This week’s Research Ethics Roundup the ramifications of only using male lab mice in preclinical research, why so few lab chimpanzees have been sent to sanctuaries, Public Citizen’s letter to the Department of Health and Human Services (HHS) on new SUPPORT trial findings, and the ethics of pricing a Zika vaccine. Read more
In the wake of the controversy over the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), a team of bioethicists set out to answer two main questions raised by the controversy: (1) “what do people think about the risks and benefits of research on medical practices?,” and (2) “what do people think about different approaches to informing patients that this type of research is being conducted?” Their research, the Research on Medical Practices Ethics Study, examined the views of the general population regarding research on medical practices through a series [...] Read more
by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager
Research on the comparative effectiveness of commonly used interventions is becoming increasingly common as clinicians, researchers, and healthcare funders seek to improve the efficiency and effectiveness of health care by developing a strong evidence base about medical interventions. With the growth of such efforts, questions have emerged about how oversight rules and mechanisms for the protection of human subjects should apply to such endeavors. In October, following more than a year of deliberation and public consultation, the Office for Human Research Protections (OHRP) released draft guidance regarding how the [...] Read more
by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager
On Friday, October 24, the Office for Human Research Protections (OHRP) released a draft guidance document titled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The draft guidance follows more than a year of deliberation and public consultation prompted by the controversy surrounding the Surfactant, Positive Pressure, and Oxygenation Trial (SUPPORT).
SUPPORT was a multisite randomized trial that took place from 2005 to 2009 and sought to determine, in part, the optimal oxygen saturation for extremely premature infants. [...] Read more
by Alice Dreger, PhD, Professor of Clinical Medical Humanities and Bioethics at the Feinberg School of Medicine at Northwestern University
The heated debate about the National Institutes of Health- (NIH-) funded Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) continued on October 27 in Atlanta at the annual [...] Read more
