The Association for the Accreditation of Human Research Protection Programs, or AAHRPP as it's known, has issued a final version of its first major revisions to its standards, which are now eight years old. The process began in late 2008 and included a comprehensive review of the standards as well as a period for public comment. The result is a reduction in standards, from 22 to 15, and a reduction in the number of elements, from 77 to 60.
An AAHRPP press release describes the revisions as "providing a more logical framework for a human research protection program (HRPP) and better definition of the primary roles and responsibilities of the entities that comprise an HRPP."
It also says that the revised version allows for more flexibility in interpreting the standards and strengthens the standards on global research, conflict of interest, community-based research, and data and safety monitoring.
Starting March 1, 2010, organizations interested in applying for accredidation will follow the final revised accreditation standards, which will then be referred to as the AAHRPP Accreditation Standards. But from now until February 28, 2010, organizations may follow either the revised standards or the pre-revised accreditation standards.
Those interested in checking out the revised standards or comparing them with the current standards can do so at AAHRPP's Web site.
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.