Video still of Jonathan Moreno
VIDEO SAMPLE: Why Regulate Social and Behavioral Research, with Jonathan D. Moreno, PhD

Release Date: December 7, 2020

Expiration Date: December 7, 2023

Amount of CME credit: 1.25 AMA PRA Category 1 Credits™

Amount of Nursing Contact Hours: 1.25 Contact Hours

Pharmacists: 1.25 ACPE contact hours of continuing pharmacy education credit 

Estimated Length of Time for Completion: 75 minutes

Program Overview

Intended for researchers in the social and behavioral sciences, as well as IRB members and staff, this course provides an overview of ethical principles and federal regulations that govern research in these fields. Topics include: 

  • The rationale for regulating social and behavioral research  
  • Landmark studies that have raised ethical questions 
  • Social and behavioral science under the Common Rule 
  • Ethics and regulation of ethnographic studies and studies that involve deception 
  • Privacy and confidentiality 

This course can be taken alone or as a supplement to Ethics of Research with Human Subjects

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

Researchers in the social and behavioral sciences, and IRB members and staff.

Educational Objectives

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

  • Summarize the rationale for regulating social and behavioral research. 
  • Explain how social and behavioral research is regulated under the Common Rule. 
  • Explain privacy and confidentiality considerations in social and behavioral research. 
  • Outline ethical and regulatory issues specific to ethnographic studies and studies that involve deception. 

Successful completion of this educational activity and receipt of certificate of credit includes achieving a minimum score of 83% on the 1 quiz. 

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 1.25 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 1.25 contact hours.

Pharmacists

Penn Medicine is jointly accredited by the Accreditation Council for Pharmacy Education (ACPE).

This practice-based activity is approved for up to 1.25 ACPE contact hours of continuing pharmacy education credit. UAN: JA0000324-0000-20-007-H05-P

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 1.25 Category 1 credits for completing this activity.

Meet the Faculty

Justin Clapp, PhD, MPH

Justin Clapp, PhD, MPH is Assistant Professor of Anesthesiology and Critical Care at the Perelman School of Medicine and Associated Faculty in Anthropology at the University of Pennsylvania. He is a linguistic/medical anthropologist who uses qualitative methods along with anthropological theory to examine issues in health care communication, medical decision making, and empirical bioethics. Much of his recent work has focused on better understanding how providers and patients decide on preference-sensitive, elective treatment options in perioperative contexts (surgery, anesthesia, intensive care). The goal of this work is to develop models of decision making better tailored to the intricacies of provider-patient interaction.

Dr. Clapp is also researching the communication of pain in clinical settings, the intersection of medicine and social determinants of health, the norms and practices of research ethics review, and several topics in medical education. He teaches courses in the Anthropology department and the MPH program, and he collaborates with investigators across the Perelman School of Medicine on qualitative projects. He received his PhD in anthropology from the University of Pennsylvania and his MPH from the University of Pennsylvania Perelman School of Medicine.

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David Heagerty, BA, CIP

David Heagerty is an Associate Director at the University of Pennsylvania IRB. He serves on multiple IRBs at Penn, including the Social/Behavioral Committee, where he is a primary reviewer for research proposals qualifying for exempt and expedited review. Mr. Heagerty’sprimary interests include mentoring IRB staff, education and training on matters related to IRB review, and social/behavioral research.

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Holly Fernandez Lynch, JD, MBE

Holly Fernandez Lynch, JD, MBE, is an attorney-bioethicist and the John Russell Dickson, MD, Presidential Assistant Professor of Medical Ethics. She is also the assistant faculty director of Online Education in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine. Prof. Fernandez Lynch earned her BA, Master of Bioethics, and JD all from the University of Pennsylvania. Prior to returning to the university as a faculty member, she was executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Teaching Faculty in the Master of Bioethics program at Harvard Medical School. She has also worked as an attorney in private practice focused on pharmaceuticals regulation, and as a bioethicist at the NIH’s Division of AIDS and President Obama's Commission for the Study of Bioethical Issues. 

Prof. Fernandez Lynch’s scholarly work focuses primarily on the ethics and regulation of human subjects research, as well as the law and ethics of conscientious refusals in health care. She is the founder and chair of the Consortium to Advance Effective Research Ethics Oversight (AEREO), established in 2018 to carry out an empirical research agenda to evaluate and improve the effectiveness of research ethics review and oversight by IRBs and Human Research Protection Programs. She has also served as a member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) since 2014.  Prof. Fernandez Lynch’s work has been published in leading bioethics, medical, and law journals, including JAMA; The New England Journal of Medicine; Science; Health Affairs; The Journal of Law, Medicine, and Ethics; and The American Journal of Bioethics, in addition to popular outlets such as The New York Times, The Boston Globe, and STAT. She is the author of Conflicts of Conscience in Health Care: An Institutional Compromise (MIT Press 2008), as well as the co-editor of books covering human subjects research regulation; FDA regulation of drugs and new technologies; health law and behavioral economics; law, religion, and health; biospecimen research; big data, health law, and bioethics; and transparency in health care (forthcoming). 

Within the department’s online education initiatives, Prof. Fernandez Lynch plays a primary role in supporting the academic progress of students pursuing the Master of Health Care Innovation. She is also the curriculum director of online medical ethics education, overseeing the training of Penn medical students in clinical and research ethics. 

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Jonathan D. Moreno, PhD

Jonathan D. Moreno, PhD, is a Penn Integrates Knowledge university professor at the University of Pennsylvania, holding the David and Lyn Silfen chair. He is also Professor of Medical Ethics and Health Policy, of History and Sociology of Science, and of Philosophy. In 2013 his online neuroethics course drew more than 36,000 registrants.

Dr. Moreno is also a Senior Fellow at the Center for American Progress in Washington, DC, and the author of several books on national security, science, and ethics, including Mind Wars: Brain Science and the Military in the 21st Century and The Body Politic: The Battle Over Science in America. He is an elected member of the National Academy of Medicine and is a National Associate of the National Research Council. He has served as a senior staff member for three presidential advisory commissions and as an adviser to many non-governmental organizations. Dr. Moreno is the U.S. member of the UNESCO International Bioethics Committee.

Dr. Moreno received his PhD in philosophy from Washington University in St. Louis, was an Andrew W. Mellon post-doctoral fellow, holds an honorary doctorate from Hofstra University, and is a recipient of the Benjamin Rush Medal from the College of William and Mary Law School and the Dr. Jean Mayer Award for Global Citizenship from Tufts University. In 2014 he was named to a three-year term as an honorary Visiting Professor in History at the University of Kent in Canterbury, England. 

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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, MD 
  • 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

If you have questions, please contact Caitlin O'Neill, Program Manager for Online Educational Initiatives, at MEHPonline@pennmedicine.upenn.edu.

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.