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The World Conferences on Research Integrity have produced significant collaborative conference statements including the Singapore Statement on Research Integrity and more recently the Hong Principles on Researcher Assessment. The 7th World Conference on Research Integrity (7WCRI) takes place in Cape Town from the 29th May 2022 to 1st June 2022. The theme of the conference is Fostering Research in an unequal world. We have proposed the Cape Town statement on Fostering Research Integrity through the promotion of fairness, equity and diversity in research collaborations and contexts as the major collaborative output for this conference. This paper serves to introduce the reader and conference attendees to the motivation and thinking behind this proposal which will be discussed further at the conference.The proposed Cape Town Statement needs to accomplish two aims. First it must clearly demonstrate why inequity and unfair practices in research collaborations and contexts is a research integrity (RI) matter. Second it must identify some key values or principles and action guides that will address the issue of equity and fairness in research within the context of the complete research life cycle from research agenda setting and call to proposal development, through grant application, allocation and management of funding, data production, analysis, management and sharing, to outputs, translation, and evaluation.This background paper serves to outline the rationale and justification for the proposed Cape Town Statement as a major collaborative output of the 7WCRI. It is not in itself the proposed statement but rather represents a summary of some of the thought processes and contributions thus far. We argue that the domain of RI and previous WCRI RI statements have focused the RI project primarily at a micro and meso or project level, with researchers and institutions being the main target for guidance. The Cape Town Statement project aims to widen the lens, bring in a macro perspective and ensure that other role players, including those that support global research structures and systems, are brought into focus, and encouraged to take accountability for their own spheres of influence.

Letter by IJsselmuiden on 'From the Editor' article by Farham (Farham B. Fix the system. S Afr Med J 2022;112(5):299. https://doi.org/10.7196/SAMJ.2022.v112i5.16571); and response by Farham.

Steering health systems towards universal health coverage requires research on themes that are of particular interest to health planning, management, policy and systems researchers. Some issues, such as strikes regarded as illegal and health sector corruption, because of their social and political sensitivity have, for too long, remained outside adequate research inquiry. Their emergence in the research agenda raises some challenges for Human Research Ethics Committees, particularly related to their conflicts of interests as reviewers, that need clarification.

The COVID-19 pandemic is considerably the biggest global health challenge of this modern era. Spreading across all regions of the world, this corona virus disease has disrupted even some of the most advanced economies and healthcare systems. With an increasing global death toll and no near end in sight, questions on the efficacy of global response mechanisms, including the role and relevancy of global health institutions, have emerged. Using a reflexive content analytic approach, this study sheds light on some of these questions, underscoring the disconnect between science, policymaking, and society. Global health funding approaches; politicization of the pandemic, including political blame gaming; mistrust of government and other institutions; and a lack of robust accountability measures are some of the pandemic response obstacles. However, COVID-19 has also presented an opportunity for a collaboration that may potentially solidify global solidarity. A pandemic response built on strategic global health diplomacy, vaccine diplomacy, and science diplomacy can spur both political and economic benefits, advancing development, health security, and justice. The virus thrives and flourishes in face of political divisions and lack of cooperation. While the current global crisis has exacerbated the existing social injustices in societies, national unity and global solidarity is essential to winning the fight against the COVID-19 pandemic.

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). The urgent need for continued capacity development in Africa has necessitated research initiatives to identify existing capacity. This discussion paper describes the mapping of RECs in Africa through MARC (Mapping African Research Ethics Capacity) project, second phase (2012 to date) and discusses the findings. MARC provides a platform and tool on COHRED's Health Research HRWeb, which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs.

© The Author(s) 2019., The quantity and complexity of scientific and technological information provided to policymakers have been on the rise for decades. Yet little is known about how to provide science advice to legislatures, even though scientific information is widely acknowledged as valuable for decision-making in many policy domains. We asked academics, science advisers, and policymakers from both developed and developing nations to identify, review and refine, and then rank the most pressing research questions on legislative science advice (LSA). Experts generally agree that the state of evidence is poor, especially regarding developing and lower-middle income countries. Many fundamental questions about science advice processes remain unanswered and are of great interest: whether legislative use of scientific evidence improves the implementation and outcome of social programs and policies; under what conditions legislators and staff seek out scientific information or use what is presented to them; and how different communication channels affect informational trust and use. Environment and health are the highest priority policy domains for the field. The context-specific nature of many of the submitted questions—whether to policy issues, institutions, or locations—suggests one of the significant challenges is aggregating generalizable evidence on LSA practices. Understanding these research needs represents a first step in advancing a global agenda for LSA research., This material is based upon work supported by the National Science Foundation under Grant No. 1842117.

