A scientist who has made the University of Rochester a national model for protecting human research subjects has been appointed to a federal committee charged with doing the same for people nationwide.
Gary L. Chadwick, Pharm.D, M.P.H., associate provost and director of the University’s Office for Human Subject Protection, has been named to the Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protection.
At the University, Chadwick’s team oversees more than 2,000 studies involving thousands of human volunteers who take part in research at the Medical Center, the College, the Warner School, and other University units. Participants take part in a wide range of studies, for example, evaluating vaccines to stop HIV, studying the factors that contribute to healthy relationships, testing new types of defibrillators for heart disease, or learning how language skills develop in young children. It’s Chadwick’s team that makes sure that doctors, nurses, scientists, information analysts and others follow rigorous procedures to ensure the safety of these research subjects every step of the way.
Since Chadwick joined the University in 1996, the University has become a national leader in developing oversight mechanisms for such research. A training manual that he and his Rochester colleagues wrote has sold more than 75,000 copies and is recommended by Federal regulators for physician investigators and research scientists. Since 2007, the University has been accredited by the Association for the Accreditation of Human Research Protection Programs, an organization that demands extensive safeguards exceeding federal regulations.
The University’s track record under his leadership is one of several factors that helped the University become a recognized leader in clinical research in recent years. Since 2006 the University has been home to a Clinical and Translational Science Institute, whose mission is to accelerate the passage of new research findings from laboratories into the lives of patients. Much of the effort involves the thorough training of doctors, nurses, scientists and others to carry out complex studies with people, all the while assuring the safety of those who are volunteering their time to take part.
The CTSI partnership has enabled dozens of University investigators to launch large studies of human health. In addition, CTSI helped the University attract funds to build the new Saunders Research Building, has been an economic boost creating hundreds of jobs for the region – and assures that patients in the Rochester are among the first in the world to have access to potential new treatments for conditions like cancer, heart disease, and Parkinson’s disease.
“Rochester is truly a hub of clinical research,” said Chadwick. “Central to the effort is a program that rigorously protects all our human research subjects. After all, it’s thanks to them that we are able to explore broad questions about human health and to test new treatments for disease.”
Chadwick, a professor of Clinical Community and Preventive Medicine and Medical Humanities, will serve a four-year term, through July 2015. He is one of 11 national experts who are voting members of the panel.
The committee provides advice on matters relating to the responsible conduct of research involving human subjects. Issues include human subject regulations, Federal privacy regulations, consideration of the rights of special populations such as children and people with impaired decision-making capacity, and the rights of people who donate biological specimens used in research studies.