Ethical and Regulatory Aspects of Clinical Research Info

This course is offered to anyone interested or involved in the ethics of clinical research with human subjects. Participants represent multiple disciplines including research teams, IRB members, physicians, psychologists, nurses, social workers, administrative staff, students, and others.

Past Years' Courses

2023 Course Information

Syllabus
Lectures
- Session 1: Introduction/Framework/History/Institutional Review Boards – September 20, 2023
  - Introduction to Course - Holly Taylor PhD MPH
  - Framework for Ethical Conduct of Research - Christine Grady RN PhD
  - History of Research Ethics - Susan Lederer PhD
  - Institutional Review Boards - Holly Taylor PhD MPH
- Session 2: Informed Consent/Decision Making/Capacity Assessment – September 27, 2023
  - Informed Consent - Christine Grady RN PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Scott Kim MD PhD
  - Capacity Assessment in Practice - Julie Brintnall-Karabelas LCSW-C
  - Nuts and Bolts of Consent - Holly Taylor PhD MPH
- Session 3: Study Design/Risk-Benefit/Inclusion of Children in Research – October 4, 2023
  - Study Design - Holly Taylor PhD MPH
  - Risk/Benefit - Dave Wendler PhD
  - Ethical Inclusion of Children in Research - Seema Shah JD
- Session 4: Incidental Findings/Return of Results/Inclusion of Native Populations – October 11, 2023
  - Incidental and Secondary Findings - Ben Berkman JD MPH
  - Return of Results - Leila Jamal PhD ScM CGC
  - Genetics and Inclusion of Indigenous Populations - Katrina Claw PhD
- Session 5: Equity/Subject Selection/Recruitment and Retention – October 18, 2023
  - Equity in Clinical Research - Yukiko Asada PhD
  - Subject Selection - Holly Taylor PhD MPH
  - Recruitment and Retention - Dave Wendler PhD
- Session 6: International/Standards of Care/Post-trial Obligations/Community Engagement – October 25, 2023
  - Introduction and Standards of Care - Annette Rid MD PhD
  - Post-trial Obligations - Joseph Millum PhD
  - Community Engagement in Health Research - Dorcas Kamuya PhD MPH
- Session 7: Emerging Tech – November 1, 2023
  - Wearables - Marielle Gross MD MBE
  - Removal of Brain Implants - Saskia Hendriks MD PhD
  - LLMs - Vasiliki Rahimzadeh PhD – Presentation available upon request: please contact bioethics-inquiries@mail.nih.gov

2022 Course Information

Syllabus
Lectures
- Session 1: Introduction/Framework/History/Institutional Review Boards – September 21, 2022
  - Introduction to Course - Holly Taylor PhD MPH
  - Framework for Ethical Conduct of Research - Christine Grady RN PhD
  - History of Research Ethics - Susan Lederer PhD
  - Institutional Review Boards - Holly Taylor PhD MPH
- Session 2: Study Design/Risk-Benefit/Perspectives from the Field – September 28, 2022
  - Study Design - Holly Taylor PhD MPH
  - Risk/Benefit - Dave Wendler PhD
  - Phase I Research Roundtable - Julie Ledgerwood DO, Philip Arlen, MD
- Session 3: Subject Selection/Recruitment and Retention/Inclusion of Children – October 12, 2022
  - Fair Subject Selection - Holly Taylor PhD MPH
  - Recruitment and Retention - Dave Wendler PhD
  - Ethical Inclusion of Children in Research - Seema Shah JD
- Session 4: Equity and Inclusion – October 19, 2022
  - When are Health Inequalities Unfair? - Yukiko Asada PhD
  - Federal Inclusion Policy - Holly Taylor PhD MPH
  - What Does Commitment to Diversity in Clinical Research Look Like in Practice - Aisha Langford PhD MPH
  - What Does Genetics Have to Say About Diversity? - Holly Taylor PhD MPH
- Session 5: Informed Consent/Decision Making/Capacity Assessment – October 26, 2022
  - Informed Consent - Christine Grady RN PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Scott Kim MD PhD
  - Capacity Assessment in Practice - Carol Squires LCSW
  - Nuts and Bolts of Consent - Holly Taylor PhD MPH
- Session 6: Incidental Findings/Return of Results/Inclusion of Native Populations – November 2, 2022
  - Incidental and Secondary Findings - Ben Berkman JD MPH
  - Returning Research Results in the Context of Evolving Science - Leila Jamal PhD ScM CGC
  - Genetics and Inclusion of Indigenous Populations - Katrina Claw PhD
- Session 7: International/Standards of Care/Post-trial Obligations/Community Engagement – November 9, 2022
  - Introduction and Standards of Care - Annette Rid MD PhD
  - Post-trial Obligations - Joseph Millum PhD
  - Community Engagement in Health Research - Dorcas Kamuya PhD MPH

