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Conference sessions recordings for AER/SBER21 have expired. Per our registration policies, access to session recordings is for 90 days after the meeting. Once access expires, individuals can purchase recordings for an additional 90 days via our Knowledge Center. PRIM&R members receive free access to session recordings one year after the meeting.
Welcome Remarks from PRIM&R's Board Chair and Executive Director, and AER21 Opening General Session: Advancing Justice and Equity in Research—How Can Research Stakeholders Be Agents of Change?
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A01 - Microaggressions, Unconscious Bias, and Systemic Racism: What Do These Terms Really Mean?
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A02 - Knock, Knock, FDA Is Here: What You Need to Know for Bioresearch Monitoring (BIMO) Inspections of IRBs, Clinical Investigators, and Sponsor Investigators
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A04 - Finding the Right Balance: Appropriate Secondary Use of Clinical Trial Data
Location: Livestreamed
Pharma/Biotech Perspectives Track
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel I: Inclusion of Persons With Disabilities in Clinical Research
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel II: Weeding Out Useless Research: What’s an IRB to Do?
Location: Livestreamed
Wednesday, Nov 17th
1:00 PM – 1:45 PM ET
AER21 Mid-day Break Sponsored Presentation by WCG IRB: Critical Considerations for Informed Consent in Cell and Gene Therapy Trials
Location: Livestreamed
Exhibitor SymposiaResearch Involving Data and Biospecimens Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B01 - A Dialogue With OHRP
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B02 - Justice in Human Research: Accessibility, Inclusivity, and Intersectionality
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B04 - When Is an Investigational Device Exemption (IDE) Needed for Medical Device Clinical Investigations?
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B05 - Research Silos—The Growing Problem of Restricting International Transfer of Data and Specimens
Location: Livestreamed
Global Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B09 - Explaining Explainable Machine Learning (XML)—What Research Review Boards Need to Know
Location: Livestreamed
Research Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B10 - Data Risks—Strategies for Maintaining Research Integrity via Conflict of Interest (COI) Review
Location: Livestreamed
Responsible Conduct of Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B13 - Complex Conflict of Interest (COI)—Understanding the COI Landscape
Location: On-Demand
Legal Considerations in HRPPs TrackResponsible Conduct of Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B14 - Research With Children—Parental Permission and Assent and Child-Centric Trial Education
B15 - Operationalizing Research Databases and Biobanks at Your Institution
Location: On-Demand
Research Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B16 - A Dialogue With AAHRPP, Inc.
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
3:00 PM – 3:30 PM ET
Sponsored Session by Cayuse: Best Practice Applications and Emerging Research Designs
Location: On-Demand
Exhibitor Symposia
Sponsored By
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Scientific Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
10:00 AM – 11:15 AM ET
Conference Welcome; In Memoriam: Tribute to Robert J. Levine, MD, and Jeffrey Cohen, PhD; and Keynote Address: Ethics of AI Research: Implementation and Implications
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C02 - Is Your Institution Ready to Conduct Human Gene Therapy Research?
Location: Livestreamed
Pharma/Biotech Perspectives TrackResearch Involving Data and Biospecimens Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C03 - Situational Vulnerability/Research With Risk Susceptible Populations Not Referenced in the Regulations
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C04 - Beyond eConsent—Virtual Research in the Digital Age
Location: Livestreamed
Research Conducted in the Digital World Track
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel III: Exception from Informed Consent (EFIC) for Research at 25
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel IV: Data Advocacy, Governance, and Ethics in an Age of Big Data
Location: Livestreamed
Thursday, Nov 18th
12:45 PM – 1:30 PM ET
AER21 Mid-day Break: Sponsored Presentation by Advarra--The Post-Pandemic Pivot: How to Leverage Strategic Partners so Your Teams Can Focus on What Matters
Location: Livestreamed
Exhibitor SymposiaHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D01 - A Dialogue With FDA
Location: Livestreamed
A Dialogue With the Feds TrackFDA Regulated Research Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D02 - Embedding a Racial Justice Lens into Research and IRB Review With Human Subjects—How to Be an Anti-Racist at Work Every Day
Location: Livestreamed
Advancing Justice and Equity Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D03 - Developing a Rapid Response Central IRB Model—Use of an Emergency Preparedness Model to Develop and Streamline Procedures
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackGlobal Research TrackIRB Operations Advanced TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D04 - Electronic Consent and Other Emerging Approaches to Consent in Global Research
Location: Livestreamed
Global Research Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D08 - Navigating the Regulatory Maze When Proposing Study Visits in Participant Homes
Location: Livestreamed
Legal Considerations in HRPPs Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D09 - New Guidelines for Human Stem Cell-Related Research—Implications for IRBs and Institutions
Location: Livestreamed
Research Involving Data and Biospecimens Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D12 - Ain't No Mountain High Enough”—Ensuring a Successful Informed Consent Process Throughout the Life of the Study
Location: On-Demand
IRB Basics Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D16 - A Dialogue With ORI
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D17 - A Dialogue With SACHRP
Location: On-Demand
A Dialogue With the Feds Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Meet the Author Book Discussion: Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals
Location: Livestreamed
Networking Track
Sponsored By
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Programmatic Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
4:00 PM – 5:00 PM ET
Federal Agency Affiliate Session: Department of Energy (DOE) Human Subjects Protection Program (HSPP): Human Subjects Research or Not Human Subjects Research?
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
10:00 AM – 11:15 AM ET
Conference Welcome and Keynote Address: Chasing My Cure: Lessons and Ethical Implications of Being a Physician-Scientist-Subject-Patient-Advocate
Location: Livestreamed
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E04 - Advancing Justice Through Community Engagement in Governance for Research Biobanks
F03 - The IRB’s Critical Role in Understanding Sponsor and Investigator Responsibilities for Investigational New Drug Application (IND) Safety Reporting in Order to Assure the Protection of Human Subjects
Location: Livestreamed
FDA Regulated Research Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F06 - Bystanders in Human Subject Research
Location: Livestreamed
Legal Considerations in HRPPs Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F07 - Ethical Issues in Complex Trial Design
Location: Livestreamed
Pharma/Biotech Perspectives Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F09 - NIH's New Data Management and Sharing Policy—How Academic Medical Centers Can Prepare for January 2023
Location: Livestreamed
Research Involving Data and Biospecimens Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F12 - Access to Clinical Research for People With Limited English Proficiency (LEP)
Location: On-Demand
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F13 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: On-Demand
Research Conducted in the Digital World Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F16 - A Dialogue With the VA
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
3:00 PM – 4:00 PM ET
Leveraging Community and Participant Perspective to Strengthen Research
Location: Livestreamed
Networking TrackAdvancing Justice and Equity Track
Friday, Nov 19th
3:00 PM – 4:00 PM ET
The Ethical Research Podcast: Live Audience Recording
Location: Livestreamed
Networking Track
Compliance, Regulatory, and QA/QI Professionals
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
Never Let a Crisis Go to Waste: Lessons Learned from the COVID-19 Pandemic for Clinical Research
Location: Livestreamed
Tuesday, Nov 16th
2:30 PM – 5:30 PM ET
Crossing Borders: HRPPs and Protection of Subjects in Transnational Research
Location: Livestreamed
Tuesday, Nov 16th
2:30 PM – 5:30 PM ET
Intersectionality in Research Oversight: A Theoretical and Practical Framework Exploring Inequality
Welcome Remarks from PRIM&R's Board Chair and Executive Director, and AER21 Opening General Session: Advancing Justice and Equity in Research—How Can Research Stakeholders Be Agents of Change?
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A01 - Microaggressions, Unconscious Bias, and Systemic Racism: What Do These Terms Really Mean?
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A02 - Knock, Knock, FDA Is Here: What You Need to Know for Bioresearch Monitoring (BIMO) Inspections of IRBs, Clinical Investigators, and Sponsor Investigators
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A03 - Beyond Reliance Agreements: Local Considerations, Risk Mitigation, and Compliance
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A05 - QA/QI Solutions for a Changing Research Landscape
Location: Livestreamed
QA/QI and Postapproval Monitoring Track
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel I: Inclusion of Persons With Disabilities in Clinical Research
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel II: Weeding Out Useless Research: What’s an IRB to Do?
Location: Livestreamed
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B01 - A Dialogue With OHRP
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B02 - Justice in Human Research: Accessibility, Inclusivity, and Intersectionality
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B04 - When Is an Investigational Device Exemption (IDE) Needed for Medical Device Clinical Investigations?
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B09 - Explaining Explainable Machine Learning (XML)—What Research Review Boards Need to Know
Location: Livestreamed
Research Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B10 - Data Risks—Strategies for Maintaining Research Integrity via Conflict of Interest (COI) Review
Location: Livestreamed
Responsible Conduct of Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B13 - Complex Conflict of Interest (COI)—Understanding the COI Landscape
Location: On-Demand
Legal Considerations in HRPPs TrackResponsible Conduct of Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B15 - Operationalizing Research Databases and Biobanks at Your Institution
Location: On-Demand
Research Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B16 - A Dialogue With AAHRPP, Inc.
