Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include the (...) nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

Global health research partnerships are increasingly taking the form of consortia of institutions from high-income countries and low- and middle-income countries that undertake programs of research. These partnerships differ from collaborations that carry out single projects in the multiplicity of their goals, scope of their activities, and nature of their management. Although such consortia typically aim to reduce health disparities between and within countries, what is required for them to do so has not been clearly defined. This article takes a (...) conceptual approach to explore how the governance of transnational global health research consortia should be structured to advance health equity. To do so, it applies an account called shared health governance to derive procedural and substantive guidance. A checklist based on this guidance is proposed to assist research consortia determine where their governance practices strongly promote equity and where they may fall short. (shrink)

The increase in the volume of research conducted in Low and Middle Income Countries (LMIC), has brought a renewed international focus on processes for ethical conduct of research. Several programs have been initiated to strengthen the capacity for research ethics in LMIC. However, most such programs focus on individual training or development of ethics review committees. The objective of this paper is to present an approach to institutional capacity assessment in research ethics and application of this approach in the form (...) of a case study from an institution in Africa. (shrink)

International research is an essential means of reducing health disparities between and within countries and should do so as a matter of global justice. Research funders from high-income countries have an obligation of justice to support health research in low and middle-income countries that furthers such objectives. This paper investigates how their current funding schemes are designed to incentivise health systems research in LMICs that promotes health equity. Semi-structured in-depth interviews were performed with 16 grants officers working for 11 funders (...) and organisations that support health systems research: the Alliance for Health Policy and Systems Research, Comic Relief, Doris Duke Foundation, European Commission, International Development Research Centre, Norwegian Agency for Development Cooperation, Research Council of Norway, Rockefeller Foundation, UK Department of International Development, UK Medical Research Council, and Wellcome Trust. Thematic analysis of the data demonstrates their funding schemes promote health systems research with five key features that advance health equity: being conducted with worst-off populations, focusing on research topics that advance equitable health systems, having LMIC ownership of the research agenda, strengthening LMIC research capacity, and having an impact on health disparities. The different types of incentives that encouraged proposed projects to have these features are identified and classified by their strength. It is suggested that research funders ought to create and maintain funding schemes with strong incentives for the features identified above in order to more effectively help reduce global health disparities. (shrink)

203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers.

Scholarship focusing on how international research can contribute to justice in global health has primarily explored requirements for the conduct of clinical trials. Yet health systems research in low- and middle-income countries has increasingly been identified as vital to the reduction of health disparities between and within countries. This paper expands an existing ethical framework based on the health capability paradigm – research for health justice – to externally-funded health systems research in LMICs. It argues that a specific form of (...) health systems research in LMICs is required if the enterprise is to advance global health equity. “Research for health justice” requirements for priority setting, research capacity strengthening, and post-study benefits in health systems research are derived in light of the field's distinctive characteristics. Specific obligations are established for external research actors, including governments, funders, sponsors, and investigators. How these framework requirements differ from those for international clinical research is discussed. (shrink)

Thus far, little work in bioethics has specifically focused on global health research priority-setting. Yet features of global health research priority-setting raise ethical considerations and concerns related to health justice. For example, such processes are often exclusively disease-driven, meaning they rely heavily on burden of disease considerations. They, therefore, tend to undervalue non-biomedical research topics, which have been identified as essential to helping reduce health disparities. In recognition of these ethical concerns and the limited scholarship and dialogue addressing them, we (...) convened an international workshop in September 2015. The workshop aimed to initiate discussion on the appropriate relationship between global and national levels of health research priority-setting and to begin exploring what might be ethically required for priority-setting at each of those levels. This paper comprises our reflections following the workshop. Its main objective is to launch a research agenda for the ethics of global health research priority-setting. We identify three domains of global health research priority-setting—scope, underlying values and substantive requirements, and procedural considerations. For each domain, specific research questions are highlighted and why they need to be explored is explained. Some preliminary thoughts and normative arguments as to how the research questions might be answered are also offered. For example, we provide initial ideas about the appropriate relationship between different priority-setting levels and what values and substantive considerations should guide or underpin global health research priority-setting as a matter of justice. We anticipate that framing a new research agenda for the ethics of global health research priority-setting will spur ethicists, researchers, and policymakers to refocus their efforts on developing more rigorous and ethically sound approaches to priority-setting. (shrink)

The paper by Lynch et al. raises interesting ethical questions regarding whether and how much SARS-CoV-2 Human Challenge Studies participants should be paid. We appreciate the timely e...

