Thailand. PLOS ONE 2014; 9(6): e100058. doi:10.1371/ journal.pone.0100058; K.F. King et al. Community engagement and the human infrastructure of global health research. BMC Med Ethics 2014; 15: 84. DOI: 10.1186/1472-6939-15-84; J. Koen et al. �It Looks Like You Just Want Them When Things Get Rough�: Civil Society Perspectives on Negative Trial Results and Stakeholder Engagement in HIV Preven- tion Trials. Dev World Bioeth 2013; 13(3): 138–148; K.M. MacQueen et al. 2012. Stakeholder Engagement Toolkit for HIV Prevention Trials. FHI 360. Available at https://www.fhi360.org/resource/stakeholder- engagement-toolkit-hiv-prevention-trials; UNAIDS/AVAC (2011). Good participatory practice: Guidelines for biomedical HIV prevention trials. Joint United Nations Programme on HIV/AIDS (UNAIDS). Geneva, Switzerland. Available at http://www.unaids.org/en/resources/ documents/2011/20110629_JC1853_GPP_Guidelines_2011%20OK; M. Ukpong & K. Peterson 2009. Oral Tenofovir Controversy II: Voices from the Field: A series of reports of the Oral Tenofovir Trials from the perspectives of Active Community Voices engaged on the field in Cam- bodia, Cameroon, Nigeria, Thailand and Malawi. NHVMAS 2009; P.0.Tindana et al. Grand Challenges in Global Health: Community Engagement in Research in Developing Countries. PLoS Med 2007; 4(9): e273. doi:10.1371/journal.pmed.0040273 12 D.M. Kamuya et al. �When they see us, it�s like they have seen the ben- efits!�: experiences of study benefits negotiations in community-based studies on the Kenyan coast. BMC Med Ethics. 2014; 15: 90. doi: 10.1186/1472-6939-15-90; G.M. Lairumbi et al. Forms of benefit sharing in global health research undertaken in resource poor settings: a qualita- tive study of stakeholders� views in Kenya. Philos Ethics Humanit Med. 2012 Jan 17; 7: 7. doi: 10.1186/1747-5341-7-7; G.M. Lairumbi et al. Stakeholders understanding of the concept of benefit sharing in health research in Kenya: a qualitative study. BMC Med Ethics. 2011; 12: 20. doi: 10.1186/1472-6939-12-20; S. Molyneux et al. Benefits and payments for research participants: Experiences and views from a research centre on the Kenyan coast. BMC Med Ethics 2012; 13: 13; DOI: 10.1186/ 1472-6939-13-13 13 G.M. Lairumbi et al. (2008). Promoting the social value of research in Kenya: Examining the practical aspects of collaborative partnerships using an ethical framework. Soc Sci Med 2008; 67; 734–747 The Social Value of Research: Perceptions of Stakeholders 129 VC 2017 John Wiley & Sons Ltd http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm http://www.cioms.ch/publications/guidelines/guidelines_nov_2002_blurb.htm http://www.ncbi.nlm.nih.gov/books/NBK184571/ http://www.ncbi.nlm.nih.gov/books/NBK184571/ http://https://www.fhi360.org/resource/stakeholder-engagement-toolkit-hiv-prevention-trials http://https://www.fhi360.org/resource/stakeholder-engagement-toolkit-hiv-prevention-trials http://www.unaids.org/en/resources/documents/2011/20110629_JC1853_GPP_Guidelines_2011%20OK http://www.unaids.org/en/resources/documents/2011/20110629_JC1853_GPP_Guidelines_2011%20OK AIMS This article reports on a subset of data from a qualitative study exploring perceptions of research conducted in provincial health facilities in KwaZulu-Natal, South Africa.14 KwaZulu-Natal is an appropriate location for such research, because its population is heterogeneous, and it has for the past few decades been the focus of intense health research activity, primarily in the fields of HIV/AIDS and TB. Research in this province has informed clinical treatment protocols and the develop- ment of new treatments for these diseases.15 The study participants were managers in the provincial government�s Department of Health (DoH), and researchers both internal and external to the Depart- ment. DoH managers control access by researchers to provincial health facilities and are among those stake- holders who are likely to use the results of research.16 Varying notions of �valuable� research in provincial health facilities emerged as a key theme, as reported and discussed below. METHODS Semi-structured in-depth interviews were conducted with two critical stakeholder groups: firstly, researchers (both those external to the DoH who conduct health research within DoH facilities as well as doctors employed by the DoH who conduct research as part of their clinical