While the FDA and OHRP share a mission in protecting volunteers in research, the FDA has a unique responsibility as a public health and consumer protection agency. The dual mission is reflected in the purpose for Investigational New Drug and Investigational Device Exemption regulations which propose to assure safety and rights of subjects, permit evaluation of a drug’s safety and effectiveness, and encourage discovery and development of useful devices intended for human use. Read more
Have you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed three AER21 sessions on implementing OHRP and FDA regulations. In each session, the presenters dismantled any fear I had surrounding interaction with regulatory entities by offering rubber-meets-the-road application of regulatory requirements and resources to be properly prepared. Read more
The COVID-19 pandemic has brought many issues to the public’s attention that used to be of interest only to clinical research and drug development communities: clinical trial design, efficiency and timelines of clinical research studies, drugs’ approval process, and pre-approval access to investigational therapies are just a few. Read more
In July, PRIM&R collaborated with CITI Program to host the advanced-level webinar Data and Safety Monitoring: Advanced Issues and Case Studies. Expanding on introductory knowledge in the module Data and Safety Monitoring in Human Subjects Research, part of CITI Program’s Biomedical Basic course, this webinar described ways in which the IRB, the data and safety monitoring board (DSMB), the investigator, and the sponsor can work together to ensure scientific integrity and subject safety in clinical trials. Summaries of government and non-government organizations’ guidance as well as interactive case studies offered strategies for handling complex situations that may arise during data and safety monitoring, including when and how to report adverse and unanticipated events, when a DSMB is needed, and what is considered a conflict of interest. Read more
This week’s Research Ethics Roundup covers President Trump’s call for removing a majority of FDA regulations, the argument for calling for efficacy data before human research begins, USDA’s decision to remove Animal Welfare Act records, and FDA’s case for conducting phase three testing. Read more
