VIDEO SAMPLE: Informed Consent Under the Common Rule, by Ezekiel J. Emanuel, MD, PhD.

 

 

 

 

 

 

 

 

 

 

 

Release Date: November 20, 2019

Expiration Date: November 20, 2022

Amount of CME credit: 4.50 AMA PRA Category 1 Credits™

Amount of Nursing Contact Hours: 4.50 Contact Hours

Pharmacists: 4.50  ACPE contact hours of continuing pharmacy education credit

Estimated Length of Time for Completion: approximately 4.5 hours

Program Overview

The goal of this activity is to provide learners with basic knowledge and skills on how to make ethical evaluations on research protocols, including understanding of specific ethical requirements and regulations. In this activity, learners will engage with the content by moving through a series of website pages that offer brief lecture videos, links to related readings, downloadable resources, and quizzes.

Penn Med logoThis activity is co-provided by the Perelman School of Medicine at the University of Pennsylvania and Penn Medicine Nursing.

Target Audience

This continuing education activity has been designed for investigators, research team members and IRB members, as well as all other healthcare professionals who have an interest in ethics of human research.

Penn faculty, staff, and students/trainees: Successfully complete the online course Ethics of Research with Human Subjects to fulfill your institutional human subjects research training requirements.

  • Penn: Penn’s IRB will accept this course as an alternative to CITI training.

Educational Objectives

 After completing this course, the Learner will be able to:

  • Outline the historical context for current approaches to research ethics and regulation.
  • Outline the 8-principle framework for evaluating the ethics of research studies.
  • Identify key U.S. regulatory requirements for research with human subjects.
  • Identify important international guidelines for research with human subjects, including their key provisions.
  • Assess the ethical and regulatory compliance of research protocols.

Successful completion of this educational activity and receipt of certificate of credit includes achieving a minimum score of 80% on the 3 quizzes.

Accreditation and Designation of Credit

Physicians

The Perelman School of Medicine at the University of Pennsylvania is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Penn Medicine designates this enduring material for a maximum of 4.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

This activity has been designated by the Perelman School of Medicine at the University of Pennsylvania for 4.5 hours of Patient Safety/Risk Management.

If you intend to claim MOC points for ABIM, please view the instructions for creating/updating your CE/CME profile.

Nurses

Penn Medicine Nursing is an approved provider of continuing nursing education by the Pennsylvania State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation.  Approval # 124-3-H-15.

Penn Medicine Nursing awards this activity 4.50 contact hours.

Pharmacists

Penn Medicine is jointly accredited by the Accreditation Council for Pharmacy Education (ACPE).

This practice-based activity is approved for up to 4.50 ACPE contact hours of continuing pharmacy education credit. UAN: JA0000324-0000-19-013-H05-P

Physician Assistants

AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society.

PAs may receive a maximum of 4.50 Category 1 credits for completing this activity.

Meet the Faculty

Ezekiel J. Emanuel, MD, PhD

Ezekiel J. Emanuel, MD, PhD, is the vice provost for Global Initiatives, the Diane v.S. Levy and Robert M. Levy University professor, and co-director of the Healthcare Transformation Institute at the University of Pennsylvania. He is also the special advisor to the director general of the World Health Organization. He is on leave for 2019–2021 from being the chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania.

From January 2009 to January 2011, Dr. Emanuel served as a special advisor on Health Policy to the Director of the Office of Management and Budget and National Economic Council. Prior to that, he was the founding chair of the Department of Bioethics at the National Institutes of Health from 1997 to August of 2011. 

Dr. Emanuel received his MD from Harvard Medical School and his PhD in political philosophy from Harvard University. He has published over 300 articles mainly on health care reform, research ethics, and end-of-life care. He has also authored or edited 13 books. His book, Prescription for the Future, identifies standout medical organizations that have achieved higher-quality, more patient-focused, and lower-cost care, and from their examples distills 12 transformational practices that could transform the entire health care sector. His new book, Which Country Has the World’s Best Health Care? was recently published by Public Affairs. Dr. Emanuel is the most widely cited bioethicist in history. 

