Release Date: March 4, 2020
Expiration Date: March 4, 2023
Amount of CME credit: 1.50 AMA PRA Category 1 Credits™
Amount of Nursing Contact Hours: 1.50 Contact Hours
Pharmacists: 1.50 ACPE contact hours of continuing pharmacy education credit
Estimated Length of Time for Completion: 1.5 hours
This course provides an overview of ethical principles relevant to the design of trials involving human subjects. Learners will review foundational study designs and design tools with a focus on ethical and regulatory considerations.
- Differentiating between research and quality improvement.
- Observational and interventional designs.
- Randomization, blinding, and placebos.
- First-in-Human, or Phase I, trials.
- Cluster randomization.
- Comparative effectiveness research.
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.
After completing this course, the learner will be able to:
- Summarize features of sound study design, a key prerequisite for ethical research with human subjects.
- Recognize areas of ethical ambiguity in the design of research trials involving human subjects.
- Outline strategies to address potential ethical challenges in the design of research studies.
Successful completion of this educational activity and receipt of certificate of credit includes achieving a minimum score of 7 out of 8 on the multiple choice quiz.
Accreditation and Designation of Credit
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 1.50 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 1.50 contact hours.
Penn Medicine is jointly accredited by the Accreditation Council for Pharmacy Education (ACPE).
This practice-based activity is approved for up to 1.50 ACPE contact hours of continuing pharmacy education credit. UAN: JA0000324-0000-19-013-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 1.50 Category 1 credits for completing this activity.
Meet the Faculty
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 following faculty member has reported the following relevant financial relationships with commercial interests related to the content of this educational activity:
|Name||Company||Type of Relationship|
|Steven Joffee, MD, MPH||Pfizer||Research Grant|
The planning committee members listed below 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
- Connie Ulrich, PhD, MSN
- Adam Zolkover, MA
- Laura C. Hart, MFA
The faculty reported that there will be no mention of investigational and/or off-label use of products in this presentation.
Acknowledgment of Commercial Support
There was no commercial support used in the development of this educational activity.
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.
If you have questions, please contact Caitlin O'Neill, Program Manager for Online Educational Initiatives, at 215-746-3971 or MEHPonline@pennmedicine.upenn.edu.