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Research in Global Settings


ONLINEACPECMECNESafetyCommunicationEthics/ProfessionalismCollaborative and Team-Based CME/CEPSRM - Patient Safety/Risk ManagementComplimentary - No FeeMEHP Courses

  • Overview
  • Register
  • Faculty
  • Online Content & Tests


Date & Location
Monday, November 8, 2021, 8:00 AM - Friday, November 8, 2024, 11:00 PM

Course Overview
Intended for researchers and those involved in research oversight, this activity provides an overview of ethical principles of biomedical research in global settings, with a special emphasis on research in low- and middle-income countries (LMICs). We will begin with an 8-principle framework for conducting ethical research, then examine areas requiring special attention, including:

  • Determining ethical standards of care for the control arm of trials.
  • Adapting the informed consent process to various cultural contexts.
  • Providing ancillary care for research participants.
  • Researchers’ post-trial obligations to research participants and their communities.

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

Content Last Reviewed: November 8, 2021


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

Learning Objectives

After completing this activity, participants should be able to:


  1. Outline the 8-principle framework for conducting ethical research in LMICs
  2. Explain ethical controversies related to standards of care for the control arm of research studies
  3. Outline culturally appropriate strategies for engaging research participants in the informed consent process
  4. Define ancillary care in the context of biomedical research
  5. Outline researchers’ obligations to study participants and communities in which research has taken place after a trial has concluded

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
• Research in Low- and Middle-Income Countries (10:17)
• Standards of Care (11:25)
• Informed Consent in Cultural Context (11:35)
• Ancillary Care (7:30)
• Post-Trial Obligations (9:17)
 
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 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
 
Nurses: This program provides 1.0 NCPD hours.
 
Pharmacists: This knowledge-based activity is approved for 1.0 ACPE contact hours of continuing pharmacy education credit. 
UAN: JA0000324-0000-21-045-H04-P

Credits
AMA PRA Category 1 Credits™ (1.00 hours), ACPE (1.00 hours), NCPD Hours (ANCC) (1.00 hours), Non-Physician Attendance / Participation (1.00 hours), Patient Safety/Risk Management PSRM (1.00 hours)
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About the Instructors:

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.

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.

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
Steven Joffe, MD, MPH, Chief, Division of Medical Ethics
Chair, Department of Medical Ethics and Health Policy
Perelman School of Medicine
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 5 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.
Register to Access
Post-Trial Obligations (9:17)
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Ancillary (7:30)
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Informed Consent in Cultural Context (11:35)
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Standards of Care (11:25)
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Research in Low- and Middle-Income Countries (10:17)
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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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Research in Global Settings Post-Test
Please note the requirements to claim credit below: 
  • There are 5 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.
Purchase

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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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