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Tweets by 2020 Advancing Ethical Research Virtual Conference
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Clinical Research Staff
Tuesday, Dec 1
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Jada Bussey-Jones, MD, FACP – Emory University; Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A6 - Human Challenge Trials (HCTs) for COVID-19: What IRBs Should Know
Location: Live
Seema K. Shah, J.D. – NIH Clinical Center; Luke Gelinas, PhD – Advarra; Jerry A. Menikoff, MD, JD – Office for Human Research Protections; Richard Gorman – Biodefense Advanced Research and Development Authority
Pharma/Biotech Perspectives Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A7 - Navigating Uncertainty: Research With Undocumented Immigrants and Refugees
Location: Live
Maysa Al-Hussaini, MD FRCPath CIP – King Hussein Cancer Center; Colleen Kohashi, MA, CIP – UC Berkeley; Melissa McGee, J.D. – University of New Hampshire; Julia G. Gorey, JD – OHRP
Populations Requiring Additional Protections Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A8 - Assessing and Addressing the Ethical, Regulatory, and Governance Challenges of Networking Biorepositories
Location: Live
Aaron J. Goldenberg, PhD, MA, MPH – Case Western Reserve University; A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6; Kyle B. Brothers, MD, PhD – University of Louisville; Julie Kaneshiro, MA – Office for Human Research Protections
Research Involving Data and Biospecimens Track
Tuesday, Dec 1
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
Location: Live
Nancy M.P King, JD – Wake Forest School of Medicine; Jonathan Moreno, PhD – University of Pennsylvania
Sponsored By:
Tuesday, Dec 1
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—IRB’s Role in Racial Bias
Location: Live
Eric Allen, MA, CIP, CPIA – University of South Florida; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Danielle A. Griffin, Ed.D., CIP – University of Houston
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Adaptable QA/QI Audit Approaches: How to Adjust Without Compromising Quality
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Eunice Yim Newbert, MPH – Boston Children's Hospital
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Introduction to the IRB: Ethics and Regulation
Location: Live
Ada Sue Selwitz, MA – University of Kentucky; David H. Strauss, MD – Columbia University; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Wednesday, Dec 2
10:00 AM – 11:15 AM ET
Panel: Scientific and Ethical Challenges of COVID-19 Prevention Trials in a Complex Sociopolitical Context
Location: Live
Nancy E. Kass, ScD – The Johns Hopkins University; E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO); Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada; Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B1 - A Dialogue With FDA
Location: Live
Bridget Foltz – FDA; Joanne R. Less, PhD – US Food and Drug Administration; Laurie Muldowney, MD – FDA; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Minerva Hughes, JD, PhD – FDA; Diane M. Maloney, JD – Food and Drug Administration
A Dialogue With the Feds Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B4 - Shaping Your Clinical Research Culture
Location: Live
Edye Edens, JD, MA, CIP, CCRP – First Class Solutions, Inc.; Daniel A. Perez, BS, CCRP – MACRO Trials
Leadership Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B6 - Research with Children: Ethical Considerations, Parental Permission, and Assent
Location: Live
Ran Goldman, MD – University of British Columbia; Mary Cataletto, MD – NYU Long Island School of Medicine; Casey Mumaw, MA, CIP – Indiana University; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Populations Requiring Additional Protections Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B8 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: Live
Danielle A. Griffin, Ed.D., CIP – University of Houston; Lorraine R. Reitzel, PhD, FAAHB, FSRNT – University of Houston
Research Conducted in the Digital World Track
Wednesday, Dec 2
2:30 PM – 5:30 PM ET
Workshop: Achieving Excellence in Research: Moving from Diversity and Inclusion to Equity and Justice
Location: Live
Quincy J. Byrdsong, EdD, CIP, CCRP – Lipscomb University; Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A1 - Vaccine Research During a Global Pandemic: A Case Study of COVID-19
Location: Live
Karla Childers, MSJ – Johnson & Johnson; Walter L. Straus, MD, MPH – Merck Co., Inc.
Pharma/Biotech Perspectives Track
Tuesday, Dec 8
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
Location: Live
Ryan Lowry, CIP – University of Colorado, Anschutz Medical Campus; Erin McDonagh, CCRP – University of Colorado Denver, Anschutz Medical Campus; Lori Bickel – CDER, FDA
FDA Regulated Research Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A5 - Protecting Privacy in an Era of Shifting Requirements for Privacy and Concepts of Identifiability
Location: Live
Alexa Limeres, JD – Centers for Disease Control and Prevention; Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Christine Suver, PhD, PMP – Sage Bionetworks
Legal Considerations in HRPPs Track
Tuesday, Dec 8
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Community-Based Participatory Research
Location: Live
Kelsie D. Kelly, PhD, MPH – University of Virginia School of Medicine; Jeanita Richardson, PhD, MEd – University of Virginia
Tuesday, Dec 8
2:30 PM – 5:30 PM ET
Workshop: Research With American Indian and Alaska Native (AI/AN) Tribes and Communities
Location: Live
Francine C. Gachupin, PhD, MPH – University of Arizona; Dakotah C. Lane, MD – Lummi Tribal Health Center; Elizabeth J. Coronado, JD – Lummi Nation; William L. Freeman, MD, MPH, CIP – Northwest Indian College
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B2 - Mobile Medical Applications and IRB Review
Location: Live
James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bakul Patel, MSEE, MBA – Center for Devices and Radiological Health (CDRH) Food and Drug Administration
FDA Regulated Research Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B4 - Strategies that Promote Diversity and Inclusion in Clinical Research: What Role Does the IRB Play?
Location: Live
Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; David H. Strauss, MD – Columbia University; Tesheia Johnson, MBA, MHS – Yale University; Laura Meloney, MS, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital/Harvard Medical School
Hot Topics Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B8 - Improvements in the FDA Expanded Access Program Compared to Growing Demand for Right To Try Laws
Location: Live
Paul Papagni, JD, CIP – Holy Cross Hospital/Trinity Health; Carolyn Riley Chapman, PhD MS – NYU Langone Health; Richard Klein – GE2P2 Global
Pharma/Biotech Perspectives Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B10 - Assessing the Ethics of Using Wearable Technologies to Facilitate Public Health Initiatives
Location: Live
Kayte Spector-Bagdady, JD, M Bioethics – University of Michigan Medical School; Dena B. Mendelsohn, JD, MPH – Elektra Labs
Research Conducted in the Digital World Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B11 - Planning for Respondent Distress
Location: Pre-recorded
Sharon Zack, MS – Westat; Kerry Y. Levin, PhD – Westat; Mihiri Silva – Westat
Populations Requiring Additional Protections Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B12 - Ethics of Mandatory Research Biopsies in Clinical Trials
Location: Pre-recorded
Laura Levit, JD – American Society of Clinical Oncology; Mark J. Ratain, MD – University of Chicago Medicine; Jennifer J. Gao, MD – Oncology Center of Excellence, U.S. Food and Drug Administration; Julie Kaneshiro, MA – Office for Human Research Protections
Research Involving Data and Biospecimens Track
Wednesday, Dec 9
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?
Location: Live
Martha Jones, MA, CIP – Mass General Brigham; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Bruce G. Gordon, MD – University of Nebraska Medical Center; Stephanie Henderson; Brenda Ruotolo, CIP – Columbia University in the City of New York; Sujatha Sridhar, MBBS, MCE – The University of Texas Health Science Center at Houston; Lauren Sauer, MS – Johns Hopkins University
Tuesday, Dec 15
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Wylie Burke, MD, PhD – University of Washington, Department of Bioethics and Humanities; Albert J. Allen, MD, PhD – Eli Lilly and Company
Tuesday, Dec 15
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
Location: Live
Stephanie A. Kraft, JD – Seattle Children’s Hospital and Research Institute; Stephanie S. Cargill, PhD MSPH – Saint Louis University
Empirical Research Ethics Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A4 - Assessing Benefit and Risk in Pediatric Clinical Trials
Location: Live
Kathryn Blake, PharmD, BCPS, FCCP – Nemours Children's Health System; Donna L. Snyder, MD, MBE – Food and Drug Administration; Richard Gorman – Biodefense Advanced Research and Development Authority
FDA Regulated Research Track
Tuesday, Dec 15
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
Location: Live
Aisha Langford, MPH, PhD – NYU Langone Health; Jerry A. Menikoff, MD, JD – Office for Human Research Protections; Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems
Legal Considerations in HRPPs Track
Tuesday, Dec 15
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
Location: Live
Megan Doerr, MS, LGC – Sage Bionetworks; Sara Meeder, CIP – Maimonides Medical Center; Vanessa Barone, MPH – Sage Bionetworks
Research Conducted in the Digital World Track
Tuesday, Dec 15
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Diversity, Equity, and Inclusion in your Research Compliance Program
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Robert E. Nobles, II, DrPH, MPH, CIP – Emory University; Iris L. Jenkins, PhD – University of Massachusetts Amherst
Tuesday, Dec 15
2:30 PM – 5:30 PM ET
Workshop: Keeping Data Private, Secure, and Confidential: New International Privacy Regulations and Their Impact on Research
Location: Live
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; John R. Baumann, PhD – Indiana University; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bethany Johnson, JD, CIP – Indiana University
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B1 - Not Your Grandfather's Electronic Informed Consent (eConsent): An Interactive Tool to Enhance Informed Consent
Location: Live
Christine Suver, PhD, PMP – Sage Bionetworks; Nichelle Cobb, PhD – University of Wisconsin-Madison
Flexibility and Innovation in IRB Processes Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B2 - A Conversation With All of Us: Considerations for a Diverse Cohort at a National Scale
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Katherine D. Blizinsky, PhD – National Institutes of Health; Ericka Thomas, M.S. – All of Us Research Program/National Institutes of Health; Ysabel Duron, BA – The Latino Cancer Institute
Hot Topics Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B7 - Ethical Issues in Complex Trial Design
Location: Live
Marianne Kearney Chase – MGH; Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Pharma/Biotech Perspectives Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B9 - Research Using Artificial Intelligence (AI): Regulatory and Privacy Implications and Protections
Location: Live
Sara R. Jordan, PhD – Future of Privacy Forum; Rachele Hendricks-Sturrup, DHSc, MSc, MA – Future of Privacy Forum
Research Conducted in the Digital World Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B12 - Planned Emergency Research
Location: Pre-recorded
Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine; Michele Russell-Einhorn, JD – Advarra; Robert Silbergleit, MD – University of Michigan; Luke Gelinas, PhD – Advarra
Hot Topics Track
Compliance, Regulatory, and QA/QI Professionals
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A3 - Bioresearch Monitoring (BIMO) Inspections—Regulatory Violations Observed in IRB, Clinical Investigator, and Sponsor-Investigator Inspections
