Dean Bard Teaches Short Course on Human Subject Research
During the first week of January, Dean Bard co-taught a week long course in human subject research with long-time adjunct and Dinsmore & Shohl partner, Dr. Frank Woodside, a first in short course history. Eight students participated in the class.
The course included lively discussion of the legal and ethical issues that govern research either funded by the federal government or intended to prove the safety & efficacy of new prescription drugs or devices. The students also enjoyed presentations from the Vice President for Research’s Office, including Dr. Jane Strasser, Associate Vice President for Research and Comparative Medicine at the University of Cincinnati, Mike Linke (the chair of the University of Cincinnati’s Institutional Review Board), Angela Braggs-Brown (the director of the Office of Human Subject Research) and Holly Bante, Director, Conflict of Interest & Asst. Professor, College of Medicine. Click here for more pictures from the class.
“It was a fun and energizing way to start the semester. Human Subject Research regulation has been one of my primary areas of scholarship.” It presents complex regulatory issues that are relevant to any program that gets federal funding but it also has interesting ethical issues about how much risk individuals should be allowed to take. Research compliance is also a growth area in terms of hiring lawyers so I wanted to introduce students to something that would open new career doors for them.”
Said Dr. Woodside “I appreciate that I was asked to participate; learned a great deal; enjoyed the interaction with the students.”
Angela Braggs-Brown is the Director of UC’s Human Research Protection Program (HRPP), she is also a member of the UC IRB. She has been involved with FDA regulated research in addition to social behavioral and policy research over the last 15 years. Ms. Braggs-Brown is Regulatory Affairs Certified (RAC) as well as a Certified IRB Professional (CIP).
Dr. Mike Linke has served on the University of Cincinnati IRB for over 20 years and was appointed Chair in 2004. Dr. Linke is a Health Science Officer at the Cincinnati VA Medical Center and an Associate Professor at the UC College of Medicine. In 2012, under his leadership the UC IRB Social and Behavioral IRB merged with the Medical IRB to form a single IRB that reviews all human subjects research conducted at UC. He now serves as Chair of the combined board. He led the formation of the National Institutes of Health StrokeNet Central IRB and serves as Chair of the Central IRB. StrokeNet is funded by the NIH to conduct clinical trials for stroke prevention, treatment, and recovery. UC serves as the National Clinical Coordinating Center and the network consists of 25 Regional Coordinating Centers with over 300 clinical sites. Awarded the Greater Cincinnati Health Council’s first ever Servant Leadership Award for his efforts in creating and leading the Consortium of Greater Cincinnati IRBs He also serves in various roles in the VA human subjects protection program and has been actively involved in the human subjects research accreditation processes at UC and the VA.
Jane Strasser is the Associate Vice President for Research and Comparative Medicine at UC. As UC’s Institutional Official she is responsible for ensuring that the Human Research Protection Program is supported and compliant. As the Research Integrity Officer she is responsible for investigating allegations of research misconduct and protecting the integrity of the research record. Dr. Strasser is an Associate Professor of Pediatric Infectious Diseases and the Director of the Office of Research Integrity.