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
3:00 PM – 3:30 PM ET
Sponsored Session by Cayuse: Best Practice Applications and Emerging Research Designs
Location: On-Demand
Exhibitor Symposia
Sponsored By
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
SBER Network Discussion: Postapproval Monitoring for SBER—Alternatives to Continuing Review for Minimal Risk Research
Location: Livestreamed
Networking TrackSBER TrackQA/QI and Postapproval Monitoring Track
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Scientific Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
10:00 AM – 11:15 AM ET
Conference Welcome; In Memoriam: Tribute to Robert J. Levine, MD, and Jeffrey Cohen, PhD; and Keynote Address: Ethics of AI Research: Implementation and Implications
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C02 - Is Your Institution Ready to Conduct Human Gene Therapy Research?
Location: Livestreamed
Pharma/Biotech Perspectives TrackResearch Involving Data and Biospecimens Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C05 - When The @#&% Hits the Fan—When HRPP Noncompliance and Research Misconduct Occur Together
Location: Livestreamed
Responsible Conduct of Research TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel III: Exception from Informed Consent (EFIC) for Research at 25
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel IV: Data Advocacy, Governance, and Ethics in an Age of Big Data
Location: Livestreamed
Thursday, Nov 18th
12:45 PM – 1:30 PM ET
AER21 Mid-day Break: Sponsored Presentation by Advarra--The Post-Pandemic Pivot: How to Leverage Strategic Partners so Your Teams Can Focus on What Matters
Location: Livestreamed
Exhibitor SymposiaHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D01 - A Dialogue With FDA
Location: Livestreamed
A Dialogue With the Feds TrackFDA Regulated Research Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D02 - Embedding a Racial Justice Lens into Research and IRB Review With Human Subjects—How to Be an Anti-Racist at Work Every Day
Location: Livestreamed
Advancing Justice and Equity Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D03 - Developing a Rapid Response Central IRB Model—Use of an Emergency Preparedness Model to Develop and Streamline Procedures
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackGlobal Research TrackIRB Operations Advanced TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D08 - Navigating the Regulatory Maze When Proposing Study Visits in Participant Homes
Location: Livestreamed
Legal Considerations in HRPPs Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D09 - New Guidelines for Human Stem Cell-Related Research—Implications for IRBs and Institutions
Location: Livestreamed
Research Involving Data and Biospecimens Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D10 - Clinical Trials in SBER
Location: Livestreamed
SBER Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D12 - Ain't No Mountain High Enough”—Ensuring a Successful Informed Consent Process Throughout the Life of the Study
Location: On-Demand
IRB Basics Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D14 - Ideas and Practices for Auditing of Single IRB Studies
Location: On-Demand
QA/QI and Postapproval Monitoring Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D16 - A Dialogue With ORI
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D17 - A Dialogue With SACHRP
Location: On-Demand
A Dialogue With the Feds Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Meet the Author Book Discussion: Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals
Location: Livestreamed
Networking Track
Sponsored By
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Programmatic Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
4:00 PM – 5:00 PM ET
Federal Agency Affiliate Session: Department of Energy (DOE) Human Subjects Protection Program (HSPP): Human Subjects Research or Not Human Subjects Research?
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
10:00 AM – 11:15 AM ET
Conference Welcome and Keynote Address: Chasing My Cure: Lessons and Ethical Implications of Being a Physician-Scientist-Subject-Patient-Advocate
Location: Livestreamed
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E04 - Advancing Justice Through Community Engagement in Governance for Research Biobanks
F03 - The IRB’s Critical Role in Understanding Sponsor and Investigator Responsibilities for Investigational New Drug Application (IND) Safety Reporting in Order to Assure the Protection of Human Subjects
Location: Livestreamed
FDA Regulated Research Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F04 - Bringing Continuous Improvement to Your HRPP—Proving Your HRPP Processes Are Hitting All the Right Milestones for Your Stakeholders
Location: Livestreamed
HRPP Leadership and Institutional Officials TrackEducation and Training TrackQA/QI and Postapproval Monitoring Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F06 - Bystanders in Human Subject Research
Location: Livestreamed
Legal Considerations in HRPPs Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F07 - Ethical Issues in Complex Trial Design
Location: Livestreamed
Pharma/Biotech Perspectives Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F08 - Trust, But Verify—Conducting Routine Audits of IRB to Help Ensure Compliance
Location: Livestreamed
QA/QI and Postapproval Monitoring Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F09 - NIH's New Data Management and Sharing Policy—How Academic Medical Centers Can Prepare for January 2023
Location: Livestreamed
Research Involving Data and Biospecimens Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F12 - Access to Clinical Research for People With Limited English Proficiency (LEP)
Location: On-Demand
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F16 - A Dialogue With the VA
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
3:00 PM – 4:00 PM ET
Leveraging Community and Participant Perspective to Strengthen Research
Location: Livestreamed
Networking TrackAdvancing Justice and Equity Track
Friday, Nov 19th
3:00 PM – 4:00 PM ET
The Ethical Research Podcast: Live Audience Recording
Location: Livestreamed
Networking Track
Diversity, Equity, and Inclusion
Tuesday, Nov 16th
10:00 AM – 11:15 AM ET
SBER21 Opening General Session: Welcome from Conference Co-Chairs and Keynote Address: Lessons from Researchers to Improve Institutional Review Processes and Outcomes
Location: Livestreamed
SBER Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A03 - A Case Study in Diversity, Equity, and Inclusion (DEI) Efforts—An Office of Research Administration’s Social Justice Working Group
Location: Livestreamed
SBER TrackAdvancing Justice and Equity Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A04 - Understanding and Applying Family Educational Rights and Privacy Act (FERPA) in Higher Education
Location: On-Demand
SBER TrackIRB Operations Advanced TrackResearch Involving Data and Biospecimens Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A05 - During the Best of Times and the Worst of Times: Communication Between IRBs and Researchers
Location: On-Demand
SBER TrackIRB Operations Advanced TrackLeadership TrackFlexibility and Innovation in HRPP Processes Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A06 - Research With Non-Traditional Vulnerable Populations in SBER
Welcome Remarks from PRIM&R's Board Chair and Executive Director, and AER21 Opening General Session: Advancing Justice and Equity in Research—How Can Research Stakeholders Be Agents of Change?
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A01 - Microaggressions, Unconscious Bias, and Systemic Racism: What Do These Terms Really Mean?
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel I: Inclusion of Persons With Disabilities in Clinical Research
Location: Livestreamed
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B02 - Justice in Human Research: Accessibility, Inclusivity, and Intersectionality
Location: Livestreamed
Advancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C01 - Teaching Social Justice and Advocacy for Social Change—Ideas for Researchers, Leadership, IRB Members, Staff, and Communities
F05 - Advancing Justice and Equity Through IRB Review
Location: Livestreamed
IRB Operations Advanced TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F12 - Access to Clinical Research for People With Limited English Proficiency (LEP)
Location: On-Demand
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
HRPP Educators
Tuesday, Nov 16th
10:00 AM – 11:15 AM ET
SBER21 Opening General Session: Welcome from Conference Co-Chairs and Keynote Address: Lessons from Researchers to Improve Institutional Review Processes and Outcomes
Location: Livestreamed
SBER Track
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
Never Let a Crisis Go to Waste: Lessons Learned from the COVID-19 Pandemic for Clinical Research
Location: Livestreamed
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A03 - A Case Study in Diversity, Equity, and Inclusion (DEI) Efforts—An Office of Research Administration’s Social Justice Working Group
Location: Livestreamed
SBER TrackAdvancing Justice and Equity Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A04 - Understanding and Applying Family Educational Rights and Privacy Act (FERPA) in Higher Education
Location: On-Demand
SBER TrackIRB Operations Advanced TrackResearch Involving Data and Biospecimens Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A05 - During the Best of Times and the Worst of Times: Communication Between IRBs and Researchers
Location: On-Demand
SBER TrackIRB Operations Advanced TrackLeadership TrackFlexibility and Innovation in HRPP Processes Track
Wednesday, Nov 17th
10:00 AM – 11:30 AM ET
Welcome Remarks from PRIM&R's Board Chair and Executive Director, and AER21 Opening General Session: Advancing Justice and Equity in Research—How Can Research Stakeholders Be Agents of Change?
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A01 - Microaggressions, Unconscious Bias, and Systemic Racism: What Do These Terms Really Mean?
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A03 - Beyond Reliance Agreements: Local Considerations, Risk Mitigation, and Compliance
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel I: Inclusion of Persons With Disabilities in Clinical Research
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel II: Weeding Out Useless Research: What’s an IRB to Do?