Location: Live
Jan L. Hewett, BSN, JD – Food & Drug Administration; Deborah Barnard, MS – University of Colorado Denver
FDA Regulated Research Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A4 - Are Hospital Based IRBs Ready for the Endangered Species List
Location: Live
Scott J. Lipkin, DPM, CIP – Miami Cancer Institute; Baptist Health South Florida; Liz Michaels, MS, CIP – Meriter Hospital; Cheryl L. Byers, MHA, CIP, CHRC – Advarra
Institutional Officials and HRPP Leadership Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A6 - Human Challenge Trials (HCTs) for COVID-19: What IRBs Should Know
Location: Live
Seema K. Shah, J.D. – NIH Clinical Center; Luke Gelinas, PhD – Advarra; Jerry A. Menikoff, MD, JD – Office for Human Research Protections; Richard Gorman – Biodefense Advanced Research and Development Authority
Pharma/Biotech Perspectives Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A8 - Assessing and Addressing the Ethical, Regulatory, and Governance Challenges of Networking Biorepositories
Location: Live
Aaron J. Goldenberg, PhD, MA, MPH – Case Western Reserve University; A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6; Kyle B. Brothers, MD, PhD – University of Louisville; Julie Kaneshiro, MA – Office for Human Research Protections
Research Involving Data and Biospecimens Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A9 - Beyond the Regulations: How to Effectively and Efficiently Manage Research Misconduct Cases
Location: Live
Kele Piper, CHRC, CIP, MS – Massachusetts General Hospital; Monika S. Markowitz, PhD – Virginia Commonwealth University
Responsible Conduct of Research Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A12 - Nuts and Bolts of Assessing IRB Compliance
Location: Pre-recorded
Keren R. Dunn, CIP – Cedars-Sinai Medical Center; Heather Savage, CIP – University of New Mexico; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
QA/QI and Post-Approval Monitoring Track
Tuesday, Dec 1
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
Location: Live
Nancy M.P King, JD – Wake Forest School of Medicine; Jonathan Moreno, PhD – University of Pennsylvania
Sponsored By:
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Adaptable QA/QI Audit Approaches: How to Adjust Without Compromising Quality
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Eunice Yim Newbert, MPH – Boston Children's Hospital
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B1 - A Dialogue With FDA
Location: Live
Bridget Foltz – FDA; Joanne R. Less, PhD – US Food and Drug Administration; Laurie Muldowney, MD – FDA; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Minerva Hughes, JD, PhD – FDA; Diane M. Maloney, JD – Food and Drug Administration
A Dialogue With the Feds Track
Wednesday, Dec 2
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
Location: Live
Michele Russell-Einhorn, JD – Advarra; Jason M. Malone, MPA, CIP – University of Washington; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
QA/QI and Post-Approval Monitoring Track
Tuesday, Dec 8
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
Location: Live
Ryan Lowry, CIP – University of Colorado, Anschutz Medical Campus; Erin McDonagh, CCRP – University of Colorado Denver, Anschutz Medical Campus; Lori Bickel – CDER, FDA
FDA Regulated Research Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A4 - Evaluating the Quality and Effectiveness of HRPPs: Problems and New Approaches
Location: Live
Holly A. Taylor, PhD, MPH – National Institutes of Health; Holly Fernandez Lynch, JD, MBe – Perelman School of Medicine, University of Pennsylvania; Richard James – University of Pennsylvania Biomedical Library
Institutional Officials and HRPP Leadership Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A6 - California Consumer Privacy Act (CCPA) and Emerging State Privacy Laws
Location: Live
David Peloquin, JD – Ropes & Gray
Pharma/Biotech Perspectives Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A8 - Remote Study Auditing and Monitoring Best Practices
Location: Live
Stephanie deRijke, RN, MSN – Emory University; Caren Frost, PhD, MPH – University of Utah
QA/QI and Post-Approval Monitoring Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B1 - A Dialogue With OHRP
Location: Live
Julie Kaneshiro, MA – Office for Human Research Protections; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Ivor A. Pritchard, PhD – OHRP; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP); Amanda P. Sly, MS, CIP – OHRP; Paul Lees – OHRP; Crystal Kelly, MPH – Office for Human Research Protections (OHRP)
A Dialogue With the Feds Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B2 - Mobile Medical Applications and IRB Review
Location: Live
James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bakul Patel, MSEE, MBA – Center for Devices and Radiological Health (CDRH) Food and Drug Administration
FDA Regulated Research Track
Wednesday, Dec 9
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
Location: Live
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Dena Johnson, M.Ed., CIP, CCRP – Vanderbilt University Medical Center; Joshua Fedewa, MS, CIP – University of Texas Southwestern Medical Center
IRB Operations Advanced Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B8 - Improvements in the FDA Expanded Access Program Compared to Growing Demand for Right To Try Laws
Location: Live
Paul Papagni, JD, CIP – Holy Cross Hospital/Trinity Health; Carolyn Riley Chapman, PhD MS – NYU Langone Health; Richard Klein – GE2P2 Global
Pharma/Biotech Perspectives Track
Wednesday, Dec 9
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?
Location: Live
Martha Jones, MA, CIP – Mass General Brigham; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Bruce G. Gordon, MD – University of Nebraska Medical Center; Stephanie Henderson; Brenda Ruotolo, CIP – Columbia University in the City of New York; Sujatha Sridhar, MBBS, MCE – The University of Texas Health Science Center at Houston; Lauren Sauer, MS – Johns Hopkins University
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A1 - A Dialogue With the NIH
Location: Live
Carrie D. Wolinetz, PhD – National Institutes of Health
A Dialogue With the Feds Track
Tuesday, Dec 15
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
Location: Live
Aisha Langford, MPH, PhD – NYU Langone Health; Jerry A. Menikoff, MD, JD – Office for Human Research Protections; Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems
Legal Considerations in HRPPs Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A8 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Live
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala J. Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
QA/QI and Post-Approval Monitoring Track
Tuesday, Dec 15
2:30 PM – 5:30 PM ET
Workshop: Keeping Data Private, Secure, and Confidential: New International Privacy Regulations and Their Impact on Research
Location: Live
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; John R. Baumann, PhD – Indiana University; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bethany Johnson, JD, CIP – Indiana University
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B1 - Not Your Grandfather's Electronic Informed Consent (eConsent): An Interactive Tool to Enhance Informed Consent
Location: Live
Christine Suver, PhD, PMP – Sage Bionetworks; Nichelle Cobb, PhD – University of Wisconsin-Madison
Flexibility and Innovation in IRB Processes Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B2 - A Conversation With All of Us: Considerations for a Diverse Cohort at a National Scale
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Katherine D. Blizinsky, PhD – National Institutes of Health; Ericka Thomas, M.S. – All of Us Research Program/National Institutes of Health; Ysabel Duron, BA – The Latino Cancer Institute
Hot Topics Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B8 - Advancing Ethical Research in Pregnancy: Subpart B, FDA Guidance, and the Example of HIV Research
Location: Live
Kristen Sullivan, PhD, MSW, MBA, MA – University of North Carolina at Chapel Hill; Maggie Little, BPhil, PhD – Kennedy Institute of Ethics, Georgetown University; Anne D. Lyerly, MD, MA – University of North Carolina at Chapel Hill
Populations Requiring Additional Protections Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B9 - Research Using Artificial Intelligence (AI): Regulatory and Privacy Implications and Protections
Location: Live
Sara R. Jordan, PhD – Future of Privacy Forum; Rachele Hendricks-Sturrup, DHSc, MSc, MA – Future of Privacy Forum
Research Conducted in the Digital World Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B12 - Planned Emergency Research
Location: Pre-recorded
Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine; Michele Russell-Einhorn, JD – Advarra; Robert Silbergleit, MD – University of Michigan; Luke Gelinas, PhD – Advarra
Hot Topics Track
Diversity, Equity, and Inclusion
Tuesday, Dec 1
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Jada Bussey-Jones, MD, FACP – Emory University; Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A7 - Navigating Uncertainty: Research With Undocumented Immigrants and Refugees
Location: Live
Maysa Al-Hussaini, MD FRCPath CIP – King Hussein Cancer Center; Colleen Kohashi, MA, CIP – UC Berkeley; Melissa McGee, J.D. – University of New Hampshire; Julia G. Gorey, JD – OHRP
Populations Requiring Additional Protections Track
Tuesday, Dec 1
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—IRB’s Role in Racial Bias
Location: Live
Eric Allen, MA, CIP, CPIA – University of South Florida; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Danielle A. Griffin, Ed.D., CIP – University of Houston
Wednesday, Dec 2
10:00 AM – 11:15 AM ET
Panel: Scientific and Ethical Challenges of COVID-19 Prevention Trials in a Complex Sociopolitical Context
Location: Live
Nancy E. Kass, ScD – The Johns Hopkins University; E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO); Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada; Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B4 - Shaping Your Clinical Research Culture
Location: Live
Edye Edens, JD, MA, CIP, CCRP – First Class Solutions, Inc.; Daniel A. Perez, BS, CCRP – MACRO Trials
Leadership Track
Wednesday, Dec 2
2:30 PM – 5:30 PM ET
Workshop: Achieving Excellence in Research: Moving from Diversity and Inclusion to Equity and Justice
Location: Live
Quincy J. Byrdsong, EdD, CIP, CCRP – Lipscomb University; Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A1 - Vaccine Research During a Global Pandemic: A Case Study of COVID-19
Location: Live
Karla Childers, MSJ – Johnson & Johnson; Walter L. Straus, MD, MPH – Merck Co., Inc.
Pharma/Biotech Perspectives Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A7 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Live
Katie B. Speanburg, EdM – Abt Associates, Inc.; Jonathan Hill-Rorie, MPH – The Fenway Institute; Laura Bitterman, MSN, AGPCNP-BC – Department of Veterans Affairs
Populations Requiring Additional Protections Track
Tuesday, Dec 8
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Community-Based Participatory Research
Location: Live
Kelsie D. Kelly, PhD, MPH – University of Virginia School of Medicine; Jeanita Richardson, PhD, MEd – University of Virginia
Tuesday, Dec 8
2:30 PM – 5:30 PM ET
Workshop: Research With American Indian and Alaska Native (AI/AN) Tribes and Communities
Location: Live
Francine C. Gachupin, PhD, MPH – University of Arizona; Dakotah C. Lane, MD – Lummi Tribal Health Center; Elizabeth J. Coronado, JD – Lummi Nation; William L. Freeman, MD, MPH, CIP – Northwest Indian College
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B3 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Live
Delia Wolf Christiani, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health; Robert Hood – AAHRPP, Inc.; Amal S. H Al Omari, MS, PhD – King Hussein Cancer Center
Global Research Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B4 - Strategies that Promote Diversity and Inclusion in Clinical Research: What Role Does the IRB Play?
