Clinical research expert Barbara Hammack, PhD, likes to ask investigators what keeps them up at night. She’s not just being nosy or looking to heighten their anxiety. As a member of the CCTSI’s Research Ethics Consult Service says, “We ask this in an effort to let them figure out what they think is risky about their research.”
Hammack says it was the notion that all research involves some risk that inspired the topic of the CCTSI’s 9th Annual Research Ethics Conference, Risky Research: What Keeps You Awake at Night?
Held in the Gossard Forum of the Fulginiti Pavilion, attendees filled nearly all 140 seats. “Every year the conference steering committee chooses a specific topic in research ethics that is timely and engaging,” says conference organizer and CCTSI’s Director of Research Ethics Marilyn Coors, PhD. This year, the committee of Hammack, Coors, David Badesch, MD and Jackie Glover, PhD chose a topic they hoped would attract the physicians who lead the clinical research on the Anschutz Medical Campus. “We were trying to mix things up in terms of format and with the overall topic, which was less specific than in the past,” says Hammack. “What constitutes risk? Who is the decision maker? These were the key questions.”
John Lantos, MD professor of pediatrics at the University of Missouri-Kansas City School of Medicine and director of the Children's Mercy Bioethics Center at Children's Mercy Hospital delivered the keynote address. He started his talk by asserting that all research is risky, and so is life. He asked the audience, “But when is a study so risk free that safeguards may not be necessary? Or when do we know enough about an innovation that we don’t need to study it anymore?”
He brought the perspective of both a clinician and ethicist to his discussion of a large pragmatic trial on the best dosage of aspirin as well as a series of studies on ECMO, an innovative high-risk technique used in babies with life-threatening heart and/or lung problems. He led the audience through discussions of both trials, engaging the researchers along the way with questions about whether or not they would approve of particular aspects of the study if they were on the Institutional Review Board (IRB). He also asked, in both cases, if it would be riskier to be in the study or not be in the study?
During the discussion of a randomized control study on ECMO, Research Services Director Ethan Carter, PhD said, “This raises the issue of personal risk vs. societal risk. I might be willing to gamble on something if I understand risks that are personal, but I may not feel comfortable making that decision for others.”
Later in the morning, Larry Allen, MD (below) presented Shared Decision Making Can Result in Better Choices, which featured his work with decision making for individuals in advanced heart failure. William Cornwell, MD followed with his presentation on Defining the Limits of the Cardiovascular System Through Invasive Exercise Testing in Health and Disease. Cornwell’s study involves heart failure patients who have an artificial heart (or Left Ventricular Assist Device) and as part of the study, engage in vigorous exercise with a catheter inserted into the heart.
In terms of minimizing risks, Cornwell discussed the advantages of personal experience (he has exercised with a catheter in his own heart just so he knows what it feels like for his patients), multidisciplinary collaborations, the importance of SARC, COMIRB, patient safety advocates and a DSMB and importantly, humility. He says, he constantly asks himself, “Have I imagined everything that could go wrong?”
The day continued with presentations from Margaret Macy, MD on early phase clinical therapeutic trials in pediatric oncology; Terry Fry, MD on balancing high-risk and high-efficacy of CAR T cell trials in children; and Joseph Sakai, MD, on deep brain stimulation for cocaine use disorder.
“We want to provide value to the research community by presenting an ethical framework for their work that is in addition to the regulatory environment,” says Coors. “We also aim to stimulate researchers to think deeply and intentionally with other researchers, ethics faculty and other prominent national ethicists in engaging discussion.”
If you have suggestions about future topics or speakers for next year’s Research Ethics Conference, contact Marilyn Coors