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- Sunday, November 17, 2019
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7:00 AM - 5:00 PMOn-Site Check-In Open
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7:00 AM - 5:00 PMOn-Site Check-In Open
Location: Pre-Function Hall C - 2019 SBER Conference
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8:00 AM - 8:05 AMWelcome from the Conference Co-Chairs
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8:00 AM - 8:05 AMWelcome from the Conference Co-Chairs
Location: Ballroom B -
8:05 AM - 9:00 AMKeynote Address by Katie Shilton, MLIS, PhD, Associate Professor, Information Studies, University of Maryland College Park: (Re?)building Trust in Pervasive Data Research
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8:05 AM - 9:00 AMKeynote Address by Katie Shilton, MLIS, PhD, Associate Professor, Information Studies, University of Maryland College Park: (Re?)building Trust in Pervasive Data Research
Location: Ballroom BKatie Shilton, MLIS, PhD – University of Maryland College Park ### 10146###Keynote Speaker - Preconference Programs
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8:30 AM - 5:30 PM2019 AER Conference: Pre-Conference Programs
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8:30 AM - 4:30 PMData-Driven Research: Ethical and Practical Considerations for IRBs
Location: Room 210Mary L. Gray, PhD – Microsoft Research ### 284648###Preconference Speaker @@@ Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout ### 10572###Preconference Speaker -
1:00 PM - 4:30 PMEthical and Regulatory Review of Research Case Studies
Location: Room 201Bruce G. Gordon, MD – University of Nebraska Medical Center ### 11072###Preconference Speaker @@@ Ernest D. Prentice, PhD – Research Ethics ### 10693###Preconference Speaker -
8:30 AM - 4:30 PMIRB 101sm
Location: Room 203Ada Sue Selwitz, MA – University of Kentucky ### 11100###Preconference Speaker @@@ David H. Strauss, MD – Columbia University ### 10147###Preconference Speaker -
8:30 AM - 4:30 PMQA/QI in Human Subjects Research
Location: Room 206Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health ### 187400###Preconference Speaker @@@ Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health ### 11119###Preconference Speaker @@@ Sana Khoury-Shakour, PhD – Office of Research Compliance Review, University of Michigan ### 609544###Preconference Speaker @@@ Jessica Randall, MA, CIP – Yale University ### 112654###Preconference Speaker @@@ Alyssa AK Speier, MS, CIP – Harvard T.H. Chan School of Public Health ### 428263###Preconference Speaker @@@ Eunice Yim Newbert, MPH – Boston Children's Hospital ### 25441###Preconference Speaker -
8:30 AM - 4:30 PMReimagining Your HRPP in the Single IRB Era
Location: Room 202Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Preconference Speaker @@@ Susan Z. Kornetsky, MPH – Boston Children's Hospital ### 10134###Preconference Speaker @@@ Martha Jones, MA, CIP – Partners HealthCare System, Inc. ### 59861###Preconference Speaker @@@ P. Pearl O'Rourke, MD – Harvard Medical School ### 112647###Preconference Speaker @@@ Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital ### 58254###Preconference Speaker -
8:30 AM - 12:00 PMTips and Tools for Effective IRB Education
Location: Room 201Elizabeth Kipp Campbell, PhD, CIP – MaineHealth System ### 584376###Preconference Speaker @@@ Sharon Shriver, PhD – PRIM&R ### 302147###Preconference Speaker -