2017 marked the 70 anniversary of the Nuremberg Code. The ethics of research with human beings has been shaped by the simplicity of its core logic, i.e., that the voluntary consent of research participants is sacrosanct and, when given, creates profound obligations of care and respect on the part of researchers. But there are other aspects of the global research enterprise that warrant more deliberate ethical scrutiny. One of these is the fairness of research collaborations and partnerships and the many practical challenges that make fair partnerships difficult to achieve. Corruption in governments and institutions, unequal access to research funding among researchers and research institutions, and enormous disparities in institutional capacity to support research partnerships are just some of the factors that present obstacles to fair partnerships between high income country (HIC) and low and middle income country (LMIC) partners, and within LMICs and HICs alike. Serious attention to these structural disparities, and the ways they shape the ethical character of the research enterprise, is long overdue. Achieving fairness in research partnerships is, in essence, a complex policy and management challenge. Against this backdrop, COHRED has developed and pilot-tested the Research Fairness Initiative (RFI) with several leading research institutions around the world. The RFI was designed as a tool for promoting self-reflection on, and public reporting of, institutional practices and policies related to research partnerships to create a continuous improvement process for research collaborations. Here, we report promising preliminary results of the RFI’s impact, including TDR-WHO’s recent publication of its first RFI report . The RFI provides a pragmatic strategy to explicitly address fairness in research partnerships as a fundamental requirement of the ethics of research.

This chapter investigates the strategic benefits of global health collaboration programmes. Regretting the lack of alignment or harmonisation of research priorities and cooperation patterns, authors show how recent positive research development on health issues in Africa can foster more constructive and more balanced research partnerships with European countries and institutions. In this regard, authors urge greater support for the Research Fairness Initiative as a promising emerging global standard for fostering fair and sustainable research partnerships and a more inclusive and better institutionalised framework for Africa–Europe cooperation on health development and innovation.

BackgroundCapacity in health research ethics review is key in Africa, given the increase in research activities, complexity, and use of advanced technologies. Harmonising ethics review frameworks can address challenges attributable to these complexities. Establishing an effective harmonised framework that is optimum or protection of the research subjects requires assessment of review capacity.The East African Health Research Commission commissioned a study to assess the capacity of Review Ethics Committees (RECs) in the East African Community (EAC) countries, as a step towards strengthening and harmonising the regions’ capacity and review frameworks.MethodsA desktop review of documentation (national and institutional guidelines, policies and SOPs) was conducted in five EAC countries. Semi-structured questionnaires were used to collect data from key informants. Qualitative interviews were used to collect views on stakeholders’ perception of benefits, opportunities and challenges of harmonisation.ResultsSixty-nine (69) accredited RECs were mapped. All countries had national ethics guidelines and National Research Regulatory Authorities, whose mandates varied across countries. 57% of RECs reviewed local and international research, 43% reviewed local studies only. On average, 91 protocols were reviewed annually across all RECs (range 15 to 200). Membership ranged from 6 to 22 members per REC, with age range of 29 to 75 years.Annual budget allocation ranged from $3000 to $2.9 mil„lion financed through review fees (84%) or/and institutional budget (14%). 71% of RECs had education policy but 41%had members with training in ethics. Review turn-around time ranged from 14 to 90 days. All RECs supported harmonisation and attributed it to improved efficiency, quality and standardised costs.ConclusionSimilarities and dissimilarities were noted in the EAC countries’ ethics review frameworks. Harmonisation should consider 1) harmonisation of policy frameworks and tools; 2) institutionalisation of regional joint review mechanisms, 3) standardisation of training and capacity strengthening, 4) Review of the REC operational and financing models.

