The Ethics of End-of-Trial Obligations in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania.

This study explores stakeholder experiences and perspectives on end-of-trial obligations at the close of a phase II/III Pediatric Malaria Vaccine Trial (PMVT) [GSK/PATH-MVI RTS, S) (NCT00866619]. We conducted 52 key informant interviews with major stakeholders of an international multicentre PMVT in Ghana and Tanzania. The responses fell into four main themes: (a) Communicating End-of-Trial, (b) Maintaining Health Care Services, (c) Dissemination of Results, and (d) Post-Trial Access. Interviewee responses shared important practical experiences and insights that complement current thinking in the literature on research ethics guidance: (a) accompany end-of-trial communication with information on personal and family health care responsibilities, (b) establish public health indicators to measure the impact of research on a health care system,

Good collaborative practice: reforming capacity building governance of international health research partnerships.

In line with the policy objectives of the United Nations Sustainable Development Goals, this commentary seeks to examine the extent to which provisions of international health research guidance promote capacity building and equitable partnerships in global health research. Our evaluation finds that governance of collaborative research partnerships, and in particular capacity building, in resource-constrained settings is limited but has improved with the implementation guidance of the International Ethical Guidelines for Health-related Research Involving Humans by The Council for International Organizations of Medical Sciences (CIOMS) (2016). However, more clarity is needed in national legislation, industry and ethics guidelines, and regulatory provisions to address the structural inequities and power imbalances inherent in international health research partnerships. Most notably, ethical partnership governance is not supported by the principal industry ethics guidelines - the International Conference on Harmonization Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) Good Clinical Practice (ICH-GCP). Given the strategic value of ICH-GCP guidelines in defining the role and responsibility of global health research partners, we conclude that such governance should stipulate the minimal requirements for creating an equitable environment of inclusion, mutual learning, transparency and accountability. Procedurally, this can be supported by i) shared research agenda setting with local leadership, ii) capacity assessments, and iii) construction of a memorandum of understanding (MoU). Moreover, the requirement of capacity building needs to be coordinated amongst partners to support good collaborative practice and deliver on the public health goals of the research enterprise; improving local conditions of health and reducing global health inequality. In this respect, and in order to develop consistency between sources of research governance, ICH-GCP should reference CIOMS ethical guidelines as the established standard for collaborative partnership. Moreover, greater commitment and support should be given to co-ordinate, strengthen and enforce local laws requiring equitable research partnerships and health system strengthening.

The Ethics of Health Care Delivery in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania.

This study explores ethical issues raised in providing medical care to participants and communities of low-resource settings involved in a Phase II/III pediatric malaria vaccine trial (PMVT). We conducted 52 key informant interviews with major stakeholders of an international multi-center PMVT (GSK/PATH-MVI RTS,S) (NCT00866619) in Ghana and Tanzania. Based on their stakeholder experiences, the responses fell into three main themes: (a) undue inducement, (b) community disparities, and (c) broad therapeutic misconceptions. The study identified the critical ethical aspects, from the perspectives of stakeholders, of delivering health care during a PMVT. The study showed that integrating research into health care services needs to be addressed in a manner that upholds the favorable risk-benefit ratio of research and attends to the health needs of local populations. The implementation of research should aim to improve local standards of care through building a collaborative agenda with local institutions and systems of health.

Defining Health Research for Development: The perspective of stakeholders from an international health research partnership in Ghana and Tanzania.

OBJECTIVES: The study uses a qualitative empirical method to define Health Research for Development. This project explores the perspectives of stakeholders in an international health research partnership operating in Ghana and Tanzania. METHODS: We conducted 52 key informant interviews with major stakeholders in an international multicenter partnership between GlaxoSmithKline (GSK, Vaccine Developer) and the global health nonprofit organisation PATH and its Malaria Vaccine Initiative program (PATH/MVI, Funder-Development Partner), (RTS, S) (NCT00866619). The respondents included teams from four clinical research centres (two centres in Ghana and two in Tanzania) and various collaborating partners. This paper analyses responses to the question: What is Health Research for Development? RESULTS: Based on the stakeholders' experience the respondents offered many ways of defining Health Research for Development. The responses fell into four broad themes: i) Equitable Partnerships; ii) System Sustainability; iii) Addressing Local Health Targets, and iv) Regional Commitment to Benefit Sharing. CONCLUSION: Through defining Health Research for Development six key learning points were generated from the four result themes: 1) Ensure there is local research leadership working with the collaborative partnership, and local healthcare system, to align the project agenda and activities with local research and health priorities; 2) Know the country-specific context - map the social, health, legislative and political setting; 3) Define an explicit development component and plan of action in a research project; 4) Address the barriers and opportunities to sustain system capacity. 5) Support decentralised health system decision-making to facilitate the translation pathway; 6) Govern, monitor and evaluate the development components of health research partnerships. Overall, equity and unity between partners are required to deliver health research for development.

"You cannot collect data using your own resources and put It on open access": Perspectives from Africa about public health data-sharing.

Data-sharing is a desired default in the field of public health and a source of much ethical deliberation. Sharing data potentially contributes the largest, most efficient source of scientific data, but is fraught with contextual challenges which make stakeholders, particularly those in under-resourced contexts hesitant or slow to share. Relatively little empirical research has engaged stakeholders in discussing the issue. This study sought to explore relevant experiences, contextual, and subjective explanations around the topic to provide a rich and detailed presentation of what it means to different stakeholders and contexts to share data and how that can guide practice and ethical guidance. A qualitative design involving interviews was undertaken with professionals working in public health institutions endowed with data (HDSS), ethics committees, and advisory agencies which help shape health research in Africa. A descriptive form of thematic analysis was used to summarize results into six key themes: (1) The role of HDSSs in research using public health data and data-sharing; (2) Ownership and funding are critical factors influencing data-sharing; (3) Other factors discourage data-sharing; (4) Promoting and sustaining data-sharing; (5) Ethical guidance structures; and (6) Establishing effective guidance. The themes reveal factors regarding the willingness or not to share and an intricate ethical system that current discourse could reflect. Many of the concerns resonate with the literature, but a whole other gamut of people and process issues; commitments, investments, careers, and the right ethical guidance are needed to realize a sustainable goal of reaching 'share' as a default.