2021 Course Information

Syllabus
Lectures
- Session 1: Ethical Framework, Physician-Investigator Role, History of Research Ethics – September 22, 2021
  - Introduction to Course - Holly Taylor PhD MPH
  - Framework for Ethical Conduct of Research - Christine Grady RN PhD
  - Physician-Investigator Roles - Steve Joffe MD MPH
  - Conversation about History of Research Ethics - Christine Grady and Holly Taylor
- Session 2: Randomized Clinical Trials/Risk-Benefit/Institutional Review Boards – September 29, 2021
  - Randomized Clinical Trials: Clinical Equipoise - Robert Truog MD
  - Risk/Benefit - David Wendler PhD
  - Institutional Review Boards (IRBs) - Holly Taylor PhD MPH
- Session 3: Subject Selection/Inclusion of Pregnant Women/Recruitment and Retention – October 6, 2021
  - Fair Subject Selection - Holly Taylor PhD MPH
  - Inclusion of Pregnant Women - Anne Drapkin Lyerly MD MA
  - Recruitment and Retention - Dave Wendler PhD
  - Mini Case Discussion - Holly Taylor PhD MPH
- Session 4: Informed Consent/Decision Making/Capacity Assessment – October 13, 2021
  - Informed Consent - Christine Grady RN PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Scott Kim MD PhD
  - Capacity Assessment in Practice - Katherine Todman MSW LCSW-C and Holly Taylor PhD MPH
- Session 5: Returning Results/Incidental Findings/Collaborating with Indigenous Communities – October 20, 2021
  - Ethics of Genetics Incidental Findings - Ben Berkman JD MPH
  - Returning Research Results in the Context of Evolving Science - Leila Jamal PhD ScM CGC
  - Enrollment of Native Populations: Key Considerations - Sara Hull PhD and Katrina Claw PhD
  - Case Discussion: Arizona State University Diabetes Project - Sara Hull and Holly Taylor PhD MPH
- Session 6: Vaccines – October 27, 2021
  - Vaccine Development: The Case of COVID - Christine Grady RN PhD
  - Ethics of Controlled Human Infection Trials - Annette Rid MD PhD
  - What does Equitable Inclusion have to do with Addressing Vaccine Hesitancy? - Aisha Langford PhD MPH
- Session 7: International/Standards of Care/Post-trial Obligations – November 3, 2021
  - Introduction and Standards of Care - Annette Rid MD PhD
  - Post-trial Obligations - Joseph Millum PhD
  - Case Discussion: Placebo-Controlled Trial of Antimalarial Drug - Joseph Millum PhD
  - Perspectives from Kenya - Joseph Millum and Dorcas Kamuya PhD MPH