Location: Livestreamed
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B01 - A Dialogue With OHRP
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B02 - Justice in Human Research: Accessibility, Inclusivity, and Intersectionality
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B03 - How to Conduct Education About Emergency Preparedness
Location: Livestreamed
Education and Training Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B10 - Data Risks—Strategies for Maintaining Research Integrity via Conflict of Interest (COI) Review
Location: Livestreamed
Responsible Conduct of Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B16 - A Dialogue With AAHRPP, Inc.
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Challenges and Opportunities for Institutions With Small Research Programs
Location: Livestreamed
Networking TrackSmall Research Programs Track
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Scientific Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
10:00 AM – 11:15 AM ET
Conference Welcome; In Memoriam: Tribute to Robert J. Levine, MD, and Jeffrey Cohen, PhD; and Keynote Address: Ethics of AI Research: Implementation and Implications
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C01 - Teaching Social Justice and Advocacy for Social Change—Ideas for Researchers, Leadership, IRB Members, Staff, and Communities
Education and Training TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C03 - Situational Vulnerability/Research With Risk Susceptible Populations Not Referenced in the Regulations
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C05 - When The @#&% Hits the Fan—When HRPP Noncompliance and Research Misconduct Occur Together
Location: Livestreamed
Responsible Conduct of Research TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel III: Exception from Informed Consent (EFIC) for Research at 25
Location: Livestreamed
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D01 - A Dialogue With FDA
Location: Livestreamed
A Dialogue With the Feds TrackFDA Regulated Research Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D02 - Embedding a Racial Justice Lens into Research and IRB Review With Human Subjects—How to Be an Anti-Racist at Work Every Day
Location: Livestreamed
Advancing Justice and Equity Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D11 - Educating While Engaging—Strategies for IRB Member and Staff Continuing Education
Location: On-Demand
Education and Training Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D16 - A Dialogue With ORI
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D17 - A Dialogue With SACHRP
Location: On-Demand
A Dialogue With the Feds Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Meet the Author Book Discussion: Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals
Location: Livestreamed
Networking Track
Sponsored By
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Programmatic Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
4:00 PM – 5:00 PM ET
Federal Agency Affiliate Session: Department of Energy (DOE) Human Subjects Protection Program (HSPP): Human Subjects Research or Not Human Subjects Research?
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E01 - A Philosopher's Look at the Belmont Principles (aka "Chicken Soup for the HRPP Professional's Soul")
Location: Livestreamed
IRB Basics Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E04 - Advancing Justice Through Community Engagement in Governance for Research Biobanks
Research Involving Data and Biospecimens TrackAdvancing Justice and Equity Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E05 - Extending Education Beyond the IRB
Location: Livestreamed
SBER TrackEducation and Training Track
Friday, Nov 19th
11:30 AM – 12:45 PM ET
Panel V: Ongoing and Future Challenges of COVID-19
Location: Livestreamed
Friday, Nov 19th
11:30 AM – 12:45 PM ET
Panel VI: The Conceit of Consent—What Does it Do and What Should We Ask it to Do?
Location: Livestreamed
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F09 - NIH's New Data Management and Sharing Policy—How Academic Medical Centers Can Prepare for January 2023
Location: Livestreamed
Research Involving Data and Biospecimens Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F10 - From Big to Small and Back Again—Moving from a Large Research Program to a Small Research Program
Location: Livestreamed
Small Research Programs Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F11 - "Customer Support" Is Not a Bad Word—Building Resources for Relying Institutions and Investigators
Location: On-Demand
Flexibility and Innovation in HRPP Processes TrackLeadership TrackIRB Operations Advanced Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F12 - Access to Clinical Research for People With Limited English Proficiency (LEP)
Location: On-Demand
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F14 - Translating Responsible Conduct of Research (RCR) Training at Your Organization—Tips and Tricks for Reaching Your Audience and Providing Practical Instruction
Location: On-Demand
Responsible Conduct of Research TrackEducation and Training Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F16 - A Dialogue With the VA
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
3:00 PM – 4:00 PM ET
Leveraging Community and Participant Perspective to Strengthen Research
Location: Livestreamed
Networking TrackAdvancing Justice and Equity Track
Friday, Nov 19th
3:00 PM – 4:00 PM ET
The Ethical Research Podcast: Live Audience Recording
Location: Livestreamed
Networking Track
HRPP Leadership and Institutional Officials
Tuesday, Nov 16th
10:00 AM – 11:15 AM ET
SBER21 Opening General Session: Welcome from Conference Co-Chairs and Keynote Address: Lessons from Researchers to Improve Institutional Review Processes and Outcomes
Location: Livestreamed
SBER Track
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
Never Let a Crisis Go to Waste: Lessons Learned from the COVID-19 Pandemic for Clinical Research
Location: Livestreamed
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A03 - A Case Study in Diversity, Equity, and Inclusion (DEI) Efforts—An Office of Research Administration’s Social Justice Working Group
Location: Livestreamed
SBER TrackAdvancing Justice and Equity Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A04 - Understanding and Applying Family Educational Rights and Privacy Act (FERPA) in Higher Education
Location: On-Demand
SBER TrackIRB Operations Advanced TrackResearch Involving Data and Biospecimens Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A05 - During the Best of Times and the Worst of Times: Communication Between IRBs and Researchers
Location: On-Demand
SBER TrackIRB Operations Advanced TrackLeadership TrackFlexibility and Innovation in HRPP Processes Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A08 - Confidentiality, Privacy, and Anonymity in SBE Research
Location: On-Demand
SBER TrackLegal Considerations in HRPPs Track
Tuesday, Nov 16th
1:15 PM – 2:15 PM ET
B07 - College Students and Research: Challenges and Issues for IRBs
Location: On-Demand
SBER TrackIRB Operations Advanced TrackLegal Considerations in HRPPs Track
Tuesday, Nov 16th
2:30 PM – 5:30 PM ET
Crossing Borders: HRPPs and Protection of Subjects in Transnational Research
Location: Livestreamed
Tuesday, Nov 16th
2:30 PM – 5:30 PM ET
Institutional Official Discussion: Emerging Oversight Challenges and Necessary Process Enhancements
Location: Livestreamed
Tuesday, Nov 16th
2:30 PM – 5:30 PM ET
Intersectionality in Research Oversight: A Theoretical and Practical Framework Exploring Inequality
Welcome Remarks from PRIM&R's Board Chair and Executive Director, and AER21 Opening General Session: Advancing Justice and Equity in Research—How Can Research Stakeholders Be Agents of Change?
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A01 - Microaggressions, Unconscious Bias, and Systemic Racism: What Do These Terms Really Mean?
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A02 - Knock, Knock, FDA Is Here: What You Need to Know for Bioresearch Monitoring (BIMO) Inspections of IRBs, Clinical Investigators, and Sponsor Investigators
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A03 - Beyond Reliance Agreements: Local Considerations, Risk Mitigation, and Compliance
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A04 - Finding the Right Balance: Appropriate Secondary Use of Clinical Trial Data
Location: Livestreamed
Pharma/Biotech Perspectives Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A05 - QA/QI Solutions for a Changing Research Landscape
Location: Livestreamed
QA/QI and Postapproval Monitoring Track
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel I: Inclusion of Persons With Disabilities in Clinical Research
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel II: Weeding Out Useless Research: What’s an IRB to Do?
Location: Livestreamed
Wednesday, Nov 17th
1:00 PM – 1:45 PM ET
AER21 Mid-day Break Sponsored Presentation by WCG IRB: Critical Considerations for Informed Consent in Cell and Gene Therapy Trials
Location: Livestreamed
Exhibitor SymposiaResearch Involving Data and Biospecimens Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B01 - A Dialogue With OHRP
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B02 - Justice in Human Research: Accessibility, Inclusivity, and Intersectionality
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B03 - How to Conduct Education About Emergency Preparedness
Location: Livestreamed
Education and Training Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B05 - Research Silos—The Growing Problem of Restricting International Transfer of Data and Specimens
Location: Livestreamed
Global Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B07 - How to Manage Your Non-IRB Gatekeeping Functions as an IRB
Location: Livestreamed
IRB Operations Advanced Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B08 - The Workplace Shift—New Realities, Future Uncertainty, and Meeting Staff Needs in a Post-Pandemic World
Location: Livestreamed
Leadership TrackHRPP Leadership and Institutional Officials Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B09 - Explaining Explainable Machine Learning (XML)—What Research Review Boards Need to Know
Location: Livestreamed
Research Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B10 - Data Risks—Strategies for Maintaining Research Integrity via Conflict of Interest (COI) Review
Location: Livestreamed
Responsible Conduct of Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B11 - How Do Ancillary Review Committees Strengthen Our HRPPs?
