Ethics and Trial Design
Ethics and Trial Design
Activity Overview
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.
Topics include:
- 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. 
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.
Release date: March 4, 2020
Expiration date: March 31, 2025
Amount of CME credit: 1.5 AMA PRA Category 1 Credit(s)™
Amount of Nursing Contact Hours: 1.5 NCPD hours
Pharmacists: 1.5 ACPE contact hours of continuing pharmacy education credit
Estimated Length of Time for Completion: 1.5 hours
Register: credit Register: noncredit
VIDEO SAMPLE: Research vs. QA/QI, by Steve Joffe, MD, MPH
Accreditation
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.
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 1.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity
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 1.5 NCPD hours.
Pharmacists
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
To receive credit, you must submit your post-test, evaluation and credit request within 30 days of completion.
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 1.5 Category 1 credits for completing this activity.
To receive credit, you must submit your post-test, evaluation and credit request within 30 days of completion.
The following planning committee 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 Joffe, 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.
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.