2020 Course Information

Syllabus
Lectures
- Session 1: Ethical Framework, Risk Benefit – September 23, 2020
  - Introduction to Course - Holly Taylor PhD MPH
  - Framework for Ethical Conduct of Research - Christine Grady RN PhD
  - Risk/Benefit - Dave Wendler PhD
- Session 2: Informed Consent, Privacy and Confidentiality – September 30, 2020
  - Informed Consent - Christine Grady RN PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Scott Kim MD PhD
  - Privacy and Confidentiality - Holly Taylor PhD MPH
  - Repurposing Biospecimens for COVID Research - Ben Berkman JD
- Session 3: Subject Selection – October 7, 2020
  - Fair Subject Selection - Holly Taylor PhD MPH
  - Recruitment and Retention - Dave Wendler PhD
  - Enrollment of Prisoners: Key Considerations - Holly Taylor PhD MPH
  - Case Discussion: Lead-Based Paint Abatement and Repair and Maintenance Study - Holly Taylor PhD MPH/Dave Wendler PhD
- Session 4: Genetics – October 14, 2020
  - Ethics of Genetics Research and Incidental Findings - Ben Berkman JD MPH
  - Ethics of Genetics Research and Incidental Findings - Lelia Jamal PhD ScD CGC
  - Enrollment of Native Populations: Key Considerations - Sara Hull, PhD/Katrina Claw, PhD
  - Case Discussion: Arizona State University Diabetes Project - Sara Hull, PhD/Holly Taylor PhD MPH
- Session 5: Trial Design/IRBs – October 21, 2020
  - Randomized Clinical Trials: Clinical Equipoise - Robert Truog MD
  - Pragmatic Trials - Scott Kim MD PhD
  - IRBs - Holly Taylor PhD MPH/Sara Hull, PhD
- Session 6: International Research – October 28, 2020
  - Introduction and Standard of Care - Joseph Millum PhD
  - Ancillary Care Obligations - Maria Merritt PhD
  - Perspectives from Kenya - Joseph Millum, PhD/Dorcas Kamuya, PhD
  - Mock IRB: MDR TB - Joseph Millum PhD/Holly Taylor PhD MPH
- Session 7: COVID Vaccines – November 4, 2020
  - Approaches to Vaccine Trial Design - Christine Grady RN PhD
  - Ethics of Controlled Human Infection Trials - Seema Shah JD/Nir Eyal PhD/Annette Rid MD PhD
  - Obligations to COVID Vaccine Research Subjects - Holly Taylor PhD MPH
  - Vaccine Dissemination - Anne Barnhill PhD

2019 Course Information

Syllabus
Lectures
- Session 1: Ethical Framework, Bench to Bedside, and IRB Function/Purpose – September 25, 2019
  - Framework for the Ethics of Research with Human Subjects - Christine Grady RN PhD
  - History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Susan E. Lederer PhD
  - Bench to Bedside or Bedside to Bench: The Ethics of the Investigator-Participant Relationship - Steve Joffe MD MPH
- Session 2: IRBs, Risks and Benefits, and the Ethics of Research with Children – October 2, 2019
  - Purpose and Function of IRBs: Successes and Current Challenges - Sara Hull PhD
  - Risks and Benefits - 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
  - Ethics of Pragmatic Trials - Scott Kim MD PhD
  - Ethics of Randomized Clinical Trials: Clinical Equipoise - Robert Truog MD
  - Ethics of Vaccine Research - Holly Taylor PhD MPH
- Session 4: Fair Subject Selection, Recruitment and Retention, and Participant Panel – October 23, 2019
  - Fair Subject Selection - Holly Taylor PhD MPH
  - Recruitment and Retention - Dave Wendler PhD
- Session 5: Informed Consent, Research with Those with Impaired Capacity for Consent, and Research Ethics Consultation – October 30, 2019
  - Informed Consent - Christine Grady RN PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Scott Kim MD PhD
  - Research Ethics Consultation - Marion Danis MD
- Session 6: Ethical Issues in International Research – November 6, 2019
  - Ethical Issues in International Research: Introduction and Standard of Care - Annette Rid MD, PhD
  - Ethical issues in International Research: Post-Trial Obligations - Joseph Millum PhD
  - Mock IRB: Ebola Treatment Trial - Annette Rid, MD, PhD
- Session 7: Ethics of Genetics Research and Incidental Findings, and Ethical Issues in All of Us – November 13, 2019
  - Ethics of Genetics Research and Incidental Findings - Leila Jamal PhD
  - Ethics of Genetics Research and Incidental Findings - Ben Berkman JD MPH
  - Ethical Issues in the All of Us Research Program - Katherine Blizinsky PhD