Location: On-Demand
HRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B13 - Complex Conflict of Interest (COI)—Understanding the COI Landscape
Location: On-Demand
Legal Considerations in HRPPs TrackResponsible Conduct of Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B15 - Operationalizing Research Databases and Biobanks at Your Institution
Location: On-Demand
Research Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B16 - A Dialogue With AAHRPP, Inc.
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
3:00 PM – 3:30 PM ET
Sponsored Session by Cayuse: Best Practice Applications and Emerging Research Designs
Location: On-Demand
Exhibitor Symposia
Sponsored By
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Challenges and Opportunities for Institutions With Small Research Programs
Location: Livestreamed
Networking TrackSmall Research Programs Track
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Scientific Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
10:00 AM – 11:15 AM ET
Conference Welcome; In Memoriam: Tribute to Robert J. Levine, MD, and Jeffrey Cohen, PhD; and Keynote Address: Ethics of AI Research: Implementation and Implications
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C01 - Teaching Social Justice and Advocacy for Social Change—Ideas for Researchers, Leadership, IRB Members, Staff, and Communities
Education and Training TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C02 - Is Your Institution Ready to Conduct Human Gene Therapy Research?
Location: Livestreamed
Pharma/Biotech Perspectives TrackResearch Involving Data and Biospecimens Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C03 - Situational Vulnerability/Research With Risk Susceptible Populations Not Referenced in the Regulations
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C05 - When The @#&% Hits the Fan—When HRPP Noncompliance and Research Misconduct Occur Together
Location: Livestreamed
Responsible Conduct of Research TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel III: Exception from Informed Consent (EFIC) for Research at 25
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel IV: Data Advocacy, Governance, and Ethics in an Age of Big Data
Location: Livestreamed
Thursday, Nov 18th
12:45 PM – 1:30 PM ET
AER21 Mid-day Break: Sponsored Presentation by Advarra--The Post-Pandemic Pivot: How to Leverage Strategic Partners so Your Teams Can Focus on What Matters
Location: Livestreamed
Exhibitor SymposiaHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D01 - A Dialogue With FDA
Location: Livestreamed
A Dialogue With the Feds TrackFDA Regulated Research Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D02 - Embedding a Racial Justice Lens into Research and IRB Review With Human Subjects—How to Be an Anti-Racist at Work Every Day
Location: Livestreamed
Advancing Justice and Equity Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D03 - Developing a Rapid Response Central IRB Model—Use of an Emergency Preparedness Model to Develop and Streamline Procedures
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackGlobal Research TrackIRB Operations Advanced TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D04 - Electronic Consent and Other Emerging Approaches to Consent in Global Research
Location: Livestreamed
Global Research Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D05 - Defining and Implementing Your HRPP Vision—The Importance of HRPP Leadership
Location: Livestreamed
HRPP Leadership and Institutional Officials TrackLeadership Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D07 - Championing Cohesion and Collaboration Through Change
Location: Livestreamed
Leadership TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D09 - New Guidelines for Human Stem Cell-Related Research—Implications for IRBs and Institutions
Location: Livestreamed
Research Involving Data and Biospecimens Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D10 - Clinical Trials in SBER
Location: Livestreamed
SBER Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D12 - Ain't No Mountain High Enough”—Ensuring a Successful Informed Consent Process Throughout the Life of the Study
Location: On-Demand
IRB Basics Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D13 - Best Practices for Ancillary Review in a Single IRB World
Location: On-Demand
IRB Operations Advanced Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D14 - Ideas and Practices for Auditing of Single IRB Studies
Location: On-Demand
QA/QI and Postapproval Monitoring Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D15 - How to Maintain Institutional Memory at a Small Research Program
Location: On-Demand
Small Research Programs Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D16 - A Dialogue With ORI
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D17 - A Dialogue With SACHRP
Location: On-Demand
A Dialogue With the Feds Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
HRPP/IRB Management 101: Real-World Discussions Regarding How to Effectively Run a HRPP/IRB Office
Location: Livestreamed
Networking Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Meet the Author Book Discussion: Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals
Location: Livestreamed
Networking Track
Sponsored By
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Programmatic Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
4:00 PM – 5:00 PM ET
Federal Agency Affiliate Session: Department of Energy (DOE) Human Subjects Protection Program (HSPP): Human Subjects Research or Not Human Subjects Research?
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
10:00 AM – 11:15 AM ET
Conference Welcome and Keynote Address: Chasing My Cure: Lessons and Ethical Implications of Being a Physician-Scientist-Subject-Patient-Advocate
Location: Livestreamed
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E01 - A Philosopher's Look at the Belmont Principles (aka "Chicken Soup for the HRPP Professional's Soul")
Location: Livestreamed
IRB Basics Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E02 - Indigenous-Centered Approaches to the New Common Rule and the Single IRB Mandate
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E03 - How Might Ethics Review Be Reimagined in the Age of DIY and Open Science?
Location: Livestreamed
Research Conducted in the Digital World Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E04 - Advancing Justice Through Community Engagement in Governance for Research Biobanks
F04 - Bringing Continuous Improvement to Your HRPP—Proving Your HRPP Processes Are Hitting All the Right Milestones for Your Stakeholders
Location: Livestreamed
HRPP Leadership and Institutional Officials TrackEducation and Training TrackQA/QI and Postapproval Monitoring Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F05 - Advancing Justice and Equity Through IRB Review
Location: Livestreamed
IRB Operations Advanced TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F09 - NIH's New Data Management and Sharing Policy—How Academic Medical Centers Can Prepare for January 2023
Location: Livestreamed
Research Involving Data and Biospecimens Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F10 - From Big to Small and Back Again—Moving from a Large Research Program to a Small Research Program
Location: Livestreamed
Small Research Programs Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F11 - "Customer Support" Is Not a Bad Word—Building Resources for Relying Institutions and Investigators
Location: On-Demand
Flexibility and Innovation in HRPP Processes TrackLeadership TrackIRB Operations Advanced Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F13 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: On-Demand
Research Conducted in the Digital World Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F14 - Translating Responsible Conduct of Research (RCR) Training at Your Organization—Tips and Tricks for Reaching Your Audience and Providing Practical Instruction
Location: On-Demand
Responsible Conduct of Research TrackEducation and Training Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F16 - A Dialogue With the VA
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
3:00 PM – 4:00 PM ET
I Love My Job!? Confessions of a Career Human Research Protection Professional
Leveraging Community and Participant Perspective to Strengthen Research
Location: Livestreamed
Networking TrackAdvancing Justice and Equity Track
Friday, Nov 19th
3:00 PM – 4:00 PM ET
The Ethical Research Podcast: Live Audience Recording
Location: Livestreamed
Networking Track
IRB Administrators, Manager
and Staff
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D04 - Electronic Consent and Other Emerging Approaches to Consent in Global Research
Location: Livestreamed
Global Research Track
IRB Administrators, Managers, and Staff
Tuesday, Nov 16th
10:00 AM – 11:15 AM ET
SBER21 Opening General Session: Welcome from Conference Co-Chairs and Keynote Address: Lessons from Researchers to Improve Institutional Review Processes and Outcomes
Location: Livestreamed
SBER Track
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
Introduction to the IRB: Ethics and Regulation
Location: Livestreamed
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
Never Let a Crisis Go to Waste: Lessons Learned from the COVID-19 Pandemic for Clinical Research
Location: Livestreamed
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A01 - With Great Data Comes Great Responsibility—Data Lifecycle Review Strategies
Location: Livestreamed
SBER TrackResearch Involving Data and Biospecimens Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A02 - To Consent or Not to Consent: It's About the Question, Not the Answer
Location: Livestreamed
SBER TrackIRB Operations Advanced Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A03 - A Case Study in Diversity, Equity, and Inclusion (DEI) Efforts—An Office of Research Administration’s Social Justice Working Group
Location: Livestreamed
SBER TrackAdvancing Justice and Equity Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A04 - Understanding and Applying Family Educational Rights and Privacy Act (FERPA) in Higher Education
Location: On-Demand
SBER TrackIRB Operations Advanced TrackResearch Involving Data and Biospecimens Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A05 - During the Best of Times and the Worst of Times: Communication Between IRBs and Researchers
Location: On-Demand
SBER TrackIRB Operations Advanced TrackLeadership TrackFlexibility and Innovation in HRPP Processes Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A07 - Research in K-12 Settings
Location: On-Demand
SBER TrackIRB Operations Advanced Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A08 - Confidentiality, Privacy, and Anonymity in SBE Research
Location: On-Demand
SBER TrackLegal Considerations in HRPPs Track
Tuesday, Nov 16th
1:15 PM – 2:15 PM ET
B02 - Omnium-Gatherum—A SBER Variety Show
Location: Livestreamed
SBER Track
Tuesday, Nov 16th
1:15 PM – 2:15 PM ET
B03 - Much Ado About Virtual Research: Considerations, Challenges, and Opportunities
Location: Livestreamed
SBER TrackResearch Conducted in the Digital World Track
Tuesday, Nov 16th
1:15 PM – 2:15 PM ET
B07 - College Students and Research: Challenges and Issues for IRBs
Location: On-Demand
SBER TrackIRB Operations Advanced TrackLegal Considerations in HRPPs Track
Tuesday, Nov 16th
1:15 PM – 2:15 PM ET
B09 - Exempt or Not? Don't Get Psyched Out by the Benign Behavioral Intervention Research Exemption
Location: On-Demand
SBER TrackIRB Basics Track
Tuesday, Nov 16th
2:30 PM – 3:30 PM ET
Challenges and Opportunities for Small IRB Offices at Small SBER Programs
Location: Livestreamed
SBER TrackSmall Research Programs TrackNetworking Track
Tuesday, Nov 16th
2:30 PM – 3:30 PM ET
It’s a Virtual World, We’re a Virtual HRPP: Show and Tell Virtual Tools Networking Session
Welcome Remarks from PRIM&R's Board Chair and Executive Director, and AER21 Opening General Session: Advancing Justice and Equity in Research—How Can Research Stakeholders Be Agents of Change?
