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International compilation of human research protections

OFFICE FOR HUMAN RESEARCH PROTECTIONS, US DEPARTMENT OF HEALTH AND HUMAN SERVICES
2009

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This compilation lists the approximately 1,100 laws, regulations, and guidelines that govern human subjects research in 92 countries, as well as standards from a number of international and regional organisations. Its purpose is to help these groups familiarise themselves with the laws, regulations and guidelines where the research will be conducted and to assure those standards are followed appropriately. This edition includes numerous additions and updates to the 2008 Edition, and features the laws, regulations and/or guidelines for seven new countries: Burma (also known as Myanmar), Egypt, the Gambia, San Marino, South Korea, the Sudan and Vietnam. This compilation was developed for institutional research bodies/ethics committees, researchers, sponsors, and others who are involved in international research

Research and development for medicines to be driven by needs of low and middle income countries

COUNCIL ON HEALTH RESEARCH FOR DEVELOPMENT (COHRED)
June 2008

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This briefing highlights from health research issues discussed at the World Health Assembly and the conclusions of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The IGWG process has important implications and considerations for health research and the role that developing countries can play

Research issues in sexual and reproductive health for low- and middle-income countries

DE FRANCISCO, Andres
DIXON-MUELLER, Ruth
D'ARCANGUES, Catherine
2007

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This paper outlines a conceptual framework and a number of thematic and cross-cutting research issues in sexual and reproductive health as a first step in a consultative process towards the identification of gaps and priorities for research in this field. The themes of social equity, poverty and gender addressed in this paper are of particular relevance to the field of sexual and reproductive health. So, too, are the challenges of collaborating with in-country partners to identify context-specific research priorities that address the many and varied dimensions of sexual and reproductive health and its determinants and correlates in order to build the evidence base and put policy and programmatic evidence into practice in low-resource settings

Are international health research programmes doing enough to develop research systems and skills in low and middle income countries? Responsible vertical programming : How global health research can deliver essential research, achieve impact and build na

IJSSELMUIDEN, Carel
et al
2007

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This statement from the Council on Health Research for Development considers the responsibility of research programmes carried out in low to middle income countries to build the capacity of a country’s researchers and the national research system, in the process of achieving its own research goals. It sets out 4 problems that need to be addressed: health research needed by developing countries is mostly conducted for them, sometimes with them, but rarely by them; health research in developing countries is problem-specific - or ‘vertical’ and does not usually contribute to building the national system for health research; the questions addressed by health research in developing countries are largely determined by the international community - specifically those funding ‘global health research’; and health research is not seen as a key driver of development in low income countries - which constitutes a missed opportunity towards real and sustainable progress. Also included are a set of practical steps that can be taken to make vertical research programmes more responsible

Proving our worth : developing capacity for the monitoring and evaluation of communicating research in development

PERKINS, Nicolas
Ed
October 2006

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This is a programme summary report of a workshop convened by the Research Communication Monitoring and Evaluation Group, an informal network composed of representatives from a number of UK organisations concerned about the impact of research on the reality of poverty. The workshop objectives were to mobilise a wider group of organisations working in the field of research communication to explore and analyse the different models for monitoring and evaluating research communication

Scoping study : monitoring and evaluation of research communications

BUTCHER, Catherine
YARON, Gil
August 2006

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This scoping study on the monitoring and evaluation (M&E) of research communications was carried out over 15 days to: * Provide a broad overview of the key issues in the monitoring and evaluation of research communications * Draw out differences, if and where they exist, between M&E of research communications compared with M&E generally * Identify characteristics of good practice in the M&E of research communications and highlight implications for those involved It was used to inform a workshop of the Research Communications Monitoring and Evaluation Group in 2006

Monitoring financial flows for health research 2006 : the changing landscape of health research for development

MATLIN, Stephen
DE FRANCISCO, Andres
Eds
2006

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This study aims to provide NGOs and decision-makers with an overview of currently available information on resource flows into health research. It paints the picture of a changing landscape, with an increased number of actors and increases in resources for health promotion and health research in developing countries. The document provides statistical data on global spending on R&D for health, looks at trends and patterns of morbidity and mortality and discusses health research challenges and priorities for the public sector

Can communities influence national health research agendas? A learning process leading to a framework for community engagement in shaping health research policy

