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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 (UNZASoM) 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 (57.4%, n = 31), 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 (70.7%) 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. [ABSTRACT FROM AUTHOR]

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 (LMICs). 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 (FABTP) has, for the past six years, partnered with three research institutions in Africa (University of Botswana, Makerere University in Uganda, and the University of Zambia) 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 (the Octagon Model). We believe that these lessons are generalizable and will be useful for groups conducting such assessments in the future. [ABSTRACT FROM AUTHOR]

Post-abortion care (PAC) research is increasingly being conducted in low- and middle-income countries (LMICs) 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. [ABSTRACT FROM AUTHOR]

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 (RECs) 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 (71.0%) confirmed previous experience offering goods to participants. Of these, 21 (42.9%) offered participants money only, 18 (36.7%) 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. [ABSTRACT FROM AUTHOR]

The article discusses the paper by Lynch et al. raises interesting ethical questions regarding whether and how SARS-CoV-2 Human Challenge Studies (HCS) participants. Topics include the timely ethical framework have proposed, have concerned about generalizability to low-middle income countries (LMICs.); and considering payments to research participants in LMICs, suggest consideration of additional factors by researcher.

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 (LMICs) 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 (up to) 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 (strong, moderate, weak). 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. [ABSTRACT FROM AUTHOR]

Recently, there has been a remarkable increase in biomedical research being conducted in low and middle-income countries. This increase has brought attention to the need for high quality research ethics systems within these countries and a greater focus on research ethics training. Though most programs tend to concentrate on training individuals, less attention has focused on institutions as the target of such training. In this paper we demonstrate a rapid approach to evaluating institutional research capacity. The method adapts the Octagon Model, which evaluates institutional research ethics using eight domains. The framework was applied to the University of Zambia in order to conduct a baseline assessment of university research ethics capacity. Internal and external assessments were conducted. The domains of working environment and proper skills scored highest, while relevance, target groups and identity scored lower. Consistent with previous work, a systems approach to evaluating institutional research development capacity can provide a rapid assessment of an institutional bioethics program. This case study reveals the strengths and weaknesses of the university's research ethics program and provides a framework for future capacity growth. [ABSTRACT FROM AUTHOR]

The article discusses a study related to benchmarking operational and organizational structures and functions of Research Ethics Committees (RECs) in Nigeria. It mentions guidelines to help foster protection of the rights of research participants through application of the informed-consent process in research studies. It also mentions identification of RECs in teaching hospitals, medical centers and other private hospitals.

The article discusses the ethical aspects of research capacity strengthening (RCS) which deals with the process by which societies, individuals, and organizations develop the ability to define objectives and priorities, solve national problems, and perform research functions effectively, and it mentions changes involving health research in low- and middle-income countries as of 2017. Personal motivations and fairness are examined, along with social justice motivations.

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 (LMICs) 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. [ABSTRACT FROM AUTHOR]

Currently, health systems research (HSR) 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 (RECs), 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 (of the responses (n=29), 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 (to better understand the current status) towards a larger dialogue on the topic. [ABSTRACT FROM AUTHOR]

Background:Health systems research (HSR) seeks to generate knowledge to improve the mechanisms for delivering quality health services and improving population health outcomes. HSR covers a wide range of research questions, including health financing, service delivery, human resources for health, and quality improvement. Because HSR has its own definitions, methods, and analytic approaches, there is an increasing realization that these studies may raise ethical concerns that differ from other types of research. Despite the increasing interest and investment in HSR over the past several years, there is little empirical research examining the kinds of ethical challenges that arise in the design and implementation of these studies. A deeper understanding of the kinds of ethical issues encountered in various types of HSR could help researchers prepare for these challenges and better inform ethical review processes.Methods:Using semistructured qualitative interviews with 16 researchers involved in the Future Health Systems Consortium and Johns Hopkins–Fogarty African Bioethics Consortium, we conducted an exploratory study to identify some common or poignant ethical challenges in HSR.Results:Thematic analysis of interview transcripts using an inductive approach revealed ethics issues in HSR surrounding the following topics: privacy and confidentiality, associated harms, appropriate consent, institutional review board (IRB) review, appropriate controls, research ownership and control, responsiveness, posttrial issues, sustainability, and collaboration and competition.Conclusions:Though not exhaustive, this preliminary account highlights the nuanced and unique ethical challenges that can arise in HSR and underscores the need for different kinds of ethical guidance and oversight for HSR studies. [ABSTRACT FROM AUTHOR]

The article discusses why researchers should also focus on other forms of health research like operations research, implementation research, or health systems research in addition to clinical trials for health system development. It asserts that the maximum contribution that clinical research is equipped to make to health system development is likely narrowly focused.

