In late August the U.S. Department of Health and Human Services and the Public Health Service implemented new financial conflict of interest (FCOI) regulations. The comprehensive changes – as well as the challenges introduced for research institutions – are no trifling matter. These new FCOI regulations establish more stringent and prescriptive standards and thresholds for conflict of interest disclosure, assessment and management, new policy and procedure and training requirements, and new requirements for public disclosure of policies and conflicts of interest, all of which must be followed by institutions that apply for or receive research support from PHS agencies, including the National Institutes of Health.
It’s imperative that tech transfer leaders, compliance staff, department heads, and university counsel attend this one-hour program, led by attorney and conflict of interest specialist Bernadette Broccolo. She’ll provide a detailed overview of new rules and explore strategies for navigating the compliance challenges they present. Here’s a quick look at the agenda:
- Specifics of PHS policy changes as of August 2012
- New disclosure thresholds
- Wider net for disclosure obligation
- Expansion in scope of investigator responsibilities
- Institutional determination of FCOI and corresponding FCOI reporting and management obligations
- Researcher training requirements
- Impact on academic start-ups
- IP rights as a Significant Financial Interest
- Requirements for updating disclosures
- Public disclosure rules
- Developing and implementing FCOI management plans
- Anticipating heightened government scrutiny
- Strategies for softening the administrative burden
- How seemingly mundane financial situations could unknowingly cause catastrophic conflicts
PLUS: We’ll review recent, high-profile FCOI cases
Bernadette M. Broccolo is a partner in the law firm of McDermott Will & Emery LLP and is based in the firm’s Chicago office. Bernadette is an expert in conflict of interest compliance and overall corporate compliance programs. She has been counseling health industry organizations for over 32 years on leading edge health industry relationship formation and realignments, with a recent focus on development of provider network strategies for responding to health reform; health information technology acquisitions; electronic health information network strategy development and implementation to support innovations in care delivery and payment models, translational research and personalized medicine; and comprehensive programs for human subject, animal and bench research.
Julie Gottlieb, MA is Associate Dean at the Johns Hopkins University School of Medicine and directs the School’s Office of Policy Coordination. The Office manages the review, development, and implementation of policies in areas such as conflict of interest and conflict of commitment, faculty and staff interaction with industry, professional and research misconduct, and use of the Johns Hopkins name. Ms. Gottlieb coordinated a major revision of the University’s policies on conflict of interest and professional commitment; the development of a policy on institutional conflict of interest for the Johns Hopkins University and Health System; the development of a Johns Hopkins Medicine policy on interaction with industry; and policy and guidelines on the use of the Johns Hopkins Medicine name and brand. Ms. Gottlieb has been an invited speaker at national and international meetings on conflict of interest and academic misconduct, and she has provided testimony on proposed legislation in these areas. She is a co-founder and immediate Past Chair of the AAMC Forum on Conflict of Interest in Academe, a national network of professionals involved in conflict of interest policy development and administration at academic medical centers.