Ethical and Regulatory Aspects of Clinical Research Info

2023 Course Information

• Lectures

  • Session 1: Introduction/Framework/History/Institutional Review Boards – September 20, 2023

    • - Holly Taylor PhD MPH
    • - Christine Grady RN PhD
    • - Susan Lederer PhD
    • - Holly Taylor PhD MPH

  • Session 2: Informed Consent/Decision Making/Capacity Assessment – September 27, 2023

    • - Christine Grady RN PhD
    • - Scott Kim MD PhD
    • - Julie Brintnall-Karabelas LCSW-C
    • - Holly Taylor PhD MPH

  • Session 3: Study Design/Risk-Benefit/Inclusion of Children in Research – October 4, 2023

    • - Holly Taylor PhD MPH
    • - Dave Wendler PhD
    • - Seema Shah JD

  • Session 4: Incidental Findings/Return of Results/Inclusion of Native Populations – October 11, 2023

    • - Ben Berkman JD MPH
    • - Leila Jamal PhD ScM CGC
    • - Katrina Claw PhD

  • Session 5: Equity/Subject Selection/Recruitment and Retention – October 18, 2023

    • - Yukiko Asada PhD
    • - Holly Taylor PhD MPH
    • - Dave Wendler PhD

  • Session 6: International/Standards of Care/Post-trial Obligations/Community Engagement – October 25, 2023

    • - Annette Rid MD PhD
    • - Joseph Millum PhD
    • - Dorcas Kamuya PhD MPH

  • Session 7: Emerging Tech – November 1, 2023

    • - Marielle Gross MD MBE
    • - Saskia Hendriks MD PhD
    • LLMs - Vasiliki Rahimzadeh PhD – Presentation available upon request: please contact bioethics-inquiries@mail.nih.gov

2022 Course Information

• Lectures

  • Session 1: Introduction/Framework/History/Institutional Review Boards – September 21, 2022

    • - Holly Taylor PhD MPH
    • - Christine Grady RN PhD
    • - Susan Lederer PhD
    • - Holly Taylor PhD MPH

  • Session 2: Study Design/Risk-Benefit/Perspectives from the Field – September 28, 2022

    • - Holly Taylor PhD MPH
    • - Dave Wendler PhD
    • - Julie Ledgerwood DO, Philip Arlen, MD

  • Session 3: Subject Selection/Recruitment and Retention/Inclusion of Children – October 12, 2022

    • - Holly Taylor PhD MPH
    • - Dave Wendler PhD
    • - Seema Shah JD

  • Session 4: Equity and Inclusion – October 19, 2022

    • - Yukiko Asada PhD
    • - Holly Taylor PhD MPH
    • - Aisha Langford PhD MPH
    • - Holly Taylor PhD MPH

  • Session 5: Informed Consent/Decision Making/Capacity Assessment – October 26, 2022

    • - Christine Grady RN PhD
    • - Scott Kim MD PhD
    • - Carol Squires LCSW
    • - Holly Taylor PhD MPH

  • Session 6: Incidental Findings/Return of Results/Inclusion of Native Populations – November 2, 2022

    • - Ben Berkman JD MPH
    • - Leila Jamal PhD ScM CGC
    • - Katrina Claw PhD

  • Session 7: International/Standards of Care/Post-trial Obligations/Community Engagement – November 9, 2022

    • - Annette Rid MD PhD
    • - Joseph Millum PhD
    • - Dorcas Kamuya PhD MPH

2021 Course Information

• Lectures

  • Session 1: Ethical Framework, Physician-Investigator Role, History of Research Ethics – September 22, 2021

    • - Holly Taylor PhD MPH
    • - Christine Grady RN PhD
    • - Steve Joffe MD MPH
    • - Christine Grady and Holly Taylor

  • Session 2: Randomized Clinical Trials/Risk-Benefit/Institutional Review Boards – September 29, 2021

    • - Robert Truog MD
    • - David Wendler PhD
    • - Holly Taylor PhD MPH

  • Session 3: Subject Selection/Inclusion of Pregnant Women/Recruitment and Retention – October 6, 2021

    • - Holly Taylor PhD MPH
    • - Anne Drapkin Lyerly MD MA
    • - Dave Wendler PhD
    • - Holly Taylor PhD MPH

  • Session 4: Informed Consent/Decision Making/Capacity Assessment – October 13, 2021

    • - Christine Grady RN PhD
    • - Scott Kim MD PhD
    • - Katherine Todman MSW LCSW-C and Holly Taylor PhD MPH

  • Session 5: Returning Results/Incidental Findings/Collaborating with Indigenous Communities – October 20, 2021

