Conflicting Interest and Conflicting Expectations: Challenges Presented by NIH's New Rule was a webinar held on Wednesday, October 6, 2010, from 1:00 to 2:30 PM ET. The webinar provided an overview of the challenges faced by institutions when dealing with financial conflicts of interest, especially in light of the US National Institutes of Health (NIH) rule.
Presented by two of the most respected speakers in the conflicts field, this webinar provided an array of concrete tools to assist those who are charged with developing strategies to manage the transitions required based on the NIH rule. More specifically, attendees:
- Broadened their knowledge of the laws, ethics, and recommended policies for identifying and managing conflicts of interest;
- Got a preview of the NIH rule;
- Learned about the procedures that will likely be necessary to comply with the new rule;
- Learned strategies for educating institutional leadership and faculty about effective educational approaches; and
- Compared the roles and responsibilities of institutional review boards and institutional conflicts committees in identifying, responding to, and/or managing conflicts.
Heather Pierce, JD, MPH
Heather Pierce, JD, MPH is the Association of American Medical Colleges (AAMC)’s Senior Director for Science Policy and Regulatory Counsel in Scientific Affairs. Ms. Pierce is a leader on major issues related to conflicts of interest, human subjects protection, compliance and other regulatory issues related broadly to biomedical research. She is also part of the Scientific Affairs Senior Leadership team, along with Tony Mazzaschi, and Mildred Solomon, EdD Senior Director for Implementation Science.
Ms. Pierce’s professional accomplishments include working as an Associate in the Health Care Group at Ropes & Gray in New York. Her practice focused on regulatory compliance issues including research with human subjects, medical information privacy and security, and fraud and abuse counseling. She worked with a wide range of clients including hospitals, universities, academic medical centers, and pharmaceutical companies. She also assisted with state and federal government investigations and the development of compliance and training programs. She earned her JD at New York University and her MPH at Boston University.
Patrick Taylor, JD
Patrick Taylor is currently a mid-career fellow at the Petrie-Flom Center at Harvard Law School and is an assistant clinical professor at Harvard Medical School. Until recently, he was the deputy general counsel and chief counsel for research affairs at Children’s Hospital Boston. Starting on Wall Street, he has successively worked in government, and the nonprofit world, on diverse aspects of health care law and policy and biotechnology. His current work focuses primarily on legal, ethical and policy issues in biomedical research, biotechnology, and compliance, including privacy.
Mr. Taylor’s professional associations include leadership positions with the health section of the New York State Bar Association, including as chair of the in-house counsel committee, vice chair of the legislation committee and member of the executive committee; co-chair of the standards committee of the International Society for Stem Cell Research (ISSCR); chair of the registry committee of the ISSCR; member of the ISSCR Ethics and Public Policy Committee, member of two ISSCR Task Forces, the ISSCR Task Force on Guidelines for the Conduct of Human Embryonic Stem Cell Research, and the ISSCR Task Force on Clinical Translation of Stem Cells, and chair of the recent ISSCR task force in addressing direct-to-consumer sales of unproven stem cell treatments. He has also taught health care legal, compliance and ethical issues as an adjunct professor at the Albany Medical College and the Albany Law School; was an associate of the Albany Medical College Center for Medical Ethics, Education and Research; and has served as a member of two institutional review boards, the IRB of the Albany Medical College and the IRB of Children’s Hospital Boston as well as the Children’s Hospital Stem Cell Research Oversight Committee. He is also a member of the multi-institutional Harvard Stem Cell Research Review Committee.
Mr. Taylor’s papers have appeared in many journals, including Nature, Science, Nature Biotechnology, Cell Stem Cell, Science and Engineering Ethics, Academic Medicine, Drug Development, the Journal of the American Informatics Association, the American Bar Association’s Health Lawyer, the Journal of the New York State Bar Association and the New York Health Law Journal.
He graduated from the University of Wisconsin-Madison with a BA in Zoology and Philosophy, receiving Phi Beta Kappa and highest honors. He received his JD from Columbia University Law School in 1986. Later, he was a fellow in medical ethics at Harvard Medical School in 2007-2008.
Issues surrounding conflicts of interest are relevant to everyone, but this webinar is of particular interest to:
- institutional officials;
- deans, provosts, and department chairs;
- anyone working with or for an IRB/HRPP;
- federal agency representatives;
- sponsors, including pharma, biotech, and device manufacturers;
- ethicists and policy analysts; and
- others who are interested in this always hot topic.
Please contact us via e-mail or telephone at 617.423.4112, ext. 18. Thank you!