Background:The increasing globalization of research drives a need for greater research ethics capacity in low resource countries. Several programs have attempted to expand research ethics capacity by training individuals, but few have focused on broader research ethics systems and institutions. This study describes and applies an institutional research ethics model to assess the institutional research ethics capacity of Makerere University College of Heath Sciences (MakCHS) in 2011.Methods:Internal and external stakeholders conducted the assessment of MakCHS using the multidimensional Octagon framework. Five methods were used to collect data on current ethical processes and institutional relationships.Results:MakCHS scored in the mid range on all Octagon domains, with some variation between external and internal assessments. The external Octagon scores suggest that MakCHS's areas of strengths are in identity, structure, relevance, target groups, and working environment; needs are greater in the areas of production, competence, and systems of finance and administration. Discrepancies in external and internal assessment can serve as a useful platform to shape ongoing discussions and strategic efforts.Conclusions:The assessment identified strengths, opportunities, and challenges for institutional research ethics capacity at MakCHS. We believe this systematic approach was helpful in evaluating research ethics needs and provides a benchmark for institutions to measure progress over time. [ABSTRACT FROM PUBLISHER]

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 (LMICs) 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. [ABSTRACT FROM AUTHOR]

The increasing conduct of health systems research (HSR) in low- and middle-income countries (LMICs) has not been matched by concurrent work to clarify the field's ethical dimensions. To begin to address this gap, a two-day workshop on the ethics of HSR in LMICs was convened at Johns Hopkins University in June 2013. Participants included health systems researchers, philosophers, lawyers, bioethicists and institutional review board members from Botswana, Uganda, the UK, USA and Zambia. Based on discussions from the workshop, the paper affirms that, while HSR in LMICs raises ethical issues in relation to constructs (i.e. consent, risk, equipoise) common to international clinical research, the nature of the issues that arise often differ between the two fields. Three salient features of HSR and the ethical considerations associated with each of them in LMICs are described to demonstrate this point. Recommendations for institutional review boards’ oversight of HSR in LMICs are presented. Finally, a call is made for further action to develop thinking and guidance around the ethics of HSR in resource-poor settings. [ABSTRACT FROM PUBLISHER]

Background: 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. Methods: We adapted the Octagon model originally used by the Swedish International Development Cooperation Agency to assess an organization along eight domains in research ethics: basic values and identity; structure and organization; ability to carry out activities; relevance of activities to stated goals; capacity of staff and management; administrative, financing and accounting systems; its relations with target groups; and the national context. We used a mixed methods approach to collect empirical data at the University of Botswana from March to December 2010. Results: The overall shape of the external evaluation Octagon suggests that strengths of the University of Botswana are in the areas of structure, relevance, production and identity; while the university still needs more work in the areas of systems of finance, target groups, and environment. The Octagons also show the similarities and discrepancies between the 'external' and 'internal' evaluations and provide an opportunity for exploration of these different assessments. For example, the discrepant score for 'identity' between internal and external evaluations allows for an exploration of what constitutes a strong identity for research ethics at the University of Botswana and how it can be strengthened. Conclusions: There is a general lack of frameworks for evaluating research ethics capacity in LMICs. We presented an approach that stresses evaluation from both internal and external perspectives. This case study highlights the university's rapid progress in developing research ethics capacity and points to some notable areas for improvement. We believe that such an empirically-driven and participatory assessment allows a more holistic measurement and promotion of institutional capacity strengthening for research ethics in LMICs. [ABSTRACT FROM AUTHOR]

ABSTRACT 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. [ABSTRACT FROM AUTHOR]

The article discusses the relationship between economic development and research ethics. The authors explain that there have been few attempts to describe how a country's stage of development relates to ethics challenges involving protection of research participants and promotion of ethical conduct in research. They suggest a framework which places research ethics against a broad background of development and describes broader societal and organisational features contributing to the protection of research participants and the promotion of ethical conduct in research. They discuss the basic freedoms they believe form a necessary foundation for a research ethics system: political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security.

The article focuses on the structure and role of research ethics committees in Africa. In accordance to international regulations and nations' laws, research involving humans should go through reviews from independent ethics committee, which are known as institutional review board in the U.S. and research ethics committees elsewhere. The committees are responsible in reducing the conflicts of interest and preserving the welfare of research participants.

Introduction: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. Methods: A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. Results: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. Discussion: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research. [ABSTRACT FROM AUTHOR]

Mobile phone coverage has grown, particularly within low- and middle-income countries (LMICs), presenting an opportunity to augment routine health surveillance programs. Several LMICs and global health partners are seeking opportunities to launch basic mobile phone-based surveys of noncommunicable diseases (NCDs). The increasing use of such technology in LMICs brings forth a cluster of ethical challenges; however, much of the existing literature regarding the ethics of mobile or digital health focuses on the use of technologies in high-income countries and does not consider directly the specific ethical issues associated with the conduct of mobile phone surveys (MPS) for NCD risk factor surveillance in LMICs. In this paper, we explore conceptually several of the central ethics issues in this domain, which mainly track the three phases of the MPS process: predata collection, during data collection, and postdata collection. These include identifying the nature of the activity; stakeholder engagement; appropriate design; anticipating and managing potential harms and benefits; consent; reaching intended respondents; data ownership, access and use; and ensuring LMIC sustainability. We call for future work to develop an ethics framework and guidance for the use of mobile phones for disease surveillance globally. [ABSTRACT FROM AUTHOR]