Program Description:

In June of 1966, physician-researcher Henry K. Beecher published a paper entitled “Ethics and Clinical Research” in the New England Journal of Medicine.  His paper listed 22 examples of clinical research that raised ethical questions about the conduct of research by physicians at major universities, published in major medical journals, demolishing the widely-held position that concerns about unethical research conduct were relevant only to a small number of corrupt, non-respected researchers.

Fifty years later, Beecher’s paper is often cited as the most significant publication in human research ethics. This month, we will explore the history and motivation that led to Dr. Beecher’s ground-breaking publication, and the response from the research community.  We will also discuss the development, evolution and current state of human research protections.

Target Audience:

The target audience for this activity includes physicians, pharmacists and nurses who participate in or are interested in human subject research ethics.

Learning Objectives:

Upon completion of this knowledge activity, participants should be able to:

• Review past abrogations of ethics within the field of human subject research, both in the United States and abroad.

• Examine the ways in which the medical community participated in the labeling, persecution and eventual mass murder of millions of those deemed unfit in Nazi Germany, thus leading to medically sanctioned genocide

• Use these examples of violations within human subject research ethics to incorporate a personal and professional code of ethics that emphasizes the importance of respecting the dignity of human subjects.

Acceditation Statement:

In support of improving patient care, the Center for Education Development is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

Credit Designation:

Center for Education Development designates this live educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™, 1.0 CPE credit (UAN # 0498-9999-16-009-H04-P) or 1.0 ANCC credit.

Participants should claim credit commensurate with the extent of their participation in the activity. Participants must participate in the session and complete an activity evaluation before October 10, 2018. Pharmacists are required to pass the post-test with a minimum score of 70%.

Competencies:

Center for Education Development supports recommendations that will promote life long learning through continuing education. The following desirable physician attributes are addressed through this activity:

• Provide patient-centered care
• Employ evidence-based practice
• Apply quality improvement

Required Hardware/Software:

The computer you plan to use should meet the following requirements:

• Peripherals: Computer speakers or headphones
• Monitor Screen Resolution: 320 x 480 or higher
• Media Viewing Requirements: Adobe Reader, Microsoft PowerPoint, Flash Player & HTML

Faculty Bio:

Arthur Caplan, PhD

Currently the Drs. William F and Virginia Connolly Mitty Professor and founding head of the Division of Bioethics at New York University Langone Medical Center in New York City.

He is the co-founder and Dean of Research of the NYU Sports and Society Program and the head of the ethics program in the Global Institute for Public Health at NYU.

Prior to coming to NYU he was the Sidney D. Caplan Professor of Bioethics at the University of Pennsylvania Perelman School of Medicine in Philadelphia where he created the Center for Bioethics and the Department of Medical Ethics.  Caplan has also taught at the University of Minnesota, where he founded the Center for Biomedical Ethics, the University of Pittsburgh, and Columbia University.  He received his PhD from Columbia University.

Caplan is the author or editor of thirty-five books and over 700 papers in peer reviewed journals.  His most recent book is The Ethics of Sport, (Oxford University Press, 2016).

He has served on a number of national and international committees including as the Chair, 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; the special advisory committee to the International Olympic Committee on genetics and gene therapy; the special advisory panel to the National Institutes of Mental Health on human experimentation on vulnerable subjects, the Wellcome Trust advisory panel on research in humanitarian crises, and the Co-Director of the Joint Council of Europe/United Nations Study on Trafficking in Organs and Body Parts. 

He is currently the ethics advisor to DOD/DARPA on synthetic biology, a member of the University of Pennsylvania’s External Advisory Committee for its Orphan Disease Center and a member of the Ethics and Ebola Working Group of the World Health Organization. Dr. Caplan also serves as the Chairperson of the Compassionate Use Advisory Committee (CompAC), an independent group of internationally recognized medical experts, bioethicists and patient representatives which advises Janssen/J&J about requests for compassionate use of some of its investigational medicines.

Caplan is a regular commentator on bioethics and health care issues for WebMD/Medscape, for WGBH radio in Boston and WMNF public radio in Tampa.  He appears frequently as a guest and commentator on various other national and international media outlets.

Caplan is the recipient of many awards and honors including the McGovern Medal of the American Medical Writers Association and the Franklin Award from the City of Philadelphia. He was a person of the Year-2001 from USA Today.  He was described as one of the ten most influential people in science by Discover magazine in 2008.  He has also been honored as one of the fifty most influential people in American health care by Modern Health Care magazine, one of the ten most influential people in America in biotechnology by the National Journal, one of the ten most influential people in the ethics of biotechnology by the editors of Nature Biotechnology and one of the 100 most influential people in biotechnology by Scientific American magazine.  He received the Patricia Price Browne Prize in Biomedical Ethics for 2011.  In 2014 he was selected to receive the Public Service Award from the National Science Foundation/National Science Board which honors individuals and groups that have made substantial contributions to increasing public understanding of science and engineering in the United States.  In May, 2016 the National Organization for Rare Disorders (NORD) honored him with their ‘Rare Impact Award’. 

He holds seven honorary degrees from colleges and medical schools.  He is a fellow of the Hastings Center, the NY Academy of Medicine, the College of Physicians of Philadelphia, the American College of Legal Medicine and the American Association for the Advancement of Science.

Disclosures:

Faculty reported the following financial relationships. A copy of CED’s policy on resolving conflicts of interest can be found at www.cedevelopment.org. 

 Arthur Caplan, PhD

DISCLOSURES: Advisory Committee, Janssen; Consultant, Abbvie

Center for Education Development

Thomas Zimmerman, PhD (Reviewer, CED) has nothing to disclose.

John Zitel (Reviewer, CED) has nothing to disclose

Danielle Amodio (Planner, CED) has nothing to disclose.

Stacy Gallin (External Planner, MIMEH) has nothing to disclose