BackgroundThe transition from paper-based to online submission of health research protocols using the RHinnO Ethics (RE) platform has been shown to improve efficiency and quality of ethics reviews. However, despite these documented benefits, there are only a total of 40 installations in 12 out of the 54 countries in Africa. We analysed facilitators and barriers to adoption of RE by Researc Ethics Committees.MethodsWe used a retrospective analysis to identify determinants of adoption or rejection of RE by grouping feedback from users into key emerging themes identified through three stages of RE adoption: 1) contractual 2) trial 3) full implementation.ResultsA total of 3947 protocols have been managed through RE by March 2018. Of those reached, 25 per cent adopted and continue to use RE. Of those that rejected, 14 per cent rejected after the trial. At the contractual stage, the key determinants of adoption were the guarantee of sustainable funding, pre-existing good IT infrastructure, and the assurance of technical assistance from the providers. The key determinants of rejection were concerns of cyber security, limited control and ownership by Researc Ethics Committees and cost of the annual subscription. At the trial stage, the determinants of continued adoption and use were continued IT support from providers and a proven comparative advantage over the paper-based system. The key determinant of rejection was limited support from organisation leadership. Those who have continued through the implementation stage emphasised financial sustainability and continuous improvement of the RE as key determinants.ConclusionAccelerated adoption of RE will require increased adaptability of the platform, decrease in cost of annual subscription, improved confidence in security and ownership of data. Developers, Research Ethics Committees and sponsors of RE need to develop a cost-effective funding strategy to increase efficiency, economies of scale and benefits related to harmonised and standardised digital platforms.

BackgroundRHInnO Ethics is a cloud-based online ethics review system that enables Reseach Ethics Committees (RECs) to receive, review and approve applications online. Over the last five years, RHInnO Ethics has been installed in 40 RECs that operate in 12 African countries.MethodsPharma Ethics (South Africa), Strathmore University (Kenya) and Uganda Virus Research Institute-UVRI (Uganda) started using RHInnO Ethics in 2014, 2015 and 2017 respectively. Although the platform is currently installed in 40 RECs in Africa, only 1 systematic evaluation has been done to objectively assess its impact on the quality and efficiency of ethics review. Here, we present the experiences of using RHInnO Ethics from three RECs situated in East Africa (2 RECs) and South Africa (1 REC).ResultsStrathmore University started using the online ethics review system since the beginning of its operation, while Pharma Ethics and UVRI transitioned from a manual to an electronic system. Benefits associated with the use of the platform include improved efficiency in communication among key players of the ethics review processes, improved quality of review through standardisation and harmonisation of ethics review procedures, easy management of information, increased submissions and improved turnaround time. The progress of review can also be tracked any time by all users. Challenges include change management from the manual to the online system, difficulties in learning new versions of the system and training new reviewers not conversant with the system, interruption of internet access and limited ability to personalise the platform.ConclusionThere is a need to get buy-in from regulatory authorities to enforce the adaption of the system to all RECs in order to make research coordination in Africa easier. RHInnO Ethics has been shown to improve efficiency and quality of reviews. However, the transition to and full adoption of the online system continues to be slow. To accelerate and scale up the adoption of RHInnO Ethics, there is a need for developers, RECs and sponsors of RECs to engage with REC regulatory authorities, and identify responsive models of financing and funding RECs in order to increase efficiency and quality of ethics review in sub-Saharan Africa.

Background The Global Forum 2015 panel session dialogue entitled “From evidence to policy – thinking outside the box” was held on 26 August 2015 in the Philippines to debate why evidence was not fully translated into policy and practice and what could be done to increase its uptake. This paper reports the reasons and possible actions for increasing the uptake of evidence, and highlights the actions partners could take to increase the use of evidence in the African Region. Discussion The Global Forum 2015 debate attributed African Region’s low uptake of evidence to the big gap in incentives and interests between research for health researchers and public health policy-makers; limited appreciation on the side of researchers that public health decisions are based on multiple and complex considerations; perception among users that research evidence is not relevant to local contexts; absence of knowledge translation platforms; sub-optimal collaboration and engagement between industry and research institutions; lack of involvement of civil society organizations; lack of engagement of communities in the research process; failure to engage the media; limited awareness and debate in national and local parliaments on the importance of investing in research and innovation; and dearth of research and innovation parks in the African Region. Conclusion The actions needed in the Region to increase the uptake of evidence in policy and practice include strengthening NHRS governance; bridging the motivation gap between researchers and health policy-makers; restoring trust between researchers and decision-makers; ensuring close and continuous intellectual intercourse among researchers, ministry of health policy-makers and technocrats during the life course of research projects or programmes; proactive collaboration between academia and industry; regular briefings of civil society, media, relevant parliamentary committees and development partners; development of vibrant knowledge translation platforms; development of action plans for implementing research recommendations, preferably in the context of the Sustainable Development Goals; and encouragement of competition on NHRS strengthening and research output and uptake among the countries using a barometer or scorecard to review their performance at various regional ministerial forums and taking into account the lessons learned from the MDG period.

