Date & Location
Sunday, October 1, 2023, 12:00 AM - Wednesday, April 30, 2025, 11:59 PM

Course Overview
This course provides an overview of key ethical principles and regulatory frameworks for the conduct of research with human subjects. It is intended for researchers and those involved in research oversight.

Course topics include:

  • Historical evolution of the present system of research oversight in the United States.
  • Foundational documents, including the Nuremberg Code and Belmont Report.
  • The 8 core principles of ethical human research.
  • Relevant regulations in the United States, including the revised Common Rule, FDA research requirements, and HIPAA.
  • Challenging ethical concepts relevant to research consent, including the therapeutic misconception, coercion, undue influence, and exploitation.
  • International research ethics guidelines including the Declaration of Helsinki, CIOMS, and ICH.
The course provides specific and practical information needed to understand the role of Institutional Review Boards in overseeing research, as well as the requirements for adequate informed consent.

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

Content last reviewed: March 8, 2024
Learning Objectives

After completing this activity, participants should be able to:


  1. Outline the historical context for current approaches to research ethics and regulation.
  2. Outline the 8-principle framework for evaluating the ethics of research studies.
  3. Identify key U.S. regulatory requirements for research with human subjects.
  4. Identify important international guidelines for research with human subjects, including their key provisions.
  5. Assess the ethical and regulatory compliance of research protocols.

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. This course has 3 sections. Each section has a post-test with between 5 and 10 questions. You will have 5 attempts to earn at least 90% on all post-tests individually in order to complete the course and earn your certificate.
 
The Structure of the Course
  • History and Rationale of Research Ethics
    • A History of Ethics in Medical Research (9:12)
    • The Rationale of Research Ethics and the Nuremberg Code (9:46)
    • The Belmont Report (8:33)
  • Eight Principles of Ethical Research
    • Eight Principles of Ethical Research (13:32)
    • The US Public Health Service Syphilis Study at Tuskegee (6:48)
    • The Ethics of the USPHS Syphilis Study at Tuskegee, Part I (6:32)
    • The The Ethics of the USPHS Syphilis Study at Tuskegee, Part II (6:35)
  • The Common Rule and Related Ethical Considerations
    • The Common Rule (12:43)
    • IRB Oversight of Research (7:25)
    • Assessing Research Risks and Benefits (11:42)
    • Informed Consent Under the Common Rule (7:33)
    • Ethics of Informed Consent, Part I (6:17)
    • Ethics of Informed Consent, Part II (5:51)
    • Therapeutic Misconception (8:45)
    • Coercion and Undue Inducement (11:30)
    • Exploitation (5:22)
    • The Ethics of Payment (8:52)
    • Research with Data and Specimens (11:46)
  • Additional Regulations and Guidance
    • FDA Regulated Research, Part I (7:27)
    • FDA Regulated Research, Part II (8:06)
    • Privacy and HIPAA Compliance (7:34)
    • Navigating Conflicts of Interest (9:47)
    • International Ethics Guidelines, Part I: The Declaration of Helsinki (8:42)
    • International Ethics Guidelines, Part II: CIOMS (10:28)
    • International Ethics Guidelines, Part III: ICH Guidance (E6, E8) (8:27)

Note that closed captions are available for all video segments.


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 4.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
 
ABIM MOC: Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 4.5 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.
 
Nurses: This program provides 4.5 NCPD hours.
 
Pharmacists: This knowledge-based activity is approved for 4.5 ACPE contact hours of continuing pharmacy education credit. 
UAN: JA0000324-0000-21-034-H04-P 

Credits
AMA PRA Category 1 Credits™ (4.50 hours), ABIM MOC Part 2 (4.50 hours), ACPE (4.50 hours), NCPD Hours (ANCC) (4.50 hours), Non-Physician Attendance / Participation (4.50 hours)