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The SUPPORT Trial on Oxygen Therapy in Premature Infants: Ethical and Regulatory Issues


Product Code - LGA167
Speaker(s): Moderator: Michele Russell-Einhorn, J.D., Dana-Farber Cancer Institute; Arthur L. Caplan, Ph.D., New York University Langone Medical Center; Michael A. Carome, M.D., FACP, Public Citizen
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The Surfactant, Positive Pressure and Oxygenation Randomized Trial (SUPPORT), which looked at the health outcomes of premature infants given different levels of supplementary oxygen, gained notoriety after the Department of Health and Human Services Office for Human Research Protections (OHRP) issued a compliance determination letter in March of 2013 raising serious concerns about the lack of information in, and comprehensiveness of, the research consent forms approved by the 23 institutions participating in this research. The OHRP determination letter was followed by several communications from the public advocacy group Public Citizen affirming the OHRP determination of compliance issues but going further and alleging that the egregious nature of the insufficiencies exceeded what was flagged by the government.

These communications generated controversy resulting in many opinion pieces and editorials published in the New England Journal of Medicine as well as the New York Times--some supporting the trial and criticizing the critics, others supporting the government and Public Citizen.

In addition, a lawsuit has been filed against the University of Alabama, the lead site in the study, alleging that the premature babies enrolled in the study were subjected to research that was unethically designed and exposed the subjects to undisclosed and unacceptable risks of death and blindness.

What are the issues raised by this controversy over the SUPPORT study? How does this impact Institutional Review Board (IRB) review of randomized studies? How might it influence future studies of comparative effectiveness? The faculty for this program will address these issues, with representation from those on each side of the debate.

Educational Objectives:

• Understand the regulatory requirements for Institutional Review Board (IRB) review of research.
• Learn about the complexities of research informed consent requirements and randomized clinical trials.
• Discover how usual routine clinical care differs from research interventions in a clinical trial.

Who would benefit most from attending the program?

Researchers; Institutional Review Board (IRB) members and staff; research compliance staff; health care attorneys.

Program Level: Advanced.

Credit Available: CLE. For more information, please click on the “CLE Credit” tab.

Moderator: Michele Russell-Einhorn, J.D., Dana-Farber Cancer Institute; Arthur L. Caplan, Ph.D., New York University Langone Medical Center; Michael A. Carome, M.D., FACP, Public Citizen

Moderator: Michele Russell-Einhorn, J.D., Dana-Farber Cancer Institute
Michele Russell-Einhorn is an expert in the field of the protection of human subjects in research. She is currently the Senior Director of the Office for Human Research Studies at the Dana-Farber Cancer Institute and is responsible for the management and support of scientific review and institutional review board review, as well as other regulatory matters, involving all cancer relevant research involving human subjects conducted at the five Harvard clinical institutions under the umbrella of the Dana-Farber/Harvard Cancer Center.

Trained as a lawyer, Ms. Russell-Einhorn has more than 30 years of professional expertise including service as the Conflicts of Interest Attorney for the National Institutes of Health; Director of Regulatory Affairs for the U.S.D.H.H.S Office for the Protection from Research Risks (OPRR) and its successor office, the Office for Human Research Subjects (OHRP); Director in the Global Pharmaceuticals Practice at PWC; as well as the Associate General Counsel for the J. Craig Venter Institute.

Ms. Russell-Einhorn is a member of the Subcommittee on Subpart A of the U.S.D.H.H.S. Secretary’s Advisory Committee on Human Research Protections; was the Co-Chair for three years and a core planning committee member for five years of the annual Ethics in Research Conference sponsored by Public Responsibility in Medicine and Research; and a member of the Vanderbilt University Steering Committee for an NIH Grant on Alternative IRB Models. She is a founder and leader of the IRB Directors Group of the National Comprehensive Cancer Center and is a faculty member at the American Association of Cancer Research, AACR Translational Cancer Research for Basic Scientists Workshop at which she lectures on the protection of human subjects in research followed by a field trip with all of the fellows to observe a DFCI IRB meeting.

Ms. Russell-Einhorn is a speaker at numerous conferences on various topics relating to research involving human subjects and is adjunct faculty in the Northeastern University Masters of Regulatory Affairs Program. She earned a J.D. from Boston College Law School, magna cum laude, and a B.A. from Hampshire College.

