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
TAG ARCHIVES FOR human subjects research
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
In Case You Missed It (ICYMI): From time-to-time, PRIM&R will feature particularly well-received posts from the recent past. These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, AER12 poster presenter Brandon Brown follows up on his initial findings regarding the incentives used to encourage participation in human subjects research. Read more
In this month’s installment of PRIM&R’s featured member interviews, we hear from Maureen Greene, a longtime PRIM&R member working in human subjects and animal research. This series is intended to let our community get to know our membership and hear about the impact they make through their daily work. Read on to hear from Maureen!
PRIM&R: When and why did you join the field?
Maureen Greene (MG): I joined the field of research in 1985 when I had the inquiring mind to ask: Why? Early in [...] Read more
In Case You Missed It (ICYMI): From time-to-time, Ampersand will feature particularly well-received posts from the recent past. These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, part of a series of posts working through the Notice of Proposed Rulemaking for revisions to the Federal Policy for the Protection of Human Subjects, PRIM&R Executive Director Elisa Hurley explains the impetus for [...] Read more