Location: Live
Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; David H. Strauss, MD – Columbia University; Tesheia Johnson, MBA, MHS – Yale University; Laura Meloney, MS, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital/Harvard Medical School
Hot Topics Track
Tuesday, Dec 15
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Wylie Burke, MD, PhD – University of Washington, Department of Bioethics and Humanities; Albert J. Allen, MD, PhD – Eli Lilly and Company
Tuesday, Dec 15
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Diversity, Equity, and Inclusion in your Research Compliance Program
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Robert E. Nobles, II, DrPH, MPH, CIP – Emory University; Iris L. Jenkins, PhD – University of Massachusetts Amherst
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B2 - A Conversation With All of Us: Considerations for a Diverse Cohort at a National Scale
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Katherine D. Blizinsky, PhD – National Institutes of Health; Ericka Thomas, M.S. – All of Us Research Program/National Institutes of Health; Ysabel Duron, BA – The Latino Cancer Institute
Hot Topics Track
HRPP Educators
Tuesday, Dec 1
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Jada Bussey-Jones, MD, FACP – Emory University; Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A1 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Members
Location: Live
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – University of Nebraska Medical Center; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Education and Training Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A13 - How Might Ethics Review be Reimagined in the Age of DIY and Open Science?
Location: Pre-recorded
Sarah B. Ware, PhD – BioBlaze Community Bio Lab; Camille Nebeker, EdD, MS – University of California, San Diego, Herbert Wertheim School of Public Health; Martin Codyre, BEng, MS – Giantleap Biotechnology
Research Conducted in the Digital World Track
Tuesday, Dec 1
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
Location: Live
Nancy M.P King, JD – Wake Forest School of Medicine; Jonathan Moreno, PhD – University of Pennsylvania
Sponsored By:
Tuesday, Dec 1
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—IRB’s Role in Racial Bias
Location: Live
Eric Allen, MA, CIP, CPIA – University of South Florida; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Danielle A. Griffin, Ed.D., CIP – University of Houston
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Adaptable QA/QI Audit Approaches: How to Adjust Without Compromising Quality
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Eunice Yim Newbert, MPH – Boston Children's Hospital
Wednesday, Dec 2
10:00 AM – 11:15 AM ET
Panel: Scientific and Ethical Challenges of COVID-19 Prevention Trials in a Complex Sociopolitical Context
Location: Live
Nancy E. Kass, ScD – The Johns Hopkins University; E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO); Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada; Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Wednesday, Dec 2
2:30 PM – 5:30 PM ET
Workshop: Achieving Excellence in Research: Moving from Diversity and Inclusion to Equity and Justice
Location: Live
Quincy J. Byrdsong, EdD, CIP, CCRP – Lipscomb University; Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A1 - Vaccine Research During a Global Pandemic: A Case Study of COVID-19
Location: Live
Karla Childers, MSJ – Johnson & Johnson; Walter L. Straus, MD, MPH – Merck Co., Inc.
Pharma/Biotech Perspectives Track
Tuesday, Dec 8
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Community-Based Participatory Research
Location: Live
Kelsie D. Kelly, PhD, MPH – University of Virginia School of Medicine; Jeanita Richardson, PhD, MEd – University of Virginia
Tuesday, Dec 8
2:30 PM – 5:30 PM ET
Workshop: Research With American Indian and Alaska Native (AI/AN) Tribes and Communities
Location: Live
Francine C. Gachupin, PhD, MPH – University of Arizona; Dakotah C. Lane, MD – Lummi Tribal Health Center; Elizabeth J. Coronado, JD – Lummi Nation; William L. Freeman, MD, MPH, CIP – Northwest Indian College
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B4 - Strategies that Promote Diversity and Inclusion in Clinical Research: What Role Does the IRB Play?
Location: Live
Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; David H. Strauss, MD – Columbia University; Tesheia Johnson, MBA, MHS – Yale University; Laura Meloney, MS, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital/Harvard Medical School
Hot Topics Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B7 - Toolkit for HRPP Leaders: Tips for Overseeing a Human Research Protection Program
Location: Live
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Leadership Track
Wednesday, Dec 9
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?
Location: Live
Martha Jones, MA, CIP – Mass General Brigham; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Bruce G. Gordon, MD – University of Nebraska Medical Center; Stephanie Henderson; Brenda Ruotolo, CIP – Columbia University in the City of New York; Sujatha Sridhar, MBBS, MCE – The University of Texas Health Science Center at Houston; Lauren Sauer, MS – Johns Hopkins University
Tuesday, Dec 15
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Wylie Burke, MD, PhD – University of Washington, Department of Bioethics and Humanities; Albert J. Allen, MD, PhD – Eli Lilly and Company
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A2 - Strategies for IRB Member & Staff Education
Location: Live
Charlotte H. Coley, MACT, CIP – University of North Carolina, Chapel Hill; David A. Borasky, Jr., MPH, CIP – WCG; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Education and Training Track
Tuesday, Dec 15
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
Location: Live
Aisha Langford, MPH, PhD – NYU Langone Health; Jerry A. Menikoff, MD, JD – Office for Human Research Protections; Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems
Legal Considerations in HRPPs Track
Tuesday, Dec 15
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Diversity, Equity, and Inclusion in your Research Compliance Program
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Robert E. Nobles, II, DrPH, MPH, CIP – Emory University; Iris L. Jenkins, PhD – University of Massachusetts Amherst
Tuesday, Dec 15
2:30 PM – 5:30 PM ET
Workshop: Keeping Data Private, Secure, and Confidential: New International Privacy Regulations and Their Impact on Research
Location: Live
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; John R. Baumann, PhD – Indiana University; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bethany Johnson, JD, CIP – Indiana University
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B1 - Not Your Grandfather's Electronic Informed Consent (eConsent): An Interactive Tool to Enhance Informed Consent
Location: Live
Christine Suver, PhD, PMP – Sage Bionetworks; Nichelle Cobb, PhD – University of Wisconsin-Madison
Flexibility and Innovation in IRB Processes Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B2 - A Conversation With All of Us: Considerations for a Diverse Cohort at a National Scale
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Katherine D. Blizinsky, PhD – National Institutes of Health; Ericka Thomas, M.S. – All of Us Research Program/National Institutes of Health; Ysabel Duron, BA – The Latino Cancer Institute
Hot Topics Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B5 - Making Metrics Meaningful: How HRPPs can Efficiently and Effectively Use Their Data
Location: Live
Kimberley Serpico, MEd, CIP, EdD Candidate – Harvard T.H. Chan School of Public Health; Joshua Fedewa, MS, CIP – University of Texas Southwestern Medical Center
IRB Operations Advanced Track
HRPP Leadership and Institutional Officials
Tuesday, Dec 1
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Jada Bussey-Jones, MD, FACP – Emory University; Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A2 - Distinguishing Public Health Surveillance from Public Health Research
Location: Live
Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention; Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Flexibility and Innovation in IRB Processes Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A4 - Are Hospital Based IRBs Ready for the Endangered Species List
Location: Live
Scott J. Lipkin, DPM, CIP – Miami Cancer Institute; Baptist Health South Florida; Liz Michaels, MS, CIP – Meriter Hospital; Cheryl L. Byers, MHA, CIP, CHRC – Advarra
Institutional Officials and HRPP Leadership Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A5 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Live
John Heldens, RAC, CIP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
IRB Operations Advanced Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A7 - Navigating Uncertainty: Research With Undocumented Immigrants and Refugees
Location: Live
Maysa Al-Hussaini, MD FRCPath CIP – King Hussein Cancer Center; Colleen Kohashi, MA, CIP – UC Berkeley; Melissa McGee, J.D. – University of New Hampshire; Julia G. Gorey, JD – OHRP
Populations Requiring Additional Protections Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A8 - Assessing and Addressing the Ethical, Regulatory, and Governance Challenges of Networking Biorepositories
Location: Live
Aaron J. Goldenberg, PhD, MA, MPH – Case Western Reserve University; A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6; Kyle B. Brothers, MD, PhD – University of Louisville; Julie Kaneshiro, MA – Office for Human Research Protections
Research Involving Data and Biospecimens Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A9 - Beyond the Regulations: How to Effectively and Efficiently Manage Research Misconduct Cases
Location: Live
Kele Piper, CHRC, CIP, MS – Massachusetts General Hospital; Monika S. Markowitz, PhD – Virginia Commonwealth University
Responsible Conduct of Research Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A10 - Exempt or Not? Don't Get Psyched Out by the Benign Behavioral Intervention Research Exemption
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Elicia Preslan, MS, CIP – Virginia Commonwealth University; Michelle C. Stickler, DEd, CIP – The University of Texas at Austin; Ivor A. Pritchard, PhD – OHRP
SBER Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A12 - Nuts and Bolts of Assessing IRB Compliance
Location: Pre-recorded
Keren R. Dunn, CIP – Cedars-Sinai Medical Center; Heather Savage, CIP – University of New Mexico; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
QA/QI and Post-Approval Monitoring Track
Tuesday, Dec 1
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
Location: Live
Nancy M.P King, JD – Wake Forest School of Medicine; Jonathan Moreno, PhD – University of Pennsylvania
Sponsored By:
Tuesday, Dec 1
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—IRB’s Role in Racial Bias
Location: Live
Eric Allen, MA, CIP, CPIA – University of South Florida; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Danielle A. Griffin, Ed.D., CIP – University of Houston
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Adaptable QA/QI Audit Approaches: How to Adjust Without Compromising Quality
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Eunice Yim Newbert, MPH – Boston Children's Hospital
Wednesday, Dec 2
10:00 AM – 11:15 AM ET
Panel: Scientific and Ethical Challenges of COVID-19 Prevention Trials in a Complex Sociopolitical Context
Location: Live
Nancy E. Kass, ScD – The Johns Hopkins University; E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO); Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada; Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B1 - A Dialogue With FDA
Location: Live
Bridget Foltz – FDA; Joanne R. Less, PhD – US Food and Drug Administration; Laurie Muldowney, MD – FDA; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Minerva Hughes, JD, PhD – FDA; Diane M. Maloney, JD – Food and Drug Administration
A Dialogue With the Feds Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B2 - How Do Ancillary Review Committees Strengthen Our HRPPs?
Location: Live
Linnea A. Anderson, BA, CIP – University of Minnesota; Kimberly K. Summers, PharmD – University of Texas Health San Antonio; Suzanne Stone, MA, CIP – UC Berkeley
Institutional Officials and HRPP Leadership Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B4 - Shaping Your Clinical Research Culture
Location: Live
Edye Edens, JD, MA, CIP, CCRP – First Class Solutions, Inc.; Daniel A. Perez, BS, CCRP – MACRO Trials
Leadership Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B5 - Navigating State Law Differences in the Era of Single IRB (sIRB) Review
Location: Live
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Legal Considerations in HRPPs Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B6 - Research with Children: Ethical Considerations, Parental Permission, and Assent
Location: Live
Ran Goldman, MD – University of British Columbia; Mary Cataletto, MD – NYU Long Island School of Medicine; Casey Mumaw, MA, CIP – Indiana University; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Populations Requiring Additional Protections Track
Wednesday, Dec 2
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
Location: Live
Michele Russell-Einhorn, JD – Advarra; Jason M. Malone, MPA, CIP – University of Washington; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
QA/QI and Post-Approval Monitoring Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B8 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: Live
Danielle A. Griffin, Ed.D., CIP – University of Houston; Lorraine R. Reitzel, PhD, FAAHB, FSRNT – University of Houston
Research Conducted in the Digital World Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B9 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Live
John C. Smith, MSW, CIM, CIP – Morehouse School of Medicine; Elizabeth Carroll, MPH, CIP – Adventist Healthcare, Inc.
