2010 Webinar: Legal Issues for HRPPs

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Overview

Legal Issues for HRPPs: Investigator-Initiated Research and HITECH Privacy Requirements featured two well-known legal experts who provide critical information on investigator-initiated research and new privacy rules affecting human subjects.

On the topic of investigator-initiated research, this webinar explained:

  • The ethical and legal obligations a person holds when s/he serves the dual role of investigator and sponsor;
  • The legal implications for investigators who conduct interventional studies without federal funding or industry support at hospitals, medical schools and academic medical centers;
  • Emerging trends regarding the industry’s requirement that researchers hold the Investigational Device Exemption (IDE) or Investigational New Drug (IND) in industry-financed studies.

On the subject of privacy and security rules affecting human subjects research, this webinar addresses:

  • The 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, as well as new regulations and guidance issued by the U.S. Department of Health and Human Services; 
  • The way these new federal requirements affect research activities;
  • Distribution of responsibility within an institution (IRB, Privacy Office, faculty/investigators) for compliance, privacy and security breach prevention, and duties of covered entities regarding privacy or security breaches and data-sharing

Audience

This program was helpful to lawyers, privacy officers, and compliance officers who serve medical schools, universities, hospitals, and other research institutions, as well as to IRB chairs, staff, and research educators or coordinators.

Faculty

Susan Stayn, JD

Susan Stayn is senior university counsel at Stanford University, where she advises the university, the Stanford Hospital and Clinics, and the Lucile Packard Children’s Hospital on legal and regulatory compliance issues in health care and biomedical research. Before joining Stanford, Susan worked in the Office of the General Counsel of Partners HealthCare System, Inc., a leading nonprofit integrated delivery system founded by Massachusetts General Hospital and Brigham and Women’s Hospital, which also includes community and specialty hospitals, a large physician network, and a joint venture with Dana Farber Cancer Institute. She previously worked in the private and public interest sectors. Susan’s professional expertise includes privacy, informed consent, human subjects research, stem cell research, FDA issues in clinical care and research, and general federal and state regulatory compliance. Most recently, she has lectured on legal issues in health care and research at Stanford, University of California - Berkeley Law School, Public Responsibility in Medicine and Research, and the American Health Lawyers Association. Her recent writings have appeared in publications such as BNA's Medical Research Law and Policy Report, The Stanford Journal of Law, Science & Policy,The Boston Health Law Reporter, and the Massachusetts Health and Hospital Law Manual. Susan received her Bachelor of Arts from Harvard College and her JD from Columbia University School of Law.

Mark Barnes, JD, LLM

Mark Barnes serves at Harvard University as chief compliance officer, director of sponsored research, and is the institutional official for human subjects research for the Cambridge, MA-based Harvard Schools and the Harvard School of Public Health. He holds faculty appointments at Harvard Law School, Harvard School of Public Health, and Yale Medical School. For the past 25 years, he has practiced and taught health law, served as a Washington lobbyist and advocate, and administered domestic and international health care programs. Mark has held senior appointed positions in the New York City and State Departments of Health. He has also served at various periods from 2004 until 2009 as executive director of Harvard University’s AIDS treatment programs in Nigeria, Tanzania and Botswana. Mark Barnes earned his J.D. from the Yale Law School, and an LL.M. from the Columbia University School of Law.