Dr. Emanuel also serves as a venture partner at Oak HC/FT in addition to serving as a contributor for the New York Times and CNN. He is a member of the National Academy of Medicine, Association of American Physicians, the American Academy of Arts and Sciences, and the Royal College of Medicine. He turned down a Fulbright Fellowship. He is a 2018 recipient of the Dan David Prize in the category of Bioethics, an honor recognizing innovative and interdisciplinary research that cuts across traditional boundaries and paradigms. Dr. Emanuel received the 2020 Robert Wood Johnson Foundation David E. Rogers Award, given in partnership with the Association of American Medical Colleges, for his profound impact on research ethics, on bioethics training and institution-building, and on health care policy through his role in drafting the Affordable Care Act. And, he received the Lifetime Achievement Award from the American Society of Bioethics and Humanities, its highest honor.

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Steven Joffe, MD, MPH

Steven Joffe, MD, MPH, is the Art and Ilene Penn Professor of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine. He serves as interim chair of the Department of Medical Ethics and Health Policy and chief of the Division of Medical Ethics. And he directs two postdoctoral fellowships in biomedical ethics. He is also a professor of Pediatrics at the Perelman School and Children’s Hospital of Philadelphia (CHOP). He attended Harvard College, received his medical degree from the University of California at San Francisco (UCSF), and received his public health degree from UC Berkeley. He trained in pediatrics at UCSF and undertook fellowship training in pediatric hematology/oncology at the Dana-Farber Cancer Institute and Boston Children’s Hospital. Prior to coming to Penn, he served on the faculty of Harvard Medical School, and was an attending pediatric oncologist at the Dana-Farber Cancer Institute and Boston Children’s Hospital, for 13 years. 

Dr. Joffe’s research addresses the many ethical challenges that arise in the conduct of clinical and translational investigation and in genomic medicine, both in pediatric oncology and other areas of medicine and science. He has been the principal investigator (PI) of NIH, Patient-Centered Outcomes Research Institute (PCORI), and foundation-funded studies that examine the roles and responsibilities of PIs in multicenter randomized trials, accountability in the clinical research enterprise, governance of learning activities within learning health care systems, return of individual genetic results to participants in epidemiologic cohort studies, and the integration of genomic sequencing technologies into cancer care. He has also lectured widely on research ethics and on the ethical, legal, and social implications of genomic technologies. He was previously a member of the Department of Health and Human Services Secretary’s Advisory Committee for Human Research Protections, a member of the National Academy of Sciences Committee on Federal Research Regulations and Reporting Requirements, and chair of the Children’s Oncology Group Bioethics Committee. He currently serves as a member of the U.S. Food and Drug Administration’s (FDA) Pediatrics Ethics Subcommittee. 

In his teaching within the department's online educational initiatives, Dr. Joffe aims to convey a deep understanding of the ethical principles underlying research, while guiding students in how to apply those principles to real-world problems. He hopes students will take one core lesson from his teaching: it is possible to conduct studies on questions relevant to policy and practice that are both experimentally rigorous and ethically respectful of the rights and interests of the individuals who take part.

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Emily A. Largent, JD, PhD, RN

Emily Largent, JD, PhD, is the Emanuel and Robert Hart Assistant Professor of Medical Ethics and Health Policy. She holds a secondary appointment at Penn Law and is a senior fellow at the Leonard Davis Institute of Health Economics.

Dr. Largent’s work explores ethical and regulatory aspects of human subjects research with a particular focus on Alzheimer’s disease research. Her work is supported by a K01 career development award from the National Institute on Aging. In 2020, Dr. Largent was named a Greenwall Faculty Scholar, Class of 2023. Her faculty scholar project, “Autonomy on the Precipice of Cognitive Decline,” seeks to understand how our evolving understanding of Alzheimer’s disease affects patients and their families. Dr. Largent’s work has been published in leading journals, including The Hastings Center Report, American Journal of Bioethics, New England Journal of Medicine, and JAMA Neurology. She co-authored Clinical Research Ethics Consultation: A Casebook (Oxford University Press). 

