Ethics of Research with Human Subjects

Activity Overview

The goal of this activity is to provide learners with basic knowledge and skills on how to make ethical evaluations on research protocols, including understanding of specific ethical requirements and regulations. In this activity, learners will engage with the content by moving through a series of website pages that offer brief lecture videos, links to related readings, downloadable resources, and quizzes.

This activity is co-provided by the Perelman School of Medicine at the University of Pennsylvania and Penn Medicine Nursing. 

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Target Audience

This continuing education activity has been designed for investigators, research team members and IRB members, as well as all other healthcare professionals who have an interest in ethics of human research.

Penn faculty, staff, and students/trainees: Successfully complete the online course Ethics of Research with Human Subjects to fulfill your institutional human subjects research training requirements.

  • Penn: Penn’s IRB will accept this course as an alternative to CITI training.
Educational Objectives

After completing this course, the Learner will be able to:

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

Successful completion of this educational activity and receipt of certificate of credit includes achieving a minimum score of 80% on the 3 quizzes.

Credit Information

Release Date: November 20, 2019

Expiration Date: January 31, 2023

Amount of CME credit: 4.50 AMA PRA Category 1 Credits™

Amount of Nursing Contact Hours: 4.50 NCPD hours

Pharmacists: 4.50  ACPE contact hours of continuing pharmacy education credit

Estimated Length of Time for Completion: approximately 4.5 hours

Register: credit           Register: noncredit

 

VIDEO SAMPLE: Informed Consent Under the Common Rule, by Ezekiel J. Emanuel, MD, PhD

Accreditation and Designation of Credit

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 4.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

This activity has been designated by the Perelman School of Medicine at the University of Pennsylvania for 4.5 hours of Patient Safety/Risk Management.

If you intend to claim MOC points for ABIM, please view the instructions for creating/updating your CE/CME profile.

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 4.50 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 4.50 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 4.50 Category 1 credits for completing this activity.

Disclosures

The planning committee members have disclosed that they have no relevant financial relationships with any commercial interests related to the content of this educational activity:

  • Chase Brown, PharmD
  • Ezekiel J. Emanuel, MD, PhD
  • David Heagarty
  • Steven Joffe, MD, MPH
  • Holly Fernandez Lynch, JD, MBe
  • Connie Ulrich, PhD, RN, FAAN
  • Laura C. Hart, MFA
  • Patricia Smith, DNP, RN, BC

The faculty involved with this activity have reported that their presentations contain no mention of investigational and/or off-label use of products.

Acknowledgment of Commercial Support

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

Contact

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.


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