Regulatory Focus™ > News Articles > US Presidential Commission Find Federal Research Protects Subjects, But Could Do More

US Presidential Commission Find Federal Research Protects Subjects, But Could Do More

Posted 20 December 2011 | By

According to a report issued by the Presidential Commission for the Study of Bioethical Issues, although the current regulatory framework for federally sponsored research involving human volunteers in the US provides "substantial" protections for the health, rights and welfare of participants, more could be done to protect clinical study participants.  The report includes a total of 14 recommendations for changes to current practices in federally funded research.  Areas that could benefit from improvement include: enhancing accountability and responsibility in human-subjects research; providing treatment and compensation for related industries; driving equivalence in international standards for the protection of research participants; promoting community engagement in federally funded research; justify study-site selection; and ensuring that trials are ethically designed. (Pharma Times)


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