Best Practices for Managing Conflict of Interest in University Research
Originally presented October 14, 2010

As the business of technology transfer continues to evolve, increased attention is being focused on managing conflicts of interest that can arise within university research programs and tech transfer offices.

With the NIH proposing significant changes to its financial conflict of interest regulations, the enactment of the Grassley “Sunshine” legislation as part of President Obama’s health reform legislation, and the release of the AAMC’s report on conflict of interest in clinical care, the stakes are getting higher — and the management of the myriad compliance challenges is becoming more complex.

To help you navigate the COI minefield, Technology Transfer Tactics’ Distance Learning Division has lined up an attorney and a TTO exec who bring a wealth of experience on this front — Bernadette M. Broccolo of McDermott Will & Emery, LLP, and Jim Baker, Director of Technology and Economic Development at Michigan Tech University — to bring you up-to-the-minute on important recent developments as well as provide practical strategies for tackling the broad spectrum of COI issues you will face and must address in today’s tech transfer initiatives.

Here’s what you’ll learn in this nuts-and-bolts session:

• Review of the latest developments including the NIH proposed regulations, the Sunshine legislation and industry guidance
• Understand what these developments mean to your institution’s tech transfer programs
• Best practices in COI policy and procedure development, monitoring and enforcement
• Strategies for faculty COI orientation and ongoing education
• How to recognize critical red flags that should spur a COI review
• Internal review practices that stand up to external scrutiny
• Defining individual, institutional, and imputed institutional interests
• Identifying and addressing related regulatory considerations such as fraud and abuse, false claims and off-label promotion laws
• Drawing lines between sponsored research and licensing
• Keeping tabs on faculty consulting agreements and other financial relationships with vendors
• COI case studies — the good, the bad, and the really ugly

Your Expert Presenters:

Bernadette M. Broccolo is a partner in the Health Law Department of McDermott Will & Emery LLP, based in its Chicago office. She currently serves as chair of the firm’s Life Sciences Division and as co-chair of the Personalized Medicine Team. Bernadette advises clients on leading edge health industry relationship formation and realignments — joint ventures, governance restructurings, and relationships between institutional providers and physicians; conflict of interest compliance; comprehensive programs for human subject, animal and bench research; and overall corporate compliance programs. She focuses on the full scope of legal and regulatory compliance in the areas of federal taxation of exempt organizations, not-for-profit corporate governance, privacy, human subject protection, and technology contracting. Bernadette has been selected by her peers to be included in the 2010 edition of The Best Lawyers in America for her expertise in health care law and has been named Chicago Best Lawyers Health Care Lawyer of the Year for 2010.  Bernadette is listed as a leading individual in health care in Illinois and nationally in Chambers USA 2010: America’s Leading Lawyers for Business. She has also consistently been named an Illinois Super Lawyer and one of the Leading Lawyers Network s “Top Women Business Lawyers in Illinois.”

Jim Baker, PhD, is Director of Technology and Economic Development at Michigan Technological University. Jim’s current responsibilities include handling University inventions from disclosure through patenting and licensing to both established and start-up businesses. Within the university, he is also responsible for terms of industrial sponsored research, non-disclosure, and material transfer agreements, as well as other related agreements with private sector partners. In addition to university technology transfer and industrial contracting, Jim directly supports the growth of regional technology companies through a close working relationship with a diverse network of the local and regional economic development partners and service providers including the Michigan Small Business and Technology Development Center, supported by the U.S. Small Business Administration. Prior to entering the technology transfer field, Jim served as the Acting Director of the Michigan SmartCel Business Accelerator and has held positions in the engineering and information technology fields including the General Director of ChemAlliance, an online chemical industry regulatory compliance assistance center, and Program Manager of the National Center for Clean Industrial and Treatment Technologies. Jim is a registered Patent Agent and holds a Ph.D. in Environmental Engineering from Michigan Technological University.