Benefit sharing in health research

Abstract

The necessity of benefit sharing may be questioned when research activities are funded by international sources within a developing country. Benefit sharing is a topic which remains uncertain in the context of genetic research, particularly with regard to how and with whom benefits should be shared. A Material Transfer Agreement (MTA) is one way (and in some instances the only way) in which the transfer of human biological materials is regulated. With biobank research increasing and the historical exploitation of research participants in Africa a reality, it is essential that the transfer of human tissues across national boundaries is regulated with specific regard to the sharing of benefits and the respect and protection of traditional values. This paper will debate the requirement of benefit sharing when research is undertaken; discuss its meaning in the context of genetic research; and outline some South African and international perspectives on the sharing of benefits. While this paper emphasises benefit sharing in the context of genetic research, the principles apply to all human participant research.S Afr J BL 2015;8(2 Suppl 1):6064.

Human Genetics and Genomics in South Africa: Ethical, Legal and Social Implications

“…Accepting the need for a form of benefit sharing, the next issue is how benefits may be shared amongst donor communities and society at large (Knoppers et al, 2014;Mahomed and Sanne, 2015). Tangible benefits can range from monetary awards to employment opportunities and business development.…”

A framework for the promotion of ethical benefit sharing in health research

“…[2][3][4][5] For non-human biospecimens, in relation to bioprospecting, the Nagoya Protocol aims to inculcate benefit sharing alongside material transfer agreements, but human biological resources and digital sequence information are not currently included. [6][7][8] In 2016, the Council for International Organizations of Medical Sciences updated their research ethics guidelines to discuss benefit sharing for medical research and to advocate for negotiated benefit sharing agreements, but failed to explore the impact of inequity on the negotiating position of stakeholders in the global South. 9 Benefit sharing can take many forms: the most tangible is often the sharing of financial benefits from research with research participants, which occurs at the level of individuals; but there can be many other types of benefits which may have a wider scope beyond the individuals who directly participate in research.…”

“…Discourse about ensuring the fair distribution of research benefits has been ongoing for decades, emerging initially from clinical research involving human participants and subsequently extending to health genomics research 2–5. For non-human biospecimens, in relation to bioprospecting, the Nagoya Protocol aims to inculcate benefit sharing alongside material transfer agreements, but human biological resources and digital sequence information are not currently included 6–8. In 2016, the Council for International Organizations of Medical Sciences updated their research ethics guidelines to discuss benefit sharing for medical research and to advocate for negotiated benefit sharing agreements, but failed to explore the impact of inequity on the negotiating position of stakeholders in the global South 9.…”