Small Research Programs Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B10 - College Students and Research: Challenges and Issues for IRBs
Location: Live
Julie F. Simpson, PhD – University of New Hampshire; Andrea R. McDowell, PhD – Seattle University; Ivor A. Pritchard, PhD – OHRP
SBER Track
Wednesday, Dec 2
2:30 PM – 3:30 PM ET
SBER Network Discussion
Location: Live
Cecilia Brooke Cholka, PhD, CIP – University of Nevada, Reno; Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research Integrity
Wednesday, Dec 2
2:30 PM – 5:30 PM ET
Workshop: Achieving Excellence in Research: Moving from Diversity and Inclusion to Equity and Justice
Location: Live
Quincy J. Byrdsong, EdD, CIP, CCRP – Lipscomb University; Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A1 - Vaccine Research During a Global Pandemic: A Case Study of COVID-19
Location: Live
Karla Childers, MSJ – Johnson & Johnson; Walter L. Straus, MD, MPH – Merck Co., Inc.
Pharma/Biotech Perspectives Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A2 - Single IRB (sIRB) Strategies to Streamline IRB and HRPP Review
Location: Live
Jenni Beadles, MEd, CIP – Vanderbilt University Medical Center; Janelle A. Maddox-Regis, MS – Johns Hopkins University School of Medicine IRB; Sarah Mumford, MBA, CIP – University of Utah; Julia G. Gorey, JD – OHRP
Flexibility and Innovation in IRB Processes Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A4 - Evaluating the Quality and Effectiveness of HRPPs: Problems and New Approaches
Location: Live
Holly A. Taylor, PhD, MPH – National Institutes of Health; Holly Fernandez Lynch, JD, MBe – Perelman School of Medicine, University of Pennsylvania; Richard James – University of Pennsylvania Biomedical Library
Institutional Officials and HRPP Leadership Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A5 - Protecting Privacy in an Era of Shifting Requirements for Privacy and Concepts of Identifiability
Location: Live
Alexa Limeres, JD – Centers for Disease Control and Prevention; Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Christine Suver, PhD, PMP – Sage Bionetworks
Legal Considerations in HRPPs Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A7 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Live
Katie B. Speanburg, EdM – Abt Associates, Inc.; Jonathan Hill-Rorie, MPH – The Fenway Institute; Laura Bitterman, MSN, AGPCNP-BC – Department of Veterans Affairs
Populations Requiring Additional Protections Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A8 - Remote Study Auditing and Monitoring Best Practices
Location: Live
Stephanie deRijke, RN, MSN – Emory University; Caren Frost, PhD, MPH – University of Utah
QA/QI and Post-Approval Monitoring Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A9 - How to Maintain Institutional Memory at a Small Research Program
Location: Live
Delilah Ofosu-Barko, BMSc – Trillium Health Partners; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health
Small Research Programs Track
Tuesday, Dec 8
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Community-Based Participatory Research
Location: Live
Kelsie D. Kelly, PhD, MPH – University of Virginia School of Medicine; Jeanita Richardson, PhD, MEd – University of Virginia
Tuesday, Dec 8
2:30 PM – 5:30 PM ET
Workshop: Research With American Indian and Alaska Native (AI/AN) Tribes and Communities
Location: Live
Francine C. Gachupin, PhD, MPH – University of Arizona; Dakotah C. Lane, MD – Lummi Tribal Health Center; Elizabeth J. Coronado, JD – Lummi Nation; William L. Freeman, MD, MPH, CIP – Northwest Indian College
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B3 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Live
Delia Wolf Christiani, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health; Robert Hood – AAHRPP, Inc.; Amal S. H Al Omari, MS, PhD – King Hussein Cancer Center
Global Research Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B4 - Strategies that Promote Diversity and Inclusion in Clinical Research: What Role Does the IRB Play?
Location: Live
Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; David H. Strauss, MD – Columbia University; Tesheia Johnson, MBA, MHS – Yale University; Laura Meloney, MS, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital/Harvard Medical School
Hot Topics Track
Wednesday, Dec 9
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
Location: Live
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Dena Johnson, M.Ed., CIP, CCRP – Vanderbilt University Medical Center; Joshua Fedewa, MS, CIP – University of Texas Southwestern Medical Center
IRB Operations Advanced Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B7 - Toolkit for HRPP Leaders: Tips for Overseeing a Human Research Protection Program
Location: Live
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Leadership Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B9 - Operationalizing Research Databases and Biobanks at Your Institution
Location: Live
R. Peter Iafrate, PharmD – University of Florida; A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6; Lauren Sauer, MS – Johns Hopkins University; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Research Involving Data and Biospecimens Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B11 - Planning for Respondent Distress
Location: Pre-recorded
Sharon Zack, MS – Westat; Kerry Y. Levin, PhD – Westat; Mihiri Silva – Westat
Populations Requiring Additional Protections Track
Wednesday, Dec 9
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?
Location: Live
Martha Jones, MA, CIP – Mass General Brigham; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Bruce G. Gordon, MD – University of Nebraska Medical Center; Stephanie Henderson; Brenda Ruotolo, CIP – Columbia University in the City of New York; Sujatha Sridhar, MBBS, MCE – The University of Texas Health Science Center at Houston; Lauren Sauer, MS – Johns Hopkins University
Tuesday, Dec 15
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Wylie Burke, MD, PhD – University of Washington, Department of Bioethics and Humanities; Albert J. Allen, MD, PhD – Eli Lilly and Company
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A2 - Strategies for IRB Member & Staff Education
Location: Live
Charlotte H. Coley, MACT, CIP – University of North Carolina, Chapel Hill; David A. Borasky, Jr., MPH, CIP – WCG; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Education and Training Track
Tuesday, Dec 15
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
Location: Live
Stephanie A. Kraft, JD – Seattle Children’s Hospital and Research Institute; Stephanie S. Cargill, PhD MSPH – Saint Louis University
Empirical Research Ethics Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A5 - How to Investigate, Mitigate, Report, and Learn from Noncompliance: Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Live
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
Institutional Officials and HRPP Leadership Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A6 - Overturning Staff Turnover: Retaining Your Greatest Assets
Location: Live
Brenda Ruotolo, CIP – Columbia University in the City of New York; Nathalia Henry-Whitely, MS, CHRC, CIP – Northwestern University
Leadership Track
Tuesday, Dec 15
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
Location: Live
Aisha Langford, MPH, PhD – NYU Langone Health; Jerry A. Menikoff, MD, JD – Office for Human Research Protections; Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems
Legal Considerations in HRPPs Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A8 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Live
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala J. Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
QA/QI and Post-Approval Monitoring Track
Tuesday, Dec 15
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Diversity, Equity, and Inclusion in your Research Compliance Program
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Robert E. Nobles, II, DrPH, MPH, CIP – Emory University; Iris L. Jenkins, PhD – University of Massachusetts Amherst
Tuesday, Dec 15
2:30 PM – 5:30 PM ET
Workshop: Keeping Data Private, Secure, and Confidential: New International Privacy Regulations and Their Impact on Research
Location: Live
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; John R. Baumann, PhD – Indiana University; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bethany Johnson, JD, CIP – Indiana University
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B2 - A Conversation With All of Us: Considerations for a Diverse Cohort at a National Scale
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Katherine D. Blizinsky, PhD – National Institutes of Health; Ericka Thomas, M.S. – All of Us Research Program/National Institutes of Health; Ysabel Duron, BA – The Latino Cancer Institute
Hot Topics Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B4 - Advanced Considerations for Serving as a Reviewing IRB
Location: Live
Ann Johnson, PhD, MPH, CIP – University of Utah; Crystal Lijadu, BS, MLS (ASCP) – Thomas Jefferson University; Janelle A. Maddox-Regis, MS – Johns Hopkins University School of Medicine IRB
IRB Operations Advanced Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B5 - Making Metrics Meaningful: How HRPPs can Efficiently and Effectively Use Their Data
Location: Live
Kimberley Serpico, MEd, CIP, EdD Candidate – Harvard T.H. Chan School of Public Health; Joshua Fedewa, MS, CIP – University of Texas Southwestern Medical Center
IRB Operations Advanced Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B6 - Effectively Managing Teams and Meetings in a Remote Environment
Location: Live
Stacey Goretzka, CIP – Medical University of South Carolina; David A. Borasky, Jr., MPH, CIP – WCG
Leadership Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B7 - Ethical Issues in Complex Trial Design
Location: Live
Marianne Kearney Chase – MGH; Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Pharma/Biotech Perspectives Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B10 - Operationalizing Data Sharing Policies: Challenges and Solutions
Location: Live
Jessica Huening, JD – Yale University; Challace Pahlevan-Ibrekic, MBE, CIP – Northwell Health; Kristofor Langlais, PhD – NIH Office of Science Policy, Office of the Director
Research Involving Data and Biospecimens Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B11 - Complex Conflict of Interest (COI): Understanding the COI Landscape
Location: Pre-recorded
Valerie H. Bonham, JD – Ropes & Gray LLP; John R. Baumann, PhD – Indiana University; Marylana Saadeh Helou, JD – Epstein Becker & Green PC
Legal Considerations in HRPPs Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B12 - Planned Emergency Research
Location: Pre-recorded
Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine; Michele Russell-Einhorn, JD – Advarra; Robert Silbergleit, MD – University of Michigan; Luke Gelinas, PhD – Advarra
Hot Topics Track
Wednesday, Dec 16
2:30 PM – 5:30 PM ET
Workshop: Exploring Hot Topics in SBER
Location: Live
Linda E. Mayo, BA, CIP – The University of New Mexico; Julie F. Simpson, PhD – University of New Hampshire; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Administrators, Managers, and Staff
Tuesday, Dec 1
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Jada Bussey-Jones, MD, FACP – Emory University; Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A2 - Distinguishing Public Health Surveillance from Public Health Research
Location: Live
Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention; Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Flexibility and Innovation in IRB Processes Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A4 - Are Hospital Based IRBs Ready for the Endangered Species List
Location: Live
Scott J. Lipkin, DPM, CIP – Miami Cancer Institute; Baptist Health South Florida; Liz Michaels, MS, CIP – Meriter Hospital; Cheryl L. Byers, MHA, CIP, CHRC – Advarra
Institutional Officials and HRPP Leadership Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A5 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Live
John Heldens, RAC, CIP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
IRB Operations Advanced Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A7 - Navigating Uncertainty: Research With Undocumented Immigrants and Refugees
Location: Live
Maysa Al-Hussaini, MD FRCPath CIP – King Hussein Cancer Center; Colleen Kohashi, MA, CIP – UC Berkeley; Melissa McGee, J.D. – University of New Hampshire; Julia G. Gorey, JD – OHRP
Populations Requiring Additional Protections Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A9 - Beyond the Regulations: How to Effectively and Efficiently Manage Research Misconduct Cases
Location: Live
Kele Piper, CHRC, CIP, MS – Massachusetts General Hospital; Monika S. Markowitz, PhD – Virginia Commonwealth University
Responsible Conduct of Research Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A10 - Exempt or Not? Don't Get Psyched Out by the Benign Behavioral Intervention Research Exemption
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Elicia Preslan, MS, CIP – Virginia Commonwealth University; Michelle C. Stickler, DEd, CIP – The University of Texas at Austin; Ivor A. Pritchard, PhD – OHRP
SBER Track
Tuesday, Dec 1
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
Location: Pre-recorded
Danielle Giltner, JD, CIP – Indiana University; Warren H. Capell, MD – CPC Clinical Research University of Colorado Anschutz Medical Campus; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Basics Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A12 - Nuts and Bolts of Assessing IRB Compliance
Location: Pre-recorded
Keren R. Dunn, CIP – Cedars-Sinai Medical Center; Heather Savage, CIP – University of New Mexico; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
QA/QI and Post-Approval Monitoring Track
Tuesday, Dec 1
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
Location: Live
Nancy M.P King, JD – Wake Forest School of Medicine; Jonathan Moreno, PhD – University of Pennsylvania
Sponsored By:
Tuesday, Dec 1
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—IRB’s Role in Racial Bias
Location: Live
Eric Allen, MA, CIP, CPIA – University of South Florida; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Danielle A. Griffin, Ed.D., CIP – University of Houston
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Adaptable QA/QI Audit Approaches: How to Adjust Without Compromising Quality
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Eunice Yim Newbert, MPH – Boston Children's Hospital
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Introduction to the IRB: Ethics and Regulation
Location: Live
Ada Sue Selwitz, MA – University of Kentucky; David H. Strauss, MD – Columbia University; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Wednesday, Dec 2
10:00 AM – 11:15 AM ET
Panel: Scientific and Ethical Challenges of COVID-19 Prevention Trials in a Complex Sociopolitical Context
Location: Live
Nancy E. Kass, ScD – The Johns Hopkins University; E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO); Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada; Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B1 - A Dialogue With FDA
Location: Live
Bridget Foltz – FDA; Joanne R. Less, PhD – US Food and Drug Administration; Laurie Muldowney, MD – FDA; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Minerva Hughes, JD, PhD – FDA; Diane M. Maloney, JD – Food and Drug Administration
A Dialogue With the Feds Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B2 - How Do Ancillary Review Committees Strengthen Our HRPPs?
