Ethical and Regulatory Aspects of Clinical Research
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.
2023 Course Information
The course will be conducted online and will be available to anyone via live videocast on Wednesdays from 8:30 to 11:30am EST, September 20 – November 1, 2023.
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
- Introduction to Course
- 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
- Study Design
- 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
- Fair Subject Selection
- 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
- When are Health Inequalities Unfair?
- 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
- Informed Consent
- 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
- Incidental and Secondary Findings
- 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
- Introduction and Standards of Care
- Session 1: Introduction/Framework/History/Institutional Review Boards – September 21, 2022
Past Years' Courses
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
- Introduction to Course
- 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
- Randomized Clinical Trials: Clinical Equipoise
- 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
- Fair Subject Selection
- 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
- Informed Consent
- 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
- Ethics of Genetics Incidental Findings
- 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
- Vaccine Development: The Case of COVID
- 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
- Introduction and Standards of Care
- Session 1: Ethical Framework, Physician-Investigator Role, History of Research Ethics – September 22, 2021
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
- Informed Consent
- 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
- Fair Subject Selection
- 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
- Ethics of Genetics Research and Incidental Findings
- 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
- Randomized Clinical Trials: Clinical Equipoise
- 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
- Introduction and Standard of Care
- 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
- Approaches to Vaccine Trial Design
- Session 1: Ethical Framework, Risk Benefit – September 23, 2020
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
- Framework for the Ethics of Research with Human Subjects
- 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
- Purpose and Function of IRBs: Successes and Current Challenges
- 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
- Ethics of Pragmatic Trials
- 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
- Fair Subject Selection
- 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
- Informed Consent
- 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
- Ethical Issues in International Research: Introduction and Standard of Care
- 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
- Ethics of Genetics Research and Incidental Findings
- Session 1: Ethical Framework, Bench to Bedside, and IRB Function/Purpose – September 25, 2019
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
- Framework for the Ethics of Research with Human Subjects
- 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
- Risks and Benefits
- 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
- Incidental and Secondary Findings
- 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
- Fair Subject Selection
- 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
- Ethics of Pragmatic Trials
- 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
- Informed Consent
- 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
- Session 1: Ethical Framework, Bench to Bedside, and IRB Function/Purpose – September 26, 2018
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
- Framework for the Ethics of Research with Human Subjects
- 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
- Purpose and Function of IRBs: Successes and Current Challenges
- 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
- Risks and Benefits
- 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
- Informed Consent
- 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
- Ethics of Research with Children
- 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
- Ethical Issues in the Use of Stored Tissue and Data
- 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
- Ethical Issues in International Research: Post-trial Obligations
- Session 1: History and Framework for Ethical Clinical Research – September 27, 2017
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
- Framework for the Ethics of Research with Human Subjects
- 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
- Purpose, Function, and Proposals for Improvement
- 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
- Risks and Benefits
- 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
- Informed Consent
- 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
- Ethical Issues in the Use of Stored Tissue and Data
- 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
- Ethical Issues in International Research: Standard of Care
- 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
- Ethics of Pragmatic Trials
- Session 1: History and Framework for Ethical Clinical Research – September 28, 2016
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
- Framework for the Ethics of Research with Human Subjects
- 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
- Fair Subject Selection
- 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
- The IRB: Purpose, Function, and Proposals for Improvement
- 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
- Incidental Findings and Next-Generation Genomic Research
- 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
- Conflicts of Interest
- 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
- Ethical Conflicts in Randomize Controlled Trials
- 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
- The Ethics of Challenge Studies
- Session 1: History and Framework for Ethical Clinical Research – September 30, 2015
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
- Framework for the Ethics of Research with Human Subjects
- 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
- Purpose and Function of IRBs: Successes and Current Challenge
- Session 3: Fair Subject Selection
- Fair Subject Selection
- David Wendler PhD
- Coercion and Undue Inducement in Recruitment
- Alan Wertheimer, PhD
- Fair Subject Selection
- 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
- The Ethics in Risk-Benefit Judgments
- 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
- Informed Consent
- 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
- Exploitation
- 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
- Ethical Issues in the Use of Stored Tissue and Data
- Session 1: History, Guidance, and Framework for Ethical Clinical Research
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
- What Makes Clinical Research Ethical?
- 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
- Risks and Benefits
- 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
- Informed Consent
- 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
- Ethical Issues in the Use of Stored Tissue and Data
- 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
- Fair Subject Selection
- Session 1: History, Guidance, and Framework for Ethical Clinical Research - September 25, 2013
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
- Framework for the Ethics of Research with Human Subjects
- 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)
- Purpose and Function of IRBs: Successes and Current Challenges
- 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
- Fair Subject Selection
- 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
- Risks and Benefits
- Session 5 - October 24, 2012
- Exploitation
- Alan Wertheimer PhD
Ethical Issues in International research - Joe Millum PhD - Mock IRB
- Exploitation
- 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
- Ethical Issues in the Use of Stored Tissue and Data
- Session 1: History, Guidance, and Framework for Ethical Clinical Research - September 26, 2012
Videocasts of Past Lectures.
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