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 fo
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r 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.
25 Nov 2022
The WHO Guidelines for malaria bring together the Organization’s most up-to-date recommendations for malaria in one user-friendly and easy-to-navigate online platform.
The WHO Guidelines
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for malaria supersedes 2 previous WHO publications: the Guidelines for the treatment of malaria, third edition and the Guidelines for malaria vector control. Recommendations on malaria will continue to be reviewed and, where appropriate, updated based on the latest available evidence. Any updated recommendations will always display the date of the most recent revision in the MAGICapp platform. With each update, a new PDF version of the consolidated guidelines will also be available for download on the WHO website.
This version of the Guidelines includes updates to the case management of malaria, specifically the addition of new molecules for the treatment of uncomplicated malaria and optimization of the dosage regimen for anti-relapse treatment, along with updates on the use of antimalarial medicines in special risk populations including pregnant women.
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An Update will be published in late 2018
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 e
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nhancing 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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These Guidelines are intended to provide knowledge to the treating ophthalmologists, pediatricians, ocular oncologists, pediatric oncologists, and general physicians to arrive at an early diagnosis of retinoblastoma in the settings of district hospi
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tal, in private clinics and hospitals. The guidelines will enable the contact health personnel to refer at the right
time to the tertiary care hospital for management of retinoblastoma.
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2nd edition. These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structu
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red along the continuum of HIV testing, prevention, treatment and care
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These consolidated guidelines on HIV testing services (HTS) bring together existing and new guidance on HTS across different settings and populations.
The World Health Organization (WHO) first released consolidated
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guidelines on HTS in 2015, in response to requests from Member States, national programme managers and health workers for support to achieve the United Nations (UN) 90–90–90 global HIV targets – and specifically the first target of diagnosing 90% of all people with HIV. In 2016, based on new evidence, WHO released a supplement to address important new HIV testing approaches – HIV self-testing (HIVST) and provider-assisted referral.
Since the release of 2015 and 2016 HTS guidelines, new issues and more evidence have emerged. To address this, WHO has updated guidance on HIV testing services. In this guideline, WHO updates recommendation on HIVST and provides new recommendations on social network-based HIV testing approaches and western blotting (see box, next page). This guideline seeks to provide support to Member States, programme managers, health workers and other stakeholders seeking to achieve national and international goals to end the HIV epidemic as a public health threat by 2030.
These guidelines also provide operational guidance on HTS demand creation and messaging; implementation considerations for priority populations; HIV testing strategies for diagnosis HIV; optimizing the use of dual HIV/syphilis rapid diagnostic tests; and considerations for strategic planning and rationalizing resources such as optimal time points for maternal retesting
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These WHO guidelines which were updated in 2018, are valid for any country and suitable to local adaptations, and take account of the strength of available scientific evidence, the cost and resource implications, and patient values and preferences.
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The 2018 edition of the guidelines includes the revision of the recommendation regarding the use of 80% fraction of inspired oxygen (high FiO2) in surgical patients under general anaesthesia with tracheal intubation and the update of the section on implementation. Between 2017 and 2018, WHO re-assessed the evidence on the use of high FiO2 by updating the systematic review related to the effectiveness of this intervention to reduce SSI and commissioning an independent systematic review on adverse events potentially associated with it. Based on the updated evidence, the GDG decided to revise the strength of the recommendation from strong to conditional.
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Document No. : FDA/SMC/CTD/GL-CCT/2013/01