Location: Live
Linnea A. Anderson, BA, CIP – University of Minnesota; Kimberly K. Summers, PharmD – University of Texas Health San Antonio; Suzanne Stone, MA, CIP – UC Berkeley
Institutional Officials and HRPP Leadership Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B4 - Shaping Your Clinical Research Culture
Location: Live
Edye Edens, JD, MA, CIP, CCRP – First Class Solutions, Inc.; Daniel A. Perez, BS, CCRP – MACRO Trials
Leadership Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B5 - Navigating State Law Differences in the Era of Single IRB (sIRB) Review
Location: Live
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Legal Considerations in HRPPs Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B6 - Research with Children: Ethical Considerations, Parental Permission, and Assent
Location: Live
Ran Goldman, MD – University of British Columbia; Mary Cataletto, MD – NYU Long Island School of Medicine; Casey Mumaw, MA, CIP – Indiana University; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Populations Requiring Additional Protections Track
Wednesday, Dec 2
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
Location: Live
Michele Russell-Einhorn, JD – Advarra; Jason M. Malone, MPA, CIP – University of Washington; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
QA/QI and Post-Approval Monitoring Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B8 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: Live
Danielle A. Griffin, Ed.D., CIP – University of Houston; Lorraine R. Reitzel, PhD, FAAHB, FSRNT – University of Houston
Research Conducted in the Digital World Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B9 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Live
John C. Smith, MSW, CIM, CIP – Morehouse School of Medicine; Elizabeth Carroll, MPH, CIP – Adventist Healthcare, Inc.
Small Research Programs Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B10 - College Students and Research: Challenges and Issues for IRBs
Location: Live
Julie F. Simpson, PhD – University of New Hampshire; Andrea R. McDowell, PhD – Seattle University; Ivor A. Pritchard, PhD – OHRP
SBER Track
Wednesday, Dec 2
2:30 PM – 3:30 PM ET
SBER Network Discussion
Location: Live
Cecilia Brooke Cholka, PhD, CIP – University of Nevada, Reno; Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research Integrity
Wednesday, Dec 2
2:30 PM – 5:30 PM ET
Workshop: Achieving Excellence in Research: Moving from Diversity and Inclusion to Equity and Justice
Location: Live
Quincy J. Byrdsong, EdD, CIP, CCRP – Lipscomb University; Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A1 - Vaccine Research During a Global Pandemic: A Case Study of COVID-19
Location: Live
Karla Childers, MSJ – Johnson & Johnson; Walter L. Straus, MD, MPH – Merck Co., Inc.
Pharma/Biotech Perspectives Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A2 - Single IRB (sIRB) Strategies to Streamline IRB and HRPP Review
Location: Live
Jenni Beadles, MEd, CIP – Vanderbilt University Medical Center; Janelle A. Maddox-Regis, MS – Johns Hopkins University School of Medicine IRB; Sarah Mumford, MBA, CIP – University of Utah; Julia G. Gorey, JD – OHRP
Flexibility and Innovation in IRB Processes Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A4 - Evaluating the Quality and Effectiveness of HRPPs: Problems and New Approaches
Location: Live
Holly A. Taylor, PhD, MPH – National Institutes of Health; Holly Fernandez Lynch, JD, MBe – Perelman School of Medicine, University of Pennsylvania; Richard James – University of Pennsylvania Biomedical Library
Institutional Officials and HRPP Leadership Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A5 - Protecting Privacy in an Era of Shifting Requirements for Privacy and Concepts of Identifiability
Location: Live
Alexa Limeres, JD – Centers for Disease Control and Prevention; Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Christine Suver, PhD, PMP – Sage Bionetworks
Legal Considerations in HRPPs Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A7 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Live
Katie B. Speanburg, EdM – Abt Associates, Inc.; Jonathan Hill-Rorie, MPH – The Fenway Institute; Laura Bitterman, MSN, AGPCNP-BC – Department of Veterans Affairs
Populations Requiring Additional Protections Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A8 - Remote Study Auditing and Monitoring Best Practices
Location: Live
Stephanie deRijke, RN, MSN – Emory University; Caren Frost, PhD, MPH – University of Utah
QA/QI and Post-Approval Monitoring Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A9 - How to Maintain Institutional Memory at a Small Research Program
Location: Live
Delilah Ofosu-Barko, BMSc – Trillium Health Partners; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health
Small Research Programs Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A10 - Fundamental Issues in Qualitative Research
Location: Live
Andrew Hedrick, MPA, CIP – The Ohio State University; Patricia B. Condon, PhD – University of New Hampshire
SBER Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A13 - Getting IRB Review Right: Who Should Review a Study?
Location: Pre-recorded
Nichelle Cobb, PhD – University of Wisconsin-Madison; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Basics Track
Tuesday, Dec 8
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Community-Based Participatory Research
Location: Live
Kelsie D. Kelly, PhD, MPH – University of Virginia School of Medicine; Jeanita Richardson, PhD, MEd – University of Virginia
Tuesday, Dec 8
2:30 PM – 5:30 PM ET
Workshop: Research With American Indian and Alaska Native (AI/AN) Tribes and Communities
Location: Live
Francine C. Gachupin, PhD, MPH – University of Arizona; Dakotah C. Lane, MD – Lummi Tribal Health Center; Elizabeth J. Coronado, JD – Lummi Nation; William L. Freeman, MD, MPH, CIP – Northwest Indian College
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B2 - Mobile Medical Applications and IRB Review
Location: Live
James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bakul Patel, MSEE, MBA – Center for Devices and Radiological Health (CDRH) Food and Drug Administration
FDA Regulated Research Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B3 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Live
Delia Wolf Christiani, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health; Robert Hood – AAHRPP, Inc.; Amal S. H Al Omari, MS, PhD – King Hussein Cancer Center
Global Research Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B4 - Strategies that Promote Diversity and Inclusion in Clinical Research: What Role Does the IRB Play?
Location: Live
Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; David H. Strauss, MD – Columbia University; Tesheia Johnson, MBA, MHS – Yale University; Laura Meloney, MS, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital/Harvard Medical School
Hot Topics Track
Wednesday, Dec 9
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
Location: Live
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Dena Johnson, M.Ed., CIP, CCRP – Vanderbilt University Medical Center; Joshua Fedewa, MS, CIP – University of Texas Southwestern Medical Center
IRB Operations Advanced Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B9 - Operationalizing Research Databases and Biobanks at Your Institution
Location: Live
R. Peter Iafrate, PharmD – University of Florida; A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6; Lauren Sauer, MS – Johns Hopkins University; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Research Involving Data and Biospecimens Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B11 - Planning for Respondent Distress
Location: Pre-recorded
Sharon Zack, MS – Westat; Kerry Y. Levin, PhD – Westat; Mihiri Silva – Westat
Populations Requiring Additional Protections Track
Wednesday, Dec 9
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?
