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Ethics and Regulation of Social and Behavioral Research


ONLINECMECNEMOCEthics/ProfessionalismConferences & SymposiaComplimentary - No FeeMEHP Courses

  • Overview
  • Register
  • Faculty
  • Online Content & Tests


Date & Location
Sunday, October 1, 2023, 7:00 AM - Wednesday, October 1, 2025, 12:00 AM

Course 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. Learners will review the rationale for regulating social and behavioral research, as well as landmark studies that have raised ethical questions. Other topics include:

  • 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 it can serve as a supplement to Ethics of Research with Human Subjects.

Content Last Reviewed: February 20, 2024


Target Audience
Specialties - ALL SPECIALTIES

Learning Objectives

After completing this activity, participants should be able to:


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

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.

The Structure of the Course
• Why Regulate Social and Behavioral Research? (9:17)
• Social and Behavioral Research Under the Common Rule (11:39)
• Ethical Issues in Ethnographic Research (8:31)
• Deception in Research (9:29)
• Privacy and Confidentiality (8:13)

Each lecture includes a list of suggested readings that provide more detail about what was discussed. Links to external readings will lead you to an abstract or, if available, the full article.

Note that closed captions are available for all video segments.

Successful completion of this educational activity and receipt of certificate of credit includes achieving a minimum score of 90% on the post-test.

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 1.25 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 1.25 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 1.25 NCPD hours.

Credits
AMA PRA Category 1 Credits™ (1.25 hours), ABIM MOC Part 2 (1.25 hours), NCPD Hours (ANCC) (1.25 hours), Non-Physician Attendance / Participation (1.25 hours)
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About the Instructors:

Justin Clapp, PhD, MPH is an 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 healthcare 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.

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’s primary interests include mentoring IRB staff, education and training on matters related to IRB review, and social/behavioral research.
 
 Holly Fernandez Lynch, JD, MBE, chairs the Master of Health Care Innovation (MHCI) admissions committee and supports the academic progress of MHCI students within the Department of Medical Ethics and Health Policy’s Online Educational Initiatives. She is also the curriculum director of online clinical and research ethics education for Penn medical students.

Prof. Fernandez Lynch pursues conceptual and empirical research and scholarship with the goal of influencing institutional and governmental policy. Her work focuses on clinical research ethics and regulation, priority setting in research, access to investigational medicines outside clinical trials, FDA pharmaceutical policy, and the ethics of gatekeeping in health care. She is founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight (www.AEREO.org), an organization working to evaluate and improve IRB quality and effectiveness, and an active member of the NYU Working Group on Compassionate Use and Preapproval Access (CUPA). She serves as a member of the boards of Public Responsibility in Medicine and Research (PRIM&R) and the American Society for Law, Medicine, and Ethics, and as "ethicist in residence" at the Robert Wood Johnson Foundation. She was previously a member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP).  

Professor Fernandez Lynch has worked as an attorney in private practice, as a bioethicist serving NIH’s Division of AIDS, as an analyst with President Obama's Commission for the Study of Bioethical Issues, and as executive director of Harvard Law School's bioethics and health law research program. She was named a Greenwall Faculty Scholar in 2019 and elected a fellow of the Hastings Center in 2021.

Jonathan D. Moreno, PhD is the David and Lyn Silfen University Professor at the University of Pennsylvania, where he is a Penn Integrates Knowledge (PIK) professor. At Penn he is also Professor of Medical Ethics and Health Policy, of History and Sociology of Science, and of Philosophy. His most recent books are Everybody Wants to Go to Heaven but Nobody Wants to Die: Bioethics and the Transformation of Healthcare in America, co-authored with Penn president Amy Gutmann; and The Brain in Context: A Pragmatic Guide to Neuroscience, written with neuroscientist Jay Schulkin.  

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.

Moreno received his Ph.D. 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 College of William and Mary Law School Benjamin Rush Medal, the Dr. Jean Mayer Award for Global Citizenship from Tufts University, and the Penn Alumni Faculty Award of Merit.  He has held the honorary Visiting Professorship in History at the University of Kent in Canterbury, England. In 2018 the American Society for Bioethics and Humanities presented him with its Lifetime Achievement Award.

Disclosures
The following planning committee member has reported the following relevant financial relationships with commercial interests related to the content of this educational activity:
Ezekiel J. Emanuel, MD, PhD: Leigh Bureau, Speaker Honorarium; Oak HC/FT, Salary; Nuna, Stock Shareholder

The faculty and planning committee members listed below have disclosed that they have no relevant financial relationships with any commercial interests related to the content of this educational activity:
Steven Joffe, MD, MPH
Autumn Fiester, PhD
Dominic A. Sisti, PhD
Connie Ulrich, PhD, MSN
Amy Ashbridge, MBA
Adam Zolkover, MA
Laura C. Hart, MFA
Mila Kostic, CHCP, FACEHP
Michael Schoen, PhD
Rodman Campbell, CHCP
Patricia Smith, DNP, RN, BC

The faculty reported that there will be no mention of investigational and/or off-label use of products in this presentation.

Justin T Clapp, PhD, MPH
University of Pennsylvania Perelman School of Medicine
Philadelphia, PA
Holly Fernandez Lynch, JD, MBE
University of Pennsylvania
Philadelphia, PA
David Haegerty
Jonathan Moreno, PhD
David & Lyn Silfen University Professor, Professor of Medical Ethics & Health Policy and of History & Sociology of Science
Penn Integrates Knowledge (PIK) Professor
Philadelphia, PA

Instructions to Claim Credit
To receive your Certificate of Credit for participating in this CME/CE-certified educational curriculum, please follow these steps: 

Read all the introductory material including faculty and disclosure information
  • Review the video lectures, references and resources 
  • This test has 6 questions. You will have 5 attempts to earn at least 90% on the post-test in order to complete the course and earn your certificate. 
  • Evaluate the activity using the brief survey.
  • You must complete the post activity evaluation to receive credit. 
  • You will be able to download your certificate after completing the post-activity evaluation.
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Ethics and Regulation of Social and Behavioral Research Pre-Course Attestation
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Why Regulate Social and Behavioral Research? (9:17)
Register to Access
Social and Behavioral Research Under the Common Rule (11:39)
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Ethical Issues in Ethnographic Research (8:31)
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Deception in Research (9:29)
“In December 2023, the FDA finalized regulations to allow consent waiver for certain minimal risk investigations under the same conditions set forth in the Common Rule.”
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Privacy and Confidentiality (8:13)
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Reference List
Once the reference list opens and the pdf is displayed, please right click on the links for them to open in a new window. 
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Ethics and Regulation of Social and Behavioral Research Post-Test
Please note the steps below to claim credit:
  • There are 6 questions. You will have 5 attempts to earn at least 90% on the post-test in order to complete the course and earn your certificate.
  • Evaluate the activity using the brief survey. You must complete the post activity evaluation to receive credit.
  • You will be able to download your certificate after completing the post-activity evaluation.

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UPenn is Joint Accredited for Interprofessional Continuing Education
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.
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