2018 Course Information

Syllabus
Lectures
- Session 1: Ethical Framework, Bench to Bedside, and IRB Function/Purpose – September 26, 2018
  - Framework for the Ethics of Research with Human Subjects - Christine Grady RN PhD
  - Bench to Bedside or Bedside to Bench: The Ethics of the Investigator-Participant Relationship - Steve Joffe MD MPH
  - Purpose and Function of IRBs: Successes and Current Challenges - Sara Hull PhD
- Session 2: Risks and Benefits, and the Ethics of Research with Children – October 3, 2018
  - Risks and Benefits - Dave Wendler PhD
  - Ethics of Research with Children - Alan Fleischman MD
- Session 3: Research with Samples and Data, Big Data, and Incidental Findings – October 10, 2018
  - Incidental and Secondary Findings - Ben Berkman JD MPH
  - Research with Biospecimens and Data under the Revised Common Rule - Holly Fernandez Lynch JD MBe
  - Research with Big Data - Jeff Kahn PhD
- Session 4: Fair Subject Selection, the History of Research Ethics, and Research with Native Americans and Alaskan Natives – October 17, 2018
  - Fair Subject Selection - Dave Wendler PhD
  - History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Jonathan D. Moreno PhD
  - Community Based Research with American Indian and Alaskan Native Tribes - 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
  - Ethics of Pragmatic Trials - Scott Kim MD PhD
  - Ethics of Randomized Clinical Trials: Clinical Equipoise - Robert Truog MD
  - Ethical Issues in the All of Us Research Program - Katherine Blizinsky PhD
- Session 6: Informed Consent, Research with Those with Impaired Capacity for Consent, and Participant Panel – October 31, 2018
  - Informed Consent - Christine Grady RN PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - 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

Syllabus
Lectures
- Session 1: History and Framework for Ethical Clinical Research – September 27, 2017
  - Framework for the Ethics of Research with Human Subjects - Christine Grady RN PhD
  - History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Susan E. Lederer PhD
  - What we can learn about research ethics from experienced subjects - Rebecca Dresser JD
- Session 2: IRBs, the Common Rule, and Subject Selection – October 4, 2017
  - Purpose and Function of IRBs: Successes and Current Challenges - Sara Hull PhD
  - Common Rule Changes - Yvonne Lau MBBS, MBHL, PhD
  - Fair Subject Selection - Dave Wendler PhD
- Session 3: Risks and Benefits, Research with Pregnant Women and Research Participant Panel – October 11, 2017
  - Risks and Benefits - Dave Wendler, PhD
  - Ethics of Research with Pregnant Women - Maggie Little BPhil PhD
- Session 4: Informed consent, Research with those with Impaired Capacity for Consent, and Conflicts of Interest – October 18, 2017
  - Informed Consent - Christine Grady RN PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Scott Kim MD PhD
  - Conflicts of Interest - Steve Joffe MD MPH
- Session 5: Ethics of Research with Children, Ethics of Randomized Clinical Trials, and Ethics of Pragmatic Trials – October 25, 2017
  - Ethics of Research with Children - Robert "Skip" Nelson MD
  - Ethics of Randomized Clinical Trials: Clinical Equipoise - Robert Truog MD
  - Ethics of Pragmatic Trials - 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
  - Ethical Issues in the Use of Stored Tissue and Data - Sara Chandros Hull PhD
  - Incidental and Secondary Findings - Ben Berkman JD MPH
  - Ethical Issues in International Research: Standard of Care - Reidar Lie MD PhD
- Session 7: Stored Tissue, Big Data, and Incidental Findings – November 8, 2017
  - Ethical Issues in International Research: Post-trial Obligations - Joe Millum PhD
  - Research with Big Data - Jeff Kahn PhD
  - Mock IRB