4:30 PM - 5:30 PMPreconference Programs Networking Reception
Location: Boylston Street Hallway, Level 2 - 2019 SBER Conference
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9:00 AM - 9:15 AMBreak
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9:00 AM - 9:15 AM
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9:15 AM - 10:30 AMBreakout Session Series A
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9:15 AM - 10:30 AMA01 - Academic Ethics—How Social Science Researchers Operationalize and Exercise Research Ethics
Location: Room 304Hot Topics Track (SBER)
Alma Castro, MA, CIP – Harvard T.H. Chan School of Public Health ### 609525###Speaker @@@ Jeremy T. Goldbach, PhD, LMSW – University of Southern California ### 816604###Speaker @@@ Lara N. Sloboda, PhD – Dana Farber Cancer Insititute ### 181613###Speaker -
9:15 AM - 10:30 AMYvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS ### 112639###Speaker @@@ Cynthia S. Shindledecker, B.A., CIP – University of Michigan ### 25718###Speaker @@@ Wendy J. Weber, ND, PhD, MPH – National Center for Complementary and Integrative Health ### 587412###Speaker
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9:15 AM - 10:30 AMJulie Slayton, JD, PhD – University of Southern California ### 112668###Speaker @@@ Matt D. Stafford, MPH – Boston Children's Hospital ### 57750###Speaker
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9:15 AM - 10:30 AMA04 - OHRP's Guidance on the Revised Common Rule—A Question and Answer Session
Location: Room 309Basic Track (SBER)
Lauren Hartsmith, JD – OHRP ### 263718###Speaker @@@ Julie Kaneshiro, MA – Office for Human Research Protections ### 11084###Speaker @@@ Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker -
9:15 AM - 10:30 AMA05 - Optimizing Openness in Human Subjects Research—Balancing Transparency and Human Research Protections
Location: Room 313Hot Topics Track (SBER)
Julie Goldman, MLIS – Harvard Medical School ### 825087###Speaker @@@ Dessi Kirilova – Qualitative Data Repository www.qdr.org ### 824523###Speaker @@@ Anna M. Mitchell, BA, CIP – Boston Children's Hospital ### 824616###Speaker @@@ Diana Kapiszewski, PhD – Department of Government, Georgetown University ### 420592###Speaker -
9:15 AM - 10:30 AMA06 - Reviewing Exercise Science Research at Primarily SBER Institutions
Location: Room 310Basic Track (SBER)
Summer B. Cook, PhD – University of New Hampshire ### 825086###Speaker @@@ Michael Leary, PhD CIP – Lindenwood University ### 187411###Speaker @@@ Meghan Felicia Pronovost, MS – Harvard University ### 824623###Speaker -
9:15 AM - 10:30 AMA07 - Continuing Review or No Continuing Review, That Is the Question
Location: Room 302IRB Policy/Operations Track (SBER)
Andrew Hedrick, MPA, CIP – The Ohio State University ### 172015###Speaker @@@ Sharon L. Zack, MS – Westat ### 124855###Speaker -
9:15 AM - 10:30 AMA08 - May the Revised Common Rule Force Be With You: How to Become a Review Jedi
Location: Room 306Basic Track (SBER)
Tonya Ferraro, MEd – Boston Children's Hospital ### 420587###Speaker @@@ Kimberley Serpico, MEd, CIP, EdD Candidate – Harvard School of Public Health ### 609523###Speaker -
10:30 AM - 11:00 AMBeverage Break
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10:30 AM - 11:00 AMBeverage Break
Location: Boylston Street Hallway, Level 3 -
11:00 AM - 12:15 PMBreakout Session Series B
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11:00 AM - 12:15 PMB01 - From Flexible to More Flexibility—What's Left to Review?
