On February 17, Theodore J. Cicero, Ph.D., speaks on “What is the relationship of public policy, public accountability and public trust?” The talk will be part of a session called “Public accountability and public trust: An issue for clinical research.” The session runs from 10:30 a.m. to noon.
The general public often finds the conduct of clinical research confusing as results from clinical trials can conflict with one another, and news stories about misconduct and conflict-of-interest problems can undercut public confidence in the research enterprise, both in federally sponsored and privately funded studies.
Media reports often emphasize the negative aspects of clinical research. Even the National Institutes of Health and the Food and Drug Administration have come under scrutiny, with news stories reported about internal conflicts of interest and failure to protect the public health.
“There’s a common perception that research results can be biased in favor of the companies that develop new therapies or medical devices,” Cicero says. “Because a private corporation is often funding the research, many people suspect there may be pressure on investigators to report positive results.”
As vice chancellor for research, Cicero is responsible for supervising all aspects of research administration — such as grants management, federal compliance and regulatory activities, animal studies, human studies, conflict of interest, research integrity, funding opportunities and technology transfer.
“There’s a sense that the relationship between those funding clinical trials and those conducting the trials can get too close,” Cicero says. “That perception does a great deal of damage to the research enterprise.”
For most of the 20th century, the public expected science and technology to generate “miracles” like the polio vaccine, and there was very little reporting on the risks involved in clinical research. In the last quarter century, however, the risks became more widely known, from exposure of the Tuskegee trials to the deaths of research subjects in clinical trials.
“Mechanisms to shore up public trust through research integrity and accountability have become more critical than ever,” Cicero says. “For example in the last 12 months, we’ve launched a new committee at Washington University to look very carefully at all research involving human subjects, both to review clinical studies for potential safety issues and to ensure there are no conflicts of interest.”
He says the new committee acts as a quality-control mechanism to audit the existing Human Studies Committee that already reviews and approves all clinical studies. Cicero says Washington University is also fine-tuning the ways in which it obtains informed consent from subjects who volunteer for clinical studies. For several years, the University also has required investigators to report potential conflicts of interest, not only in clinical studies but in all areas of research.
He says there is much more work for research institutions and universities to do in order to protect study subjects and make them feel safe, and he says such efforts are necessary to restore public faith and confidence in the research enterprise.
Cicero is a member of the steering committee of the Association of American Medical Colleges Group on Research Advancement and Development. He is also a member of the Association of American Universities Senior Research Officers and serves on its steering committee. And he is chairman of the State of Missouri’s Seed Capital Investment Board and the Research Alliance of Missouri.
He is a life fellow of the American College of Neuropsychopharmacology and past president of the College on Problems of Drug Dependence. He also serves on the board of scientific counselors of the National Institute for Drug Abuse and is a field editor for the Journal of Pharmacology and Experimental Therapeutics. He has more than 170 publications related to the neurobiological substrates of substance abuse and has active grants from the National Institute of Drug Abuse.
In 1991, Cicero was appointed as the associate vice chancellor/associate dean of the School of Medicine. He was appointed vice chancellor for research at Washington University in 1996. He also currently serves as vice chairman for research in the Department of Psychiatry at Washington University School of Medicine.
Washington University School of Medicine’s full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News and World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.