Full Schedule

9:30 AM - 10:00 AM ET

Attendee Orientation

10:00 AM - 11:15 AM ET

Remarks from PRIM&R's Executive Director, followed by Opening General Session: Clarifying the Myths and Challenging Bias About Race in Research Review

10:00 AM - 5:00 PM ET

Visit the Supporters/Exhibitors

10:00 AM - 5:00 PM ET

Visit the Virtual Poster Gallery

11:15 AM - 11:30 AM ET

Break

11:30 AM - 12:45 PM ET

Panel: Coloring Outside the Lines: Ethical Conduct of Unregulated Research

12:45 PM - 1:15 PM ET

Mid-Day Break

12:45 PM - 1:15 PM ET

Supporter/Exhibitor Presentation from Axiom Mentor: Increase IRB Efficiency to Save Money

Sponsored By:

1:15 PM - 2:15 PM ET

W1A1 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Members

Education and Training Track

1:15 PM - 2:15 PM ET

W1A2 - Distinguishing Public Health Surveillance from Public Health Research

Flexibility and Innovation in IRB Processes Track

1:15 PM - 2:15 PM ET

W1A3 - Bioresearch Monitoring (BIMO) Inspections—Regulatory Violations Observed in IRB, Clinical Investigator, and Sponsor-Investigator Inspections

FDA Regulated Research Track

1:15 PM - 2:15 PM ET

W1A4 - Are Hospital Based IRBs Ready for the Endangered Species List

Institutional Officials and HRPP Leadership Track

1:15 PM - 2:15 PM ET

W1A5 - The Etiquette and Necessity of Communication in the Single IRB World

IRB Operations Advanced Track

1:15 PM - 2:15 PM ET

W1A6 - Human Challenge Trials (HCTs) for COVID-19: What IRBs Should Know

Pharma/Biotech Perspectives Track

1:15 PM - 2:15 PM ET

W1A7 - Navigating Uncertainty: Research With Undocumented Immigrants and Refugees

Populations Requiring Additional Protections Track

1:15 PM - 2:15 PM ET

W1A8 - Assessing and Addressing the Ethical, Regulatory, and Governance Challenges of Networking Biorepositories

Research Involving Data and Biospecimens Track

1:15 PM - 2:15 PM ET

W1A9 - Beyond the Regulations: How to Effectively and Efficiently Manage Research Misconduct Cases

Responsible Conduct of Research Track

1:15 PM - 2:15 PM ET

W1A10 - Exempt or Not? Don't Get Psyched Out by the Benign Behavioral Intervention Research Exemption

SBER Track

1:15 PM - 2:15 PM ET

W1A11 - Covering All of Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review

IRB Basics Track

1:15 PM - 2:15 PM ET

W1A12 - Nuts and Bolts of Assessing IRB Compliance

QA/QI and Post-Approval Monitoring Track

1:15 PM - 2:15 PM ET

W1A13 - How Might Ethics Review be Reimagined in the Age of DIY and Open Science?

Research Conducted in the Digital World Track

2:15 PM - 2:30 PM ET

Break

2:30 PM - 3:00 PM ET

PRIM&R Membership Presentation

2:30 PM - 3:00 PM ET

PRIM&R’s Ethical Research Oversight Course (EROC) Demonstration

2:30 PM - 3:30 PM ET

Meet the Author Book Discussion: Everybody Wants to Go to Heaven but Nobody Wants to Die: Bioethics and the Transformation of Health Care

Sponsored By:

2:30 PM - 3:30 PM ET

The Certified IRB Professional (CIP®) Credential Presentation

2:30 PM - 3:30 PM ET

Virtual Roundtable: Ask the IRB Chairs!

2:30 PM - 3:30 PM ET

Virtual Roundtable: Racial Justice Working Group—IRB’s Role in Racial Bias

2:30 PM - 5:00 PM ET

Federal Agency/Accrediting Body Office hours

2:30 PM - 5:30 PM ET

Workshop: Adaptable QA/QI Audit Approaches: How to Adjust Without Compromising Quality

2:30 PM - 5:30 PM ET

Workshop: Introduction to the IRB: Ethics and Regulation

3:00 PM - 4:30 PM ET

Visit the PRIM&R Booth

3:30 PM - 5:00 PM ET

CIP Office Hours

4:00 PM - 5:00 PM ET

Scientific Poster Panel: Outstanding Work

5:00 PM - 5:45 PM ET

Second City Improv Happy Hour Sponsored by WCG IRB

Sponsored By:

10:00 AM - 11:15 AM ET

Panel: Scientific and Ethical Challenges of COVID-19 Prevention Trials in a Complex Sociopolitical Context