BATISTA, Ricardo
et al
2006

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This paper is a record of a consultation on 'Communities Matter' which reviewed case studies of successes and failures of community and civil society engagement, participation and action in health research. The group discussion focused on opportunities and obstacles for communities to engage in health research. It analysed strategies that can be applied to increase a community’s voice in health research, and looked at the concepts, definitions and frameworks that can be used for promoting, advocating and supporting community engagement in health research

Successful communication : a toolkit for researchers and civil society organisations

HOVLAND, Ingie
October 2005

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From the introduction: "This toolkit is for researchers and practitioners who wish to communicate to policymakers. The tools are therefore specifically geared towards the needs of researchers and practitioners in civil society organisations (CSOs), including development NGOs, research institutes, think tanks, universities and networks. The toolkit addresses the questions of how researchers and CSOs can best communicate evidence in order to inform or influence policy, to achieve their own stated development objectives, or simply to make their own knowledge accessible and understandable to a wider audience." After a brief but useful introduction, tools are presented in four sections: planning, packaging, targeting and monitoring

Part 46 : protection of human subjects

OFFICE FOR HUMAN RESEARCH PROTECTIONS (OHRP)
June 2005

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This policy regulations outline the basic US Health and Human Services Policy for Protection of Human Research Subjects. It also provides additional policy information about protection for pregnant women, human foetuses, neonates and children involved as subjects in research. This is an important document for anyone who is completing research with human research subjects in the United States

Participatory vulnerability analysis : a step-by-step guide for field staff

CHIWAKA, Ethelet
Yates, Roger
2005

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This guide is to assist field workers and communities to analyse people's vulnerability. The guide is divided into three major parts: part 1 provides insights into key aspects of vulnerability, as different people often have different levels of understanding about it; part 2 contains suggestions of how best to prepare for a PVA, how to conduct the analysis and how to generate action; part 3 is an appendix providing suggestions for compiling the data generated through PVA, ideas for advocacy work and an example terms of reference

No development without research : a challenge for research capacity strengthening

NUYENS, Yvo
2005

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This document provides an overview of key players, programmes and issues around research capacity strengthening. Fragmentation, overlapping and insufficient coordination of programmes prevent the bridging of the 'know-do gap'. The document depicts a framework encompassing the individual level (training), the institutional level (development of institutions) and the macro level (enabling environment, which includes the national health research system). Crucially, it describes research 'as an iterative process in phases, starting with managing the research agenda and ending with utilizing evidence in decision-making in policy and practice'

Research for people's health : a researcher's encounter at the Second People's Health Assembly

PEOPLE'S HEALTH MOVEMENT
2005

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This bilingual booklet describes a "research encounter" which brought together researchers from all over the world committed to people's health problems. The purpose was to reflect and debate the problems and inequities related to research on health. The booklet describes the themes that were raised, the ideas that emerged, and challenges. It includes a 'declaration' with recommendations for governments, researchers and training institutions

Tools for policy impact : a handbook for researchers

START, Daniel
HOVLAND, Ingie
October 2004

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"This handbook presents work in progress on tools for policy impact, specifically geared towards the needs of researchers. "The handbook is particularly targeted at civil society organisations, or the parts of them, whose activities involve gathering evidence, doing research, learning lessons or advising on strategy for social, environmental and economic development in the North and South"

Researching across cultures : issues of ethics and power [whole issue]

MARSHALL, Anne
BATTEN, Suzanne
September 2004

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Cultural diversity manifests in all relationships, including research relationships. Academic investigators work across a broad range of cultures that goes beyond ethnicity. What implications are most important for academic researchers to consider when designing and implementing a project? A review of relevant literature suggests that ethical implications begin with the power aspects in the research relationship. Consent, research processes, research design, data ownership, and uses of data are also salient issues that arise. [Authors' abstract]

Human subject regulations decision charts

OFFICE FOR HUMAN RESEARCH PROTECTIONS (OHRP)
September 2004

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These graphic aids are a guide to help decide if a research activity involving human subjects needs to be reviewed by an institutional review board (IRB) under the requirements of the US Department of Health and Human Services. The charts specify the following: whether an activity is research that must be reviewed by an IRB, whether the review may be performed by expedited procedures, and whether informed consent or its documentation may be waived. This document is useful for institutional review boards (IRBs), investigators, and others who are conducting research with human subjects

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