    • - Ben Berkman JD MPH
    • - Leila Jamal PhD ScM CGC
    • Enrollment of Native Populations: Key Considerations - Sara Hull PhD and Katrina Claw PhD
    • - Sara Hull and Holly Taylor PhD MPH

  • Session 6: Vaccines – October 27, 2021

    • - Christine Grady RN PhD
    • - Annette Rid MD PhD
    • - Aisha Langford PhD MPH

  • Session 7: International/Standards of Care/Post-trial Obligations – November 3, 2021

    • - Annette Rid MD PhD
    • - Joseph Millum PhD
    • - Joseph Millum PhD
    • Perspectives from Kenya - Joseph Millum and Dorcas Kamuya PhD MPH

2020 Course Information

• Lectures

  • Session 1: Ethical Framework, Risk Benefit – September 23, 2020

    • Introduction to Course - Holly Taylor PhD MPH
    • - Christine Grady RN PhD
    • - Dave Wendler PhD

  • Session 2: Informed Consent, Privacy and Confidentiality – September 30, 2020

    • - Christine Grady RN PhD
    • - Scott Kim MD PhD
    • - Holly Taylor PhD MPH
    • - Ben Berkman JD

  • Session 3: Subject Selection – October 7, 2020

    • - Holly Taylor PhD MPH
    • - Dave Wendler PhD
    • Enrollment of Prisoners: Key Considerations - Holly Taylor PhD MPH
    • - Holly Taylor PhD MPH/Dave Wendler PhD

  • Session 4: Genetics – October 14, 2020

    • - Ben Berkman JD MPH
    • - Lelia Jamal PhD ScD CGC
    • Enrollment of Native Populations: Key Considerations - Sara Hull, PhD/Katrina Claw, PhD
    • - Sara Hull, PhD/Holly Taylor PhD MPH

  • Session 5: Trial Design/IRBs – October 21, 2020

    • - Robert Truog MD
    • - Scott Kim MD PhD
    • - Holly Taylor PhD MPH/Sara Hull, PhD

  • Session 6: International Research – October 28, 2020

    • - Joseph Millum PhD
    • - Maria Merritt PhD
    • Perspectives from Kenya - Joseph Millum, PhD/Dorcas Kamuya, PhD
    • - Joseph Millum PhD/Holly Taylor PhD MPH

  • Session 7: COVID Vaccines – November 4, 2020

    • - Christine Grady RN PhD
    • Ethics of Controlled Human Infection Trials - Seema Shah JD/Nir Eyal PhD/Annette Rid MD PhD
    • - Holly Taylor PhD MPH
    • - Anne Barnhill PhD

2019 Course Information

• Lectures

  • Session 1: Ethical Framework, Bench to Bedside, and IRB Function/Purpose – September 25, 2019

    • - Christine Grady RN PhD
    • - Susan E. Lederer PhD
    • - Steve Joffe MD MPH

  • Session 2: IRBs, Risks and Benefits, and the Ethics of Research with Children – October 2, 2019

    • - Sara Hull PhD
    • - Dave Wendler PhD
    • Ethics of Research with Pregnant Women - Maggie Little PhD

  • Session 3: Ethics of Pragmatic Trials, Ethics of Randomized Clinical Trials, and Ethics of Vaccine Research – October 16, 2019

    • - Scott Kim MD PhD
    • - Robert Truog MD
    • - Holly Taylor PhD MPH

  • Session 4: Fair Subject Selection, Recruitment and Retention, and Participant Panel – October 23, 2019

    • - Holly Taylor PhD MPH
    • - Dave Wendler PhD

  • Session 5: Informed Consent, Research with Those with Impaired Capacity for Consent, and Research Ethics Consultation – October 30, 2019

    • - Christine Grady RN PhD
    • - Scott Kim MD PhD
    • - Marion Danis MD

  • Session 6: Ethical Issues in International Research – November 6, 2019

    • - Annette Rid MD, PhD
    • - Joseph Millum PhD
    • - Annette Rid, MD, PhD

  • Session 7: Ethics of Genetics Research and Incidental Findings, and Ethical Issues in All of Us – November 13, 2019

    • - Leila Jamal PhD
    • - Ben Berkman JD MPH
    • - Katherine Blizinsky PhD

2018 Course Information

• Lectures

  • Session 1: Ethical Framework, Bench to Bedside, and IRB Function/Purpose – September 26, 2018

    • - Christine Grady RN PhD
    • - Steve Joffe MD MPH
    • - Sara Hull PhD

  • Session 2: Risks and Benefits, and the Ethics of Research with Children – October 3, 2018

    • - Dave Wendler PhD
    • - Alan Fleischman MD

  • Session 3: Research with Samples and Data, Big Data, and Incidental Findings – October 10, 2018

