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Ethical Aspects of AI in Biomedical Research: The Example of the Bridge2AI Initiative

Vardit Ravitsky, PhD, is the President and CEO of The Hastings Center, an independent, nonpartisan bioethics research institute that is among the most prestigious bioethics and health policy institutes in the world. Ravitsky joins the Center from the University of Montreal where she was Professor at the Bioethics Program, School of Public Health. She is also a Senior Lecturer on Global Health and Social Medicine at Harvard Medical School. She received her PhD from Bar-Ilan University in Israel, her MA from the University of New Mexico, and her BA from the Sorbonne University in Paris, France.

Ravitsky runs an active research program and holds several positions on advisory boards. Her research in bioethics focuses on ethical, legal, and social implications of genomics and assisted reproductive technologies, with an emphasis on emerging biotechnologies and their implications for women’s autonomy and for disability rights. She also studies the ethics of AI in biomedicine.

Community and Patient Engagement in Research

Alicia Bilheimer & Alexandra Lightfoot from NC TraCS discuss how to engage community partners and patients in research. Recorded on Zoom 1/18/2024.

Tribal Consultation and Universities: An Introduction

Danielle Hiraldo and Marissa Carmi from UNC’s American Indian Center discuss the basics of conducting research in partnership with Native American tribes. Topics include: commonly used terms, past research trends, meaningful consultation with tribal partners, and ideas on UNC’s tribal consultation policy. Recorded on Zoom 11/17/2023.

Pregnant Women and Research: Tackling the Complexities of Inclusion

Anne Drapkin Lyerly, MD, MA discusses the ethical imperative of including pregnant people in research studies, drawing from historical and modern cases. Lyerly talk about how to protect people through research, not from it, touching on topics of consent, risks, benefits, and reproductive justice.

PCORI and Patient Engaged Research with Decisionally Impaired People

Kathleen C. Thomas (PCORI) discusses the ethics, challenges, and advantages of engaging decisionally impaired people in research.

Introduction to IRB Meeting Organization, Structure & Efficiencies

Carley Emerson kicks off OHRE’s IRB staff retreat, titled “IRB Meeting Organization, Structure & Efficiencies” and introduces special guest Bruce Gordon, MD from the University of Nebraska Medical Center.

Focus on Criteria for Approval in IRB Review

IRB Meeting Organization, Structure & Efficiencies: Focus on Criteria for Approval in IRB Review (1/4). Bruce Gordon, MD (University of Nebraska Medical Center) presents.

Review of Adverse Events, Unanticipated Problems, and Noncompliance

Focus on Criteria for Approval in IRB Review: Review of Adverse Events, Unanticipated Problems, and Noncompliance (2/4). Bruce Gordon, MD (University of Nebraska Medical Center) presents.

Noncompliance and Corrective Action Plans

IRB Meeting Organization, Structure & Efficiencies: Noncompliance and Corrective Action Plans (3/4). Bruce Gordon, MD (University of Nebraska Medical Center) presents.

What Makes a Good IRB Chair?

Focus on Criteria for Approval in IRB Review: What Makes a Good IRB Chair? (4/4). Bruce Gordon, MD (University of Nebraska Medical Center) presents.

IRB 101

A short introduction to the IRB at UNC. Great for undergraduates, interns, grad students, and anyone new to IRBs and research compliance.

Reliance 101

Compliance Manager Ariana Peden outlines the basics of reliance agreements at UNC, providing examples of when reliance agreements are (and aren’t) required. Peden provides the historical context for reliance agreements, overviews the reliance process, looks at reliance in IRBIS, and answers reliance questions from OHRE staff.

State of the OHRE/IRB with Carley Emerson

Carley Emerson describes the State of OHRE and the IRB at UNC Chapel Hill. A brief question and answer session follows. Presented live via Zoom on 06/22/2023.

Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals

Jill A. Fisher, Ph.D., explains how human research subjects are selected for phase 1 clinical trials, focusing specifically on the (in)equitable selection of subjects and how America’s system of clinical research rewards high risk behaviors among some participants. This presentation was recorded June 15, 2023. Fisher is a Professor of Social Medicine and core faculty in the UNC Center for Bioethics.

Additional Reading

Appraising Harm in Phase I Trials: Healthy Volunteers’ Accounts of Adverse Events by Lisa McManus, Arlene Davis, Rebecca L. Forcier, and Jill A. Fisher

The Journal of Law, Medicine & Ethics, 47 (2019): 323-333.
DOI: 10.1177/1073110519857289

Data Monitoring Committees

Dr. David J. Weber (IRB Chair, Professor of Medicine, Associate Chief Medical Officer and Medical Director in the Department of Infection Prevention at UNC Medical Center) discusses Data Safety Monitoring Committees (DMC or DSMB). Topics include policies on oversight and monitoring, who monitors a trial, different types of DSMBs and more.

UNC Office of Sponsored Programs 2023 Town Hall Meeting

Town Halls are annual meetings where the Office of Sponsored Programs shares updates in an interactive session and answers questions posed by the audience.

Agenda:

  • Updates on Payments to Study Subjects
  • Data Management & Sharing Plans
  • RAM Reports: New Features
  • New Intent to Fund Option in RAMSeS
  • New/Upcoming Fringe Benefit Rates
  • F&A Proposal, Space Study, Single Audit
  • Carolina RAPiDs Update
  • Research Core Updates
  • 2023 Symposium

Click here for previous years’ town hall meetings.

Podcasts

PRIM&R and the Human Research Protection Office at Washington University in St. Louis (WU) have partnered to create More than Meets the IRB: A joint initiative of Washington University in St. Louis and PRIM&R, a series of relevant, and educational podcasts, provided at no cost to an ever-growing audience of research ethics professionals and lay people.

signals-icon  More than Meets the IRB: the Podcasts


Other Materials:

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