There has been growing consensus to develop relevant guidance to improve the ethical review of global health policy and systems research and address the current absence of formal ethics guidance.

With developed country governments and high resource institutions engaging in research in low- and middle-income countries, we argue that these entities have a moral obligation to help build and strengthen research infrastructure and capacity so local scientists and institutions can adequately conduct studies to understand and resolve the health burdens in low and middle income countries. We explore the moral justifications and motivations behind engaging in research capacity strengthening in the health sector in LMIC at multiple levels. In highlighting these (...) issues, this paper aims to initiate a global discourse around why capacity development in LMIC has a moral basis at the individual, institutional and system levels. (shrink)

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees.Our data (...) show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

We describe and evaluate FABTP and the efforts of its trainees. Our data show that since 2001, the 28 former FABTP trainees have auth.

The ethical concept of responsiveness has largely been interpreted in the context of international clinical research. In light of the increasing conduct of externally funded health systems research in low- and middle-income countries, this article examines how responsiveness might be understood for such research and how it can be applied. It contends that four features set HSR in LMICs apart from international clinical research: a focus on systems; being context-driven; being policy-driven; and being closely linked to development objectives. These features (...) support reinterpreting responsiveness for HSR in LMICs as responsiveness to systems needs, where health system performance assessments can be relied upon to identify systems needs, and/or responsiveness to systems priorities, which entails aligning research with HSR priorities set through country-owned processes involving national and sub-national policymakers from host countries. Both concepts may be difficult to achieve in practice. Country ownership is not an established fact for many countries and alignment to their priorities may be meaningless without it. It is argued that more work is, therefore, needed to identify strategies for how the responsiveness requirement can be ethically fulfilled for HSR in LMICs under non-ideal conditions such as where host countries have not set HSR priorities via country-owned processes. Embeddedness is proposed as one approach that could be the focus of further development. (shrink)

Currently, health systems research is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees, as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is a need for (...) additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted, no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step towards a larger dialogue on the topic. (shrink)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss include the (...) nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research to improve emergency (...) care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (shrink)

ABSTRACT There are disagreements among ethicists on what comprises an “appropriate” good to offer research participants. Debates often focus on the type, quantity, timing, and ethical appropriateness of such offers, particularly in settings where participants may be socio-economically vulnerable, such as in parts of Zambia. This was a Cross-sectional online survey of researchers and Research Ethics Committees designed to understand practices, attitudes and policies associated with provision of goods to research participants. Of 122 responding researchers, 69 met eligibility criteria. Responses (...) were also received from five of the six Zambian RECs involved in reviewing research proposals. Forty-nine researchers confirmed previous experience offering goods to participants. Of these, 21 offered participants money only, 18 offered non-monetary goods, while the rest offered both monetary and non-monetary goods. Generally, goods were offered and approved by RECs to compensate for time, lost wages and transportation. One REC and 34.8% of researchers reported being subject to an institutional policy on offering goods to participants. While reimbursement is the main reason for offering goods to participants in Zambia, caution is required when deciding on the type and quantity of goods to offer given the potential for community mistrust and manipulation. (shrink)

