TAG ARCHIVES FOR human subjects research

8
May2017

In April, PRIM&R hosted the webinar Compensation or Inducement? What IRBs Need to Know about Paying Subjects for Participation. Presented by Alex John London, PhD, and Betsy Ripley, MD, MS, RAC, this webinar provided foundational knowledge about the underlying ethical principles that govern compensating tresearch subjects. Through case studies, examples, and review of existing guidance and regulations, attendees learned strategies for evaluating payment to subjects for their participation in studies. Here, the presenters answer some of the questions time didn’t permit us to answer live. Read more

14
Apr2017

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

5
Apr2017

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

28
Aug2016

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

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