Joint United Nations Programme on HIV/AIDS
Actualización de las orientaciones provisionales 7 de junio de 2016
Updated 6 September 2016. This guidance has been developed to provide advice on the prevention of potential sexual transmission of Zika virus. The primary transmission route of Zika virus is via the Aedes mosquito. However, sexual transmission of Zika virus may also be possible, with limited evidenc...e recorded in a few cases. This is of concern due to an association between Zika virus infection and potential complications, including microcephaly and Guillain-Barré syndrome.
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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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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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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.