Date & Location
Wednesday, March 4, 2020, 12:00 AM - Saturday, March 4, 2023, 11:59 PM

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

Content last reviewed: March 4, 2020
Learning Objectives

After completing this activity, participants should be able to:


  1. Summarize features of sound study design, a key prerequisite for ethical research with human subjects.
  2. Recognize areas of ethical ambiguity in the design of research trials involving human subjects.
  3. Outline strategies to address potential ethical challenges in the design of research studies.

Registration
There is no registration fee but you are still required to register.
 
In this activity, learners will engage with the content by moving through a series of brief video lectures with links to related readings, downloadable resources, and quizzes.
 
The Structure of the Course
Research vs. QA / QI
Observational Research Design
Interventional Research Design
Randomization
Blinding and Placebos
First-in-Human Trials
Cluster Randomization
Comparative Effectiveness Research
 
Each lecture includes a list of suggested readings that provide more detail about what was discussed. Links to external readings will lead you to an abstract or, if available, the full article.
 
Successful completion of this educational activity and receipt of certificate of credit includes achieving a minimum score of 90% on the post-test.

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. 

DESIGNATION OF CREDIT
Physicians: Penn Medicine designates this live activity 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.

Nurses: This program provides 1.5 NCPD Hours.

Pharmacists: This knowledge-based activity is approved for 1.5 ACPE contact hours of continuing pharmacy education credit. 
UAN: JA0000324-0000-21-031-H04-P


Credits
AMA PRA Category 1 Credits™ (1.50 hours), ACPE (1.50 hours), NCPD Hours (ANCC) (1.50 hours), Non-Physician Attendance / Participation (1.50 hours)