Location: Live
Martha Jones, MA, CIP – Mass General Brigham; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Bruce G. Gordon, MD – University of Nebraska Medical Center; Stephanie Henderson; Brenda Ruotolo, CIP – Columbia University in the City of New York; Sujatha Sridhar, MBBS, MCE – The University of Texas Health Science Center at Houston; Lauren Sauer, MS – Johns Hopkins University
Tuesday, Dec 15
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Wylie Burke, MD, PhD – University of Washington, Department of Bioethics and Humanities; Albert J. Allen, MD, PhD – Eli Lilly and Company
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A2 - Strategies for IRB Member & Staff Education
Location: Live
Charlotte H. Coley, MACT, CIP – University of North Carolina, Chapel Hill; David A. Borasky, Jr., MPH, CIP – WCG; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Education and Training Track
Tuesday, Dec 15
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
Location: Live
Stephanie A. Kraft, JD – Seattle Children’s Hospital and Research Institute; Stephanie S. Cargill, PhD MSPH – Saint Louis University
Empirical Research Ethics Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A4 - Assessing Benefit and Risk in Pediatric Clinical Trials
Location: Live
Kathryn Blake, PharmD, BCPS, FCCP – Nemours Children's Health System; Donna L. Snyder, MD, MBE – Food and Drug Administration; Richard Gorman – Biodefense Advanced Research and Development Authority
FDA Regulated Research Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A5 - How to Investigate, Mitigate, Report, and Learn from Noncompliance: Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Live
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
Institutional Officials and HRPP Leadership Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A6 - Overturning Staff Turnover: Retaining Your Greatest Assets
Location: Live
Brenda Ruotolo, CIP – Columbia University in the City of New York; Nathalia Henry-Whitely, MS, CHRC, CIP – Northwestern University
Leadership Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A8 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Live
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala J. Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
QA/QI and Post-Approval Monitoring Track
Tuesday, Dec 15
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
Location: Live
Megan Doerr, MS, LGC – Sage Bionetworks; Sara Meeder, CIP – Maimonides Medical Center; Vanessa Barone, MPH – Sage Bionetworks
Research Conducted in the Digital World Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A10 - Confidentiality, Privacy and Anonymity in SBER
Location: Live
Nalinee D. Patin, CIP – Clemson University; Julie F. Simpson, PhD – University of New Hampshire
SBER Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A11 - Research in K-12 Settings
Location: Pre-recorded
Julie Slayton, JD, PhD – University of Southern California; Linda E. Mayo, BA, CIP – The University of New Mexico
SBER Track
Tuesday, Dec 15
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Diversity, Equity, and Inclusion in your Research Compliance Program
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Robert E. Nobles, II, DrPH, MPH, CIP – Emory University; Iris L. Jenkins, PhD – University of Massachusetts Amherst
Tuesday, Dec 15
2:30 PM – 5:30 PM ET
Workshop: Keeping Data Private, Secure, and Confidential: New International Privacy Regulations and Their Impact on Research
Location: Live
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; John R. Baumann, PhD – Indiana University; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bethany Johnson, JD, CIP – Indiana University
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B1 - Not Your Grandfather's Electronic Informed Consent (eConsent): An Interactive Tool to Enhance Informed Consent
Location: Live
Christine Suver, PhD, PMP – Sage Bionetworks; Nichelle Cobb, PhD – University of Wisconsin-Madison
Flexibility and Innovation in IRB Processes Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B2 - A Conversation With All of Us: Considerations for a Diverse Cohort at a National Scale
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Katherine D. Blizinsky, PhD – National Institutes of Health; Ericka Thomas, M.S. – All of Us Research Program/National Institutes of Health; Ysabel Duron, BA – The Latino Cancer Institute
Hot Topics Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B4 - Advanced Considerations for Serving as a Reviewing IRB
Location: Live
Ann Johnson, PhD, MPH, CIP – University of Utah; Crystal Lijadu, BS, MLS (ASCP) – Thomas Jefferson University; Janelle A. Maddox-Regis, MS – Johns Hopkins University School of Medicine IRB
IRB Operations Advanced Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B5 - Making Metrics Meaningful: How HRPPs can Efficiently and Effectively Use Their Data
Location: Live
Kimberley Serpico, MEd, CIP, EdD Candidate – Harvard T.H. Chan School of Public Health; Joshua Fedewa, MS, CIP – University of Texas Southwestern Medical Center
IRB Operations Advanced Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B7 - Ethical Issues in Complex Trial Design
Location: Live
Marianne Kearney Chase – MGH; Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Pharma/Biotech Perspectives Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B8 - Advancing Ethical Research in Pregnancy: Subpart B, FDA Guidance, and the Example of HIV Research
Location: Live
Kristen Sullivan, PhD, MSW, MBA, MA – University of North Carolina at Chapel Hill; Maggie Little, BPhil, PhD – Kennedy Institute of Ethics, Georgetown University; Anne D. Lyerly, MD, MA – University of North Carolina at Chapel Hill
Populations Requiring Additional Protections Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B9 - Research Using Artificial Intelligence (AI): Regulatory and Privacy Implications and Protections
Location: Live
Sara R. Jordan, PhD – Future of Privacy Forum; Rachele Hendricks-Sturrup, DHSc, MSc, MA – Future of Privacy Forum
Research Conducted in the Digital World Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B10 - Operationalizing Data Sharing Policies: Challenges and Solutions
Location: Live
Jessica Huening, JD – Yale University; Challace Pahlevan-Ibrekic, MBE, CIP – Northwell Health; Kristofor Langlais, PhD – NIH Office of Science Policy, Office of the Director
Research Involving Data and Biospecimens Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B11 - Complex Conflict of Interest (COI): Understanding the COI Landscape
Location: Pre-recorded
Valerie H. Bonham, JD – Ropes & Gray LLP; John R. Baumann, PhD – Indiana University; Marylana Saadeh Helou, JD – Epstein Becker & Green PC
Legal Considerations in HRPPs Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B12 - Planned Emergency Research
Location: Pre-recorded
Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine; Michele Russell-Einhorn, JD – Advarra; Robert Silbergleit, MD – University of Michigan; Luke Gelinas, PhD – Advarra
Hot Topics Track
Wednesday, Dec 16
2:30 PM – 5:30 PM ET
Workshop: Exploring Hot Topics in SBER
Location: Live
Linda E. Mayo, BA, CIP – The University of New Mexico; Julie F. Simpson, PhD – University of New Hampshire; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Members, Chairs, and Vice Chairs
Tuesday, Dec 1
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Jada Bussey-Jones, MD, FACP – Emory University; Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A1 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Members
Location: Live
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – University of Nebraska Medical Center; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Education and Training Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A2 - Distinguishing Public Health Surveillance from Public Health Research
Location: Live
Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention; Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Flexibility and Innovation in IRB Processes Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A5 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Live
John Heldens, RAC, CIP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
IRB Operations Advanced Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A6 - Human Challenge Trials (HCTs) for COVID-19: What IRBs Should Know
Location: Live
Seema K. Shah, J.D. – NIH Clinical Center; Luke Gelinas, PhD – Advarra; Jerry A. Menikoff, MD, JD – Office for Human Research Protections; Richard Gorman – Biodefense Advanced Research and Development Authority
Pharma/Biotech Perspectives Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A7 - Navigating Uncertainty: Research With Undocumented Immigrants and Refugees
Location: Live
Maysa Al-Hussaini, MD FRCPath CIP – King Hussein Cancer Center; Colleen Kohashi, MA, CIP – UC Berkeley; Melissa McGee, J.D. – University of New Hampshire; Julia G. Gorey, JD – OHRP
Populations Requiring Additional Protections Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A8 - Assessing and Addressing the Ethical, Regulatory, and Governance Challenges of Networking Biorepositories
Location: Live
Aaron J. Goldenberg, PhD, MA, MPH – Case Western Reserve University; A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6; Kyle B. Brothers, MD, PhD – University of Louisville; Julie Kaneshiro, MA – Office for Human Research Protections
Research Involving Data and Biospecimens Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A9 - Beyond the Regulations: How to Effectively and Efficiently Manage Research Misconduct Cases
Location: Live
Kele Piper, CHRC, CIP, MS – Massachusetts General Hospital; Monika S. Markowitz, PhD – Virginia Commonwealth University
Responsible Conduct of Research Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A10 - Exempt or Not? Don't Get Psyched Out by the Benign Behavioral Intervention Research Exemption
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Elicia Preslan, MS, CIP – Virginia Commonwealth University; Michelle C. Stickler, DEd, CIP – The University of Texas at Austin; Ivor A. Pritchard, PhD – OHRP
SBER Track
Tuesday, Dec 1
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
Location: Pre-recorded
Danielle Giltner, JD, CIP – Indiana University; Warren H. Capell, MD – CPC Clinical Research University of Colorado Anschutz Medical Campus; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Basics Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A13 - How Might Ethics Review be Reimagined in the Age of DIY and Open Science?
Location: Pre-recorded
Sarah B. Ware, PhD – BioBlaze Community Bio Lab; Camille Nebeker, EdD, MS – University of California, San Diego, Herbert Wertheim School of Public Health; Martin Codyre, BEng, MS – Giantleap Biotechnology
Research Conducted in the Digital World Track
Tuesday, Dec 1
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
Location: Live
Nancy M.P King, JD – Wake Forest School of Medicine; Jonathan Moreno, PhD – University of Pennsylvania
Sponsored By:
Tuesday, Dec 1
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—IRB’s Role in Racial Bias
Location: Live
Eric Allen, MA, CIP, CPIA – University of South Florida; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Danielle A. Griffin, Ed.D., CIP – University of Houston
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Adaptable QA/QI Audit Approaches: How to Adjust Without Compromising Quality
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Eunice Yim Newbert, MPH – Boston Children's Hospital
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Introduction to the IRB: Ethics and Regulation
Location: Live
Ada Sue Selwitz, MA – University of Kentucky; David H. Strauss, MD – Columbia University; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Wednesday, Dec 2
10:00 AM – 11:15 AM ET
Panel: Scientific and Ethical Challenges of COVID-19 Prevention Trials in a Complex Sociopolitical Context
Location: Live
Nancy E. Kass, ScD – The Johns Hopkins University; E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO); Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada; Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B1 - A Dialogue With FDA
Location: Live
Bridget Foltz – FDA; Joanne R. Less, PhD – US Food and Drug Administration; Laurie Muldowney, MD – FDA; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Minerva Hughes, JD, PhD – FDA; Diane M. Maloney, JD – Food and Drug Administration
A Dialogue With the Feds Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B2 - How Do Ancillary Review Committees Strengthen Our HRPPs?
Location: Live
Linnea A. Anderson, BA, CIP – University of Minnesota; Kimberly K. Summers, PharmD – University of Texas Health San Antonio; Suzanne Stone, MA, CIP – UC Berkeley
Institutional Officials and HRPP Leadership Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B3 - Meeting Management for IRB Chairs
Location: Live
Brenda J. Klement – Morehouse School of Medicine; Susan Sonne, PharmD, BCPP – Medical University of South Carolina
IRB Chairs Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B4 - Shaping Your Clinical Research Culture
Location: Live
Edye Edens, JD, MA, CIP, CCRP – First Class Solutions, Inc.; Daniel A. Perez, BS, CCRP – MACRO Trials
Leadership Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B5 - Navigating State Law Differences in the Era of Single IRB (sIRB) Review
Location: Live
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Legal Considerations in HRPPs Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B6 - Research with Children: Ethical Considerations, Parental Permission, and Assent
Location: Live
Ran Goldman, MD – University of British Columbia; Mary Cataletto, MD – NYU Long Island School of Medicine; Casey Mumaw, MA, CIP – Indiana University; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Populations Requiring Additional Protections Track
Wednesday, Dec 2
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
Location: Live
Michele Russell-Einhorn, JD – Advarra; Jason M. Malone, MPA, CIP – University of Washington; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
QA/QI and Post-Approval Monitoring Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B8 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: Live
Danielle A. Griffin, Ed.D., CIP – University of Houston; Lorraine R. Reitzel, PhD, FAAHB, FSRNT – University of Houston
Research Conducted in the Digital World Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B9 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Live
John C. Smith, MSW, CIM, CIP – Morehouse School of Medicine; Elizabeth Carroll, MPH, CIP – Adventist Healthcare, Inc.
Small Research Programs Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B10 - College Students and Research: Challenges and Issues for IRBs
Location: Live
Julie F. Simpson, PhD – University of New Hampshire; Andrea R. McDowell, PhD – Seattle University; Ivor A. Pritchard, PhD – OHRP
SBER Track
Wednesday, Dec 2
2:30 PM – 3:30 PM ET
SBER Network Discussion
Location: Live
Cecilia Brooke Cholka, PhD, CIP – University of Nevada, Reno; Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research Integrity
Wednesday, Dec 2
2:30 PM – 5:30 PM ET
Workshop: Achieving Excellence in Research: Moving from Diversity and Inclusion to Equity and Justice
Location: Live
Quincy J. Byrdsong, EdD, CIP, CCRP – Lipscomb University; Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A1 - Vaccine Research During a Global Pandemic: A Case Study of COVID-19
Location: Live
Karla Childers, MSJ – Johnson & Johnson; Walter L. Straus, MD, MPH – Merck Co., Inc.
