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


Objectives
  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.

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.  

All activities listed on this transcript have been approved for AMA PRA Category 1 Credit™.


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