Ethics

The Problem

Current and future advances in biotechnology could help to reduce the degree of suffering and death associated with malnutrition and disease 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, and cultural 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 ESC issues encountered in global health research through two major programmatic initiatives:

  1. The Ethical, Social and Cultural (ESC) Program
  2. The Water Efficient Maize for Africa (WEMA) Ethical, Social, Cultural and Commercial (ESC2) Program.

The Ethical Social and Cultural Program

The ESC Program provides ethics consultation and research services to the Grand Challenges in Global Health (GCGH) initiative, and more broadly, to the Global Health portfolio of the Bill & Melinda Gates Foundation, to address 5 major areas of ESC challenges:

  1. Community engagement
  2. Regulation of research and development as it relates to the acceleration of clinical trials
  3. Collaboration in the use and sharing of biological tissues and information
  4. Public health ethics
  5. Trust in public-private partnerships

Our international team of inter-disciplinary scholars drawn from the developing and developed world engages in evidence-based research using empirical methods to devise novel, practical solutions to these challenges, through 4 inter-connected activities:

1.  ESC Advisory Service: Provides rapid, effective, custom-made solutions to complex ESC challenges through:

  • Alignment with the ‘critical path’ of the science project(s) it serves;
  • Deployment of ESC team specialists with expertise in the five major challenge areas;
  • Ensuring that appropriate voices of the south are captured through the inclusion of ESC team members from the developing world;
  • Our open global network of contacts that can be tapped for their specific expertise; and
  • Effective knowledge translation through working papers and case studies.

2.  Case Studies in Community Engagement: Enables our team to provide guidance to research funders and sponsors, investigators, regulators, research ethics committees and host communities on how to conduct effective community engagement in a wide range of global health research contexts. They do this by improving basic knowledge in this critical and under-developed area of research and identifying and disseminating ‘good practices’ for community engagement.

3.  Working Papers: Working Papers on ESC issues addressed in the advisory service consultations and case studies provide an effective vehicle for knowledge dissemination and uptake.

4.  Working Groups: Working Groups comprising of researchers in the developing world, with the support of the ESC Program, aim to overcome barriers to the adoption of available and effective biotechnologies.

The Water Efficient Maize for Africa (WEMA) Ethical, Social, Cultural and Commercial (ESC2) Program

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?

We have developed and applied innovative models of ESC issues risk mitigation, knowledge generation and translation. As a result, we removed barriers that enabled more than 40 global health research projects – including those funded through the Bill & Melinda Gates Foundation Global Health portfolio and WEMA – to move expedioustly along the path from lab to village. Figure 1 illustrates our model for addressing the five major ESC challenges through knowledge generation, dissemination and translation. ESC issues are identified and addressed through Advisory Service Consultations or through the Case Studies, and the knowledge that is created is disseminated through the Working Papers and subsequently adopted by the global health community.

Figure1: The ESC Program    

  1. ESC Advisory Service: We have engaged in 43 ESC consultations to date, helping research teams overcome ESC barriers and meet their milestones, in projects aimed at developing new approaches to tackle HIV/AIDS, malnutrition, polio, malaria, tuberculosis, pneumonia and other diseases. In some cases issues were successfully addressed that had threatened to shut down projects.  Altogether, the pillar has undertaken 28 GCGH and 15 non-GCGH consultations – a 5-fold increase of the latter in less than one year. These consulations have addressed diverse ESC issues including those relating to research subject privacy, data sharing, risk and efficiency in clinical trials, and pediatric research.  
  2. Case Studies in Community Engagement: We have undertaken 10 global case studies to identify best practices for effective community engagement in various contexts of global health research. For example, our early work in this area was instrumental in providing guidance to Dr. Anthony James on how to effectively engage the host community around site selection for planned caged field trials of genetically modified mosquitoes. To our knowledge, Dr. James is the first insect vector scientist in the world to have adopted a principle-based framework to guide the introduction and testing of genetically-modified technology into the host community. This approach stands as an important precedent expected to have a profound impact in the field.  
  3. Working Papers: Our program has a remarkable and growing record of dissemination of high-impact knowledge, with the cumulative production of 73 working papers addressing issues across the five major ESC challenge areas, as well as other salient topics in global health. Our in-house, expert Writing Consultant, Dr. Jocalyn Clark, provides strategic advice on effective writing, publication and dissemination planning and good publication practice geared at training members of the McLaughlin-Rotman Centre for Global Health team to produce the highest-quality publications possible

"I have been leading a consultation within the Advisory Service team on stem cell research oversight and developing research ethics capacity at Peking University, Beijing, under the guidance of Dr. Jim Lavery since late 2005. The focus of our engagement has been on making sure that the Deng team (Grand Challenge #4, Development of Novel Mouse Models for HIV and HCV infection) receives assistance in achieving the regulatory milestones in their project, given the concerns about lack of effective regulation in stem cell research (especially in Asia).  The central role of the Advisory Service in the project has been to support the progress of the science while ensuring that proper ethics and regulatory checks are built into their daily work. Regular guidance and oversight has been provided through the establishment of an international Regulatory and Ethics Board (REB), a regulatory specialist post, and a Stem Cell Research Oversight committee that oversees research at the university (including the Deng lab). I have worked in close collaboration with the project staff, funders, university administration and REB members through a process of building trust, and regular site meetings and follow-ups. This experience and unique approach to stem cell regulation in China has been documented through a publication in the Brown Journal of World Affairs in 2008." -Anant Bhan, MD Bioethicist                   

WEMA ESC2 Program  

  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?  

ESC Program  

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

  1. Advisory Service Model: Applying our proven ESC advisory service model and taking it to scale, we will continue to provide rapid and effective ethics consultation services to the full Bill & Melinda Gates Foundation Global Health portfolio of projects.
  2. Community Engagement Model: We will disseminate ‘best practices’ for effective community engagement suitable for application in a broad range of global health research contexts.
  3. Working Papers: We aim to publish papers currently under preparation with the goal of continuing to disseminate and translate knowledge into practice.  

WEMA ESC2 Program  

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 Medicine 2009; 6(6): e1000071.doi:10.1371 (June 9, 2009).

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): 312-318.

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: 1340-1341.

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: 194-197 doi:10.1136/jme.2009.032672.