Pharma/Biotech Perspectives Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A2 - Single IRB (sIRB) Strategies to Streamline IRB and HRPP Review
Location: Live
Jenni Beadles, MEd, CIP – Vanderbilt University Medical Center; Janelle A. Maddox-Regis, MS – Johns Hopkins University School of Medicine IRB; Sarah Mumford, MBA, CIP – University of Utah; Julia G. Gorey, JD – OHRP
Flexibility and Innovation in IRB Processes Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A5 - Protecting Privacy in an Era of Shifting Requirements for Privacy and Concepts of Identifiability
Location: Live
Alexa Limeres, JD – Centers for Disease Control and Prevention; Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Christine Suver, PhD, PMP – Sage Bionetworks
Legal Considerations in HRPPs Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A7 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Live
Katie B. Speanburg, EdM – Abt Associates, Inc.; Jonathan Hill-Rorie, MPH – The Fenway Institute; Laura Bitterman, MSN, AGPCNP-BC – Department of Veterans Affairs
Populations Requiring Additional Protections Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A9 - How to Maintain Institutional Memory at a Small Research Program
Location: Live
Delilah Ofosu-Barko, BMSc – Trillium Health Partners; Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health
Small Research Programs Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A10 - Fundamental Issues in Qualitative Research
Location: Live
Andrew Hedrick, MPA, CIP – The Ohio State University; Patricia B. Condon, PhD – University of New Hampshire
SBER Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A13 - Getting IRB Review Right: Who Should Review a Study?
Location: Pre-recorded
Nichelle Cobb, PhD – University of Wisconsin-Madison; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Basics Track
Tuesday, Dec 8
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Community-Based Participatory Research
Location: Live
Kelsie D. Kelly, PhD, MPH – University of Virginia School of Medicine; Jeanita Richardson, PhD, MEd – University of Virginia
Tuesday, Dec 8
2:30 PM – 5:30 PM ET
Workshop: Research With American Indian and Alaska Native (AI/AN) Tribes and Communities
Location: Live
Francine C. Gachupin, PhD, MPH – University of Arizona; Dakotah C. Lane, MD – Lummi Tribal Health Center; Elizabeth J. Coronado, JD – Lummi Nation; William L. Freeman, MD, MPH, CIP – Northwest Indian College
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B2 - Mobile Medical Applications and IRB Review
Location: Live
James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bakul Patel, MSEE, MBA – Center for Devices and Radiological Health (CDRH) Food and Drug Administration
FDA Regulated Research Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B3 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Live
Delia Wolf Christiani, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health; Robert Hood – AAHRPP, Inc.; Amal S. H Al Omari, MS, PhD – King Hussein Cancer Center
Global Research Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B4 - Strategies that Promote Diversity and Inclusion in Clinical Research: What Role Does the IRB Play?
Location: Live
Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; David H. Strauss, MD – Columbia University; Tesheia Johnson, MBA, MHS – Yale University; Laura Meloney, MS, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital/Harvard Medical School
Hot Topics Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B5 - Unique Challenges of Being an IRB Chairperson at Medium to Small Institution
Location: Live
Brenda J. Klement – Morehouse School of Medicine; Meredith C. Frey, PhD – Otterbein University
IRB Chairs Track
Wednesday, Dec 9
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
Location: Live
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Dena Johnson, M.Ed., CIP, CCRP – Vanderbilt University Medical Center; Joshua Fedewa, MS, CIP – University of Texas Southwestern Medical Center
IRB Operations Advanced Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B10 - Assessing the Ethics of Using Wearable Technologies to Facilitate Public Health Initiatives
Location: Live
Kayte Spector-Bagdady, JD, M Bioethics – University of Michigan Medical School; Dena B. Mendelsohn, JD, MPH – Elektra Labs
Research Conducted in the Digital World Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B11 - Planning for Respondent Distress
Location: Pre-recorded
Sharon Zack, MS – Westat; Kerry Y. Levin, PhD – Westat; Mihiri Silva – Westat
Populations Requiring Additional Protections Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B12 - Ethics of Mandatory Research Biopsies in Clinical Trials
Location: Pre-recorded
Laura Levit, JD – American Society of Clinical Oncology; Mark J. Ratain, MD – University of Chicago Medicine; Jennifer J. Gao, MD – Oncology Center of Excellence, U.S. Food and Drug Administration; Julie Kaneshiro, MA – Office for Human Research Protections
Research Involving Data and Biospecimens Track
Wednesday, Dec 9
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?
Location: Live
Martha Jones, MA, CIP – Mass General Brigham; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Bruce G. Gordon, MD – University of Nebraska Medical Center; Stephanie Henderson; Brenda Ruotolo, CIP – Columbia University in the City of New York; Sujatha Sridhar, MBBS, MCE – The University of Texas Health Science Center at Houston; Lauren Sauer, MS – Johns Hopkins University
Tuesday, Dec 15
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Wylie Burke, MD, PhD – University of Washington, Department of Bioethics and Humanities; Albert J. Allen, MD, PhD – Eli Lilly and Company
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A2 - Strategies for IRB Member & Staff Education
Location: Live
Charlotte H. Coley, MACT, CIP – University of North Carolina, Chapel Hill; David A. Borasky, Jr., MPH, CIP – WCG; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Education and Training Track
Tuesday, Dec 15
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
Location: Live
Stephanie A. Kraft, JD – Seattle Children’s Hospital and Research Institute; Stephanie S. Cargill, PhD MSPH – Saint Louis University
Empirical Research Ethics Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A4 - Assessing Benefit and Risk in Pediatric Clinical Trials
Location: Live
Kathryn Blake, PharmD, BCPS, FCCP – Nemours Children's Health System; Donna L. Snyder, MD, MBE – Food and Drug Administration; Richard Gorman – Biodefense Advanced Research and Development Authority
FDA Regulated Research Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A5 - How to Investigate, Mitigate, Report, and Learn from Noncompliance: Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Live
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine; Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
Institutional Officials and HRPP Leadership Track
Tuesday, Dec 15
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
Location: Live
Aisha Langford, MPH, PhD – NYU Langone Health; Jerry A. Menikoff, MD, JD – Office for Human Research Protections; Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems
Legal Considerations in HRPPs Track
Tuesday, Dec 15
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
Location: Live
Megan Doerr, MS, LGC – Sage Bionetworks; Sara Meeder, CIP – Maimonides Medical Center; Vanessa Barone, MPH – Sage Bionetworks
Research Conducted in the Digital World Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A10 - Confidentiality, Privacy and Anonymity in SBER
Location: Live
Nalinee D. Patin, CIP – Clemson University; Julie F. Simpson, PhD – University of New Hampshire
SBER Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A11 - Research in K-12 Settings
Location: Pre-recorded
Julie Slayton, JD, PhD – University of Southern California; Linda E. Mayo, BA, CIP – The University of New Mexico
SBER Track
Tuesday, Dec 15
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Diversity, Equity, and Inclusion in your Research Compliance Program
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Robert E. Nobles, II, DrPH, MPH, CIP – Emory University; Iris L. Jenkins, PhD – University of Massachusetts Amherst
Tuesday, Dec 15
2:30 PM – 5:30 PM ET
Workshop: Keeping Data Private, Secure, and Confidential: New International Privacy Regulations and Their Impact on Research
Location: Live
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; John R. Baumann, PhD – Indiana University; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bethany Johnson, JD, CIP – Indiana University
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B1 - Not Your Grandfather's Electronic Informed Consent (eConsent): An Interactive Tool to Enhance Informed Consent
Location: Live
Christine Suver, PhD, PMP – Sage Bionetworks; Nichelle Cobb, PhD – University of Wisconsin-Madison
Flexibility and Innovation in IRB Processes Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B2 - A Conversation With All of Us: Considerations for a Diverse Cohort at a National Scale
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Katherine D. Blizinsky, PhD – National Institutes of Health; Ericka Thomas, M.S. – All of Us Research Program/National Institutes of Health; Ysabel Duron, BA – The Latino Cancer Institute
Hot Topics Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B3 - IRB Chairs Forum: A structured Discussion for IRB Chairs
Location: Live
R. Peter Iafrate, PharmD – University of Florida; Sharon Ellison, PharmD – Duke University Health System, Inc.
IRB Chairs Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B4 - Advanced Considerations for Serving as a Reviewing IRB
Location: Live
Ann Johnson, PhD, MPH, CIP – University of Utah; Crystal Lijadu, BS, MLS (ASCP) – Thomas Jefferson University; Janelle A. Maddox-Regis, MS – Johns Hopkins University School of Medicine IRB
IRB Operations Advanced Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B6 - Effectively Managing Teams and Meetings in a Remote Environment
Location: Live
Stacey Goretzka, CIP – Medical University of South Carolina; David A. Borasky, Jr., MPH, CIP – WCG
Leadership Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B7 - Ethical Issues in Complex Trial Design
Location: Live
Marianne Kearney Chase – MGH; Luke Gelinas, PhD – Advarra; Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
Pharma/Biotech Perspectives Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B8 - Advancing Ethical Research in Pregnancy: Subpart B, FDA Guidance, and the Example of HIV Research
Location: Live
Kristen Sullivan, PhD, MSW, MBA, MA – University of North Carolina at Chapel Hill; Maggie Little, BPhil, PhD – Kennedy Institute of Ethics, Georgetown University; Anne D. Lyerly, MD, MA – University of North Carolina at Chapel Hill
Populations Requiring Additional Protections Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B9 - Research Using Artificial Intelligence (AI): Regulatory and Privacy Implications and Protections
Location: Live
Sara R. Jordan, PhD – Future of Privacy Forum; Rachele Hendricks-Sturrup, DHSc, MSc, MA – Future of Privacy Forum
Research Conducted in the Digital World Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B11 - Complex Conflict of Interest (COI): Understanding the COI Landscape
Location: Pre-recorded
Valerie H. Bonham, JD – Ropes & Gray LLP; John R. Baumann, PhD – Indiana University; Marylana Saadeh Helou, JD – Epstein Becker & Green PC
Legal Considerations in HRPPs Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B12 - Planned Emergency Research
Location: Pre-recorded
Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine; Michele Russell-Einhorn, JD – Advarra; Robert Silbergleit, MD – University of Michigan; Luke Gelinas, PhD – Advarra
Hot Topics Track
Wednesday, Dec 16
2:30 PM – 5:30 PM ET
Workshop: Exploring Hot Topics in SBER
Location: Live
Linda E. Mayo, BA, CIP – The University of New Mexico; Julie F. Simpson, PhD – University of New Hampshire; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Non-Scientist/Unaffiliated IRB Member
Tuesday, Dec 1
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Jada Bussey-Jones, MD, FACP – Emory University; Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A1 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Members
Location: Live
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Nancy A. Olson, JD – University of Nebraska Medical Center; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Education and Training Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A2 - Distinguishing Public Health Surveillance from Public Health Research
Location: Live
Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention; Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Flexibility and Innovation in IRB Processes Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A7 - Navigating Uncertainty: Research With Undocumented Immigrants and Refugees
Location: Live
Maysa Al-Hussaini, MD FRCPath CIP – King Hussein Cancer Center; Colleen Kohashi, MA, CIP – UC Berkeley; Melissa McGee, J.D. – University of New Hampshire; Julia G. Gorey, JD – OHRP
Populations Requiring Additional Protections Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A10 - Exempt or Not? Don't Get Psyched Out by the Benign Behavioral Intervention Research Exemption
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Elicia Preslan, MS, CIP – Virginia Commonwealth University; Michelle C. Stickler, DEd, CIP – The University of Texas at Austin; Ivor A. Pritchard, PhD – OHRP
SBER Track
Tuesday, Dec 1
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
Location: Pre-recorded
Danielle Giltner, JD, CIP – Indiana University; Warren H. Capell, MD – CPC Clinical Research University of Colorado Anschutz Medical Campus; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Basics Track
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A13 - How Might Ethics Review be Reimagined in the Age of DIY and Open Science?
