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Research with Vulnerable Populations


ONLINEACPECMECNECommunicationEthics/ProfessionalismConferences & SymposiaComplimentary - No FeeState Required CME

  • Overview
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Add to Calendar Research with Vulnerable Populations 3/3/2021 8:00:00 AM 3/3/2024 11:00:00 PM America/New_York For More Details: https://upenn.cloud-cme.com/ResearchwithVulnerablePopulations Online false MM/DD/YYYY


Date & Location
Wednesday, March 3, 2021, 8:00 AM - Sunday, March 3, 2024, 11:00 PM, Online, Philadelphia, PA

Course 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 

Content Last Reviewed: March 3, 2021


Target Audience
Specialties - ALL SPECIALTIES
Professions - Healthcare Administration, Nurse Practitioners, Other Healthcare Professionals, Pharmacists, Physicians, Researchers, Students


Objectives

After completing this activity, participants should be able to:


  1. Identify key regulatory and ethical guidance for research with participants perceived as vulnerable.
  2. Outline the ethical implications of various definitions of vulnerability
  3. 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

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
• The Concept of Vulnerability in Research (9:08)
• Research with Children (11:18)
• Research with Pregnant Women and Fetuses (9:19)
• Research with Prisoners (12:43)
• Research with the Cognitively Impaired: Ethical Issues (6:41)
• Research with the Cognitively Impaired: Strategies (6:50)
• Research in Emergency Settings (12:36)
 
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 1.50 AMA PRA Category 1 Credits™.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses: This activity awards 1.5 NCPD hours

Pharmacists: This practice-based activity is approved for 1.5 ACPE contact hours of continuing pharmacy education credit.
UAN: JA0000324-0000-21-046-H04-P


Credits
AMA PRA Category 1 Credits™ (1.50 hours), Non-Physician Attendance / Participation (1.50 hours), NCPD Hours (ANCC) (1.50 hours), ACPE (1.50 hours)

About the Instructors:


Jill M. Baren, MD, MS, MBA serves as provost and vice president of Academic Affairs at the University of the Sciences and is a tenured professor of Biological Sciences and Humanities in the Misher College of Arts and Sciences. She previously served as faculty leadership development fellow in the Office of the Provost at the University of Pennsylvania and as an American College of Education Fellow in the Office of the President at Villanova University. Dr. Baren is a national leader in academic medicine. She is board certified in Emergency Medicine and Pediatric Emergency Medicine and has held prior faculty positions at the University of California at Los Angeles, Yale University, and the University of Pennsylvania. At Penn Medicine, Dr. Baren served as the first woman chair of Emergency Medicine, chief of Emergency Services for the Health System, and chair of the Human Research Advisory Committee in the Office of the Vice Provost for Research. She is also a graduate of the Executive Leadership in Academic Medicine (ELAM) Program at Drexel University College of Medicine. 

Dr. Baren is the immediate past president of the American Board of Emergency Medicine, serving 40,000 practicing emergency physicians and trainees. She has lectured nationally and internationally on academic leadership and mentorship. She has published over 150 peer-reviewed articles, editorials and book chapters, and has edited several books including her own textbook, Baren’s Pediatric Emergency Medicine. Her research focuses on ethics and informed consent within emergency clinical trials, and it has received funding from the National Institute of Neurological Disorders and Stroke, the National Institute of Child Health and Human Development, the National Heart, Lung, and Blood Institute, and the Robert Wood Johnson Foundation. Dr. Baren has served as a consultant to the NIH, the FDA and multiple national research networks on informed consent regulations in clinical trials of life-threatening conditions. 

Dr. Baren attended Brown University where she received a BS degree in Biochemistry. She received her MD degree, summa cum laude, from the University of Pittsburgh School of Medicine and is a member of the Alpha Omega Alpha National Medical Honor Society. She holds an MS in Bioethics from the University of Pennsylvania and an executive MBA degree from the Heller School of Management and Social Policy at Brandeis University, where she was inducted into the Beta Gamma Sigma National Business School Honor Society. 

Ezekiel J. Emanuel, MD, PhD, is the Vice Provost for Global Initiatives and the Diane v.S. Levy and Robert M. Levy University Professor at the University of Pennsylvania.

Dr. Emanuel is an oncologist and world leader in health policy and bioethics. He is a special advisor to the Director General of the World Health Organization, Senior Fellow at the Center for American Progress, and member of the Council on Foreign Relations. He was the founding chair of the Department of Bioethics at the National Institutes of Health and held that position until August of 2011. From 2009 to 2011, he served as a special advisor on health policy to the director of the Office of Management and Budget and National Economic Council. In this role, he was instrumental in drafting the Affordable Care Act (ACA). Emanuel also served on the Biden-Harris Transition Covid Advisory Board.