The recent Philippine National Health Research System (PNHRS) Week Celebration highlighted the growing commitment to Disaster Risk Reduction (DRR) in the Philippines. The event was lead by the Philippine Council for Health Research and Development of the Department of Science and Technology and the Department of Health, and saw the participation of national and international experts in DRR, and numerous research consortia from all over the Philippines. With a central focus on the Sendai Framework for Disaster Risk Reduction, the DRR related events recognised the significant disaster risks faced in the Philippines. They also illustrated the Philippine strengths and experience in DRR. Key innovations in science and technology showcased at the conference include the web-base hazard mapping applications ‘Project NOAH’ and ‘FaultFinder’. Other notable innovations include ‘Surveillance in Post Extreme Emergencies and Disasters’ (SPEED) which monitors potential outbreaks through a syndromic reporting system. Three areas noted for further development in DRR science and technology included: integrated national hazard assessment, strengthened collaboration, and improved documentation. Finally, the event saw the proposal to develop the Philippines into a global hub for DRR. The combination of the risk profile of the Philippines, established national structures and experience in DRR, as well as scientific and technological innovation in this field are potential factors that could position the Philippines as a future global leader in DRR. The purpose of this article is to formally document the key messages of the DRR-related events of the PNHRS Week Celebration.

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed. This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development’s (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa.

Research partnerships between high-income countries (HICs) and low- and medium-income countries (LMICs) often display a set of asymmetries that hinder the development of science, technology and health systems in the LMICs. In practice, this means that research partnerships, instead of addressing local priorities, often result in the appropriation of local data, the relegation of southern scientists to the category of ‘field experts’, the publication of research papers in high-impact journals without LMIC partners as coauthors and the tokenisation of LMIC partners and institutions to obtain competitive funding.1 2 There are numerous studies on power imbalances pertaining to research partnerships, often calling for general or specific interventions to improve them, but without apparent actual change in practice.3–5 Over the past 20 years, only two explicit guidelines have been developed to tackle these imbalances. The Canadian Coalition for Global Health Research (CCGHR) developed a set of recommendations, focused on six main principles, to promote ethical partnerships, including the use of innovative methodologies.6 The Commission for Research Partnerships with Developing Countries (KFPE)7 has also advocated the use of 11 principles which deal with a wide range of issues, from agenda setting to dissemination. The work of KFPE is 20 years old, but it is not well known outside Switzerland; moreover, it does not provide a practical framework to assess how these principles are implemented in research projects and actual collaborations. Other agencies involved in the advocacy of ethical research partnerships include the United States Agency for International Development, the Dutch Ministry of Foreign Affairs, the International Development Research Centre (Canada) and the Norwegian Programme for Development, Research and Education (NUFU).8 The Sustainable Development Goal (SDG) 17 is focused on partnerships as means to achieve the other SDGs, recognising that joint research in health and other fields is essential. …

Over the past 25 years, the ethics of international health research have shifted from addressing narrow issues such as cultural differences in informed consent practices towards a greater emphasis on development and social justice. We anticipate that the next 'era' in international research ethics will involve an intensification of this focus on the role of research in achieving global justice. Three values, in particular, will shape how ethics considerations should evolve: solidarity; respect for Southern innovation; and commitment to action. We expect continuing debate on whether researchers and research sponsors should recognise more than a minimal set of obligations for the care and benefit of research participants and their communities. As the debate about the role of research in development intensifies, we expect to see new and more elaborate mechanisms for financing on-going access to beneficial interventions, ancillary care and other research-related benefits, as well as a greater involvement in research funding by developing country governments and private foundations. Ethics review and oversight need to reflect on these new values and on ways of operationalising them, or risk becoming marginalised in the research process.