There are disagreements among ethicists on what comprises an “appropriate” good to offer research participants. Debates often focus on the type, quantity, timing, and ethical appropriateness of such offers, particularly in settings where participants may be socio-economically vulnerable, such as in parts of Zambia. This was a Cross-sectional online survey of researchers and Research Ethics Committees designed to understand practices, attitudes and policies associated with provision of goods to research participants. Of 122 responding researchers, 69 met eligibility criteria. Responses were (...) also received from five of the six Zambian RECs involved in reviewing research proposals. Forty-nine researchers confirmed previous experience offering goods to participants. Of these, 21 offered participants money only, 18 offered non-monetary goods, while the rest offered both monetary and non-monetary goods. Generally, goods were offered and approved by RECs to compensate for time, lost wages and transportation. One REC and 34.8% of researchers reported being subject to an institutional policy on offering goods to participants. While reimbursement is the main reason for offering goods to participants in Zambia, caution is required when deciding on the type and quantity of goods to offer given the potential for community mistrust and manipulation. (shrink)

Post-abortion care research is increasingly being conducted in low- and middle-income countries to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitative approach, the study identified several ethics challenges encountered by PAC researchers in Zambia, including those associated with seeking ethics and regulatory approvals at institutional and national levels. Persistent stigma around abortion and (...) community perceptions that PAC studies encourage adolescents to seek abortion affected adolescents’ right to exercise their autonomy and to make decisions as well as exposed adolescents to social stigmatization risks. Challenges with recruitment was reported to result in abandoning of studies, thereby undermining development of PAC services that are more responsive to adolescent needs. Training needs identified included knowledge of best practices for conducting and disseminating PAC research. Strategies for addressing the ethical challenges included trust building and using less value-laden terminology when seeking permission and consent. It is essential to the future of PAC research in Zambia and globally that these important challenges be addressed through the development of comprehensive ethics guidance. (shrink)

ABSTRACT The amount of biomedical research being conducted around the world has greatly expanded over the past 15 years, with particularly large growth occurring in low- and middle-income countries. This increased focus on understanding and responding to disease burdens around the world has brought forth a desire to help LMIC institutions enhance their own capacity to conduct scientifically and ethically sound research. In support of these goals the Johns Hopkins-Fogarty African Bioethics Training Program has, for the past six years, partnered (...) with three research institutions in Africa to support research ethics capacity. Each partnership began with a baseline evaluation of institutional research ethics environments in order to properly tailor capacity strengthening activities and help direct limited institutional resources. Through the course of these partnerships we have learned several lessons regarding the evaluation process and the framework used to complete the assessments. We believe that these lessons are generalizable and will be useful for groups conducting such assessments in the future. (shrink)

In many settings, and perhaps especially in low-middle income countries, training institutions do not adequately prepare their students for the ethical challenges that confront them in professional life. We conducted a survey to assess the training needs in research ethics among the faculty at the University of Zambia, School of Medicine using a structured questionnaire distributed to faculty members in January 2015. The study was approved by the University of Zambia Biomedical Research Ethics Committee. Seventy-five faculty members of various ranks (...) completed the questionnaire. It was found that 31% of the faculty had not received any research ethics training. Of those who had received training, most of them had received it through short workshops of five days or less, while only 27.7% received ethics training as a component of an academic degree and 22.2% obtained it through electronic web-based courses. While most faculty reported being well-prepared to guide their students in developing a research methods section of a research protocol, only 25.3% felt they were well-prepared to guide on ethical considerations. This study has demonstrated gaps in research ethics training among faculty members at UNZASoM. Mandatory instruction in research ethics among faculty and students is recommended. (shrink)

Health systems research is widely identified as an indispensable means to achieve the goal of health equity between and within countries. Numerous health systems research consortia comprised of institutions from high-income countries and low and middle-income countries are currently undertaking programs of research in LMICs. These partnerships differ from collaborations that carry out single projects in the multiplicity of their goals, scope of their activities, and nature of their management. Recent conceptual work has explored what features might be necessary for (...) health systems research consortia and their research programs to promote health equity. Identified features include selecting research priorities that focus on improving access to high-quality health services and/or financial protection for disadvantaged populations in LMICs and conducting research capacity strengthening that promotes the independent conduct of health systems research in LMICs. Yet, there has been no attempt to investigate whether existing consortia have such characteristics. This paper describes the results of a survey undertaken with health systems research consortia leaders worldwide to assess how consistent current practice is with the proposed ethical guidance. The findings suggest that consortia may be fairly well organised to promote health equity, but have scope for improvement, particularly in terms of achieving inclusive priority-setting. (shrink)

