The 2014 edition of the International Compilation of Human Research Standards has been released and is now available online.
The 2014 edition of the International Compilation of Human Research Standards has been released and is now available online: http://www.hhs.gov/ohrp/international/index.html.
The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 107 countries, as well as standards issued by a number of international and regional organizations. The standards address such issues as informed consent, research ethics committee review, reporting requirements, vulnerable populations, and more.
Three new countries are spotlighted in the 2014 edition: Cameroon, Mozambique, and Zambia. The 2014 edition also includes hundreds of updates from the 2013 edition.
The listings are organized into seven categories:
Many of the listings include a hyperlink, allowing the user to link directly to the law, regulation, or guideline of interest. The Compilation is available in both PDF and MS Word versions.
Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors, and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually.
Semaglutide Significantly Improves Steatohepatitis, Fibrosis in Phase III MASH Trial
May 2nd 2025Interim results from the Phase III ESSENCE trial published in The New England Journal of Medicine show once-weekly semaglutide improved liver histology, metabolic markers, and weight loss in patients with biopsy-confirmed metabolic dysfunction–associated steatohepatitis and stage 2 or 3 fibrosis.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.