BLOOMBERG BNA WEBINAR EVENT: The SUPPORT Trial on Oxygen Therapy in Premature Infants: Ethical and Regulatory Issues
Wednesday, July 17, 2013
1:00 PM - 2:30 PM ET
The Surfactant, Positive Pressure and Oxygenation Randomized Trial (SUPPORT), which looked at the health outcomes of premature infants given different levels of supplementary oxygen, gained notoriety after the Department of Health and Human Services Office for Human Research Protections (OHRP) issued a compliance determination letter in March of 2013 raising serious concerns about the lack of information in, and comprehensiveness of, the research consent forms approved by the 23 institutions participating in this research. The OHRP determination letter was followed by several communications from the public advocacy group Public Citizen affirming the OHRP determination of compliance issues but going further and alleging that the egregious nature of the insufficiencies exceeded what was flagged by the government.
These communications generated controversy resulting in many opinion pieces and editorials published in theNew England Journal of Medicine as well as the New York Times–some supporting the trial and criticizing the critics, others supporting the government and Public Citizen.
In addition, a lawsuit has been filed against the University of Alabama, the lead site in the study, alleging that the premature babies enrolled in the study were subjected to research that was unethically designed and exposed the subjects to undisclosed and unacceptable risks of death and blindness.
What are the issues raised by this controversy over the SUPPORT study? How does this impact Institutional Review Board (IRB) review of randomized studies? How might it influence future studies of comparative effectiveness? The faculty for this program will address these issues, with representation from those on each side of the debate.
• Understand the regulatory requirements for Institutional Review Board (IRB) review of research.
• Learn about the complexities of research informed consent requirements and randomized clinical trials.
• Discover how usual routine clinical care differs from research interventions in a clinical trial.
Who would benefit most from attending the program?
Researchers; Institutional Review Board (IRB) members and staff; research compliance staff; health care attorneys.
Program Level: Advanced.
Credit Available: This program’s CLE-credit eligibility varies by state.