Background McLaren Health Care charges fees for IRB review of research studies supported by pharmaceutical, medical device, and other for-profit entities. The current IRB review fees were last increased in April 2024. Following a comprehensive review of fee structures, resource utilization, and a fair market value analysis, McLaren Health Care will implement new fees for the review and oversight of human subject research studies supported by industry and other for-profit entities, effective February 1, ...
Background On January 6, 2025, the International Council for Harmonisation (ICH) released the final version of ICH GCP E6(R3), updating the 2016 E6(R2) standard. The revised guideline reflects modern approaches to clinical research, including decentralized trials, electronic systems, and risk-based oversight. This revision introduces significant changes affecting the responsibilities of investigators, sponsors, and Institutional Review Boards (IRBs). The U.S. Food and Drug Administration (FDA) officiall...