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
TAG ARCHIVES FOR FDA
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
This week’s Research Ethics Roundup examines new international guidelines that focus on research in low-and middle-income countries, experts’ unease over increasing changes to the FDA’s mission, the academic debate over primate research, and what 21st Century Cures means for public health. Read more
This week’s Research Ethics Roundup reviews researchers’ efforts to learn about how traumatic brain injury affects women’s brains, the first CRISPR gene-editing human subjects trial, why patient groups object to changing FDA rules on off-label promotion, and scientists’ arguments for why living conditions for lab mice need to change.
Wanted: Women’s Brains — to Jump-Start Lagging Research on Female Concussions: In this STAT News article, Usha Lee McFarling examines new efforts to collect data on the effects of traumatic injury on women’s [...] Read more