Location: Room 311Advanced Track (SBER)
Rebecca D. Armstrong, DVM, PhD – University of California, Berkeley ### 42218###Speaker @@@ Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno ### 585105###Speaker -
11:00 AM - 12:15 PMB02 - The European General Data Protection Regulation (GDPR)—Oversight and Impact
Location: Room 312Hot Topics Track (SBER)
Michael A. DiMaio – Ropes & Gray LLP ### 825251###Speaker @@@ Sara M. Stevenson, MPA – College of Charleston ### 824681###Speaker -
11:00 AM - 12:15 PMJennifer B. Dier, CIP, CCRP, CHRC – UC San Diego ### 609643###Speaker @@@ Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS ### 112639###Speaker @@@ Linda E. Petree, BA, CIP – The University of New Mexico ### 255981###Speaker
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11:00 AM - 12:15 PMB04 - Challenges and Opportunities for Small IRB Offices at Small Research Programs
Location: Room 313IRB Policy/Operations Track (SBER)
Aimee E. Huard, PhD – Great Bay Community College ### 420591###Speaker @@@ Sandy Martinez, MA – Central Washington University ### 824596###Speaker @@@ Andrea R. McDowell, PhD – Seattle University ### 175574###Speaker -
11:00 AM - 12:15 PMB05 - Exempt or Not? Don't Get Psyched Out By the Benign Behavioral Intervention Research Exemption
Location: Room 310Basic Track (SBER)
Sandra H. Berry – RAND Corporation ### 825146###Speaker @@@ Nancy A. Olson, JD – Consultant ### 11093###Speaker @@@ Michele Russell-Einhorn, JD – Advarra ### 10144###Speaker @@@ Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker -
11:00 AM - 12:15 PMRobleinscky Isabel Dominguez, BS, CIP – Boston Children's Hospital ### 824456###Speaker @@@ Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis ### 426680###Speaker @@@ Ashley D. Hicks, CIP – Tufts University ### 185846###Speaker
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11:00 AM - 12:15 PMJonathan M. Girard – Harvard University ### 586785###Speaker @@@ Meghan Felicia Pronovost, MS – Harvard University ### 824623###Speaker
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11:00 AM - 12:15 PMB08 - Understanding and Applying Family Educational Rights and Privacy Act (FERPA) in Higher Education
Location: Room 309Advanced Track (SBER)
Casey Mumaw, MA, CIP – Indiana University ### 420597###Speaker @@@ Nalinee D. Patin, CIP – Clemson University ### 587337###Speaker -
12:15 PM - 1:30 PMNetworking Luncheon
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12:15 PM - 1:30 PMNetworking Luncheon
Location: Exhibit Hall D -
1:30 PM - 2:45 PMPlenary Session
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1:30 PM - 2:45 PMPlenary Session: Strategies and Solutions for Working With Challenging Principal Investigators (PIs)
Location: Ballroom BAndrew Hedrick, MPA, CIP – The Ohio State University ### 172015###Moderator @@@ RoseAnn Fleming, CIP – University of Southern California Institutional Review Board ### 824460###Panelist @@@ Julie Slayton, JD, PhD – University of Southern California ### 112668###Panelist @@@ Jessica R. Williams, MA, MS, CIP – University of Kentucky ### 824692###Panelist -
2:45 PM - 3:15 PMBeverage Break
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2:45 PM - 3:15 PMBeverage Break
Location: Boylston Street Hallway, Level 3 -
3:15 PM - 4:30 PMBreakout Session Series C
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3:15 PM - 4:30 PMCecilia Brooke Cholka, MA, CIP – University of Nevada, Reno ### 585105###Speaker @@@ Jeffrey M. Cohen, PhD – Department of Bioethics, Clarkson University ### 11067###Speaker
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3:15 PM - 4:30 PMLinda E. Petree, BA, CIP – The University of New Mexico ### 255981###Speaker @@@ Julie Slayton, JD, PhD – University of Southern California ### 112668###Speaker
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3:15 PM - 4:30 PMC03 - The "Nuts and Bolts" of Running an IRB Meeting Virtually
Location: Room 309IRB Policy/Operations Track (SBER)
Jaime A. Arango, EdD, CIP – CITI Program ### 11361###Speaker @@@ Nicolaas Bodkin, CIP – Capella University ### 824370###Speaker @@@ Angela L. Bruch, PhD – Capella University ### 824374###Speaker -