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A01 - Microaggressions, Unconscious Bias, and Systemic Racism: What Do These Terms Really Mean?
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A02 - Knock, Knock, FDA Is Here: What You Need to Know for Bioresearch Monitoring (BIMO) Inspections of IRBs, Clinical Investigators, and Sponsor Investigators
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A03 - Beyond Reliance Agreements: Local Considerations, Risk Mitigation, and Compliance
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A04 - Finding the Right Balance: Appropriate Secondary Use of Clinical Trial Data
Location: Livestreamed
Pharma/Biotech Perspectives Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A05 - QA/QI Solutions for a Changing Research Landscape
Location: Livestreamed
QA/QI and Postapproval Monitoring Track
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel I: Inclusion of Persons With Disabilities in Clinical Research
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel II: Weeding Out Useless Research: What’s an IRB to Do?
Location: Livestreamed
Wednesday, Nov 17th
1:00 PM – 1:45 PM ET
AER21 Mid-day Break Sponsored Presentation by WCG IRB: Critical Considerations for Informed Consent in Cell and Gene Therapy Trials
Location: Livestreamed
Exhibitor SymposiaResearch Involving Data and Biospecimens Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B01 - A Dialogue With OHRP
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B02 - Justice in Human Research: Accessibility, Inclusivity, and Intersectionality
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B03 - How to Conduct Education About Emergency Preparedness
Location: Livestreamed
Education and Training Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B04 - When Is an Investigational Device Exemption (IDE) Needed for Medical Device Clinical Investigations?
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B05 - Research Silos—The Growing Problem of Restricting International Transfer of Data and Specimens
Location: Livestreamed
Global Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B06 - Essential Documentation: IRB Record Keeping, Written Procedures, Minutes, and More
Location: Livestreamed
IRB Basics Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B07 - How to Manage Your Non-IRB Gatekeeping Functions as an IRB
Location: Livestreamed
IRB Operations Advanced Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B08 - The Workplace Shift—New Realities, Future Uncertainty, and Meeting Staff Needs in a Post-Pandemic World
Location: Livestreamed
Leadership TrackHRPP Leadership and Institutional Officials Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B09 - Explaining Explainable Machine Learning (XML)—What Research Review Boards Need to Know
Location: Livestreamed
Research Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B10 - Data Risks—Strategies for Maintaining Research Integrity via Conflict of Interest (COI) Review
Location: Livestreamed
Responsible Conduct of Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B11 - How Do Ancillary Review Committees Strengthen Our HRPPs?
Location: On-Demand
HRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B12 - How Do I Consent Thee? Let Me Count the Ways
Location: On-Demand
IRB Chairs TrackResearch Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B13 - Complex Conflict of Interest (COI)—Understanding the COI Landscape
Location: On-Demand
Legal Considerations in HRPPs TrackResponsible Conduct of Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B14 - Research With Children—Parental Permission and Assent and Child-Centric Trial Education
B15 - Operationalizing Research Databases and Biobanks at Your Institution
Location: On-Demand
Research Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B16 - A Dialogue With AAHRPP, Inc.
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
3:00 PM – 3:30 PM ET
Sponsored Session by Cayuse: Best Practice Applications and Emerging Research Designs
Location: On-Demand
Exhibitor Symposia
Sponsored By
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Challenges and Opportunities for Institutions With Small Research Programs
Location: Livestreamed
Networking TrackSmall Research Programs Track
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Return of the IRB Jedi: Exploring Regulations, Guidance, and Institutional Policies
Location: Livestreamed
Networking TrackIRB Basics Track
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
SBER Network Discussion: Postapproval Monitoring for SBER—Alternatives to Continuing Review for Minimal Risk Research
Location: Livestreamed
Networking TrackSBER TrackQA/QI and Postapproval Monitoring Track
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Scientific Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
10:00 AM – 11:15 AM ET
Conference Welcome; In Memoriam: Tribute to Robert J. Levine, MD, and Jeffrey Cohen, PhD; and Keynote Address: Ethics of AI Research: Implementation and Implications
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C01 - Teaching Social Justice and Advocacy for Social Change—Ideas for Researchers, Leadership, IRB Members, Staff, and Communities
Education and Training TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C02 - Is Your Institution Ready to Conduct Human Gene Therapy Research?
Location: Livestreamed
Pharma/Biotech Perspectives TrackResearch Involving Data and Biospecimens Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C03 - Situational Vulnerability/Research With Risk Susceptible Populations Not Referenced in the Regulations
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C04 - Beyond eConsent—Virtual Research in the Digital Age
Location: Livestreamed
Research Conducted in the Digital World Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C05 - When The @#&% Hits the Fan—When HRPP Noncompliance and Research Misconduct Occur Together
Location: Livestreamed
Responsible Conduct of Research TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel III: Exception from Informed Consent (EFIC) for Research at 25
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel IV: Data Advocacy, Governance, and Ethics in an Age of Big Data
Location: Livestreamed
Thursday, Nov 18th
12:45 PM – 1:30 PM ET
AER21 Mid-day Break: Sponsored Presentation by Advarra--The Post-Pandemic Pivot: How to Leverage Strategic Partners so Your Teams Can Focus on What Matters
Location: Livestreamed
Exhibitor SymposiaHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D01 - A Dialogue With FDA
Location: Livestreamed
A Dialogue With the Feds TrackFDA Regulated Research Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D02 - Embedding a Racial Justice Lens into Research and IRB Review With Human Subjects—How to Be an Anti-Racist at Work Every Day
Location: Livestreamed
Advancing Justice and Equity Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D03 - Developing a Rapid Response Central IRB Model—Use of an Emergency Preparedness Model to Develop and Streamline Procedures
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackGlobal Research TrackIRB Operations Advanced TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D07 - Championing Cohesion and Collaboration Through Change
Location: Livestreamed
Leadership TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D08 - Navigating the Regulatory Maze When Proposing Study Visits in Participant Homes
Location: Livestreamed
Legal Considerations in HRPPs Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D09 - New Guidelines for Human Stem Cell-Related Research—Implications for IRBs and Institutions
Location: Livestreamed
Research Involving Data and Biospecimens Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D10 - Clinical Trials in SBER
Location: Livestreamed
SBER Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D11 - Educating While Engaging—Strategies for IRB Member and Staff Continuing Education
Location: On-Demand
Education and Training Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D12 - Ain't No Mountain High Enough”—Ensuring a Successful Informed Consent Process Throughout the Life of the Study
Location: On-Demand
IRB Basics Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D13 - Best Practices for Ancillary Review in a Single IRB World
Location: On-Demand
IRB Operations Advanced Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D14 - Ideas and Practices for Auditing of Single IRB Studies
Location: On-Demand
QA/QI and Postapproval Monitoring Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D15 - How to Maintain Institutional Memory at a Small Research Program
Location: On-Demand
Small Research Programs Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D16 - A Dialogue With ORI
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D17 - A Dialogue With SACHRP
Location: On-Demand
A Dialogue With the Feds Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
HRPP/IRB Management 101: Real-World Discussions Regarding How to Effectively Run a HRPP/IRB Office
Location: Livestreamed
Networking Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Meet the Author Book Discussion: Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals
Location: Livestreamed
Networking Track
Sponsored By
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Programmatic Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
The Certified IRB Professional (CIP®) Credential Presentation
Location: Livestreamed
Networking Track
Sponsored By
Thursday, Nov 18th
4:00 PM – 5:00 PM ET
Federal Agency Affiliate Session: Department of Energy (DOE) Human Subjects Protection Program (HSPP): Human Subjects Research or Not Human Subjects Research?
