This document contains: The systematic reviews and GRADE assessments used at the Index-TB Guideline Panel in July 2015; The Evidence to Decision tables that record the Panel’s assessment and recommendations from
this meeting
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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Pre-Publication draft version. Lat reviewed on 7th July 2017
Cochrane Database Syst Rev. 2016 Jul 1; (6): 1–61 -Published online 2016 July 1