Background Childhood disability in South Africa has failed to receive adequate attention from governmental agencies, such as the health, education and social welfare departments, despite there being more than 1 million disabled children in the country. This study sought to assess the unmet rehabilitation, education and welfare needs of disabled children living in a peri-urban township. Methods As no register of disabled children existed, snowball sampling was used to recruit a convenience sample of 156 disabled children living in Orange Farm township near Soweto, South Africa. Children’s impairments, their health and educational needs, and the availability and utilization of services were assessed using a structured interview. Results Few disabled children attended pre-school (35%) or school (44%). Only a quarter (26%) of children in need of rehabilitation received such services. Children with motor impairments were more likely to receive rehabilitation than those with intellectual impairment (44% vs. 8%, P

The global environment is in critical decline. Whether one's concern about environmental epidemiology stems from the perspectives of environmental health, climate change, ecological collapse, or growing inequity, clear problems exist. Natural capital resources are being depleted; disregard for the integrity of ecosystems is entrenched in current business practices. Indeed, despite increasing rhetoric to the contrary, the disregard displayed by those who hold power globally toward long-term sustainability and, thus, the health and well-being of future generations, could be described as wanton. Six years ago, the Millennium Development Goals were announced by the United Nations as a rallying point for action to achieve a sustainable future, particularly by reducing the gap between the "have mores" and "have nots." The attainment of these Goals is now endangered, as is, apparently, the spirit of optimism and idealism that inspired them at the Millennium Summit. We call for a reinvigoration of both concern about-and action on-sustainability. In particular, we appeal to those engaged in the field of environmental epidemiology (and other specialties with whom they engage) to consider how they might help by incorporating sustainability issues (including global ecological integrity and global environmental justice) into their own research programs. This incorporation would make a vital contribution to protect both present and future generations and to reduce resource and health gaps between North and South. Simply put, we propose that sustainability becomes integral to advancing the science of environmental epidemiology and related environmental disciplines.

The Commission on Health Research for Development tabled its findings in 1990 following three years of intensive data gathering on global health research [1]. The report documented for the first time the major mismatch between global expenditure on health research and the nature and extent of global mortality: only 5% of the world’s health research budget was spent on conditions responsible for 93% of global mortality. This discrepancy was later restated as the ‘‘10/90 Gap’’ – a more ‘‘communication-friendly’’ term that became the slogan for global disparities in health research funding [2]. The work of the Commission was built on the belief that health research can play a key role in the overall development of resource-poor countries, both through focusing national research efforts on national health priorities rather than on sponsordriven interests, and through the identification and documentation of health inequities and consequent action taken to reduce or eliminate these. Essential National Health Research (ENHR) was promoted as the strategy through which to operationalize ‘‘health research for development’’ (HRfD) [1]. Several modifications have been made to this early conceptualization of HRfD in response to a rapidly changing global environment, and as a consequence of experience gained since 1990. A major expansion in understanding how to optimize the impact of health research in the South was generated in the process leading up to the International Conference on Health Research for Development in Bangkok in 2000. At this landmark meeting, which focused on review of progress with HRfD over a decade, the concept of ‘‘national health research systems’’ [3] was widely discussed and endorsed.

HIV treatment for participants who become infected during HIV vaccine trials has been the focus of ethical controversy. The obligations of sponsors to ensure that participants have access to antiretrovirals have been a particular focus of this debate. This paper presents three arguments that have been made in this regard, and some of their limitations, in anticipation of HIV vaccine trials in South Africa. The first argument is that HIV risk behaviour increases in such trials, and HIV infection can be viewed as a research-related injury, justifying sponsor provision of treatment on grounds of compensation for harm. We conclude that risk-behaviour studies to date do not show general increases in risk behaviour that could constitute the basis for a general obligation. Participation may well adversely impact on risk behaviour for some individuals, and conceivably this could be demonstrated. This argument may, therefore, have merit at the individual level; however, it seems a weak platform from which to argue that sponsors should treat all HIV infections acquired during trials. The second argument is that treatment should be provided based on distributive justice. We conclude that traditional concepts of "distributive justice" in research appear limited in justifying obligations of sponsors to ensure access to antiretrovirals. Further, using research initiatives to reduce global health care inequities is controversial, and even proponents may disagree about the fairest use of finite resources. The third argument is that sponsors should ensure antiretroviral access on grounds of beneficence; namely, the maxim that if one can do something beneficial without sacrificing anything of comparable significance, it ought to be done. Thus, sponsors should provide more interventions than those minimally required to conduct the research. However, beneficence may demand levels of altruism that exceeds what is reasonable. While the latter arguments may provide stronger justifications than the first, it is difficult to use these arguments to establish that sponsor provision of antiretrovirals to infected individuals is obligatory.

