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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.