Arthur L. Caplan, Ph.D., New York University Langone Medical Center
Dr. Caplan holds the Drs. William F. and Virginia Connolly Mitty Professorship and is the founding head of the Division of Bioethics at New York University’s Langone Medical Center.

Before joining NYU, Dr. Caplan was the Sidney D. Caplan Professor of Bioethics at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, where he created the Center for Bioethics and the Department of Medical Ethics. He also previously taught at the University of Minnesota, where he founded the Center for Biomedical Ethics; the University of Pittsburgh; and Columbia University. He served as the Associate Director of the Hastings Center from 1984-1987.

Dr. Caplan has authored or edited thirty books and more than 550 journal papers. He has served on a number of national and international committees including as Chair of the National Cancer Institute Biobanking Ethics Working Group; the Chair of the Advisory Committee to the United Nations on Human Cloning; the Chair of the Advisory Committee to the Department of Health and Human Services on Blood Safety and Availability; a member of the Presidential Advisory Committee on Gulf War Illnesses; and many more.

Dr. Caplan is the recipient of numerous awards and honors including the McGovern Medal of the American Medical Writers Association and the Franklin Award from the City of Philadelphia. He received the Patricia Price Browne Prize in Biomedical Ethics and has been described as one of the ten most influential people in science. He has also been honored as one of the fifty most influential people in American health care; one of the ten most influential people in America in biotechnology; and one of the ten most influential people in the ethics of biotechnology.

Dr. Caplan is a graduate of Brandeis University, and he did his graduate work at Columbia University, from which he earned a Ph.D. in the history and philosophy of science.

Michael A. Carome, M.D., FACP, Public Citizen
Michael A. Carome, M.D., is the Director of Public Citizen’s Health Research Group. His areas of expertise include drug and medical device safety and the protection of human research subjects. Prior to joining Public Citizen in 2011, he was Associate Director for Regulatory Affairs, Office for Human Research Protections (OHRP), Department of Health and Human Services from 2002-2010; Staff Nephrologist at the Walter Reed Army Medical Center’s (WRAMC’s) Department of Medicine from 1992-2010; and a Commissioned Corps officer in the U.S. Public Health Service. Earlier in his federal career, Dr. Carome served as Director, Division of Compliance Oversight, OHRP; Chief of the Compliance Oversight Branch in the Office for Protection from Research Risks, National Institutes of Health (NIH); and Assistant Professor of Medicine, Department of Medicine, Uniformed Services University of Health Sciences.

Dr. Carome earned his undergraduate Bachelor of Science degree in psychology at Georgetown University and his medical degree at Case Western Reserve University. He completed his internal medicine residency and nephrology fellowship training at WRAMC. During his fellowship training, he was a Guest Researcher at the Renal Cell Biology Section, National Institute of Diabetes and Digestive and Kidney Diseases, NIH. Dr. Carome is board certified in internal medicine is a fellow in the American College of Physicians.

This program’s CLE-credit eligibility varies by state. Bloomberg BNA is an accredited provider in the states of New York*, California, Pennsylvania, Texas and Virginia, and most other jurisdictions grant CLE credit on a per-program basis. At this time, Bloomberg BNA does not apply directly to the states of Florida, Rhode Island, Montana and Hawaii although credit is usually available for attorneys who wish to apply individually. Additionally, the following states currently do not grant credit for Bloomberg BNA OnDemand programming: Arkansas, Ohio, Nebraska, and Delaware. All requests are subject to approval once the live webinar has taken place or the customer has viewed the OnDemand version. Please contact the Bloomberg BNA accreditations desk if you have specific questions that have not been addressed.

If you have further questions regarding a specific state or how to file for CLE credit, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditation Coordinator.

Hardship Policy
Bloomberg BNA offers a hardship policy for attorneys earning less than $50,000 per year. If an attorney wishes to take advantage of this option, he or she must contact Bloomberg BNA directly. For attorneys who are unemployed or earning less than $35,000 per year, a full discount off the price of the program will be awarded upon written proof of hardship. Attorneys earning between $35,000 and $50,000 per year will receive a 50% discount off the price of the program. Any attorney working in the public service sector also qualifies for a special price. If you have further questions regarding the hardship policy or seek additional information, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditations Coordinator, or email us at accreditations@bna.com.

Questions
For more information about Mandatory or Minimum Continuing Legal Education (MCLE) requirements, visit the American Bar Association website at http://www.abanet.org/cle/mandatory.html.

*Bloomberg BNA is an accredited provider in New York for experienced attorneys only.