I Want to do Clinical Research but the FDA Wants me to do What?!?

Monday, March 30, 2009, 4 - 5:30 p.m.
President's Room, Coffman Memorial Union
(Map)

“This drug has worked with a number of my patients. Now I want to try it on a larger scale, but I have run into many layers of rules, regulations and paperwork for the FDA. Why can’t I just do my research??” Join Dr. Harvey Arbit for a discussion of why the FDA does what it does and the implications this has for clinical researchers. Dr. Arbit will present a brief history of FDA regulations and define key concepts and obligations for investigators, sponsors and sponsor/investigators. Using examples and agency samples, the presentation and discussion will focus on why it is important to understand these obligations and what can happen when things go wrong.

Dr. Arbit is the Director of the IND/IDE Assistance Program in the Office of Clinical Research at the University of Minnesota Academic Health Center. He is also an adjunct associate professor in the College of Pharmacy, Department of Pharmaceutical Care and Health Systems. Dr. Arbit has over 30 years experience in the pharmaceutical and medical device industries where he held director and vice president level positions in the areas of regulatory affairs, clinical research, quality assurance, and product development. He currently serves on the steering committee of CTTI and on the board of directors of SoCRA. Dr. Arbit’s education includes a bachelor’s degree in pharmacy, a PharmD, and an MBA as well as a residency in clinical hospital pharmacy. He is also regulatory affairs certified and clinical research certified.

Trying to Maintain Integrity in a Contrary Research Environment

Wednesday, November 14, 2007, 4 - 5:30 p.m.
President's Room, Coffman Memorial Union
(Map)

Discovering that someone in the laboratory or other research site has been engaging in misconduct has to be one of a researcher's worst nightmares. Researchers trust that rules, oversight, training, and mentoring will ensure that everyone behaves properly. However, certain aspects of the research environment exert strong pressures in the opposite direction. Competition, for example, is associated with higher levels of questionable research conduct. High expectations should promote responsible research, but counter-normative behavior tends to compromise integrity. Training and mentoring are important, but their actual effects are mixed at best. Dr. Melissa S. Anderson will discuss aspects of the research environment that threaten or compromise integrity, based on empirical evidence from a national survey of NIH-supported researchers. The presentation and discussion will concern ways of countering these pressures.

Melissa S. Anderson, Ph.D., is the Director of the Postsecondary Education Research Institute, the Coordinator of the Graduate Program in Higher Education, and Associate Professor of Higher Education at the University of Minnesota. Her research over the past 20 years has focused on scientific integrity. The research that she and her colleagues published in Nature in 2005 provided the first estimates -- based on cross-disciplinary, national data -- of the prevalence of misconduct in science. Her most recent research on training and mentoring in the responsible conduct of research in relation to scientists' actual behavior appeared in Academic Medicine

Who? Me?!
Conflict of Interest: Perception vs. Reality

Wednesday, June 6, 2007, 4 - 5:30 p.m.
215 Ben Pomeroy Student-Alumni Learning Ctr
1964 Fitch Avenue, St. Paul campus,
(Directions & Map)

Join University experts on conflict of interest for a discussion of the outside relationships that could impact research and scholarship in your field. University policy and procedures governing individual and institutional conflict of interest as well as outside consulting and commitment will be reviewed and discussed. As work with outside agencies or commercial enterprises increases and new opportunities arise, assessing the potential for conflict and developing management strategies becomes very complex. Learning when and what to disclose and how these disclosures are managed will be explained with time allowed to answer your questions.

Richard W. Bianco is Associate Vice President for Research at the University of Minnesota. In this capacity he oversees research compliance including the Research Subjects Protection Program (administrative home of the IRB and IACUC.) He serves as the Institutional Official for Human Subjects Protection and the Animal Care Program. Mr. Bianco also directs the conflict of interest management program for the University of Minnesota.

In addition Richard Bianco is Director of Experimental Surgery, Assistant Professor of Surgery, and Executive Vice Chairman for Administration of the Department of Surgery in the University of Minnesota Medical School.

From Leviathan to Peer Review:
Social Science and IRBs

Wednesday, March 21, 2007, 4 - 5:30 p.m.
Walter F. Mondale Hall, Room 25

Social Science Research and IRBs: Can't We Get Along?

Psychologists, anthropologists, oral historians, and educational researchers-to name but a few-have expressed sincere concern that IRB review of their research violates principles of academic freedom and inhibits important investigation. While biomedical fields have accepted IRBs, social and behavioral science (SBS) has viewed their role as an encroachment on research. This talk and subsequent conversation will address these often controversial issues, offer a somewhat novel rationale for IRB review of SBS research, and consider implications of viewing IRBs as peer-review bodies.

J. Michael Oakes, Ph.D., is Assistant Professor in the Division of Epidemiology, School of Public Health, at the University of Minnesota and a fellow of the Minnesota Population Research Center. He is an active researcher and frequent principal investigator on a wide variety of studies involving human subjects.

Originally trained in sociology, Dr. Oakes has authored more than 35 papers exploring problems at the intersection of social and medical sciences; he recently released his first text, Methods in Social Epidemiology.

Additionally, he has published several articles on various aspects of IRBs and is a frequent speaker at IRB-related conferences. He co-founded and currently chairs the novel and highly regarded student research IRB panel at the University of Minnesota.

Finally, Dr. Oakes is an AAHRPP site visitor, member of NIH study section HSOD, and consults with a number of not-for-profit community organizations aiming to reduce health disparities among populations.

For more information, please contact Carol Foth at fothx001@umn.edu or 612-624-1854.