This week’s Research Ethics Roundup looks at how researchers can learn about chronic traumatic encephalopathy (CTE) from living mixed martial arts (MMA) fighters, why scientists are increasingly providing research primates with cage-mates, how research misconduct is handled in Canada, and the argument for more Food and Drug Administration (FDA) oversight of stem-cell clinics. Read more
In September, PRIM&R hosted the webinar Mouse Anesthesia for IACUCs and Researchers, presented by Dr. Jim Marx, DVM, PhD, DACLAM, a veterinarian and researchers whose own research focuses on improving the care of mice in biomedical research. This basic-level webinar, ideal for researchers and IACUC staff, explains the fundamentals of administering and monitoring anesthesia in mice, including how to determine the proper anesthetic depth for a given protocol, how to make basic recommendations about anesthetic protocols to achieve the different planes of anesthesia, and how to understand the basics of anesthetic monitoring as an indicator of correct administration of anesthesia.
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Historically, medically-oriented research has dominated the ethical discussions that underlie federal regulations around human subjects protections. Read more
You are a member of an IRB reviewing a study protocol for a new artificial heart that, if approved by the FDA, will likely save many lives. The study sponsor, a very small company, plans to test the device in patients who will probably die without the device. It cannot afford to test the device with an adequate sample size, so it proposes to increase the sample size with funds raised by auctioning off the right to participate. Any delay in approval will likely cost lives.
You have no other information to make your decision and no clever way to dodge it. How will you vote? Read more
While it may be a common complaint among researchers that IRBs overregulate, many IRBs opt to “uncheck the box” by building additional flexibility into the regulations that allows them to reduce investigator burden while still ensuring equivalent protections for human subjects. Read more
This week’s Research Ethics Roundup looks at a top Food and Drug Administration (FDA) official’s speech on real world evidence, a National Academies report that highlights the lack of guidance for the research community on the security concerns around dual-use research, how and why the All of Us Research Program is working with traditionally marginalized communities, and the effectiveness of Animal and Plant Health Inspection Service (APHIS) inspections of Agricultural Research Service facilities. Read more