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
10:00 AM – 11:15 AM ET
Conference Welcome and Keynote Address: Chasing My Cure: Lessons and Ethical Implications of Being a Physician-Scientist-Subject-Patient-Advocate
Location: Livestreamed
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E01 - A Philosopher's Look at the Belmont Principles (aka "Chicken Soup for the HRPP Professional's Soul")
Location: Livestreamed
IRB Basics Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E02 - Indigenous-Centered Approaches to the New Common Rule and the Single IRB Mandate
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E03 - How Might Ethics Review Be Reimagined in the Age of DIY and Open Science?
Location: Livestreamed
Research Conducted in the Digital World Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E04 - Advancing Justice Through Community Engagement in Governance for Research Biobanks
F03 - The IRB’s Critical Role in Understanding Sponsor and Investigator Responsibilities for Investigational New Drug Application (IND) Safety Reporting in Order to Assure the Protection of Human Subjects
Location: Livestreamed
FDA Regulated Research Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F04 - Bringing Continuous Improvement to Your HRPP—Proving Your HRPP Processes Are Hitting All the Right Milestones for Your Stakeholders
Location: Livestreamed
HRPP Leadership and Institutional Officials TrackEducation and Training TrackQA/QI and Postapproval Monitoring Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F05 - Advancing Justice and Equity Through IRB Review
Location: Livestreamed
IRB Operations Advanced TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F06 - Bystanders in Human Subject Research
Location: Livestreamed
Legal Considerations in HRPPs Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F07 - Ethical Issues in Complex Trial Design
Location: Livestreamed
Pharma/Biotech Perspectives Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F08 - Trust, But Verify—Conducting Routine Audits of IRB to Help Ensure Compliance
Location: Livestreamed
QA/QI and Postapproval Monitoring Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F09 - NIH's New Data Management and Sharing Policy—How Academic Medical Centers Can Prepare for January 2023
Location: Livestreamed
Research Involving Data and Biospecimens Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F10 - From Big to Small and Back Again—Moving from a Large Research Program to a Small Research Program
Location: Livestreamed
Small Research Programs Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F11 - "Customer Support" Is Not a Bad Word—Building Resources for Relying Institutions and Investigators
Location: On-Demand
Flexibility and Innovation in HRPP Processes TrackLeadership TrackIRB Operations Advanced Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F12 - Access to Clinical Research for People With Limited English Proficiency (LEP)
Location: On-Demand
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F13 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: On-Demand
Research Conducted in the Digital World Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F14 - Translating Responsible Conduct of Research (RCR) Training at Your Organization—Tips and Tricks for Reaching Your Audience and Providing Practical Instruction
Location: On-Demand
Responsible Conduct of Research TrackEducation and Training Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F16 - A Dialogue With the VA
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
3:00 PM – 4:00 PM ET
I Love My Job!? Confessions of a Career Human Research Protection Professional
Leveraging Community and Participant Perspective to Strengthen Research
Location: Livestreamed
Networking TrackAdvancing Justice and Equity Track
Friday, Nov 19th
3:00 PM – 4:00 PM ET
The Ethical Research Podcast: Live Audience Recording
Location: Livestreamed
Networking Track
IRB Members, Chairs, and Vice Chairs
Tuesday, Nov 16th
10:00 AM – 11:15 AM ET
SBER21 Opening General Session: Welcome from Conference Co-Chairs and Keynote Address: Lessons from Researchers to Improve Institutional Review Processes and Outcomes
Location: Livestreamed
SBER Track
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
Introduction to the IRB: Ethics and Regulation
Location: Livestreamed
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
IRB Chairs Boot Camp
Location: Livestreamed
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
Never Let a Crisis Go to Waste: Lessons Learned from the COVID-19 Pandemic for Clinical Research
Location: Livestreamed
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A01 - With Great Data Comes Great Responsibility—Data Lifecycle Review Strategies
Location: Livestreamed
SBER TrackResearch Involving Data and Biospecimens Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A02 - To Consent or Not to Consent: It's About the Question, Not the Answer
Location: Livestreamed
SBER TrackIRB Operations Advanced Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A06 - Research With Non-Traditional Vulnerable Populations in SBER
Welcome Remarks from PRIM&R's Board Chair and Executive Director, and AER21 Opening General Session: Advancing Justice and Equity in Research—How Can Research Stakeholders Be Agents of Change?
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A01 - Microaggressions, Unconscious Bias, and Systemic Racism: What Do These Terms Really Mean?
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A02 - Knock, Knock, FDA Is Here: What You Need to Know for Bioresearch Monitoring (BIMO) Inspections of IRBs, Clinical Investigators, and Sponsor Investigators
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A03 - Beyond Reliance Agreements: Local Considerations, Risk Mitigation, and Compliance
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A04 - Finding the Right Balance: Appropriate Secondary Use of Clinical Trial Data
Location: Livestreamed
Pharma/Biotech Perspectives Track
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel I: Inclusion of Persons With Disabilities in Clinical Research
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel II: Weeding Out Useless Research: What’s an IRB to Do?
Location: Livestreamed
Wednesday, Nov 17th
1:00 PM – 1:45 PM ET
AER21 Mid-day Break Sponsored Presentation by WCG IRB: Critical Considerations for Informed Consent in Cell and Gene Therapy Trials
Location: Livestreamed
Exhibitor SymposiaResearch Involving Data and Biospecimens Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B01 - A Dialogue With OHRP
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B02 - Justice in Human Research: Accessibility, Inclusivity, and Intersectionality
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B03 - How to Conduct Education About Emergency Preparedness
Location: Livestreamed
Education and Training Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B04 - When Is an Investigational Device Exemption (IDE) Needed for Medical Device Clinical Investigations?
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B05 - Research Silos—The Growing Problem of Restricting International Transfer of Data and Specimens
Location: Livestreamed
Global Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B06 - Essential Documentation: IRB Record Keeping, Written Procedures, Minutes, and More
Location: Livestreamed
IRB Basics Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B09 - Explaining Explainable Machine Learning (XML)—What Research Review Boards Need to Know
Location: Livestreamed
Research Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B10 - Data Risks—Strategies for Maintaining Research Integrity via Conflict of Interest (COI) Review
Location: Livestreamed
Responsible Conduct of Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B12 - How Do I Consent Thee? Let Me Count the Ways
Location: On-Demand
IRB Chairs TrackResearch Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B13 - Complex Conflict of Interest (COI)—Understanding the COI Landscape
Location: On-Demand
Legal Considerations in HRPPs TrackResponsible Conduct of Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B14 - Research With Children—Parental Permission and Assent and Child-Centric Trial Education
B15 - Operationalizing Research Databases and Biobanks at Your Institution
Location: On-Demand
Research Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B16 - A Dialogue With AAHRPP, Inc.
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
3:00 PM – 3:30 PM ET
Sponsored Session by Cayuse: Best Practice Applications and Emerging Research Designs
Location: On-Demand
Exhibitor Symposia
Sponsored By
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Return of the IRB Jedi: Exploring Regulations, Guidance, and Institutional Policies
Location: Livestreamed
Networking TrackIRB Basics Track
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Scientific Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
10:00 AM – 11:15 AM ET
Conference Welcome; In Memoriam: Tribute to Robert J. Levine, MD, and Jeffrey Cohen, PhD; and Keynote Address: Ethics of AI Research: Implementation and Implications
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C01 - Teaching Social Justice and Advocacy for Social Change—Ideas for Researchers, Leadership, IRB Members, Staff, and Communities
Education and Training TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C02 - Is Your Institution Ready to Conduct Human Gene Therapy Research?
