International Journal of Infectious Diseases 46 (2016) 56–60
This new edition and fully updated publication replaces the 2012 UCG and is being circulated free of charge to all public and private sector prescribers, pharmacists, and regulatory authorities in the country
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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These guidelines have been developed specifically to address ethical issues of conducting research in children.
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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ECDC MISSION REPORT 19–21 September 2016 ; 14–15 November 2016
Technical Report
AIDS Medicines and diagnostics service
September 2016
World Health Organization Department of Reproductive Health and Research
Brocher Foundation, Hermance, Geneva, Switzerland, 27–29 April 2016
Module 2
Community Educators and Advocates
July 2017
Module 2: Community educators and advocates. Community educators and advocates are needed to increase awareness about PrEP in their communities. This module provides information on PrEP that should be considered in community-led activities ...that aim to increase knowledge about PrEP and generate demand and access.
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Module 6
Pharmacists
July 2017
Module 6: Pharmacists. This module is for pharmacists and people working in pharmacies. It provides information on the medicines used in PrEP, including on storage conditions. It gives suggestions for how pharmacists and pharmacy staff can monitor PrEP adherence... and support PrEP users to take their medication regularly.
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Module 8
Site Planning
July 2017
Module 8: Site planning. This module is for people involved in organizing PrEP services at specific sites. It outlines the steps to be taken in planning a PrEP service and gives suggestions for personnel, infrastructure and commodities that could be considered... when implementing PrEP.
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Module 9
Strategic planning
July 2017
Module 9: Strategic planning. As WHO recommends offering PrEP to people at substantial HIV risk, this module offers public health guidance for policy-makers on how to prioritize services, in order to reach those who could benefit most from PrEP, and in wh...ich settings PrEP services could be most cost-effective.
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Manual of Operations
First Edition 2016