The National Academies of Sciences, Engineering and Medicine released a new report in late June that looks at federally funded research and is now recommending an independent commission be established to take a close look at ethical and legal issues of human subjects...
Pearl IRB is proud to announce its recent accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction by demonstrating two primary techniques including extensive safeguards in all levels of...
FDA released a new guidance today that reflects items that have appeared across several past guidance documents. It is entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for...
At the end of February, FDA released a final rule, entitled “Additional Safeguards for Children in Clinical Investigations of Food and Drug Administrated-Regulated Products.” The final rule says that FDA will not allow waivers of parental or guardian permission for...
Two articles in the Hastings Center Report, entitled “Ethical Oversight of Learning Health Care Systems” challenge the current ethical practices for protecting human volunteers in medical studies, according to a recent article on medicalnewstoday.com. The Hastings...