Location: Livestreamed
Pharma/Biotech Perspectives TrackResearch Involving Data and Biospecimens Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C03 - Situational Vulnerability/Research With Risk Susceptible Populations Not Referenced in the Regulations
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C04 - Beyond eConsent—Virtual Research in the Digital Age
Location: Livestreamed
Research Conducted in the Digital World Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C05 - When The @#&% Hits the Fan—When HRPP Noncompliance and Research Misconduct Occur Together
Location: Livestreamed
Responsible Conduct of Research TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel III: Exception from Informed Consent (EFIC) for Research at 25
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel IV: Data Advocacy, Governance, and Ethics in an Age of Big Data
Location: Livestreamed
Thursday, Nov 18th
12:45 PM – 1:30 PM ET
AER21 Mid-day Break: Sponsored Presentation by Advarra--The Post-Pandemic Pivot: How to Leverage Strategic Partners so Your Teams Can Focus on What Matters
Location: Livestreamed
Exhibitor SymposiaHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D01 - A Dialogue With FDA
Location: Livestreamed
A Dialogue With the Feds TrackFDA Regulated Research Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D02 - Embedding a Racial Justice Lens into Research and IRB Review With Human Subjects—How to Be an Anti-Racist at Work Every Day
Location: Livestreamed
Advancing Justice and Equity Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D03 - Developing a Rapid Response Central IRB Model—Use of an Emergency Preparedness Model to Develop and Streamline Procedures
Location: Livestreamed
Flexibility and Innovation in HRPP Processes TrackGlobal Research TrackIRB Operations Advanced TrackHRPP Leadership and Institutional Officials Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D04 - Electronic Consent and Other Emerging Approaches to Consent in Global Research
Location: Livestreamed
Global Research Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D06 - Unique Challenges Being an IRB Chairperson at Medium to Small Institution
Location: Livestreamed
IRB Chairs TrackSmall Research Programs Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D08 - Navigating the Regulatory Maze When Proposing Study Visits in Participant Homes
Location: Livestreamed
Legal Considerations in HRPPs Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D09 - New Guidelines for Human Stem Cell-Related Research—Implications for IRBs and Institutions
Location: Livestreamed
Research Involving Data and Biospecimens Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D10 - Clinical Trials in SBER
Location: Livestreamed
SBER Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D11 - Educating While Engaging—Strategies for IRB Member and Staff Continuing Education
Location: On-Demand
Education and Training Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D12 - Ain't No Mountain High Enough”—Ensuring a Successful Informed Consent Process Throughout the Life of the Study
Location: On-Demand
IRB Basics Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D14 - Ideas and Practices for Auditing of Single IRB Studies
Location: On-Demand
QA/QI and Postapproval Monitoring Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D16 - A Dialogue With ORI
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D17 - A Dialogue With SACHRP
Location: On-Demand
A Dialogue With the Feds Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Meet the Author Book Discussion: Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals
Location: Livestreamed
Networking Track
Sponsored By
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Programmatic Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
4:00 PM – 5:00 PM ET
Federal Agency Affiliate Session: Department of Energy (DOE) Human Subjects Protection Program (HSPP): Human Subjects Research or Not Human Subjects Research?
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
10:00 AM – 11:15 AM ET
Conference Welcome and Keynote Address: Chasing My Cure: Lessons and Ethical Implications of Being a Physician-Scientist-Subject-Patient-Advocate
Location: Livestreamed
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E01 - A Philosopher's Look at the Belmont Principles (aka "Chicken Soup for the HRPP Professional's Soul")
Location: Livestreamed
IRB Basics Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E02 - Indigenous-Centered Approaches to the New Common Rule and the Single IRB Mandate
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E03 - How Might Ethics Review Be Reimagined in the Age of DIY and Open Science?
Location: Livestreamed
Research Conducted in the Digital World Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E04 - Advancing Justice Through Community Engagement in Governance for Research Biobanks
F03 - The IRB’s Critical Role in Understanding Sponsor and Investigator Responsibilities for Investigational New Drug Application (IND) Safety Reporting in Order to Assure the Protection of Human Subjects
Location: Livestreamed
FDA Regulated Research Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F05 - Advancing Justice and Equity Through IRB Review
Location: Livestreamed
IRB Operations Advanced TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F06 - Bystanders in Human Subject Research
Location: Livestreamed
Legal Considerations in HRPPs Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F07 - Ethical Issues in Complex Trial Design
Location: Livestreamed
Pharma/Biotech Perspectives Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F08 - Trust, But Verify—Conducting Routine Audits of IRB to Help Ensure Compliance
Location: Livestreamed
QA/QI and Postapproval Monitoring Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F09 - NIH's New Data Management and Sharing Policy—How Academic Medical Centers Can Prepare for January 2023
Location: Livestreamed
Research Involving Data and Biospecimens Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F11 - "Customer Support" Is Not a Bad Word—Building Resources for Relying Institutions and Investigators
Location: On-Demand
Flexibility and Innovation in HRPP Processes TrackLeadership TrackIRB Operations Advanced Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F12 - Access to Clinical Research for People With Limited English Proficiency (LEP)
Location: On-Demand
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F13 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: On-Demand
Research Conducted in the Digital World Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F15 - Risk Mitigation in Mixed SBER and Biomedical Research—A Case-Based Approach
Location: On-Demand
SBER Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F16 - A Dialogue With the VA
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
3:00 PM – 4:00 PM ET
IRB Chairs Forum: A Structured Discussion for IRB Chairs
Location: Livestreamed
Networking TrackIRB Chairs Track
Friday, Nov 19th
3:00 PM – 4:00 PM ET
Leveraging Community and Participant Perspective to Strengthen Research
Location: Livestreamed
Networking TrackAdvancing Justice and Equity Track
Friday, Nov 19th
3:00 PM – 4:00 PM ET
The Ethical Research Podcast: Live Audience Recording
Location: Livestreamed
Networking Track
Non-Scientist/Unaffiliated IRB Member
Tuesday, Nov 16th
10:00 AM – 11:15 AM ET
SBER21 Opening General Session: Welcome from Conference Co-Chairs and Keynote Address: Lessons from Researchers to Improve Institutional Review Processes and Outcomes
Location: Livestreamed
SBER Track
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
Introduction to the IRB: Ethics and Regulation
Location: Livestreamed
Tuesday, Nov 16th
10:00 AM – 1:00 PM ET
Never Let a Crisis Go to Waste: Lessons Learned from the COVID-19 Pandemic for Clinical Research
Location: Livestreamed
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A01 - With Great Data Comes Great Responsibility—Data Lifecycle Review Strategies
Location: Livestreamed
SBER TrackResearch Involving Data and Biospecimens Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A02 - To Consent or Not to Consent: It's About the Question, Not the Answer
Location: Livestreamed
SBER TrackIRB Operations Advanced Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A06 - Research With Non-Traditional Vulnerable Populations in SBER
Welcome Remarks from PRIM&R's Board Chair and Executive Director, and AER21 Opening General Session: Advancing Justice and Equity in Research—How Can Research Stakeholders Be Agents of Change?
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A01 - Microaggressions, Unconscious Bias, and Systemic Racism: What Do These Terms Really Mean?
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A04 - Finding the Right Balance: Appropriate Secondary Use of Clinical Trial Data
Location: Livestreamed
Pharma/Biotech Perspectives Track
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel I: Inclusion of Persons With Disabilities in Clinical Research
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel II: Weeding Out Useless Research: What’s an IRB to Do?
Location: Livestreamed
Wednesday, Nov 17th
1:00 PM – 1:45 PM ET
AER21 Mid-day Break Sponsored Presentation by WCG IRB: Critical Considerations for Informed Consent in Cell and Gene Therapy Trials
Location: Livestreamed
Exhibitor SymposiaResearch Involving Data and Biospecimens Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B01 - A Dialogue With OHRP
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B02 - Justice in Human Research: Accessibility, Inclusivity, and Intersectionality
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B04 - When Is an Investigational Device Exemption (IDE) Needed for Medical Device Clinical Investigations?
Location: Livestreamed
FDA Regulated Research Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B06 - Essential Documentation: IRB Record Keeping, Written Procedures, Minutes, and More
Location: Livestreamed
IRB Basics Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B09 - Explaining Explainable Machine Learning (XML)—What Research Review Boards Need to Know
Location: Livestreamed
Research Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B10 - Data Risks—Strategies for Maintaining Research Integrity via Conflict of Interest (COI) Review
Location: Livestreamed
Responsible Conduct of Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B12 - How Do I Consent Thee? Let Me Count the Ways
Location: On-Demand
IRB Chairs TrackResearch Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B16 - A Dialogue With AAHRPP, Inc.
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
3:00 PM – 3:30 PM ET
Sponsored Session by Cayuse: Best Practice Applications and Emerging Research Designs
Location: On-Demand
Exhibitor Symposia
Sponsored By
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Return of the IRB Jedi: Exploring Regulations, Guidance, and Institutional Policies
Location: Livestreamed
Networking TrackIRB Basics Track
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
Scientific Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
10:00 AM – 11:15 AM ET
Conference Welcome; In Memoriam: Tribute to Robert J. Levine, MD, and Jeffrey Cohen, PhD; and Keynote Address: Ethics of AI Research: Implementation and Implications
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C01 - Teaching Social Justice and Advocacy for Social Change—Ideas for Researchers, Leadership, IRB Members, Staff, and Communities
Education and Training TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C02 - Is Your Institution Ready to Conduct Human Gene Therapy Research?