ABSTRACT Post-abortion care research is increasingly being conducted in low- and middle-income countries to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitative approach, the study identified several ethics challenges encountered by PAC researchers in Zambia, including those associated with seeking ethics and regulatory approvals at institutional and national levels. Persistent stigma around abortion (...) and community perceptions that PAC studies encourage adolescents to seek abortion affected adolescents’ right to exercise their autonomy and to make decisions as well as exposed adolescents to social stigmatization risks. Challenges with recruitment was reported to result in abandoning of studies, thereby undermining development of PAC services that are more responsive to adolescent needs. Training needs identified included knowledge of best practices for conducting and disseminating PAC research. Strategies for addressing the ethical challenges included trust building and using less value-laden terminology when seeking permission and consent. It is essential to the future of PAC research in Zambia and globally that these important challenges be addressed through the development of comprehensive ethics guidance. (shrink)

Inequities in health and health care are one of the greatest challenges facing the international community today. This problem raises serious questions for health care planners, politicians and ethicists alike. The major world religions can play an important role in this discussion. Therefore, interreligious dialogue on this topic between ethicists and health care professionals is of increasing relevance and urgency. This article gives an overview on the positions of Islam and Christianity on equity and the distribution of resources in health (...) care. It has been written in close collaboration and constant dialogue between the two authors coming from the two religions. Although there is no specific concept for the modern term equity in either of the two religions, several areas of agreement have been identified: All human beings share the same values and status, which constitutes the basis for an equitable distribution of rights and benefits. Special provisions need to be made for the most needy and disadvantaged. The obligation to provide equitable health services extends beyond national and religious boundaries. Several areas require intensified research and further dialogue: the relationship between the individual and the community interms of rights and responsibilities, how to operationalize the moral duty to decrease global inequalities in health, and the understanding and interpretation of human rights in regard to social services. (shrink)

Global health research partnerships are increasingly taking the form of consortia. Recent scholarship has proposed what features of governance may be necessary for these consortia to advance justice in global health. That guidance purports three elements of global health research consortia are essential — their research priorities, research capacity development strategies, research translation strategies — and should be structured to promote the health of the worst-off globally. This paper adopted a reflective equilibrium approach, testing the proposed ethical guidance against the (...) experience of a global health research consortium with equity objectives. Case study research was performed with Future Health Systems, a health systems research consortium funded over two phases. Data on FHS Phase-2 were gathered through in-depth interviews with steering committee members and junior researchers and collection of consortium-related documents. Thematic analysis of the data for consistency with the proposed guidance generated recommendations for how the guidance might be better articulated and identified areas where it could usefully be expanded. Factors facilitating FHS alignment with the ethical guidance were also identified, including early engagement and partnership with low and middle-income country stakeholders, the learning developed during FHS Phase-1, and aspects of the grant program funding it. (shrink)

ABSTRACTHate crimes in the United States have drastically increased since 2015, particularly for the American Muslim population. There was a 17% hike in hate crimes against American Muslims in 2017...

The amount of biomedical research being conducted around the world has greatly expanded over the past 15 years, with particularly large growth occurring in low- and middle-income countries. This increased focus on understanding and responding to disease burdens around the world has brought forth a desire to help LMIC institutions enhance their own capacity to conduct scientifically and ethically sound research. In support of these goals the Johns Hopkins-Fogarty African Bioethics Training Program has, for the past six years, partnered with (...) three research institutions in Africa to support research ethics capacity. Each partnership began with a baseline evaluation of institutional research ethics environments in order to properly tailor capacity strengthening activities and help direct limited institutional resources. Through the course of these partnerships we have learned several lessons regarding the evaluation process and the framework used to complete the assessments. We believe that these lessons are generalizable and will be useful for groups conducting such assessments in the future. (shrink)