Background Wide social disparities and weak health care systems in Africa make timely development of essential medicines, vaccines, medical technologies in and for Africa a desperate need, given the burden of diseases facing the continent. We estimate that it takes, on average, 1.5 years to get research ethics clearance in many African institutions for complex research proposals needed to deal with disease and solutions. Such delay comes with potentially high human costs. The need for Research Ethics Committees (RECs) to promptly and competently review protocols is therefore critical. Competent and efficiently RECs can save human lives, reduce costs and ultimately contribute to scientific development. Methods Research for Health and Innovation Organiser (RHInnO Ethics) is both an information management system and an expert-decision support system for individual RECs that is currently installed in 29 RECs in 8 African countries. It enables online, better quality, efficient and standardised reviews that can reduce review time in complex, multicentre trials by 12 months or more. Results What progress has been achieved in the process of implementing RHInnO Ethics since its inception in 2013? While training courses (long and short) have been considered as the mainstay of research ethics capacity building for decades, the development of this software-as-a-service platform has led to a more substantial understanding of how we can both accelerate and enhance the quality of ethics review of health research. We present experiences of our end users on how RHInnO Ethics contributes in enhancing the quality and efficiency of ethics review process. Conclusions Health research ethics review needs to go beyond training. We also present new functionalities in RHInnO Ethics version 2.0, including EthiCALL-( RECs connecting with other RECs worldwide) , Ethi XPERT (RECs updates on research ethics developments) as well as Invoicing, REC accreditation and pharmacovigilance functionalities that promise to revolutionise the research ethics review process in Africa and beyond.

Background The sheer amount of research being conducted in Africa, the under-resourced research ethics committees (RECs), and the lack of modern review technologies has resulted in unprecedented review timelines – with an estimated 1.5 years to get ethical clearance in many African countries. The Research for Health Innovation Organiser (RHInnO), a cloud-based ethics review platform, has ushered a new frontier of digital ethics review in Africa. It facilitates and manages the entire ethics review process. RHInnO ethics integration is estimated to reduce the review time by 12 months. In 2015, RHInnO ethics was used by 25 RECs in 8 African countries. We evaluated its impact on efficiency, data security and cost. Methods Qualitative and quantitative data was collected using an online questionnaire administered to REC administrators/chairpersons in user countries. Results Responses were received from 60% of RECs using RHInnO ethics. Reported areas of high impact (81%-100% of respondents) included: improved protocol submission and distribution process, improved quality of communication between RECs and researchers, improved standardisation of review process and improved data security. Reported areas of medium impact (60%-80% of respondents) included reduced REC administrator9s workload and reduced RECs9 administrative costs. Improved reviews of multicentre trials were reported as a low impact area by over 60% of respondents. Respondents (20%) who used RHInnO ethics for more than 2 years reported 57% reduction in review time while those who used RHInnO ethics for less than a year, (80%) reported it is too early to see the impact on reduction of review timelines. Conclusions RHInnO ethics had high impact on data security, submission process, communication, standardisation and cost reduction. However, a long-term evaluation approach is needed to determine impact on review timelines. Integration of new monitoring and evaluation (M&E) indicators on efficiency into the platform would improve RECs capacity to conduct long-term impact analysis.

Nutrition research, like most biomedical disciplines, adopted and often uses experimental approaches based on Beadle and Tatum's one gene-one polypeptide hypothesis, thereby reducing biological processes to single reactions or pathways. Systems thinking is needed to understand the complexity of health and disease processes requiring measurements of physiological processes, as well as environmental and social factors, which may alter the expression of genetic information. Analysis of physiological processes with omics technologies to assess systems' responses has only become available over the past decade and remains costly. Studies of environmental and social conditions known to alter health are often not connected to biomedical research. While these facts are widely accepted, developing and conducting comprehensive research programs for health are often beyond financial and human resources of single research groups. We propose a new research program on essential nutrients for optimal underpinning of growth and health (ENOUGH) that will use systems approaches with more comprehensive measurements and biostatistical analysis of the many biological and environmental factors that influence undernutrition. Creating a knowledge base for nutrition and health is a necessary first step toward developing solutions targeted to different populations in diverse social and physical environments for the two billion undernourished people in developed and developing economies.

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed. This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development's (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa.

A case-control study was done to assess a potential association between drinking water and pancreatic cancer in Washington County, Maryland. Cases of pancreatic cancer occurring from 1975 through 1989 were identified from the cancer registry. Controls were selected from the private 1975 census of Washington County. There were 101 cases and 206 controls. Chlorinated municipal water was used as a source of drinking water by 79% of cases and 63% of controls, yielding a significant odds ratio of 2.2. Adjustment for age and smoking had almost no effect on the risk, although both age and smoking were independently associated with an increased risk of pancreatic cancer. Although these findings must be interpreted with caution because of limitations in exposure assessment, these results have implications for the prevention of pancreatic cancer because chlorination of water is so widely practiced.

