The research community has a full plate as it sifts through the final rule on the Common Rule issued last week. Many are now fully appreciating the December gift from the National Institutes of Health that granted an extension for developing policies to streamline multi-site studies under a single Institutional Review Board (IRB). On December … Continue Reading
An overview of stakeholder comments on proposed revisions to informed consent forms and the posting of informed consent forms within 60 days after closure of enrollment On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection … Continue Reading
In the world of healthcare policy and law, we usually discuss issues impacting providers, but don’t often report about the training and infrastructure behind what allows our healthcare system to treat patients in our facilities. Many warnings have come and gone about how we are not training enough physicians for primary care, and the ACA … Continue Reading