2016 Course Information

Syllabus
Lectures
- Session 1: History and Framework for Ethical Clinical Research – September 28, 2016
  - Framework for the Ethics of Research with Human Subjects - Christine Grady RN PhD
  - History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Susan E. Lederer PhD
  - Changes to the Common Rule - Ivor Pritchard PhD
- Session 2: IRBs, Fair Subject Selection, and Participant Perspectives – October 5, 2016
  - Purpose, Function, and Proposals for Improvement - Sara Hull PhD
  - Fair Subject Selection - David Wendler PhD
- Session 3: Risk and Benefits, Research with Children, and Research with Pregnant Women – October 19, 2016
  - Risks and Benefits - Dave Wendler PhD
  - Ethics of Research with Children - 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
  - Informed Consent - Christine Grady RN PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Scott Kim MD PhD
  - Research with Big Data - Jeff Kahn PhD
- Session 5: Ethics of Randomized Trials, Research with Stored Tissue and Data, and Conflicts of Interest – November 2, 2016
  - Ethical Issues in the Use of Stored Tissue and Data - Sara Chandros Hull PhD
  - Ethics of Randomized Clinical Trials: Clinical Equipoise - Robert Truog MD
  - Conflicts of Interest - Steve Joffe MD MPH
- Session 6: International Research Ethics and Community Engagement Research – November 9, 2016
  - Ethical Issues in International Research: Standard of Care - Reidar Lie MD PhD
  - Ethical Issues in International Research: Post-trial Obligations - Joe Millum PhD
  - Community Engagement and Research with Alaskan Natives - Stacy Rasmus PhD
- Session 7: Ethics of Pragmatic Trials and Incidental Findings – November 16, 2016
  - Ethics of Pragmatic Trials - Scott Kim MD PhD
  - How to Think about Incidental Findings - Ben Berkman JD MPH

2015 Course Information

Syllabus
Lectures
- Session 1: History and Framework for Ethical Clinical Research – September 30, 2015
  - Framework for the Ethics of Research with Human Subjects - Christine Grady RN PhD
  - History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Susan E. Lederer PhD
  - Update on the Common Rule NPRM - Carrie Wolinetz PhD
- Session 2: Fair Subject Selection, Community Engagement and Community Voices – October 7, 2015
  - Fair Subject Selection - David Wendler, PhD
  - Participation of Minorities in NIH Research - Moon S Chen Jr MPH PhD & Kendra Thao
  - Ethics of Community Engaged Research: Background and Lessons Learned in NYC - Carol Horowitz MD MPH and Crispin Goytia BA
  - Community-based Research with LGBTQP Populations: Sharing Experience - Héctor Torres PsyD
  - Scientifically informed community-engaged LGBT Health Research - Brian Mustanki PhD
- Session 3: IRBs, Risk and Benefits, and Research with Children – October 14, 2015
  - The IRB: Purpose, Function, and Proposals for Improvement - Sara Chandros Hull PhD
  - Informed Consent - Christine Grady RN PhD
  - Risk-Benefit Judgments in Clinical Research - 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
  - Incidental Findings and Next-Generation Genomic Research - Ben Berkman JD MPH
  - Research Involving Adults with Impaired Decision-Making Capacity - Scott Kim MD PhD
  - The Ethics of Genetic Research with Stored Samples and Data - Sarah Hull PhD
- Session 5: International Research Ethics and Conflicts of Interest – October 28, 2015
  - Conflicts of Interest - Steven Joffe MD MPH
  - Post-trial Obligations and Reasonable Availability - Seema Shah JD
  - International Research and Standards of Care - Joseph Millum PhD
- Session 6: Ethics of Randomized Trials, Informed Consent and mock IRB – November 4, 2015
  - Ethical Conflicts in Randomize Controlled Trials - Robert D Truog MD
  - Research Involving Children (Focusing on FDA Regulations) - Robert 'Skip' Nelson MD PhD
- Federal Holiday, no class – November 11, 2015
- Session 7: Special Topics in Research Ethics – November 18, 2015
  - The Ethics of Challenge Studies - Seema Shah, JD

