Release Date: March 3, 2021
Expiration Date: March 3, 2024
Amount of CME credit: 1.5 AMA PRA Category 1 Credits™
Amount of Nursing Contact Hours: 1.5 Contact Hours
Pharmacists: 1.5 ACPE contact hours of continuing pharmacy education credit.
Estimated Length of Time for Completion: 90 minutes
This learning activity provides an overview of ethical and regulatory principles of research with participants perceived as vulnerable. Learners will review definitions of vulnerability, relevant regulations in the United States, and their implications for special protections among various populations, including:
- Pregnant women and fetuses
- The cognitively impaired
- Patients in emergency settings
This activity is co-provided by the Perelman School of Medicine at the University of Pennsylvania and Penn Medicine Nursing.
This continuing education activity has been designed for researchers and those involved in research oversight, including physicians, nurses, pharmacists.
After completing this course, the learner will be able to:
- Identify key regulatory and ethical guidance for research with participants perceived as vulnerable.
- Outline the ethical implications of various definitions of vulnerability.
- Explain special regulatory requirements and unique ethical dilemmas pertaining to research with children, pregnant women and fetuses, prisoners, the cognitively impaired, and patients in emergency settings.
Successful completion of this educational activity and receipt of certificate of credit includes achieving a minimum score of 83% on the quiz.
Accreditation and Designation of Credit
In support of improving patient care, Penn Medicine 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.
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 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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 1.5 contact hours.
Penn Medicine is jointly accredited by the Accreditation Council for Pharmacy Education (ACPE).
This practice-based activity is approved for up to 1.5 ACPE contact hours of continuing pharmacy education credit. UAN: JA0000324-0000-20-007-H05-P
To receive credit, you must submit your post-test, evaluation and credit request within 30 days of completion.
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 1.5 Category 1 credits for completing this activity.
Meet the Faculty
Jill M. Baren, MD, MS, MBA
Jill M. Baren, MD, MS, MBA serves as provost and vice president of Academic Affairs at the University of the Sciences and is a tenured professor of Biological Sciences and Humanities in the Misher College of Arts and Sciences. She previously served as faculty leadership development fellow in the Office of the Provost at the University of Pennsylvania and as an American College of Education Fellow in the Office of the President at Villanova University. Dr. Baren is a national leader in academic medicine. She is board certified in Emergency Medicine and Pediatric Emergency Medicine and has held prior faculty positions at the University of California at Los Angeles, Yale University, and the University of Pennsylvania. At Penn Medicine, Dr. Baren served as the first woman chair of Emergency Medicine, chief of Emergency Services for the Health System, and chair of the Human Research Advisory Committee in the Office of the Vice Provost for Research. She is also a graduate of the Executive Leadership in Academic Medicine (ELAM) Program at Drexel University College of Medicine.
Dr. Baren is the immediate past president of the American Board of Emergency Medicine, serving 40,000 practicing emergency physicians and trainees. She has lectured nationally and internationally on academic leadership and mentorship. She has published over 150 peer-reviewed articles, editorials and book chapters, and has edited several books including her own textbook, Baren’s Pediatric Emergency Medicine. Her research focuses on ethics and informed consent within emergency clinical trials, and it has received funding from the National Institute of Neurological Disorders and Stroke, the National Institute of Child Health and Human Development, the National Heart, Lung, and Blood Institute, and the Robert Wood Johnson Foundation. Dr. Baren has served as a consultant to the NIH, the FDA and multiple national research networks on informed consent regulations in clinical trials of life-threatening conditions.
Dr. Baren attended Brown University where she received a BS degree in Biochemistry. She received her MD degree, summa cum laude, from the University of Pittsburgh School of Medicine and is a member of the Alpha Omega Alpha National Medical Honor Society. She holds an MS in Bioethics from the University of Pennsylvania and an executive MBA degree from the Heller School of Management and Social Policy at Brandeis University, where she was inducted into the Beta Gamma Sigma National Business School Honor Society.
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 including Reinventing American Health Care (2014), Prescription for the Future (2018), and Which Country Has the World’s Best Health Care? (2020). 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, the Association of American Physicians, the American Academy of Arts and Sciences, and the Royal College of Medicine. He recently served on the Biden administration transition team’s COVID-19 task force. Dr. Emanuel 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. He 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. He recently received the Lifetime Achievement Award from the American Society of Bioethics and Humanities, its highest honor.
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.
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.
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.
Dominic A. Sisti, PhD
Dominic Sisti, PhD, is director of the Scattergood Program for the Applied Ethics of Behavioral Health Care and assistant professor in the Department of Medical Ethics and Health Policy at the University of Pennsylvania. He holds secondary appointments in the Department of Psychiatry, where he directs the ethics curriculum in the residency program, and the Department of Philosophy. Dr. Sisti's research examines the ethics of mental health care services and policies, including long-term psychiatric care for individuals with serious mental illness, and ethical issues in prison and jail health care. He also studies the philosophical, ethical, and policy implications of defining and redefining mental disorders in the DSM. Most recently, Dr. Sisti has been studying the ethical implications of artificial intelligence and social media in the context of mental health care delivery.
Dr. Sisti's writings have appeared in peer-reviewed journals such as JAMA, JAMA Psychiatry, Psychiatric Services, the Hastings Center Report, and the Journal of Medical Ethics. His scholarship has been featured by popular media outlets such as the New York Times, The Economist, NPR, the Philadelphia Inquirer, Slate, and The Atlantic. He is editor of three books: Health, Disease, and Illness: Concepts in Medicine (with Arthur Caplan and James McCartney, Georgetown University Press, 2004), The Case of Terri Schiavo: Ethics at the End of Life (with Arthur Caplan and James McCartney, Prometheus Books, 2006), and Applied Ethics in Mental Healthcare: An Interdisciplinary Reader (with Arthur Caplan and Hila Rimon-Greenspan, MIT Press, 2013).
Dr. Sisti was an Edmund Pellegrino Fellow at the Center for Clinical Bioethics at Georgetown University. He received his bachelor's degree in biology from Villanova University, a Master of Bioethics from the University of Pennsylvania, and his doctorate in philosophy from Michigan State University. His research has been funded by the Thomas Scattergood Behavioral Health Foundation, the Greenwall Foundation, The Quattrone Center for the Fair Administration of Justice, the Leonard Davis Institute, and the Dana Foundation. Dr. Sisti teaches graduate courses on clinical ethics, ethics in behavioral health care, and social media, ehealth, and biomedical ethics. He has organized and led the ethics track for the American Psychiatric Association's annual meeting since 2012.
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
- David Heagerty, BA, CIP
- Holly Fernandez Lynch, JD, MBe
- Steven Joffe, MD, MPH
- Connie Ulrich, PhD, MSN
- Adam D. Zolkover, MA
- Laura C. Hart, MFA
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.
If you have questions, please contact Caitlin O'Neill, Program Manager for Online Educational Initiatives, at MEHPonline@pennmedicine.upenn.edu.
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 firstname.lastname@example.org or at 215-898-8005.