Stem Cell Research Guidelines fix responsibility for investigators, institutions and sponsors

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The ‘National Guidelines for Stem Cell Research‘, issued recently by the Union health ministry, has fixed the responsibility for investigators, institutions and sponsors in the conduct of stem cell research in the country.

According to the Guidelines, the investigators and institutions where stem cell research is being conducted bear the ultimate responsibility of ensuring that research activities are in accordance with the national regulations and guidelines.  In particular, scientists whose research involves human ES cells should work closely with monitoring/regulatory bodies, demonstrate respect for autonomy and privacy of those who donate gametes, blastocysts, embryos or somatic cells for stem cell research, and be sensitive to public concerns about research that involves human embryos.

Those working with human iPS cells shall be particularly careful with the vectors and genes used for induction of stemness against malignant transformation. Sponsors shall also take note of their responsibilities and liabilities under various statutes, regulations and guidelines governing research and development in this field in the country.

As per the guidelines, each institution shall maintain a register of its investigators conducting stem cell research and ensure that all registered users are kept up to date with existing guidelines and regulations regarding the use of these cells. It shall also be the responsibility of the institution to ensure that most current standards are applied.  Each institution shall constitute an IC-SCR as provided in these guidelines and provide adequate support for its functioning. All records pertaining to clinical adult stem cell research must be maintained for a period of at least five years and those for ES/iPS cell research for atleast10 years.

The guidelines further explain that the physician/scientist engaged in stem cell research shall endeavour to avoid any activity that leads to unnecessary hype, or unrealistic expectations in the minds of study subjects or public at large regarding stem cell therapy. The study subject and other responsible family members must be given adequate and unbiased information about the trial protocol, its limitations and potential adverse effects. They must also be informed about the given indication for therapy. The investigator’s responsibility is to generate robust scientific evidence through good clinical trials which may then be applied for the benefit of the patients.

According to the Guidelines, the institutions conducting stem cell research shall establish suitable mechanisms for creating awareness and communicating scientific evidences to the public.  The basic scientists engaged in human stem cell research shall be vigilant to safeguard rights and dignity of human donors and aborted foetuses from whom samples for research have been obtained. The biological material should be treated with utmost respect and care in all experiments. The use of human embryos shall be restricted as much as possible, and shall be resorted to where there are no other alternatives. Also, special care should be taken in introducing human cells in animals, particularly in early developmental stages, which may lead to development of chimeras or incorporation into brain/gonads.

Source: PharmaBiz

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