10:00 AM - 5:00 PM ET

Visit the Supporters/Exhibitors

10:00 AM - 5:00 PM ET

Visit the Virtual Poster Gallery

11:15 AM - 11:30 AM ET

Break

11:30 AM - 12:45 PM ET

Panel: Ethical, Legal, and Regulatory Challenges of Conducting Research on Involuntarily Admitted Patients

12:45 PM - 1:15 PM ET

Supporter/Exhibitor Presentation from WCG IRB: Points to Consider for Human Subjects Protections in Next-Generation Vaccine Trials

Sponsored By:

1:15 PM - 2:15 PM ET

W1B1 - A Dialogue With FDA

A Dialogue With the Feds Track

1:15 PM - 2:15 PM ET

W1B2 - How Do Ancillary Review Committees Strengthen Our HRPPs?

Institutional Officials and HRPP Leadership Track

1:15 PM - 2:15 PM ET

W1B3 - Meeting Management for IRB Chairs

IRB Chairs Track

1:15 PM - 2:15 PM ET

W1B4 - Shaping Your Clinical Research Culture

Leadership Track

1:15 PM - 2:15 PM ET

W1B5 - Navigating State Law Differences in the Era of Single IRB (sIRB) Review

Legal Considerations in HRPPs Track

1:15 PM - 2:15 PM ET

W1B6 - Research with Children: Ethical Considerations, Parental Permission, and Assent

Populations Requiring Additional Protections Track

1:15 PM - 2:15 PM ET

W1B7 - Protocol Deviations, Protocol Violations, Protocol Variances, Protocol Exceptions, and Noncompliance: What Really Needs to be Reported to an IRB

QA/QI and Post-Approval Monitoring Track

1:15 PM - 2:15 PM ET

W1B8 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology

Research Conducted in the Digital World Track

1:15 PM - 2:15 PM ET

W1B9 - Challenges and Opportunities for Institutions With Small Research Programs

Small Research Programs Track

1:15 PM - 2:15 PM ET

W1B10 - College Students and Research: Challenges and Issues for IRBs

SBER Track

1:15 PM - 2:15 PM ET

W1B11 - A Dialogue with the VA

2:15 PM - 2:30 PM ET

Break

2:30 PM - 3:30 PM ET

SBER Network Discussion

2:30 PM - 3:30 PM ET

Virtual Roundtable: COVID-19’s Impact on the Field—Challenges for IRBs in Reviewing COVID-Related Research

2:30 PM - 3:30 PM ET

Virtual Roundtable: IRB Administrators Group—Tools, Tips, and Tricks for Managing Single IRB (sIRB) Review

2:30 PM - 5:00 PM ET

CIP Office Hours

2:30 PM - 5:00 PM ET

Federal Agency/Accrediting Body Office hours

2:30 PM - 5:30 PM ET

Workshop: Achieving Excellence in Research: Moving from Diversity and Inclusion to Equity and Justice

3:00 PM - 4:30 PM ET

Visit the PRIM&R Booth

4:00 PM - 5:00 PM ET

Programmatic Poster Panel: Outstanding Work

9:30 AM - 10:00 AM ET

Attendee Orientation

10:00 AM - 11:15 AM ET

PRIM&R Board Chair Remarks; ARENA Legacy Award Presentation; Opening Keynote Address: Improving Openness and Reproducibility of Research

10:00 AM - 5:00 PM ET

Visit the Supporters/Exhibitors

10:00 AM - 5:00 PM ET

Visit the Virtual Poster Gallery

11:15 AM - 11:30 AM ET

Break

11:30 AM - 12:45 PM ET

Panel Presentation: In IRBs We Trust? Building Trust Between IRBs and Researchers and Between IRBs Under Single IRB (sIRB)

12:45 PM - 1:15 PM ET

Mid-Day Break

12:45 PM - 1:15 PM ET

Supporter/Exhibitor Presentation from Advarra: Operational Data as a Communication Mechanism Between Research Administration and Research Teams

Sponsored By:

1:15 PM - 2:15 PM ET

W2A1 - Vaccine Research During a Global Pandemic: A Case Study of COVID-19

Pharma/Biotech Perspectives Track

1:15 PM - 2:15 PM ET

W2A2 - Single IRB (sIRB) Strategies to Streamline IRB and HRPP Review

Flexibility and Innovation in IRB Processes Track

1:15 PM - 2:15 PM ET

W2A3 - Implementing a Streamlined Process to Facilitate Physicians' Requests for Individual Patient Expanded Access Applications at an Academic Medical Center