We examined the process of informed consent in an antiretroviral trial in Nigeria. A semi-structured questionnaire was administered to 88 out of 180 people enrolled in the trial. This covered all aspects of the information disclosed in the leaflet of the antiretroviral trial. We found that 75 (85 per cent) of the respondents knew that the purpose of the research was to test a new drug and 13 (14 per cent) believed that they were receiving free treatment for HIV. Participants understood certain aspects of the research, especially the benefits and duration. Their understanding of the trial's risks and their right to refuse to participate and to withdraw was low. Their level of understanding was significantly related to age but not to gender, marriage, education, religion, employment and occupation. Signed informed consent is not a guarantee that participants have understood the information given to them and therefore made a voluntary decision to participate. Researchers should make sure that the process of obtaining informed consent achieves the desired outcome. This is especially important in the developing world where access to health care is limited, potential participants are poor and literacy levels are low.

OBJECTIVE: Literature on human resources for health in Africa has focused on personal health services. Little is known about graduate public health education. This paper maps "advanced" public health education in Africa. Public health includes all professionals needed to manage and optimize health systems and the public's health. METHODS: Data were collected through questionnaires and personal visits to departments, institutes and schools of community medicine or public health. Simple descriptive statistics were used to analyse the data. FINDINGS: For more than 900 million people, there are fewer than 500 full-time staff, around two-thirds of whom are male. More men (89%) than women (72%) hold senior degrees. Over half (55%) of countries do not have any postgraduate public health programme. This shortage is most severe in lusophone and francophone Africa. The units offering public health programmes are small: 81% have less than 20 staff, and 62% less than 10. On the other hand, over 80% of Africans live in countries where at least one programme is available, and there are six larger schools with over 25 staff. Programmes are often narrowly focused on medical professionals, but "open" programmes are increasing in number. Public health education and research are not linked. CONCLUSION: Africa urgently needs a plan for developing its public health education capacity. Lack of critical mass seems a key gap to be addressed by strengthening subregional centres, each of which should provide programmes to surrounding countries. Research linked to public health education and to educational institutions needs to increase.

Using a semi structured questionnaire, a study of 88 out of 180 people enrolled in a ntiretroviral therapy (ART) clinical trial in,Africa was conducted to determine the voluntariness of their participation and their satisfaction with the consent process. Results revealed that participation was driven mainly by unmet health needs and participant reported benefits (free drug and tests). The absence of alternatives to access medical services has the potential to create ethical challenges to voluntary participation. Most of the participants saw the consent process as satisfactory; however, one has to wonder if the satisfaction might be based on the hope in the treatment being giving and/or on the trust they have in investigators and the institution. It is then of importance that research participants be given enough time to reflect on the information provided during the consent process before obtaining consent from them. Research participants from a developing country can be empowered to make autonomous decisions about participating in a study

