Research with Vulnerable Populations

Activity Overview

This learning activity provides an overview of ethical and regulatory principles of research with participants perceived as vulnerable. Learners will review definitions of vulnerability, relevant regulations in the United States, and their implications for special protections among various populations, including: 

  • Children 
  • Pregnant women and fetuses 
  • Prisoners 
  • The cognitively impaired 
  • Patients in emergency settings 

 

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

Target Audience

This continuing education activity has been designed for researchers and those involved in research oversight, including physicians, nurses, pharmacists. 

Educational Objectives

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

  • Identify key regulatory and ethical guidance for research with participants perceived as vulnerable. 
  • Outline the ethical implications of various definitions of vulnerability. 
  • Explain special regulatory requirements and unique ethical dilemmas pertaining to research with children, pregnant women and fetuses, prisoners, the cognitively impaired, and patients in emergency settings. 

Successful completion of this educational activity and receipt of certificate of credit includes achieving a minimum score of 83% on the quiz.

Credit Information

Release Date: March 3, 2021

Expiration Date: March 3, 2024

Amount of CME credit: 1.5 AMA PRA Category 1 Credits™

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: 90 minutes

Register: credit           Register: noncredit

 

VIDEO SAMPLE: Research with Vulnerable Populations, with 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 1.5 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 1.5 ACPE contact hours of continuing pharmacy education credit. UAN: JA0000324-0000-20-007-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.

Disclosures

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

  • Jill Baren, MD, MS, MBA
  • Chase Brown, PharmD
  • Ezekiel J. Emanuel, MD, PhD
  • David Heagerty, BA, CIP  
  • Emily Largent, JD, PhD, RN
  • Holly Fernandez Lynch, JD, MBe  
  • Steven Joffe, MD, MPH  
  • Dominic Sisti, PhD
  • Connie Ulrich, PhD, MSN  
  • Adam D. Zolkover, MA  
  • Laura C. Hart, MFA 

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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