Release Date: November 8, 2021
Expiration Date: November 8, 2024
Amount of CME credit: 1.0 AMA PRA Category 1 Credits™
Amount of Nursing Contact Hours: 1.0 Contact Hours
Pharmacists: 1.0 ACPE contact hours of continuing pharmacy education credit.
Estimated Length of Time for Completion: 1 hour
This activity provides an overview of ethical principles of biomedical research in global settings, with an emphasis on research in low- and middle-income countries (LMICs). We will begin with an 8-principle framework for conducting ethical research, then examine areas requiring special attention, including:
- Determining ethical standards of care for the control arm of trials.
- Adapting the informed consent process to various cultural contexts.
- Providing ancillary care for research participants.
- Researchers’ post-trial obligations to research participants and their communities.
This activity is co-provided by the Perelman School of Medicine at the University of Pennsylvania and Penn Medicine Nursing.
Researchers and those involved in research oversight, with an emphasis on research in low- and middle-income countries (LMICs).
After completing this course, the learner will be able to:
- Outline the 8-principle framework for conducting ethical research in LMICs.
- Explain ethical controversies related to standards of care for the control arm of research studies.
- Outline culturally appropriate strategies for engaging research participants in the informed consent process.
- Define ancillary care in the context of biomedical research.
- Outline researchers’ obligations to study participants and communities in which research has taken place after a trial has concluded.
Successful completion of this educational activity and receipt of certificate of credit includes achieving a minimum score of 80% on one 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 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
To receive credit, you must submit your post-test, evaluation and credit request within 30 days of completion.
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. This program awards 1 contact hour.
Penn Medicine is jointly accredited by the Accreditation Council for Pharmacy Education (ACPE).
This practice-based activity is approved for up to 1 ACPE contact hours of continuing pharmacy education credit. UAN: JA0000324-0000-20-007-H05-P
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 Category 1 credit 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.
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.
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
- Ezekiel J. Emanuel, MD, PhD
- 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 email@example.com or at 215-898-8005.