This week’s Research Ethics Roundup examines the New England Journal of Medicine’s (NEJM) editor-in-chief’s call for a new approach to sharing clinical trial data, how experts are trying to improve drug testing success rates by reviewing pre-clinical research assumptions, a National Academies committee’s call for a nongovernmental body to promote research integrity, and a new study that rebuts critics’ claims that the Food and Drug Administration (FDA) is slow to approve new drugs for the American market. Read more
TAG ARCHIVES FOR FDA
This month’s question places you in the FDA commissioner’s seat: You are the Commissioner of the FDA. A friend has informed you of the following situation: Over 1,000 people with severe, refractive emphysema have banded together to test a drug that is approved for asthma but not emphysema. Participants “drew straws” to determine which of them would ask their physicians for a prescription. While the FDA has no authority over the practice of medicine, it does have authority over clinical studies that create generalizable knowledge. Read more
In March, PRIM&R hosted the webinar Electronic Informed Consent: Ethical, Regulatory, and Practical Implications. Presented by Cheryl Grandinetti, PharmD, a health science policy analyst at the FDA, and Christian Simon, PhD, a bioethicist at the University of Iowa who conducts research on electronic informed consent (eIC), this webinar helped attendees understand the definition of eIC, grasp its regulatory requirements and context for using it in FDA-regulated clinical trials, better anticipate the challenges and benefits associated with eIC, and recognize how investigators and IRBs can promote its ethical and effective use. The presenters were joined by additional panelists Leonard Sacks, MD from the FDA and [...] 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
This week’s Research Ethics Roundup examines what the new 21st Century Cures law means for harmonization efforts, why cancer trials struggle with minority enrollment, a new study on reporting of bias-reducing methodologies in animal research, and the argument for open access publishing.
Cures Law Requires FDA, HHS to Harmonize Regs
Jeannie Baumann reports for Bloomberg BNA about a provision in the new 21st Century Cures law that requires the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) to address any differences between their corresponding [...] Read more