3:15 PM - 4:30 PMC04 - Clinical Trials in SBER (ClinicalTrials.gov Registration)—Part II
Location: Room 304Advanced Track (SBER)
Kate Sasamoto, JD – Office of Research Compliance Review, University of Michigan ### 609545###Speaker @@@ Wendy J. Weber, ND, PhD, MPH – National Center for Complementary and Integrative Health ### 587412###Speaker -
3:15 PM - 4:30 PMAlma Castro, MA, CIP – Harvard T.H. Chan School of Public Health ### 609525###Speaker @@@ Matt D. Stafford, MPH – Boston Children's Hospital ### 57750###Speaker @@@ Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker
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3:15 PM - 4:30 PMC06 - College Students and Research—Challenges and Issues for IRBs
Location: Room 311Basic Track (SBER)
Andrea R. McDowell, PhD – Seattle University ### 175574###Speaker @@@ Julie F. Simpson, PhD – University of New Hampshire ### 57933###Speaker -
3:15 PM - 4:30 PMC07 - Incentives and Compensation for Subjects in SBER
Location: Room 306IRB Policy/Operations Track (SBER)
Colleen Kohashi, MA, CIP – UC Berkeley ### 118172###Speaker @@@ Melissa McGee, J.D. – University of New Hampshire ### 824599###Speaker -
3:15 PM - 4:30 PMC08 - Conflicted Cultures of Compliance—How the Revised Federal Regulations Change Conversations Between Ethnographers and IRBs
Location: Room 313Hot Topics Track (SBER)
Montana Miller, PhD – Bowling Green State University ### 830142###Speaker @@@ Laura Henderson, MA – Baystate Health ### 420588###Speaker - 2019 SBER Conference
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4:30 PM - 5:30 PMSBER19 Networking Reception
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4:30 PM - 5:30 PMSBER19 Networking Reception
Location: Boylston Street Hallway, Level 3 - Monday, November 18, 2019
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7:00 AM - 6:00 PMA Capella Musical Performance
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7:00 AM - 8:00 AMA Capella Musical Performance
Location: Pre-Function Hall C/ Veterans Memorial Auditorium -
7:00 AM - 6:00 PMContinental Breakfast to Welcome First-Time Attendees
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7:00 AM - 8:00 AMContinental Breakfast to Welcome First-Time Attendees
Location: Ballroom A -
7:00 AM - 5:00 PMOn-Site Check-In Open
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7:00 AM - 5:00 PMOn-Site Check-In Open
Location: Pre-Function Hall C -
8:00 AM - 8:15 AMWelcome from the Conference Co-Chairs
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8:00 AM - 8:15 AMWelcome from the Conference Co-Chairs
Location: Veterans Memorial Auditorium -
8:15 AM - 8:40 AMRemarks from PRIM&R’s Executive Director, Elisa A. Hurley, PhD
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8:15 AM - 8:40 AMRemarks from PRIM&R’s Executive Director, Elisa A. Hurley, PhD
Location: Veterans Memorial Auditorium -
8:40 AM - 9:45 AMKeynote Address by Janine Clayton MD, Associate Director for Research on Women’s Health; Director Office of Research on Women’s Health, NIH: It’s About Quality Construction—Advancing a Foundational Framework for Rigorous Research Relevant to the Health of Women
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8:40 AM - 9:45 AMKeynote Address by Janine Clayton MD, Associate Director for Research on Women’s Health; Director Office of Research on Women’s Health, NIH: It’s About Quality Construction—Advancing a Foundational Framework for Rigorous Research Relevant to the Health of Women
Location: Veterans Memorial AuditoriumJanine Austin Clayton, MD – NIH ### 825084###Keynote Speaker -
9:45 AM - 10:15 AMBeverage Break With Supporters and Exhibitors
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9:45 AM - 10:15 AMBeverage Break With Supporters and Exhibitors
Location: Exhibit Hall C -
10:15 AM - 11:30 AMConcurrent Plenary Sessions
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10:15 AM - 11:30 AMPanel I: Diverse Representation in Clinical Trials—Why Does It Matter and How Do We Move Forward?
