For this month’s question you are a member of a local IRB reviewing an influenza vaccine study. The investigator wants to ask enrolled study participants to help recruit additional study participants. The investigator wants to express her gratitude for this assistance. She has asked the IRB whether tangible expressions of gratitude, e.g., cash, would be acceptable. Read more
MISST is an acronym the Connected and Open Research Ethics (CORE) initiative research team uses to describe research that involves the use of mobile, imaging, pervasive-sensing, social media, and location-tracking strategies that can passively observe human behavior. The CORE is a growing community where conversations about research ethics and technology are beginning. We seek to increase awareness of this resource and we invite IRBs and research stakeholders to get involved—specifically, we want to hear from the PRIM&R community! We invite you to join the conversation by signing up for the CORE Network and sharing your questions about how to do this research and/or your expertise and lessons learned. You can also follow CORE on Twitter and LinkedIn. Together we can learn from one another and begin to have an informed discussion developing an ethical framework for MISST. Read more
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
For Sharon Shriver, it’s a simple equation. “Poorly designed research is inherently unethical,” says the director of programs for PRIM&R. Part of the remedy, Shriver says, is to incorporate ethical considerations into study design. “It’s not a focus for institutional review boards [IRBs], but it should be,” she notes. Read more
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