Location: Pre-recorded
Sarah B. Ware, PhD – BioBlaze Community Bio Lab; Camille Nebeker, EdD, MS – University of California, San Diego, Herbert Wertheim School of Public Health; Martin Codyre, BEng, MS – Giantleap Biotechnology
Research Conducted in the Digital World Track
Tuesday, Dec 1
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—IRB’s Role in Racial Bias
Location: Live
Eric Allen, MA, CIP, CPIA – University of South Florida; Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School; Danielle A. Griffin, Ed.D., CIP – University of Houston
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Adaptable QA/QI Audit Approaches: How to Adjust Without Compromising Quality
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Eunice Yim Newbert, MPH – Boston Children's Hospital
Tuesday, Dec 1
2:30 PM – 5:30 PM ET
Workshop: Introduction to the IRB: Ethics and Regulation
Location: Live
Ada Sue Selwitz, MA – University of Kentucky; David H. Strauss, MD – Columbia University; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Wednesday, Dec 2
10:00 AM – 11:15 AM ET
Panel: Scientific and Ethical Challenges of COVID-19 Prevention Trials in a Complex Sociopolitical Context
Location: Live
Nancy E. Kass, ScD – The Johns Hopkins University; E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO); Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada; Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B3 - Meeting Management for IRB Chairs
Location: Live
Brenda J. Klement – Morehouse School of Medicine; Susan Sonne, PharmD, BCPP – Medical University of South Carolina
IRB Chairs Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B6 - Research with Children: Ethical Considerations, Parental Permission, and Assent
Location: Live
Ran Goldman, MD – University of British Columbia; Mary Cataletto, MD – NYU Long Island School of Medicine; Casey Mumaw, MA, CIP – Indiana University; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Populations Requiring Additional Protections Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B8 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: Live
Danielle A. Griffin, Ed.D., CIP – University of Houston; Lorraine R. Reitzel, PhD, FAAHB, FSRNT – University of Houston
Research Conducted in the Digital World Track
Wednesday, Dec 2
2:30 PM – 5:30 PM ET
Workshop: Achieving Excellence in Research: Moving from Diversity and Inclusion to Equity and Justice
Location: Live
Quincy J. Byrdsong, EdD, CIP, CCRP – Lipscomb University; Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A1 - Vaccine Research During a Global Pandemic: A Case Study of COVID-19
Location: Live
Karla Childers, MSJ – Johnson & Johnson; Walter L. Straus, MD, MPH – Merck Co., Inc.
Pharma/Biotech Perspectives Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A7 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Live
Katie B. Speanburg, EdM – Abt Associates, Inc.; Jonathan Hill-Rorie, MPH – The Fenway Institute; Laura Bitterman, MSN, AGPCNP-BC – Department of Veterans Affairs
Populations Requiring Additional Protections Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A10 - Fundamental Issues in Qualitative Research
Location: Live
Andrew Hedrick, MPA, CIP – The Ohio State University; Patricia B. Condon, PhD – University of New Hampshire
SBER Track
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A13 - Getting IRB Review Right: Who Should Review a Study?
Location: Pre-recorded
Nichelle Cobb, PhD – University of Wisconsin-Madison; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Basics Track
Tuesday, Dec 8
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Community-Based Participatory Research
Location: Live
Kelsie D. Kelly, PhD, MPH – University of Virginia School of Medicine; Jeanita Richardson, PhD, MEd – University of Virginia
Tuesday, Dec 8
2:30 PM – 5:30 PM ET
Workshop: Research With American Indian and Alaska Native (AI/AN) Tribes and Communities
Location: Live
Francine C. Gachupin, PhD, MPH – University of Arizona; Dakotah C. Lane, MD – Lummi Tribal Health Center; Elizabeth J. Coronado, JD – Lummi Nation; William L. Freeman, MD, MPH, CIP – Northwest Indian College
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B3 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Live
Delia Wolf Christiani, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health; Robert Hood – AAHRPP, Inc.; Amal S. H Al Omari, MS, PhD – King Hussein Cancer Center
Global Research Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B5 - Unique Challenges of Being an IRB Chairperson at Medium to Small Institution
Location: Live
Brenda J. Klement – Morehouse School of Medicine; Meredith C. Frey, PhD – Otterbein University
IRB Chairs Track
Wednesday, Dec 9
1:15 PM – 2:15 PM ET
W2B10 - Assessing the Ethics of Using Wearable Technologies to Facilitate Public Health Initiatives
Location: Live
Kayte Spector-Bagdady, JD, M Bioethics – University of Michigan Medical School; Dena B. Mendelsohn, JD, MPH – Elektra Labs
Research Conducted in the Digital World Track
Wednesday, Dec 9
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?
Location: Live
Martha Jones, MA, CIP – Mass General Brigham; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.; Bruce G. Gordon, MD – University of Nebraska Medical Center; Stephanie Henderson; Brenda Ruotolo, CIP – Columbia University in the City of New York; Sujatha Sridhar, MBBS, MCE – The University of Texas Health Science Center at Houston; Lauren Sauer, MS – Johns Hopkins University
Tuesday, Dec 15
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
Location: Live
Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research; Wylie Burke, MD, PhD – University of Washington, Department of Bioethics and Humanities; Albert J. Allen, MD, PhD – Eli Lilly and Company
Tuesday, Dec 15
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
Location: Live
Megan Doerr, MS, LGC – Sage Bionetworks; Sara Meeder, CIP – Maimonides Medical Center; Vanessa Barone, MPH – Sage Bionetworks
Research Conducted in the Digital World Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A11 - Research in K-12 Settings
Location: Pre-recorded
Julie Slayton, JD, PhD – University of Southern California; Linda E. Mayo, BA, CIP – The University of New Mexico
SBER Track
Tuesday, Dec 15
2:30 PM – 3:30 PM ET
Virtual Roundtable: Racial Justice Working Group—Diversity, Equity, and Inclusion in your Research Compliance Program
Location: Live
Tonya Ferraro, MEd – Boston Children's Hospital; Robert E. Nobles, II, DrPH, MPH, CIP – Emory University; Iris L. Jenkins, PhD – University of Massachusetts Amherst
Tuesday, Dec 15
2:30 PM – 5:30 PM ET
Workshop: Keeping Data Private, Secure, and Confidential: New International Privacy Regulations and Their Impact on Research
Location: Live
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; John R. Baumann, PhD – Indiana University; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra; Bethany Johnson, JD, CIP – Indiana University
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B1 - Not Your Grandfather's Electronic Informed Consent (eConsent): An Interactive Tool to Enhance Informed Consent
Location: Live
Christine Suver, PhD, PMP – Sage Bionetworks; Nichelle Cobb, PhD – University of Wisconsin-Madison
Flexibility and Innovation in IRB Processes Track
Wednesday, Dec 16
1:15 PM – 2:15 PM ET
W3B3 - IRB Chairs Forum: A structured Discussion for IRB Chairs
Location: Live
R. Peter Iafrate, PharmD – University of Florida; Sharon Ellison, PharmD – Duke University Health System, Inc.
IRB Chairs Track
Wednesday, Dec 16
2:30 PM – 5:30 PM ET
Workshop: Exploring Hot Topics in SBER
Location: Live
Linda E. Mayo, BA, CIP – The University of New Mexico; Julie F. Simpson, PhD – University of New Hampshire; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
SBER
Tuesday, Dec 1
1:15 PM – 2:15 PM ET
W1A10 - Exempt or Not? Don't Get Psyched Out by the Benign Behavioral Intervention Research Exemption
Location: Live
John D. Horigan, MA, CIP – National Institutes of Health; Elicia Preslan, MS, CIP – Virginia Commonwealth University; Michelle C. Stickler, DEd, CIP – The University of Texas at Austin; Ivor A. Pritchard, PhD – OHRP
SBER Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B8 - Online Research: Design and Review in a World of Bots, Hackers, and Evolving Technology
Location: Live
Danielle A. Griffin, Ed.D., CIP – University of Houston; Lorraine R. Reitzel, PhD, FAAHB, FSRNT – University of Houston
Research Conducted in the Digital World Track
Wednesday, Dec 2
1:15 PM – 2:15 PM ET
W1B10 - College Students and Research: Challenges and Issues for IRBs
Location: Live
Julie F. Simpson, PhD – University of New Hampshire; Andrea R. McDowell, PhD – Seattle University; Ivor A. Pritchard, PhD – OHRP
SBER Track
Wednesday, Dec 2
2:30 PM – 3:30 PM ET
SBER Network Discussion
Location: Live
Cecilia Brooke Cholka, PhD, CIP – University of Nevada, Reno; Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research Integrity
Tuesday, Dec 8
1:15 PM – 2:15 PM ET
W2A10 - Fundamental Issues in Qualitative Research
Location: Live
Andrew Hedrick, MPA, CIP – The Ohio State University; Patricia B. Condon, PhD – University of New Hampshire
SBER Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A10 - Confidentiality, Privacy and Anonymity in SBER
Location: Live
Nalinee D. Patin, CIP – Clemson University; Julie F. Simpson, PhD – University of New Hampshire
SBER Track
Tuesday, Dec 15
1:15 PM – 2:15 PM ET
W3A11 - Research in K-12 Settings
Location: Pre-recorded
Julie Slayton, JD, PhD – University of Southern California; Linda E. Mayo, BA, CIP – The University of New Mexico
SBER Track
Wednesday, Dec 16
2:30 PM – 5:30 PM ET
Workshop: Exploring Hot Topics in SBER
Location: Live
Linda E. Mayo, BA, CIP – The University of New Mexico; Julie F. Simpson, PhD – University of New Hampshire; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
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