Bookmarks

WHO Standards for Ethics Committees now published

“Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants” a compilation of 10 standards that are applicable to the ethics review of health related research with human participants. It can be found at http://www.who.int/ethics/publications/en/

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Bookmarked by dbogecho on 9 Feb 2012

Ethics of clinical trials outsourcing and conduct in LMICs, with a focus on India.

Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage. Over the last few years, there has been continuing outrage on the issue of rising outsourcing of clinical trials to India, with concerns about little benefit or relevance to the public health needs of the country. While this dust has not even settled, allegations of unethical conduct in clinical trials have again brought a focus on the need for regulatory reform and stringent ethical safeguards.

India, as an emerging economy needs to continue to promote a strong culture of research and development, including in the health sector. However, attention needs to be paid to ensuring that stringent quality checks are built in, and that investigators conduct research in an impeccable manner. Failure to do so will dent the credibility of the research enterprise, affecting not just investigators or institutions conducting research, but also those planning to do so.

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Bookmarked by Anant Bhan on 10 May 2012

Blog posts

mamulla

Adverse event reporting

By mamulla

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An article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings

24th January 2011 • comment