FDA Regulated Research Track

1:15 PM - 2:15 PM ET

W2A4 - Evaluating the Quality and Effectiveness of HRPPs: Problems and New Approaches

Institutional Officials and HRPP Leadership Track

1:15 PM - 2:15 PM ET

W2A5 - Protecting Privacy in an Era of Shifting Requirements for Privacy and Concepts of Identifiability

Legal Considerations in HRPPs Track

1:15 PM - 2:15 PM ET

W2A6 - California Consumer Privacy Act (CCPA) and Emerging State Privacy Laws

Pharma/Biotech Perspectives Track

1:15 PM - 2:15 PM ET

W2A7 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior

Populations Requiring Additional Protections Track

1:15 PM - 2:15 PM ET

W2A8 - Remote Study Auditing and Monitoring Best Practices

QA/QI and Post-Approval Monitoring Track

1:15 PM - 2:15 PM ET

W2A9 - How to Maintain Institutional Memory at a Small Research Program

Small Research Programs Track

1:15 PM - 2:15 PM ET

W2A10 - Fundamental Issues in Qualitative Research

SBER Track

1:15 PM - 2:15 PM ET

W2A11 - A Dialogue With the DOD

A Dialogue With the Feds Track

1:15 PM - 2:15 PM ET

W2A12 - Dialogue With AAHRPP

A Dialogue With the Feds Track

1:15 PM - 2:15 PM ET

W2A13 - Getting IRB Review Right: Who Should Review a Study?

IRB Basics Track

2:15 PM - 2:30 PM ET

Break

2:30 PM - 3:00 PM ET

PRIM&R Membership Presentation

2:30 PM - 3:00 PM ET

PRIM&R’s Ethical Research Oversight Course (EROC) Demonstration

2:30 PM - 3:00 PM ET

Supporter/Exhibitor Presentation from iMedRIS: Beyond Boundaries--Collaborative Work With National and International Studies in a Rapidly Changing Research Environment

Sponsored By:

2:30 PM - 3:30 PM ET

I Love My Job!? Perspectives Throughout a Career in Human Research Protections

2:30 PM - 3:30 PM ET

The Certified IRB Professional (CIP®) Credential Presentation

2:30 PM - 3:30 PM ET

Virtual Roundtable: Ask the IRB Chairs!

2:30 PM - 3:30 PM ET

Virtual Roundtable: Racial Justice Working Group—Community-Based Participatory Research

2:30 PM - 5:00 PM ET

Federal Agency/Accrediting Body Office hours

2:30 PM - 5:30 PM ET

Workshop: Research With American Indian and Alaska Native (AI/AN) Tribes and Communities

3:00 PM - 4:30 PM ET

Visit the PRIM&R Booth

3:30 PM - 5:00 PM ET

CIP Office Hours

4:00 PM - 5:00 PM ET

Scientific Poster Panel: Outstanding Work

10:00 AM - 11:15 AM ET

Panel: Reworking Justice in Research: The Time Is Now

10:00 AM - 5:00 PM ET

Visit the Supporters/Exhibitors

10:00 AM - 5:00 PM ET

Visit the Virtual Poster Gallery

11:15 AM - 11:30 AM ET

Break

11:30 AM - 12:45 PM ET

Panel: Ethical and Regulatory Challenges in Adaptive and Platform Trials

12:45 PM - 1:15 PM ET

Supporter/Exhibitor Presentation from IRBNet: Adapting to the New Reality--Enhancing Human Research Protections and Managing Workflow and Compliance While Remaining Financially Responsible

Sponsored By:

1:15 PM - 2:15 PM ET

W2B1 - A Dialogue With OHRP

A Dialogue With the Feds Track

1:15 PM - 2:15 PM ET

W2B2 - Mobile Medical Applications and IRB Review

FDA Regulated Research Track

1:15 PM - 2:15 PM ET

W2B3 - Going Global for the First Time—Considerations for Reviewing International Research

Global Research Track

1:15 PM - 2:15 PM ET

W2B4 - Strategies that Promote Diversity and Inclusion in Clinical Research: What Role Does the IRB Play?