Dr. Largent studied science, technology, and international affairs as an undergraduate at Georgetown University and earned a second degree in nursing from Penn Nursing. She received her PhD in health policy, with a concentration in ethics, from Harvard University and her JD from Harvard Law School. Dr. Largent was previously a fellow in the Department of Bioethics at the National Institutes of Health (2008–2010) and clerked for Chief Judge Jeffrey Howard of the United States Court of Appeals for the First Circuit (2016–2017) before coming to Penn. 

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Holly Fernandez Lynch, JD, MBE

Holly Fernandez Lynch, JD, MBE, is an attorney-bioethicist and the John Russell Dickson, MD, Presidential Assistant Professor of Medical Ethics. She is also the assistant faculty director of Online Education in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine. Prof. Fernandez Lynch earned her BA, Master of Bioethics, and JD all from the University of Pennsylvania. Prior to returning to the university as a faculty member, she was executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Teaching Faculty in the Master of Bioethics program at Harvard Medical School. She has also worked as an attorney in private practice focused on pharmaceuticals regulation, and as a bioethicist at the NIH’s Division of AIDS and President Obama's Commission for the Study of Bioethical Issues. 

Prof. Fernandez Lynch’s scholarly work focuses primarily on the ethics and regulation of human subjects research, as well as the law and ethics of conscientious refusals in health care. She is the founder and chair of the Consortium to Advance Effective Research Ethics Oversight (AEREO), established in 2018 to carry out an empirical research agenda to evaluate and improve the effectiveness of research ethics review and oversight by IRBs and Human Research Protection Programs. She has also served as a member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) since 2014.  Prof. Fernandez Lynch’s work has been published in leading bioethics, medical, and law journals, including JAMA; The New England Journal of Medicine; Science; Health Affairs; The Journal of Law, Medicine, and Ethics; and The American Journal of Bioethics, in addition to popular outlets such as The New York Times, The Boston Globe, and STAT. She is the author of Conflicts of Conscience in Health Care: An Institutional Compromise (MIT Press 2008), as well as the co-editor of books covering human subjects research regulation; FDA regulation of drugs and new technologies; health law and behavioral economics; law, religion, and health; biospecimen research; big data, health law, and bioethics; and transparency in health care (forthcoming). 

Within the department’s online education initiatives, Prof. Fernandez Lynch plays a primary role in supporting the academic progress of students pursuing the Master of Health Care Innovation. She is also the curriculum director of online medical ethics education, overseeing the training of Penn medical students in clinical and research ethics. 

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Disclosures

The planning committee members have disclosed that they have no relevant financial relationships with any commercial interests related to the content of this educational activity:

  • Chase Brown, MD
  • Ezekiel J. Emanuel, MD, PhD
  • David Heagarty
  • Steven Joffe, MD, MPH
  • Holly Fernandez Lynch, JD, MBe
  • Connie Ulrich, PhD, RN, FAAN
  • Laura C. Hart, MFA
  • Patricia Smith, DNP, RN, BC

The faculty involved with this activity have reported that their presentations contain no mention of investigational and/or off-label use of products.

Acknowledgment of Commercial Support

There was no commercial support used in the development of this educational activity.

Contact

For questions related to this educational activity, contact Penn Medicine Continuing Medical and Interprofessional Education at the Perelman School of Medicine at the University of Pennsylvania at penncme@pennmedicine.upenn.edu or at 215-898-8005.

If you have questions, please contact Caitlin O'Neill, Program Manager for Online Educational Initiatives, at 215-746-3971 or MEHPonline@pennmedicine.upenn.edu.