Dr. Emanuel is the most widely cited bioethicist in history. He has over 350 publications and has authored or edited 15 books. His recent books include the books Which Country Has the World’s Best Health Care (2020), Prescription for the Future (2017), Reinventing American Health Care: How the Affordable Care Act Will Improve our Terribly Complex, Blatantly Unjust, Outrageously Expensive, Grossly Inefficient, Error Prone System (2014) and Brothers Emanuel (2013).

Dr. Emanuel regularly contributes to The New York Times, The Washington Post, The Wall Street Journal, The Atlantic, and often appears on BBC, NPR, CNN, MSNBC and other media outlets.  

He has received numerous awards including election to the Institute of Medicine (IOM) of the National Academy of Science, the American Academy of Arts and Sciences, the Association of American Physicians, and the Royal College of Medicine (UK). He received—but refused—a Fulbright Scholarship. 

He has been named a Dan David Prize Laureate in Bioethics and is a recipient of the AMA-Burroughs Wellcome Leadership Award, the Public Service Award from the American Society of Clinical Oncology, Lifetime Achievement Award from the American Society of Bioethics and Humanities, the Robert Wood Johnson Foundation David E. Rogers Award, President's Medal for Social Justice Roosevelt University, and the John Mendelsohn Award from the MD Anderson Cancer Center. 

Dr. Emanuel has received honorary degrees from Icahn School of Medicine at Mount Sinai, Union Graduate College, the Medical College of Wisconsin, and Macalester College. Dr. Emanuel is a graduate of Amherst College. He holds a MSc from Oxford University in Biochemistry and received his MD from Harvard Medical School and his PhD in political philosophy from Harvard University.

Steven Joffe, MD, MPH, is the Art and Ilene Penn Professor of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine. He serves as chair of the Department of Medical Ethics and Health Policy and chief of the Division of Medical Ethics, where he directs a National Human Genome Research Institute- (NHGRI-) funded postdoctoral training program in the ethical, legal, and social implications of genomics. In addition, he is professor of pediatrics at the Perelman School of Medicine and Children’s Hospital of Philadelphia (CHOP). He attended Harvard College, received his medical degree from the University of California at San Francisco (UCSF), and received his public health degree from UC Berkeley. He trained in pediatrics at UCSF and undertook fellowship training in pediatric hematology/oncology at the Dana-Farber Cancer Institute and Boston Children’s Hospital. Prior to coming to Penn, he served on the faculty of Harvard Medical School, and was an attending pediatric oncologist at the Dana-Farber Cancer Institute and Boston Children’s Hospital, for 13 years. 

Dr. Joffe’s research addresses the many ethical challenges that arise in the conduct of clinical and translational investigation and in genomic medicine. He has been the principal investigator (PI) of NIH, Patient-Centered Outcomes Research Institute (PCORI), and foundation-funded studies that examine the roles and responsibilities of PIs in multicenter randomized trials, accountability in the clinical research enterprise, governance of learning activities within learning health care systems, return of individual genetic results to participants in epidemiologic cohort studies, and the integration of genomic sequencing technologies into cancer care. He has also lectured widely on research ethics and on the ethical, legal, and social implications of genomic technologies. He was previously a member of the Department of Health and Human Services Secretary’s Advisory Committee for Human Research Protections, of the National Academy of Sciences Committee on Federal Research Regulations and Reporting Requirements, and of the U.S. Food and Drug Administration’s (FDA) Pediatrics Ethics Subcommittee, and of the Data and Safety Monitoring Board overseeing the federally funded phase III trials of COVID19 vaccines. In addition, he previously chaired the Children's Oncology Group Bioethics Committee and the NHGRI's Genomics and Society Working Group. He is an elected member of the National Academy of Medicine.

In his teaching within the department's online educational initiatives, Dr. Joffe aims to convey a deep understanding of the ethical principles underlying research, while guiding students in how to apply those principles to real-world problems. He hopes students will take one core lesson from his teaching: it is possible to conduct studies on questions relevant to policy and practice that are simultaneously experimentally rigorous and ethically respectful of the rights and interests of the individuals who take part.

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.

Emily Largent, JD, PhD, RN, is the Emanuel and Robert Hart Assistant Professor of Medical Ethics and Health Policy. She holds a secondary appointment at Penn Law, is a senior fellow at the Leonard Davis Institute of Health Economics, and is part of the Center for Health Incentives and Behavioral Economics (CHIBE).

Prof. Largent’s work explores ethical and regulatory aspects of human subjects research with a particular focus on Alzheimer’s disease research and the translation of research findings into care. Her work is supported by the National Institute on Aging and the Greenwall Foundation. Prof. Largent’s work has been published in leading journals, including The Hastings Center Report, American Journal of Bioethics, New England Journal of Medicine, and JAMA. She co-authored Clinical Research Ethics Consultation: A Casebook (Oxford University Press).  

