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 purpos
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e 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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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
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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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These guidelines have been developed specifically to address ethical issues of conducting research in children.
Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on
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medical device donation in 2011, which has been now reviewed, with new evidence, new references on considerations for medical device solicitation and provision, risks associated with inappropriate donations, the responsibilities of donors and recipient, and the steps they should follow before, during and after a donation. It includes three sections: description of major problems that may be faced during the donation process, listing of best practices for donors and recipients and addressing situations requiring special attention. It also has three annexes for further reading: the criteria for the acceptability of a donation, literature review on donations of medical devices between 2010 and 2023 and a flyer. This document is intended to improve the quality of medical devices donations, including medical equipment, single-use medical devices and in-vitro diagnostics, to provide maximum benefit to all stakeholders. The considerations can be used to develop institutional or national policies and regulations for medical devices donations. This document is intended for use by any organization, expert or practitioner involved in the donation, procurement, management of medical devices, including health workers, biomedical engineers, health managers, policymakers, donors, nongovernmental organizations and academic institutions.
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CIPH Curriculum for Best Practices. Putting Principles to Work
Combination file of all the documents related to the national guidelines for accreditation, supervision and regulation of ART clinics in India. Documents included:
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National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India | Preliminary Pages | Corrigendum | Chapter 1 - Introduction, Brief history of ART and Requirement of ART Clinics | Chapter 2 - Screening of Patients for ART - Selection Criteria and Possible Complications | Chapter 3 - Code of Practice, Ethical Considerations and Legal Issues | Chapter 4 - Sample Consent Forms | Chapter 5 - Training | Chapter 6 - Future Research Prospects | Chapter 7 - Providing ART Services to the Economically Weaker Sections of the Society | Chapter 8 - Establishing a National Database for Human Infertility | Chapter 9 - Composition of the National Accreditation Committee | Bibliography
| Members of the Expert Group for Formulating the National Guidelines for Accredation, Supervision and Regulation of ART Clinics
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Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical
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research and/or patient care so as to provide quality data which can be used for health research and patient treatment. As the use of laboratory tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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This report explores the reasons why global health is critical to medicine and what this means for medical education. It argues that an understanding of global health is important
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for all students and practicing doctors, rather than being an ‘add-on’ or ‘option’ for specialization.
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Myanmar, as a country going through rapid socio-political transition and institutional development also suffers with a high burden of infectious disease. An ongoing challenge has been to effectively reach its 51 million population, most of whom battle tuberculosis, acute respiratory infections, diar
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rhoea and malaria including amongst under-five children.
Limited research data on the occurrence of resistant organisms in the nation have, makes it hard to estimate the exact antimicrobial resistance (AMR) scenario. Limited peer reviewed evidence indicates significant divergence from the average resistance trends in APAC region. Nevertheless, several key steps by Government of Myanmar have been instrumental in paving the way for the country to join other nations in the South East Asia Region to speed up its plan on addressing the AMR crisis. Combating antimicrobial resistance would, however, require highest political commitment, multi-sectoral coordination, sustained investment and technical assistance.
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Antimicrobial resistance is one of the most important threats to the health worldwide. Antimicrobial resistance or drug resistance is the reduction of the pharmaceutical effects of a drug against a disease or reduction of its effectiveness in improving the clinical signs of a disease. Antimicrobial
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resistance occurs naturally but misuse of antibiotics in human and animals significantly accelerates the process of developing antimicrobial resistance. In fact, antimicrobial resistance refers to the resistance of a microorganism to one or more antimicrobial drugs which had been previously sensitive to these drugs. Antimicrobial resistance can occur in a wide variety of pathogens including bacteria, parasites, viruses, fungi, and cancer cells and may threaten the life of every person, in every age, and in every country
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This guidance is intended for use in developing standalone TB strategic plans, or TB interventions as part of multidisease or health sector plans. It describes key considerations and steps for strat
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egic planning for TB in line with the World Health Organization’s End TB strategy, and the proposed structure of the NSP. The target audience of this publication are all stakeholders involved in national strategic planning for TB (e.g., ministry of health, other government ministries, private sector, civil society, affected communities, academic and research institutions, and technical and funding partners).
The current document is an update to the 2015 Toolkit to develop a national strategic plan for TB prevention, care and control.
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National emergency medical teams are the best option for providing immediate and appropriate surge response
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for emergencies directly affecting populations, while international teams may help relieve overwhelmed health systems. The efficiency and effectiveness of countries and local authorities in mobilizing existing resources is only as good as the quality of care they are able to provide. This publication serves as a practical guide for teams and aims to compliment emergency response systems, fostering seamless collaboration with all emergency response actors and networks
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This resource consists of technical guidelines for District Medical Officers, counselors and laboratory technicians for second-line antiretroviral
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therapy drugs, operational guidelines for pilot roll-out in two centres and laboratory guidelines for viral-load testing and standard operating procedures.
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Prepared as an outcome of ICMR Subcommittee on Colorectal Cancer | Coordinated by Division of Non Communicable Diseases | This Consensus Document on Management of Colorectal Cancer summarizes the modalities of treatment including the site-specific anti-cancer therapies,
supportive and palliative ca
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re and molecular markers and research questions. It also interweaves clinical, biochemical and epidemiological studies.
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