    • - Ben Berkman JD MPH
    • - Holly Fernandez Lynch JD MBe
    • - Jeff Kahn PhD

  • Session 4: Fair Subject Selection, the History of Research Ethics, and Research with Native Americans and Alaskan Natives – October 17, 2018

    • - Dave Wendler PhD
    • - Jonathan D. Moreno PhD
    • - David R. Wilson PhD

  • Session 5: Ethics of Randomized Clinical Trials, Ethics of Pragmatic Trials, and Ethical Issues in All of Us – October 24, 2018

    • - Scott Kim MD PhD
    • - Robert Truog MD
    • - Katherine Blizinsky PhD

  • Session 6: Informed Consent, Research with Those with Impaired Capacity for Consent, and Participant Panel – October 31, 2018

    • - Christine Grady RN PhD
    • - Scott Kim MD PhD

  • Session 7: Ethical Issues in International Research – November 7, 2018

    • Ethical Issues in International Research: Introduction and Standard of Care - Annette Rid MD
    • Ethical Issues in International Research: Post Trial Obligations - Joseph Millum PhD

2017 Course Information

• Lectures

  • Session 1: History and Framework for Ethical Clinical Research – September 27, 2017

    • - Christine Grady RN PhD
    • History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Susan E. Lederer PhD
    • - Rebecca Dresser JD

  • Session 2: IRBs, the Common Rule, and Subject Selection – October 4, 2017

    • - Sara Hull PhD
    • - Yvonne Lau MBBS, MBHL, PhD
    • - Dave Wendler PhD

  • Session 3: Risks and Benefits, Research with Pregnant Women and Research Participant Panel – October 11, 2017

    • - Dave Wendler, PhD
    • - Maggie Little BPhil PhD

  • Session 4: Informed consent, Research with those with Impaired Capacity for Consent, and Conflicts of Interest – October 18, 2017

    • - Christine Grady RN PhD
    • - Scott Kim MD PhD
    • - Steve Joffe MD MPH

  • Session 5: Ethics of Research with Children, Ethics of Randomized Clinical Trials, and Ethics of Pragmatic Trials – October 25, 2017

    • - Robert "Skip" Nelson MD
    • Ethics of Randomized Clinical Trials: Clinical Equipoise - Robert Truog MD
    • - Scott Kim MD PhD

  • Session 6: Ethics of Research with Stored Tissue and Data, Incidental Findings, and the Ethics of International Research – November 1, 2017

    • - Sara Chandros Hull PhD
    • - Ben Berkman JD MPH
    • - Reidar Lie MD PhD

  • Session 7: Stored Tissue, Big Data, and Incidental Findings – November 8, 2017

    • - Joe Millum PhD
    • - Jeff Kahn PhD
    • Mock IRB

2016 Course Information

• Lectures

  • Session 1: History and Framework for Ethical Clinical Research – September 28, 2016

    • - Christine Grady RN PhD
    • - Susan E. Lederer PhD
    • - Ivor Pritchard PhD

  • Session 2: IRBs, Fair Subject Selection, and Participant Perspectives – October 5, 2016

    • - Sara Hull PhD
    • - David Wendler PhD

  • Session 3: Risk and Benefits, Research with Children, and Research with Pregnant Women – October 19, 2016

    • - Dave Wendler PhD
    • - Robert Nelson PhD
    • Ethics of Research with Pregnant Women - Maggie Little PhD

  • Session 4: Informed Consent, Research with Adults with Impaired Decision Making, and the Ethics of Research with Big Data – October 26, 2016

    • - Christine Grady RN PhD
    • - Scott Kim MD PhD
    • - Jeff Kahn PhD

  • Session 5: Ethics of Randomized Trials, Research with Stored Tissue and Data, and Conflicts of Interest – November 2, 2016

    • - Sara Chandros Hull PhD
    • - Robert Truog MD
    • - Steve Joffe MD MPH

  • Session 6: International Research Ethics and Community Engagement Research – November 9, 2016

    • - Reidar Lie MD PhD
    • - Joe Millum PhD
    • - Stacy Rasmus PhD

  • Session 7: Ethics of Pragmatic Trials and Incidental Findings – November 16, 2016

    • - Scott Kim MD PhD
    • - Ben Berkman JD MPH

2015 Course Information

• Lectures

  • Session 1: History and Framework for Ethical Clinical Research – September 30, 2015

    • - Christine Grady RN PhD
    • - Susan E. Lederer PhD
    • - Carrie Wolinetz PhD

  • Session 2: Fair Subject Selection, Community Engagement and Community Voices – October 7, 2015

