Ethics

The Problem

Current and future advances in biotechnology could help to reduce the degree of suffering and death associated with disease and malnutrition in the developing world. The transition from "lab to village" of life-changing health and agricultural innovations, however, may be prevented or delayed if the many ethical, social, cultural and commercial (ESC2) issues that arise along the critical path from discovery to development to delivery and adoption are not addressed.

How are we tackling the problem?

The Ethics pillar is committed to developing models to assist researchers and other stakeholders to identify, understand, and address ESC2 issues encountered in global health research through two major programmatic initiatives:

  1. The ESC2 Program for Global Health
  2. The ESC2 for the Water Efficient Maize for Africa (WEMA) project.

  

The ESC2 Program for Global Health

Consisting of an experienced, respected, international team of inter-disciplinary scholars drawn from the developing and developed worlds, the ESC2 Program in Global Health engages in evidence-based research and fieldwork to devise novel, rapid, effective, and customized solutions to six major areas of complex ESC2 challenges facing the foundation's strategic program teams:

  1. Research ethics strategies and barriers;
  2. Issues related to the collection, use and sharing of data & tissues;
  3. Public health ethics;
  4. Trust between public and private sectors;
  5. Harnessing innovation in low and middle income countries;
  6. Effective community engagement.

Through:

  1. Alignment with the 'critical path' of team(s) and project(s) it serves;
  2. Deployment of ESC2 team specialists with diverse expertise across global health, medicine, public health, life sciences, law, ethics, philosophy, and commercialization;
  3. Ensuring that 'voices of the South' are captured through the inclusion of ESC2 team members from low and middle income countries;
  4. Engagement with our open global network of collaborators and contractors tapped for their specific expertise; and,
  5. Effective knowledge translation.

 

The ESC2 Program for the WEMA project

The Water Efficient Maize for Africa Project (WEMA) is a public-private partnership which seeks to introduce drought-tolerant maize, royalty free, to small-scale farmers in Sub-Saharan Africa. In doing so, WEMA faces a potentially significant barrier due to diminished public trust in public-private partnerships involved in the development of genetically modified crops.

To enable WEMA to address and overcome this barrier, our team provides ESC2 auditing services to the WEMA project and concurrently uses case studies and working papers to generate knowledge that can facilitate the appropriate and successful adoption of WEMA and other agro-biotechnology crops.

What have we accomplished?

  1. Social Audit Model: We developed a social audit model in 2009 for agro-biotechnology initiatives that we successfully applied to the WEMA project with tangible results. Issues identified from the ESC² auditing service have led to the WEMA management and country teams modifying their practices and work plans. For example, WEMA teams followed the recommendation that arose from our social audit regarding stakeholder requests for input on trait selection and transparency of stacked traits in WEMA seeds. Moreover, the WEMA Executive Advisory Board and Communications Team plan to produce clear documentation on the issues that arose, validating the stakeholders’ requests. Attention to these issues is likely to impact stakeholders’ satisfaction with the WEMA project.
  2. Building Trust through the Model: The application of the social audit model to the WEMA project has helped foster improved management practices, accountability, and transparency, which, in turn, is helping to build trust among the WEMA partners, and between WEMA and the public.
  3. Working Papers: We have completed five working papers on issues related to agro-biotechnology, of which three have been published in peer-reviewed journals. These working papers, which were shared with the WEMA community, have strengthened the understanding of issues relevant to the WEMA project and generated knowledge of practices necessary for the appropriate adoption of agro-biotechnology.

What are the next steps?

We will continue to contribute to the global health community by disseminating and applying the following models we have developed:

  1. Social Audit: We will consider offering additional services in the future such as the application of our social audit model in a user’s guide or consulting service, and the creation of policy guidelines for best practices relating to trust building in agro-biotechnology public-private partnerships.
  2. Case Studies: We will identify how trust functions as a key determinant of successful agro-biotechnology public-private partnerships, in order to identify and develop best practices of partnership building in the field.
  3. Working Papers: We aim to publish papers currently under preparation with the goal of continuing to disseminate and translate knowledge into practice.

 

Key Publications

In this provocative paper, viewed 2446 times since its publication, Lavery et al. propose a mechanism to reallocate resources invested in existing trials of older products that might be better invested in more scientifically advanced products awaiting clinical testing:

Lavery JV, Ridzon R, Singh JA, Slutsky AS, Anisko JJ, Singer PA. Ethical considerations in stopping clinical trials early: Is there a legitimate role for opportunity costs. PLoS Med. 2009; 6(6): e1000071.doi:10.1371.

Here, Lavery et al. present the first set of guidelines developed for this complicated and sensitive undertaking, describing a site selection process and offering a set of preliminary considerations for addressing the ESC aspects of a research program involving genetic strategies for the control of mosquitoes as vectors for dengue viruses:

Lavery JV, Harrington LC, Scott TW. Ethical, social and cultural considerations for site selection for research with genetically modified mosquitoes. American Journal of Tropical Medicine & Hygiene. 2008; 79(3): 312-8.

In this paper, Ezezika et al. introduce a social audit model that accounts for how ESC2 issues are perceived by various stakeholders and which enables project managers to effectively monitor and improve project performance:

Ezezika O, Thomas F, Lavery J, Daar AS, and Singer PA. A social audit model for agro-biotechnology initiatives in developing countries: accounting for ethical, social, cultural, and commercialization issues. J Technol Manag Innov. 2009; 4(3): 24-33.

In this paper, Upshur et al. call to all involved in health care to bear collective responsibility for extensively drug-resistant tuberculosis (XDR-TB) and to put a stop to the disease’s progression to complete drug resistance:

Upshur R, Singh J, Ford N. Apocalypse or redemption: responding to extensively drug-resistant tuberculosis. Bull World Health Organ. 2009; 87(6): 481-3.

In this paper, Emerson and Singer present a persuasive set of moral arguments that show the global health community has an ethical obligation to finish the job of polio eradication:

Emerson CI and Singer PA. Is there an ethical obligation to complete polio eradication? The Lancet. 2010; 375: 1340-1.

In this Editor’s Choice article, Benatar and Singer propose that research be linked to improvements in health and sustainable capacity building in research. This change, they argue, could contribute to the ongoing paradigm shift to think of research as a broader goal, encompassing beneficial impacts on health, healthcare delivery and independence in poor countries:

Benatar SR and Singer PA. Responsibilities in international research: a new look re-visited. J Med Ethics. 2010; 36: 194-7 doi:10.1136/jme.2009.032672.