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...
This past May 20th was International Clinical Trials Day celebrating the life changing triumphs that result from the efforts accomplished by clinical researchers. Its birth was inaugurated back in 1747 when James Lind pursued a cure for scurvy. BioMed Central...
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...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