    • - David Wendler, PhD
    • - Moon S Chen Jr MPH PhD & Kendra Thao
    • - Carol Horowitz MD MPH and Crispin Goytia BA
    • - Héctor Torres PsyD
    • - Brian Mustanki PhD

  • Session 3: IRBs, Risk and Benefits, and Research with Children – October 14, 2015

    • - Sara Chandros Hull PhD
    • - Christine Grady RN PhD
    • - David Wendler PhD

  • Session 4: Research Involving Persons at Risk for Impaired Decision Making, Ethical Issues in Stored Tissue Research, and Incidental Findings – October 21, 2015

    • - Ben Berkman JD MPH
    • - Scott Kim MD PhD
    • - Sarah Hull PhD

  • Session 5: International Research Ethics and Conflicts of Interest – October 28, 2015

    • - Steven Joffe MD MPH
    • - Seema Shah JD
    • - Joseph Millum PhD

  • Session 6: Ethics of Randomized Trials, Informed Consent and mock IRB – November 4, 2015

    • - Robert D Truog MD
    • - Robert 'Skip' Nelson MD PhD
  • Federal Holiday, no class – November 11, 2015

  • Session 7: Special Topics in Research Ethics – November 18, 2015

    • - Seema Shah, JD

2014 Course Information

• Lectures

  • Session 1: History, Guidance, and Framework for Ethical Clinical Research

    • - Christine Grady RN PhD
    • - Susan E. Lederer PhD
    • - Jeffrey R. Botkin MD MPH

  • Session 2: IRB review, Randomized Clinical Trials, and Research with Children

    • - Richard Cannon MD
    • - Robert D. Truog MD
    • - Sara F. Goldkind MD MA

  • Session 3: Fair Subject Selection

    • - David Wendler PhD
    • - Alan Wertheimer, PhD

  • Session 4: Risks and Benefits, Research involving persons at risk for impaired decision making

    • - David Wendler PhD
    • - Scott Kim MD PhD

  • Session 5: Informed Consent, Comparative Effectiveness Trials, and Conflicts of Interest

    • - Christine Grady RN PhD
    • - Frank Miller PhD
    • - Steve Joffe MD MPH

  • Session 6: Ethics of International Research

    • - Alan Wertheimer PhD
    • - Seema Shah JD
    • - Joseph Millum PhD

  • Session 7: Ethics and Genetics Research

    • - Sara Chandros Hull PhD
    • - Ben Berkman JD

2013 Course Information

• Lectures

  • Session 1: History, Guidance, and Framework for Ethical Clinical Research - September 25, 2013

    • - Christine Grady RN PhD
    • - Susan E. Lederer PhD
    • - Ivor Pritchard PhD

  • Session 2: Risks and Benefits, Research with Children, and Conflicts of Interest - October 23, 2013

    • - Dave Wendler PhD
    • - Robert Nelson MD PhD
    • - Steven Joffe MD MPH

  • Session 3: Informed Consent, Randomized Clinical Trials, and Participant Panel - October 30, 2013

    • - Christine Grady RN PhD
    • - Robert Truog MD
    • Participant/Investigator panel

  • Session 4: Stored Tissues, and Incidental Findings - November 6, 2013

    • - Sara Chandros Hull PhD
    • - Ben Berkman JD
    • Mock IRB

  • Session 5 - November 13, 2013

    • - Dave Wendler PhD
    • - Scott Kim MD PhD
    • - Seema Shah JD

2012 Course Information

• Lectures

  • Session 1: History, Guidance, and Framework for Ethical Clinical Research - September 26, 2012

    • - Christine Grady RN PhD
    • - Susan E. Lederer PhD
    • - Ivor Pritchard PhD

  • Session 2: IRB review, Informed Consent and Investigator Panel - October 3, 2012

    • - Barbara Karp MD
    • - Christine Grady RN PhD
    • Investigator panel - Kathleen Morton RN MSN (NCI); Maryland Pao MD (NIMH); Kristina Rother MD MHSc (NIDDK) and Antonio Fojo MD PhD (NCI)

  • Session 3 - October 10, 2012

    • - Dave Wendler PhD
    • - Alan Wertheimer PhD
    • - Robert Nelson MD PhD

  • Session 4 - October 17, 2012

    • - Dave Wendler PhD
    • - Donald Rosenstein, MD
    • Participant panel

  • Session 5 - October 24, 2012

    • - Alan Wertheimer PhD
    • Ethical Issues in International research - Joe Millum PhD
    • Mock IRB
  • Session 6 - October 31, 2012 - Cancelled due to Hurricane Sandy

  • Session 7 - November 7, 2012

    • - Sara Chandros Hull PhD
    • - Ben Berkman JD
    • Case Discussion

Videocasts of Past Lectures.