We read with great interest the article by Nachega and colleagues on the current status and future prospects of epidemiology and public health training and research in the World Health Organization (WHO) Africa region. We very much agree with the authors that epidemiology and public health training at the master’s, doctoral, and postdoctoral levels in academic institutions linked with regional or national centers of research excellence in Africa is key to ensuring that Africa becomes self-sufficient in epidemiological research and education. However, and particularly with regard to the development of intermediate and advanced epidemiology and public health education and training programs in sub-Saharan Africa over recent years, a more comprehensive review of these activities would allow recent experience to inform priorities in research training in the WHO Africa region. As one example, we would like to highlight the case of the epidemiology and public health training at the School of Public Health of the University of the Witwatersrand in Johannesburg, South Africa (WSPH). The WSPH established and subsequently developed internationally recognised and sustainable degree training programs in public health and epidemiology on the mastersand more recently on the doctoral-degree level, providing basic, intermediate, and advanced theoretical training combined with hands-on experience and on-the-job training as part of its training curriculum. Since inception of the masters degree programs in public health and epidemiology with international seed funding, the programs have been very well evaluated and have produced graduates progressing to doctoral and postdoctoral training and taking on senior positions in research and academia. To date, the epidemiology program offers qualifications in epidemiology and biostatistics, population-based field epidemiology and infectiousdisease epidemiology, and is currently preparing for a degree in research-data management in collaboration with the International Network for the Demographic Evaluation of Populations and Their Health (INDEPTH network) to facilitate INDEPTH’s epidemiological activities. Growing interest in relation to rising rates of chronic disease was addressed by introducing a curriculum and short course in chronic disease epidemiology focusing on transitional societies in lowand middle-income countries to advance research and training for noncommunicable diseases. Similar activities in response to African training needs have been reported for the masters degree in public health program, and stimulated the development of an interdisciplinary doctoraldegree program in public health at the WSPH and beyond through the Consortium of Advanced Research Training in Africa, embedding graduates in interdisciplinary international research consortia with a particularly African focus. Taken together, exemplary activities at the University of the Witwatersrand, most likely mirrored by activities elsewhere in Africa, have demonstrated the ability of institutions in the south of Africa to develop and integrate training programs into university curricula. These were made sustainable by investment from the university and by government investment in higher education. Working together, both in south–south and north-south partnerships, has allowed the development of both breadth and depth in the content and supervisory capacity of these programs so as to permit them to offer relevant training linked to real-world situations in which graduates will work. Direct investment in African institutions is thus fundamental to developing African capacity not only in epidemiology and public health for the creation of nodes of excellence so as to counteract ‘brain drain’, but also to address the current and future health challenges on the African continent.

The current practice of requiring the informed consent of research subjects is relatively new. The emphasis on a person's right to accept or refuse participation in biomedical research stems direct...

In the March 2008 issue, the Bulletin of the World Health Organization published two related items on the complex issue of ownership of health information in international health programmes and on the “vertical versus horizontal” nature of the health programmes responsible for generating this information.1,2 The first is an editorial by Sanjoy Bhattacharya of the Wellcome Trust, which highlights (once again) the divide between protagonists of vertical and horizontal health programmes, and makes a call for “adaptive verticality” to optimize the potential of international health programmes to integrate with primary health care systems in low-income countries and strengthen these in the process.1 The second is a news item: an interview with Sally Stansfield of the Health Metrics Network in which she calls for country-ownership of health information and for “vertical” health programmes to integrate with and strengthen national health information systems. These she argues should become the source of information for improved public-health decision-making and, at the same time, for information needed by donors and by specific (“vertical”) health programmes.2 The problems raised by Bhattacharya and Stansfield are not confined to the health sector nor to health information. On the contrary, the issue of ownership of data and the practice of vertical programming is, in many ways, far worse in the domain of health research. In most low- and middle-income countries, foreign-funded initiatives determine national health research agendas, even in countries in which governments contribute substantially to supporting national health research systems, institutions and personnel. As a result, research activities in many low- and middle-income countries reflect more closely foreign and global health research priorities than the research needs of the countries in which research is being conducted. As externally funded research is virtually monopolised by HIV/AIDS, tuberculosis and malaria,3 little if any funding or research capacity is left to deal with other diseases, conditions or the improvement of health systems, let alone for research with a more expanded goal of social and economic development (i.e.“research for health”). The concept of “responsible vertical programming”4 defines a health research programme as “responsible” if it “succeeds in building the capacity of a country’s researchers and the national research system – in the process of achieving its own research goals”. It sets out some practical steps that decision-makers in countries and in research programmes can take to increase the synergy between national research capacity and research programme implementation. Countries have to take responsibility to put in place and resource a basic national health research system that provides mechanisms for research governance, identifies national priorities and formulates and implements a policy framework to enhance the effectiveness of the national research effort. Vertical programmes have to realize that their research cannot be conducted in isolation from national contexts and that their contributions to the research infrastructure from which they benefit will enhance research output and quality in the future. They can do this by ensuring that – as a minimum – activities align with, rather than fragment, national research system needs and by investing in equitable partnerships that strengthen the capacities of national researchers, research institutions and research systems. It is clear that health system strengthening needs both information and research. Stated in another way, national health information systems and national health research systems are key tools in generating the evidence needed to guide health and health system improvement in low- and middle-income countries, just as they are in high-income countries. “Responsible vertical programming” is about supporting long-term sustainable development as the primary objective of all development interventions in low- and middle-income countries. At the same time, we agree with Bhattacharya in acknowledging that there is still much to be learned about how best to integrate “vertical” and “horizontal” programmes. What is not in any doubt, however, is that strengthening of national research and information systems should be a key component of (large) health and health research programmes. ■