Jointly developed by WHO’s Regulatory System Strengthening, Regulation and Safety Unit and the Health Ethics & Governance Unit, it is intended to assist countries in evaluating their capacity to provide appropriate ethical oversight of health-related research. In addition to assisting in capacity-...building efforts, the tool is intended to promote policy convergence and best practices in research ethics oversight, to enhance public trust in health research, and to ensure that the rights and safety of humans involved in health-related research are adequately protected, both in ordinary times and during public health emergencies.
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These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.
The purpose of such research should be: i. directed towards enhancing knowledge about the human condition while ...maintaining sensitivity to the Indian cultural, social and natural environment; ii. conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and iii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results thereof.
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This training guide is designed to enable participants to understand the human rights perspective on migration, and how human rights laws and standards can be operationalized to make migration safer and an empowering experience for all. It provides an introduction to related principles and issues an...d is designed for persons with limited knowledge of human rights or migration.
The training guide contains session plans for the trainer and is supported by sample slide presentations and associated materials, including activities and handouts for participants, which are available electronically as individual components.
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Human African trypanosomiasis (HAT), or sleeping sickness, is a painful and protracted disease transmitted through the bite of infected tsetse flies and it is found in rural parts of sub-Saharan Africa. Sleeping sickness has two clinical phases but this review focuses only on treatment of the second...-stage, which is characterized by neurological changes and almost invariably fatal without treatment. There are only a few drugs currently available for second-stage sleeping sickness, all with considerable adverse events and variable efficacy.
The review includes nine trials with 2577 participants. Each trial reported different comparisons of the drugs currently available to treat second stage HAT (melarsoprol, eflornithine, nifurtimox) so no meta-analysis was possible.
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This is a pre-deployment training, tailored specially to the Ebola outbreak in West Africa, offered to WHO personnel, consultants, and key partners. The material covered in modules 1-4 is applicable and useful to frontline response workers, national and international. Only Module 5, which focuses on... operational aspects - the code of conduct for international civil servants and human resources arrangements for WHO deployees, are specifically geared to all internationally recruited personnel and to WHO deployees respectively
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El objetivo de esta publicación es ofrecer un enfoque práctico y gradual para la aplicación de los planes de acción nacionales sobre la RAM en el sector de la salud humana; y proporcionar un proceso y una recopilación de las herramientas existentes de la OMS para priorizar, costear, aplicar, su...pervisar y evaluar las actividades del plan de acción nacional. Los destinatarios de la publicación son las partes interesadas nacionales/subnacionales que trabajan en la RAM dentro del sector de la salud humana. Se trata de las autoridades sanitarias nacionales, los grupos de coordinación multisectorial nacionales, los expertos técnicos de alto nivel y los responsables de la formulación de políticas que participan en la ejecución de las actividades relativas a la RAM en todos los niveles del sistema de salud, y los asociados en la ejecución para acelerar la aplicación sostenible y el seguimiento y la evaluación de los planes de acción nacionales sobre la RAM.
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Participant Manual September 2012
Surveillance of Populations at High Risk for HIV Transmission
Participant Manual
October 2009
Participant Manual
February 2011
Edition 3.0
Participant Manual September 2009
Background
Asthma education, a key component of long-term asthma management, is challenging in resource-limited settings with shortages of clinical staff. Task-shifting educational roles to lay (non-clinical) staff is a potential solution. We conducted a randomised controlled trial of an enhanced a...sthma care intervention for children in Malawi, which included reallocation of asthma education tasks to lay-educators. In this qualitative sub-study, we explored the experiences of asthmatic children, their families and lay-educators, to assess the acceptability, facilitators and barriers, and perceived value of the task-shifting asthma education intervention.
Methods
We conducted six focus group discussions, including 15 children and 28 carers, and individual interviews with four lay-educators and a senior nurse. Translated transcripts were coded independently by three researchers and key themes identified.
Results
Prior to the intervention, participants reported challenges in asthma care including the busy and sometimes hostile clinical environment, lack of access to information and the erratic supply of medication. The education sessions were well received: participants reported greater understanding of asthma and their treatment and confidence to manage symptoms. The lay-educators appreciated pre-intervention training, written guidelines, and access to clinical support. Low education levels among carers presented challenges, requiring an open, non-critical and individualised approach.
Discussion
Asthma education can be successfully delivered by lay-educators with adequate training, supervision and support, with benefits to the patients, their families and the community. Wider implementation could help address human resource shortages and support progress towards Universal Health Coverage.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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As the Convention of the Rights of Children recognizes, children are human beings with a distinct set of rights, and not the passive objects of care and charity. They deserve to be full participants in society, and to live lives free of poverty. But for children, living in poverty is particularly im...pactful. The foundations for life are built in childhood. In the early part of our lives, our bodies and brains develop their capacities to function and interact with the world. We learn the social skills we need to fit into society, and acquire the human capital necessary to earn a living, support a family, and to fully take part in the life of our community Poverty can stunt this development. So can the onset of a disability. As the World Report on Disability (WHO/World Bank 2011) points out, people with disabilities are all too often excluded from the economic and social lives of their community. And the interaction between disability and poverty has the potential to develop a vicious circle that can greatly limit life opportunities.
Working Paper Series: No. 25
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This free online course on Climate Change Negotiations and Health features key information on climate change and its impacts on human health, provides an overview of the international climate change negotiations so far, and considers entry points to address health issues and priorities within climat...e change negotiations and policies.
The course provides clear, concise, and up-to-date information for anybody interested in addressing the health risks arising from climate change. The course is self-paced and includes a series of self-standing interactive lessons with different activities, exercises, case studies and videos, as well as links to other useful resources. Upon successful completion of the course, participants can receive a certificate of completion.
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West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history. On 11 August 2014, WHO convened a consultation where the participants concluded that in the particular context of the current Ebola outbreak in West Africa, it is ethically acceptable to of...fer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluat-
ed for safety and efficacy in humans as potential treatment or prevention
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COVAXINTM, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) h...igh containment facility.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
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