Location: Livestreamed
Pharma/Biotech Perspectives TrackResearch Involving Data and Biospecimens Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C03 - Situational Vulnerability/Research With Risk Susceptible Populations Not Referenced in the Regulations
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C04 - Beyond eConsent—Virtual Research in the Digital Age
Location: Livestreamed
Research Conducted in the Digital World Track
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel III: Exception from Informed Consent (EFIC) for Research at 25
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel IV: Data Advocacy, Governance, and Ethics in an Age of Big Data
Location: Livestreamed
Thursday, Nov 18th
12:45 PM – 1:30 PM ET
AER21 Mid-day Break: Sponsored Presentation by Advarra--The Post-Pandemic Pivot: How to Leverage Strategic Partners so Your Teams Can Focus on What Matters
Location: Livestreamed
Exhibitor SymposiaHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D01 - A Dialogue With FDA
Location: Livestreamed
A Dialogue With the Feds TrackFDA Regulated Research Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D02 - Embedding a Racial Justice Lens into Research and IRB Review With Human Subjects—How to Be an Anti-Racist at Work Every Day
Location: Livestreamed
Advancing Justice and Equity Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D08 - Navigating the Regulatory Maze When Proposing Study Visits in Participant Homes
Location: Livestreamed
Legal Considerations in HRPPs Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D10 - Clinical Trials in SBER
Location: Livestreamed
SBER Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D12 - Ain't No Mountain High Enough”—Ensuring a Successful Informed Consent Process Throughout the Life of the Study
Location: On-Demand
IRB Basics Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D16 - A Dialogue With ORI
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D17 - A Dialogue With SACHRP
Location: On-Demand
A Dialogue With the Feds Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Meet the Author Book Discussion: Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals
Location: Livestreamed
Networking Track
Sponsored By
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Programmatic Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Thursday, Nov 18th
4:00 PM – 5:00 PM ET
Federal Agency Affiliate Session: Department of Energy (DOE) Human Subjects Protection Program (HSPP): Human Subjects Research or Not Human Subjects Research?
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
10:00 AM – 11:15 AM ET
Conference Welcome and Keynote Address: Chasing My Cure: Lessons and Ethical Implications of Being a Physician-Scientist-Subject-Patient-Advocate
Location: Livestreamed
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E01 - A Philosopher's Look at the Belmont Principles (aka "Chicken Soup for the HRPP Professional's Soul")
Location: Livestreamed
IRB Basics Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E02 - Indigenous-Centered Approaches to the New Common Rule and the Single IRB Mandate
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E03 - How Might Ethics Review Be Reimagined in the Age of DIY and Open Science?
Location: Livestreamed
Research Conducted in the Digital World Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E04 - Advancing Justice Through Community Engagement in Governance for Research Biobanks
F03 - The IRB’s Critical Role in Understanding Sponsor and Investigator Responsibilities for Investigational New Drug Application (IND) Safety Reporting in Order to Assure the Protection of Human Subjects
Location: Livestreamed
FDA Regulated Research Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F06 - Bystanders in Human Subject Research
Location: Livestreamed
Legal Considerations in HRPPs Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F07 - Ethical Issues in Complex Trial Design
Location: Livestreamed
Pharma/Biotech Perspectives Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F09 - NIH's New Data Management and Sharing Policy—How Academic Medical Centers Can Prepare for January 2023
Location: Livestreamed
Research Involving Data and Biospecimens Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F12 - Access to Clinical Research for People With Limited English Proficiency (LEP)
Location: On-Demand
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F13 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: On-Demand
Research Conducted in the Digital World Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F15 - Risk Mitigation in Mixed SBER and Biomedical Research—A Case-Based Approach
Location: On-Demand
SBER Track
Friday, Nov 19th
1:30 PM – 2:30 PM ET
F16 - A Dialogue With the VA
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Friday, Nov 19th
3:00 PM – 4:00 PM ET
Leveraging Community and Participant Perspective to Strengthen Research
Location: Livestreamed
Networking TrackAdvancing Justice and Equity Track
Friday, Nov 19th
3:00 PM – 4:00 PM ET
The Ethical Research Podcast: Live Audience Recording
Location: Livestreamed
Networking Track
SBER Professionals
Tuesday, Nov 16th
10:00 AM – 11:15 AM ET
SBER21 Opening General Session: Welcome from Conference Co-Chairs and Keynote Address: Lessons from Researchers to Improve Institutional Review Processes and Outcomes
Location: Livestreamed
SBER Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A01 - With Great Data Comes Great Responsibility—Data Lifecycle Review Strategies
Location: Livestreamed
SBER TrackResearch Involving Data and Biospecimens Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A02 - To Consent or Not to Consent: It's About the Question, Not the Answer
Location: Livestreamed
SBER TrackIRB Operations Advanced Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A03 - A Case Study in Diversity, Equity, and Inclusion (DEI) Efforts—An Office of Research Administration’s Social Justice Working Group
Location: Livestreamed
SBER TrackAdvancing Justice and Equity Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A04 - Understanding and Applying Family Educational Rights and Privacy Act (FERPA) in Higher Education
Location: On-Demand
SBER TrackIRB Operations Advanced TrackResearch Involving Data and Biospecimens Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A05 - During the Best of Times and the Worst of Times: Communication Between IRBs and Researchers
Location: On-Demand
SBER TrackIRB Operations Advanced TrackLeadership TrackFlexibility and Innovation in HRPP Processes Track
Tuesday, Nov 16th
11:30 AM – 12:30 PM ET
A06 - Research With Non-Traditional Vulnerable Populations in SBER
Welcome Remarks from PRIM&R's Board Chair and Executive Director, and AER21 Opening General Session: Advancing Justice and Equity in Research—How Can Research Stakeholders Be Agents of Change?
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 12:45 PM ET
A01 - Microaggressions, Unconscious Bias, and Systemic Racism: What Do These Terms Really Mean?
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel I: Inclusion of Persons With Disabilities in Clinical Research
Location: Livestreamed
Wednesday, Nov 17th
11:45 AM – 1:00 PM ET
Panel II: Weeding Out Useless Research: What’s an IRB to Do?
Location: Livestreamed
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B01 - A Dialogue With OHRP
Location: Livestreamed
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B02 - Justice in Human Research: Accessibility, Inclusivity, and Intersectionality
Location: Livestreamed
Advancing Justice and Equity Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B09 - Explaining Explainable Machine Learning (XML)—What Research Review Boards Need to Know
Location: Livestreamed
Research Conducted in the Digital World Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B10 - Data Risks—Strategies for Maintaining Research Integrity via Conflict of Interest (COI) Review
Location: Livestreamed
Responsible Conduct of Research TrackResearch Involving Data and Biospecimens Track
Wednesday, Nov 17th
1:45 PM – 2:45 PM ET
B16 - A Dialogue With AAHRPP, Inc.
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Wednesday, Nov 17th
3:00 PM – 4:00 PM ET
SBER Network Discussion: Postapproval Monitoring for SBER—Alternatives to Continuing Review for Minimal Risk Research
Location: Livestreamed
Networking TrackSBER TrackQA/QI and Postapproval Monitoring Track
Thursday, Nov 18th
10:00 AM – 11:15 AM ET
Conference Welcome; In Memoriam: Tribute to Robert J. Levine, MD, and Jeffrey Cohen, PhD; and Keynote Address: Ethics of AI Research: Implementation and Implications
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:30 PM ET
C03 - Situational Vulnerability/Research With Risk Susceptible Populations Not Referenced in the Regulations
Location: Livestreamed
Populations Requiring Additional Protections TrackAdvancing Justice and Equity Track
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel III: Exception from Informed Consent (EFIC) for Research at 25
Location: Livestreamed
Thursday, Nov 18th
11:30 AM – 12:45 PM ET
Panel IV: Data Advocacy, Governance, and Ethics in an Age of Big Data
Location: Livestreamed
Thursday, Nov 18th
12:45 PM – 1:30 PM ET
AER21 Mid-day Break: Sponsored Presentation by Advarra--The Post-Pandemic Pivot: How to Leverage Strategic Partners so Your Teams Can Focus on What Matters
Location: Livestreamed
Exhibitor SymposiaHRPP Leadership and Institutional Officials TrackIRB Operations Advanced Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D02 - Embedding a Racial Justice Lens into Research and IRB Review With Human Subjects—How to Be an Anti-Racist at Work Every Day
Location: Livestreamed
Advancing Justice and Equity Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D08 - Navigating the Regulatory Maze When Proposing Study Visits in Participant Homes
Location: Livestreamed
Legal Considerations in HRPPs Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D10 - Clinical Trials in SBER
Location: Livestreamed
SBER Track
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D16 - A Dialogue With ORI
Location: On-Demand
A Dialogue With the Feds Track
Sponsored By
Thursday, Nov 18th
1:30 PM – 2:30 PM ET
D17 - A Dialogue With SACHRP
Location: On-Demand
A Dialogue With the Feds Track
Thursday, Nov 18th
3:00 PM – 4:00 PM ET
Programmatic Poster Panel: Outstanding Work
Location: Livestreamed
Networking Track
Friday, Nov 19th
10:00 AM – 11:15 AM ET
Conference Welcome and Keynote Address: Chasing My Cure: Lessons and Ethical Implications of Being a Physician-Scientist-Subject-Patient-Advocate
Location: Livestreamed
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E01 - A Philosopher's Look at the Belmont Principles (aka "Chicken Soup for the HRPP Professional's Soul")
Location: Livestreamed
IRB Basics Track
Friday, Nov 19th
11:30 AM – 12:30 PM ET
E04 - Advancing Justice Through Community Engagement in Governance for Research Biobanks
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