Hot Topics Track

1:15 PM - 2:15 PM ET

W2B5 - Unique Challenges of Being an IRB Chairperson at Medium to Small Institution

IRB Chairs Track

1:15 PM - 2:15 PM ET

W2B6 - Ensuring IRB Compliance in a Hybrid World—Strategies for Operating in a World Where Multiple Regulatory Frameworks Apply

IRB Operations Advanced Track

1:15 PM - 2:15 PM ET

W2B7 - Toolkit for HRPP Leaders: Tips for Overseeing a Human Research Protection Program

Leadership Track

1:15 PM - 2:15 PM ET

W2B8 - Improvements in the FDA Expanded Access Program Compared to Growing Demand for Right To Try Laws

Pharma/Biotech Perspectives Track

1:15 PM - 2:15 PM ET

W2B9 - Operationalizing Research Databases and Biobanks at Your Institution

Research Involving Data and Biospecimens Track

1:15 PM - 2:15 PM ET

W2B10 - Assessing the Ethics of Using Wearable Technologies to Facilitate Public Health Initiatives

Research Conducted in the Digital World Track

1:15 PM - 2:15 PM ET

W2B11 - Planning for Respondent Distress

Populations Requiring Additional Protections Track

1:15 PM - 2:15 PM ET

W2B12 - Ethics of Mandatory Research Biopsies in Clinical Trials

Research Involving Data and Biospecimens Track

2:15 PM - 2:30 PM ET

Break

2:30 PM - 3:30 PM ET

Human Subjects Trivia Game

2:30 PM - 3:30 PM ET

Virtual Roundtable: IRB Administrators Group—Challenges and Opportunities for IRB Administrators at Small to Mid-Size Research Programs

2:30 PM - 3:30 PM ET

Virtual Roundtable: SBER Professionals

2:30 PM - 5:00 PM ET

CIP Office Hours

2:30 PM - 5:00 PM ET

Federal Agency/Accrediting Body Office hours

2:30 PM - 5:30 PM ET

Workshop: Operational Solutions for Conducting Research During a National Emergency: What’s in Your Research Emergency Management Kit?

3:00 PM - 4:30 PM ET

Visit the PRIM&R Booth

4:00 PM - 5:00 PM ET

Programmatic Poster Panel: Outstanding Work

9:30 AM - 10:00 AM ET

Attendee Orientation

10:00 AM - 11:15 AM ET

Closing Remarks from PRIM&R's Executive Director, followed by Closing Keynote Address: Learning from Communities about Diversity and Justice

10:00 AM - 5:00 PM ET

Visit the Supporters/Exhibitors

10:00 AM - 5:00 PM ET

Visit the Virtual Poster Gallery

11:15 AM - 11:30 AM ET

Break

11:30 AM - 12:45 PM ET

Panel: Subjects Consenting Versus Consenting Subjects: The Ethics of Nudging People Toward Research Participation

12:45 PM - 1:15 PM ET

Mid-Day Break

12:45 PM - 1:15 PM ET

Supporter/Exhibitor Presentation from Cayuse: IRB Modernization at Kalispell Regional Medical Center

Sponsored By:

1:15 PM - 2:15 PM ET

W3A1 - A Dialogue With the NIH

A Dialogue With the Feds Track

1:15 PM - 2:15 PM ET

W3A2 - Strategies for IRB Member & Staff Education

Education and Training Track

1:15 PM - 2:15 PM ET

W3A3 - Consent Through a Wider Lens: Broadening the Scope of Ethical Review to Reflect the Realities of Research Decision-Making

Empirical Research Ethics Track

1:15 PM - 2:15 PM ET

W3A4 - Assessing Benefit and Risk in Pediatric Clinical Trials

FDA Regulated Research Track

1:15 PM - 2:15 PM ET

W3A5 - How to Investigate, Mitigate, Report, and Learn from Noncompliance: Avoiding Pitfalls and Seizing Opportunities for Improvement

Institutional Officials and HRPP Leadership Track

1:15 PM - 2:15 PM ET

W3A6 - Overturning Staff Turnover: Retaining Your Greatest Assets

Leadership Track

1:15 PM - 2:15 PM ET

W3A7 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design

Legal Considerations in HRPPs Track

1:15 PM - 2:15 PM ET

W3A8 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies

QA/QI and Post-Approval Monitoring Track

1:15 PM - 2:15 PM ET

W3A9 - Research With Mobile Health (mHealth) and Other Wearable Technologies: An Ethical Landmine and What to Do About It

Research Conducted in the Digital World Track

1:15 PM - 2:15 PM ET

W3A10 - Confidentiality, Privacy and Anonymity in SBER

SBER Track

1:15 PM - 2:15 PM ET

W3A11 - Research in K-12 Settings

SBER Track

1:15 PM - 2:15 PM ET

W3A12 - A Dialogue With the Department of Energy (DOE)

A Dialogue With the Feds Track

1:15 PM - 2:15 PM ET

W3A13 - A Dialogue With the Office of Research Integrity (ORI)

