Without a strong ethical underpinning, clinical trials can quickly lose their way, potentially harming volunteers, setting back valuable research, and damaging the reputation of the entire profession.
It’s a serious issue replete with regrettable historical reminders such as unethical syphilis experiments by U.S. researchers on misinformed patients in Guatemala in the 1940s and at the Tuskegee Institute in Alabama from the 1930s into the 1970s, the disastrous first-in-human study of theralizumab by TeGenero Immuno Therapeutics in the United Kingdom in 2006, and the death of Jesse Gelsinger in 1999, allegedly from his participation in a faulty gene therapy–related clinical trial at the University of Pennsylvania.
“We have to learn from our mistakes,” says Joy Jurnack, RN, CCRC, FACRP, a quality assurance specialist. While principal investigators (PIs) bear the ultimate regulatory responsibility to establish and ensure strong ethical practices in clinical trials, it’s a team effort, she notes. “Some clinical research coordinators [CRCs] need to have a better handle on ethics and working with PIs,” she adds.
Among other issues, the Gelsinger incident highlighted the need to address potential sponsor-related financial conflicts of interest for PIs, appropriate PI delegation of responsibilities, and adequate reporting of adverse events—especially early in a trial, Jurnack notes.
For example, financial issues need to be disclosed immediately, she says. A conflict of interest “doesn’t necessarily mean you can’t do the study, but it needs to be disclosed” and clearly addressed, she adds.
Working together, CRCs, PIs, and the rest of the clinical trial team can “connect the dots” to ensure patients are treated safely and honorably, and trials are conducted with the highest possible level of professionalism, Jurnack says.
A long-time teacher and trainer, Jurnack also advocates a careful reading of The Belmont Report, written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the late 1970s. “It’s a valuable, 10-page document that provides a cornerstone of ethical research conduct,” she says.
“I love research ethics,” Jurnack says. “There’s a thrill being involved in learning where we’ve come from as an industry [and when we’ve made mistakes] and making sure we don’t go that way again,” she notes. “It’s vital we learn from our past,” she stresses.
Author: Michael Causey