2014 Course Information

Syllabus
Lectures
- Session 1: History, Guidance, and Framework for Ethical Clinical Research
  - Framework for the Ethics of Research with Human Subjects - Christine Grady RN PhD
  - History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Susan E. Lederer PhD
  - The DHHS Secretary's Advisory Committee for Human Research Protections - Jeffrey R. Botkin MD MPH
- Session 2: IRB review, Randomized Clinical Trials, and Research with Children
  - Purpose and Function of IRBs: Successes and Current Challenge - Richard Cannon MD
  - Ethical Conflicts in Randomized Controlled Trials - Robert D. Truog MD
  - Ethics of Research with Children - Sara F. Goldkind MD MA
- Session 3: Fair Subject Selection
  - Fair Subject Selection - David Wendler PhD
  - Coercion and Undue Inducement in Recruitment - Alan Wertheimer, PhD
- Session 4: Risks and Benefits, Research involving persons at risk for impaired decision making
  - The Ethics in Risk-Benefit Judgments - David Wendler PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Scott Kim MD PhD
- Session 5: Informed Consent, Comparative Effectiveness Trials, and Conflicts of Interest
  - Informed Consent - Christine Grady RN PhD
  - Comparative Effectiveness Trials and Informed Consent - Frank Miller PhD
  - Conflicts of Interest - Steve Joffe MD MPH
- Session 6: Ethics of International Research
  - Exploitation - Alan Wertheimer PhD
  - Post Trial Obligations and Reasonable Availability - Seema Shah JD
  - Case Study: A Phase 3 Study of a Candidate HIV Vaccine - Joseph Millum PhD
- Session 7: Ethics and Genetics Research
  - Ethical Issues in the Use of Stored Tissue and Data - Sara Chandros Hull PhD
  - How to think about Incidental Findings - Ben Berkman JD

2013 Course Information

Syllabus
Lectures
- Session 1: History, Guidance, and Framework for Ethical Clinical Research - September 25, 2013
  - What Makes Clinical Research Ethical? - Christine Grady RN PhD
  - History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Susan E. Lederer PhD
  - Do the Codes Apply to My Research? Nuremberg, Helsinki, the Belmont Report, CIOMS, and the Common Rule - Ivor Pritchard PhD
- Session 2: Risks and Benefits, Research with Children, and Conflicts of Interest - October 23, 2013
  - Risks and Benefits - Dave Wendler PhD
  - Ethical Issues in Research with Children - Robert Nelson MD PhD
  - Conflicts of Interest - Steven Joffe MD MPH
- Session 3: Informed Consent, Randomized Clinical Trials, and Participant Panel - October 30, 2013
  - Informed Consent - Christine Grady RN PhD
  - Ethics of Randomized Clinical Trials: Clinical Equipoise - Robert Truog MD
  - Participant/Investigator panel
- Session 4: Stored Tissues, and Incidental Findings - November 6, 2013
  - Ethical Issues in the Use of Stored Tissue and Data - Sara Chandros Hull PhD
  - How to Think About Incidental Findings - Ben Berkman JD
  - Mock IRB
- Session 5 - November 13, 2013
  - Fair Subject Selection - Dave Wendler PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Scott Kim MD PhD
  - Ethics of International Research - Seema Shah JD

2012 Course Information

Syllabus
Lectures
- Session 1: History, Guidance, and Framework for Ethical Clinical Research - September 26, 2012
  - Framework for the Ethics of Research with Human Subjects - Christine Grady RN PhD
  - History, Scandals and Tragedies: Beecher, Tuskegee, Willowbrook and the Rest - Susan E. Lederer PhD
  - Do the Codes Apply to My Research? Nuremberg, Helsinki, the Belmont Report, CIOMS, and the Common Rule - Ivor Pritchard PhD
- Session 2: IRB review, Informed Consent and Investigator Panel - October 3, 2012
  - Purpose and Function of IRBs: Successes and Current Challenges - Barbara Karp MD
  - Informed Consent - 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
  - Fair Subject Selection - Dave Wendler PhD
  - Coercion, Undue inducement, and Incentives in Research - Alan Wertheimer PhD
  - Ethical issues in research with children - Robert Nelson MD PhD
- Session 4 - October 17, 2012
  - Risks and Benefits - Dave Wendler PhD
  - Research Involving Persons at Risk for Impaired Decision-Making - Donald Rosenstein, MD
  - Participant panel
- Session 5 - October 24, 2012
  - Exploitation - 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
  - Ethical Issues in the Use of Stored Tissue and Data - Sara Chandros Hull PhD
  - How to think about Incidental Findings - Ben Berkman JD
  - Case Discussion

Videocasts of Past Lectures.

Ethical and Regulatory Aspects of Clinical Research