A Dialogue With the Feds Track

2:15 PM - 2:30 PM ET

Break

2:30 PM - 3:00 PM ET

PRIM&R Membership Presentation

2:30 PM - 3:00 PM ET

PRIM&R’s Ethical Research Oversight Course (EROC) Demonstration

2:30 PM - 3:30 PM ET

Team Consent Village

2:30 PM - 3:30 PM ET

The Certified IRB Professional (CIP®) Credential Presentation

2:30 PM - 3:30 PM ET

Virtual Roundtable: IRB Administrators Group—Remote Training and Networking

2:30 PM - 3:30 PM ET

Virtual Roundtable: Racial Justice Working Group—Diversity, Equity, and Inclusion in your Research Compliance Program

2:30 PM - 5:00 PM ET

CIP Office Hours

2:30 PM - 5:00 PM ET

Federal Agency/Accrediting Body Office hours

2:30 PM - 5:30 PM ET

Workshop: Keeping Data Private, Secure, and Confidential: New International Privacy Regulations and Their Impact on Research

3:00 PM - 4:30 PM ET

Visit the PRIM&R Booth

4:00 PM - 5:00 PM ET

Scientific Poster Panel: Outstanding Work

10:00 AM - 11:15 AM ET

Panel: The Ethics and Methods of Conducting Digital Phenotyping Research

10:00 AM - 5:00 PM ET

Visit the Supporters/Exhibitors

10:00 AM - 5:00 PM ET

Visit the Virtual Poster Gallery

11:15 AM - 11:30 AM ET

Break

11:30 AM - 12:45 PM ET

Panel: Challenges in Decision Making in Global Adolescent Clinical Research

12:45 PM - 1:15 PM ET

Mid-Day Break

12:45 PM - 1:15 PM ET

Supporter/Exhibitor Presentation from Axiom Mentor: Increase IRB Efficiency to Save Money

Sponsored By:

1:15 PM - 2:15 PM ET

W3B1 - Not Your Grandfather's Electronic Informed Consent (eConsent): An Interactive Tool to Enhance Informed Consent

Flexibility and Innovation in IRB Processes Track

1:15 PM - 2:15 PM ET

W3B2 - A Conversation With All of Us: Considerations for a Diverse Cohort at a National Scale

Hot Topics Track

1:15 PM - 2:15 PM ET

W3B3 - IRB Chairs Forum: A structured Discussion for IRB Chairs

IRB Chairs Track

1:15 PM - 2:15 PM ET

W3B4 - Advanced Considerations for Serving as a Reviewing IRB

IRB Operations Advanced Track

1:15 PM - 2:15 PM ET

W3B5 - Making Metrics Meaningful: How HRPPs can Efficiently and Effectively Use Their Data

IRB Operations Advanced Track

1:15 PM - 2:15 PM ET

W3B6 - Effectively Managing Teams and Meetings in a Remote Environment

Leadership Track

1:15 PM - 2:15 PM ET

W3B7 - Ethical Issues in Complex Trial Design

Pharma/Biotech Perspectives Track

1:15 PM - 2:15 PM ET

W3B8 - Advancing Ethical Research in Pregnancy: Subpart B, FDA Guidance, and the Example of HIV Research

Populations Requiring Additional Protections Track

1:15 PM - 2:15 PM ET

W3B9 - Research Using Artificial Intelligence (AI): Regulatory and Privacy Implications and Protections

Research Conducted in the Digital World Track

1:15 PM - 2:15 PM ET

W3B10 - Operationalizing Data Sharing Policies: Challenges and Solutions

Research Involving Data and Biospecimens Track

1:15 PM - 2:15 PM ET

W3B11 - Complex Conflict of Interest (COI): Understanding the COI Landscape

Legal Considerations in HRPPs Track

1:15 PM - 2:15 PM ET

W3B12 - Planned Emergency Research

Hot Topics Track

2:15 PM - 2:30 PM ET

Break

2:30 PM - 3:30 PM ET

PRIM&R’s Guide to Speaking at the AER Conference

2:30 PM - 3:30 PM ET

Virtual Roundtable: COVID-19’s Impact on the Field—Prioritization of Research of Studies During the COVID-19 Pandemic

2:30 PM - 3:30 PM ET

Virtual Roundtable: What’s New in QA/QI—Approaches to Novel Research Situations

2:30 PM - 5:00 PM ET

Federal Agency/Accrediting Body Office hours

2:30 PM - 5:30 PM ET

Workshop: Exploring Hot Topics in SBER

3:00 PM - 4:30 PM ET

Visit the PRIM&R Booth

3:30 PM - 5:00 PM ET

CIP Office Hours

4:00 PM - 5:00 PM ET

Programmatic Poster Panel: Outstanding Work