Prof. Largent studied science, technology, and international affairs as an undergraduate at Georgetown University and earned a second degree in nursing from Penn Nursing. She received her PhD in health policy, with a concentration in ethics, from Harvard University and her JD from Harvard Law School. Prof. Largent was previously a fellow in the Department of Bioethics at the National Institutes of Health (2008–2010) and clerked for Chief Judge Jeffrey Howard of the United States Court of Appeals for the First Circuit (2016–2017) before coming to Penn. 

Dominic Sisti, PhD, is director of the Scattergood Program for the Applied Ethics of Behavioral Health Care and associate professor in the Department of Medical Ethics and Health Policy at the University of Pennsylvania. He holds secondary appointments in the Department of Psychiatry, where he directs the ethics curriculum in the residency program, and the Department of Philosophy. Dr. Sisti's research examines the ethics of mental health care services and policies, including long-term psychiatric care for individuals with serious mental illness, and ethical issues in prison and jail health care. He also studies the philosophical, ethical, and policy implications of defining and redefining mental disorders in the DSM. Most recently, Dr. Sisti has been studying the ethical implications of artificial intelligence and social media in the context of mental health care delivery.
 
Dr. Sisti's writings have appeared in peer-reviewed journals such as JAMA, JAMA Psychiatry, Psychiatric Services, the Hastings Center Report, and the Journal of Medical Ethics. His scholarship has been featured by popular media outlets such as the New York Times, The Economist, NPR, the Philadelphia Inquirer, Slate, and The Atlantic. He is editor of three books: Health, Disease, and Illness: Concepts in Medicine (with Arthur Caplan and James McCartney, Georgetown University Press, 2004), The Case of Terri Schiavo: Ethics at the End of Life (with Arthur Caplan and James McCartney, Prometheus Books, 2006), and Applied Ethics in Mental Healthcare: An Interdisciplinary Reader (with Arthur Caplan and Hila Rimon-Greenspan, MIT Press, 2013). 

Dr. Sisti was an Edmund Pellegrino Fellow at the Center for Clinical Bioethics at Georgetown University. He received his bachelor's degree in biology from Villanova University, a Master of Bioethics from the University of Pennsylvania, and his doctorate in philosophy from Michigan State University. His research has been funded by the Thomas Scattergood Behavioral Health Foundation, the Greenwall Foundation, The Quattrone Center for the Fair Administration of Justice, the Leonard Davis Institute, and the Dana Foundation. Dr. Sisti teaches graduate courses on clinical ethics, ethics in behavioral health care, and social media, ehealth, and biomedical ethics. He has organized and led the ethics track for the American Psychiatric Association's annual meeting since 2012. 

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.

Mitigation of Relevant Financial Relationships


Penn Medicine adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CE activity, including faculty, planners, reviewers or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.

Jill Baren, MD, MBA
Professor
HUP, CHOP
Philadelphia, PA
Chase Brown, PharmD
Clinical Pharmacy Specialist
Ezekiel J. Emanuel, MD, PhD, Vice Provost for Global Initiatives
Co-Director of the Healthcare Transformation Institute at the University of Pennsylvania
University of Pennsylvania
Philadelphia, PA
Holly Fernandez Lynch, JD, MBE
John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics
University of Pennsylvania
Philadelphia, PA
Steven Joffe, MD, MPH, Chief, Division of Medical Ethics
Chair, Department of Medical Ethics and Health Policy
Perelman School of Medicine
Philadelphia, PA
Emily Largent, JD, PhD, RN, Senior Fellow, Leonard Davis Institute of Health Economics
Emanuel and Robert Hart Assistant Professor of Medical Ethics and Health Policy, Perelman School of Medicine
University of Pennsylvania, Carey Law School
Philadelphia, PA
Dominic Sisti, PhD
Associate Professor of Medical Ethics & Health Policy
Scattergood Program for Applied Ethics in Behavioral Health Care
Philadelphia, PA

Research with Vulnerable Populations Pre-Test
How to Receive 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
  • Complete the pre-test
  • Review the video lectures, references and resources
  • Complete the post-test. 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.
Register to Access
The Concept of Vulnerability in Research (9:08)
Purchase
Research with Children (11:18)
Purchase
Research with Pregnant Women and Fetuses (9:19)
Purchase
Research with Prisoners (12:43)
Purchase
Research with the Cognitively Impaired: Ethical Issues (6:41)
Purchase
Research with the Cognitively Impaired: Strategies (6:50)
Purchase
Research in Emergency Settings (12:36)
Purchase
Reference List
Once the reference list opens and the pdf is displayed, please click right click on the links for them to open in a window. 
Purchase
Research with Vulnerable Populations Post-Test
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.
  • Once you have successfully completed the test, you should be prompted to complete the evaluation. 
Post-Test

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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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