Location: Ballroom BBarbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard ### 10123###Moderator @@@ Denise Anne Dillard, PhD – Southcentral Foundation ### 824455###Panelist @@@ Tesheia Johnson, MBA, MHS – Yale University ### 829353###Panelist @@@ Paul Underwood, MD FACC – Boston Scientific Corporation ### 843651###Panelist -
10:15 AM - 11:30 AMPanel II: Using Social Behavioral Data to Provide Insight into Health-Related Experiences
Location: Veterans Memorial AuditoriumKimberly M. Nelson, PhD, MPH – Boston University School of Public Health ### 825088###Moderator @@@ Teresa Doksum, PhD, MPH – Abt Associates Inc. ### 21633###Panelist @@@ Luke Gelinas, PhD – Advarra ### 420113###Panelist @@@ Julie Slayton, JD, PhD – University of Southern California ### 112668###Panelist -
10:15 AM - 11:30 AMPanel III: What to Expect When We Sequence Expecting Moms
Location: Ballroom CJeremy Sugarman, MD, MPH, MA – Johns Hopkins University ### 10037###Moderator @@@ Josephine M. Johnston, LLB, MBHL – The Hastings Center ### 824512###Panelist @@@ Haley K. Sullivan – Duke University ### 829474###Panelist @@@ Ingrid A. Holm, MD, MPH – Boston Children's Hospital ### 844212###Panelist -
11:30 AM - 12:45 PMNetworking Luncheon
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11:30 AM - 12:45 PMNetworking Luncheon
Location: Exhibit Hall D -
11:30 AM - 12:45 PMSBER Network Luncheon
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11:30 AM - 12:45 PMSBER Network Luncheon
Location: Room 200Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno ### 585105###Speaker @@@ Linda E. Petree, BA, CIP – The University of New Mexico ### 255981###Speaker -
11:30 AM - 12:45 PMMeet the Author Luncheon and Book Signing: The Perils of Partnership: Industry Influence, Institutional Integrity, and Public Health
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11:30 AM - 12:45 PMMeet the Author Luncheon and Book Signing: The Perils of Partnership: Industry Influence, Institutional Integrity, and Public Health
Location: Ballroom ASuzanne M. Rivera, PhD, MSW – Case Western Reserve University ### 21648###Moderator @@@ Jonathan H. Marks, MA, BCL (University of Oxford equivalent to JD, LL.M.) – Pennsylvania State University ### 824595###Panelist -
12:15 PM - 12:35 PMIndustry Expert Theater: Overview of the CIP® Exam
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12:15 PM - 12:35 PMIndustry Expert Theater: Overview of the CIP® Exam
Location: Exhibit Hall C -
12:15 PM - 12:45 PMFederal Agency Office Hours
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12:15 PM - 12:45 PMFederal Agency Office Hours
Location: Exhibit Hall C -
12:15 PM - 12:45 PMMeet and Greet With Supporters and Exhibitors
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12:15 PM - 12:45 PMMeet and Greet With Supporters and Exhibitors
Location: Exhibit Hall C -
1:00 PM - 2:15 PMBreakout Session Series A
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1:00 PM - 2:15 PMA9 - The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 304IRB Operations Advanced Track
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus ### 10590###Speaker @@@ Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis ### 426680###Speaker -
1:00 PM - 2:15 PMA01 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 312Flexibility and Innovation in IRB Processes Track
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group ### 11068###Speaker @@@ Jonathan M. Green, MD, MBA – National Institutes of Health ### 420116###Speaker -
1:00 PM - 2:15 PMA02 - Defining Roles and Expectations for the Non-Scientist and Unaffiliated IRB Member—De-Constructing Regulatory and Research Terminology
Location: Room 101Educating and Training Track
Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School ### 585128###Speaker @@@ Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc. ### 10675###Speaker @@@ Nancy A. Olson, JD – Consultant ### 11093###Speaker -
1:00 PM - 2:15 PMA03 - Ethics and Governance in Learning Healthcare Systems
Location: Room 102Empirical Research Ethics Track
Paul C. McLean – Center for Bioethics, Harvard Medical School ### 824047###Speaker @@@ Nancy E. Kass, ScD – The Johns Hopkins University ### 10595###Speaker @@@ Steven Joffe, MD, MPH – University of Pennsylvania Perelman School of Medicine ### 10030###Speaker -
1:00 PM - 2:15 PMDavid G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker @@@ Kevin A. Prohaska, DO, MPH – Food and Drug Administration ### 10694###Speaker @@@ Donna L. Snyder, MD – Food and Drug Administration ### 587406###Speaker
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1:00 PM - 2:15 PMA05 - Going Global for the First Time—Considerations for Reviewing International Research
Location: Room 103Global Research Track
Rachel Zand, PhD – University of Toronto ### 171988###Speaker @@@ Delia Y. Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health ### 11119###Speaker -
1:00 PM - 2:15 PMA06 - How to Investigate, Mitigate, Report, and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 310Institutional Officials and HRPP Leadership Track
Robert Hood – AAHRPP, Inc. ### 251843###Speaker @@@ Scott J. Lipkin, DPM, CIP – Ankura Consulting ### 10598###Speaker -
1:00 PM - 2:15 PMA07 - Back to Basics—What Is the Common Rule, When Does It Apply, and What Does It Mean? (IRB Basics Track)
Location: Room 309IRB Basics Track
George Gasparis, CIP – The PEER Consulting Group ### 10676###Speaker @@@ Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS) ### 251900###Speaker @@@ Judy Matuk, MS – HRP Consulting Group ### 172024###Speaker -
1:00 PM - 2:15 PMA08 - Tag, You’re It! You've Been Appointed an IRB Chair, Now What?
Location: Room 300IRB Chairs Track
Francis J. DiMario, MD, MA, CIP – University of Connecticut ### 112602###Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Speaker -
1:00 PM - 2:15 PMA10 - Management of Incidental Findings (IFs) in Pragmatic Clinical Trials (PCTs)
Location: Room 201Pharma/Biotech Perspectives Track
Juli Bollinger, M.S. – Johns Hopkins University ### 825085###Speaker @@@ Debra JH Mathews, PhD, MA – Johns Hopkins University Berman Institute of Bioethics ### 823745###Speaker @@@ Stephanie Morain, PhD, MPH – Baylor College of Medicine ### 429255###Speaker @@@ Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University ### 10037###Speaker -
1:00 PM - 2:15 PMA11 - Legal and Regulatory Changes: A Year in Review
Location: Room 302Legal Considerations for HRPPs Track
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ### 420105###Speaker @@@ Michele Russell-Einhorn, JD – Advarra ### 10144###Speaker @@@ Laura Odwazny, JD, MA – US DHHS ### 11092###Speaker -
1:00 PM - 2:15 PMA12 - Operationalizing Data Sharing Policies—Challenges and Solutions
Location: Room 311Research involving Data and Biospecimens Track
Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker @@@ Carrie D. Wolinetz, PhD – National Institutes of Health ### 186124###Speaker -
1:00 PM - 2:15 PMA13 - Research With the Vulnerable—The Basics and Beyond
Location: Room 203Populations Requiring Additional Protections Track
Bruce G. Gordon, MD – University of Nebraska Medical Center ### 11072###Speaker @@@ Corinne Rogers, MS, CIP – New York State Psychiatric Institute ### 10618###Speaker -
1:00 PM - 2:15 PMA14 - Staying on Top of It All—Practical Strategies for Implementing Postapproval Monitoring (PAM)
Location: Room 202SBER Track
Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno ### 585105###Speaker @@@ Andrea R. McDowell, PhD – Seattle University ### 175574###Speaker -
1:00 PM - 2:15 PMA15 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 210Research Conducted in the Digital World Track
Megan Doerr, MS, LGC – Sage Bionetworks ### 427699###Speaker @@@ Adarsh K. Gupta, DO, MS, FACOFP – Rowan University ### 112619###Speaker @@@ Sara Meeder, CIP – Maimonides Medical Center ### 589958###Speaker -
1:00 PM - 2:15 PMA16 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 204Responsible Conduct of Research Track
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP) ### 10669###Speaker @@@ Kate Gallin Heffernan, JD – Verrill Dana LLP ### 10588###Speaker @@@ Jim Kroll – National Science Foundation ### 824525###Speaker -
1:00 PM - 2:15 PMA17 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 107Small Research Programs Track
Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc. ### 11058###Speaker @@@ Fredeswinda Rivera-Ocasio, MBA – InterAmerican University of Puerto Rico ### 124835###Speaker -
1:00 PM - 2:15 PMMary Ramirez, MA, CIP – University of Michigan ### 420518###Speaker @@@ Adam C. Berger, PhD – NIH ### 855125###Speaker @@@ Lyndi Lahl, RN, MS – National Institutes of Health ### 875157###Speaker
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1:00 PM - 2:15 PMJulie F. Simpson, PhD – University of New Hampshire ### 57933###Speaker @@@ Patricia B. Condon, PhD – University of New Hampshire ### 855130###Speaker
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1:00 PM - 2:15 PMA20 - Two Hats, One Head—When IRB Members Are Also Investigators
Location: Room 109Educating and Training Track
Stephanie Collins Reed, PhD – New York State Psychiatric Institute ### 112599###Speaker @@@ Ilene F. Wilets, PhD, CIP – Program for the Protection of Human Subjects ### 64126###Speaker -
1:00 PM - 2:15 PMA21 - An Introduction to the FDA and Their Regulations for the Non-Scientist IRB Member
Location: Room 108FDA-Regulated Research Track
Janet C. Donnelly, RAC – FDA ### 10577###Speaker @@@ Patrick J. McNeilly, PhD – Food and Drug Administration ### 10688###Speaker -
1:00 PM - 2:15 PMA22 - From Non-Exempt to Exempt and Back Again—Navigating Exemption 2iii
Location: Room 104IRB Operations Advanced Track
Petrice B. Longenecker, PhD, CIP – Uniformed Services University of the Health Sciences ### 252194###Speaker @@@ Laura R. Brosch, RN, PhD – Uniformed Services University of the Health Sciences ### 10143###Speaker -
1:00 PM - 2:15 PMA23 - Making Limited Review Work Without Reinventing the Wheel
Location: Room 313IRB Operations Advanced Track
David A. Borasky, Jr., MPH, CIP – WCG ### 10124###Speaker @@@ Teresa Doksum, PhD, MPH – Abt Associates Inc. ### 21633###Speaker -
2:15 PM - 2:45 PMBeverage Break With the Supporters and Exhibitors
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2:15 PM - 2:45 PMBeverage Break With the Supporters and Exhibitors
Location: Exhibit Hall C -
2:45 PM - 4:00 PMBreakout Session Series B
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2:45 PM - 4:00 PMB01 - Standard of Care, Medical Innovation, or Research—How Should We Decide?
Location: Room 302Flexibility and Innovation in IRB Processes Track
Alexander M. Capron, LLB, MA (Hon). – University of Southern California ### 10125###Speaker @@@ Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center ### 57704###Speaker @@@ Michele Russell-Einhorn, JD – Advarra ### 10144###Speaker -
2:45 PM - 4:00 PMB02 - Dear IRB, Please Tell Me What to Do and How to Avoid Mistakes
Location: Room 200Educating and Training Track
Ximena L. Levy, MD, MPH, CIP – Florida Atlantic University ### 824594###Speaker @@@ Muhammad Waseem, MD, MS, CIP, CPI, CCRP – Lincoln Medical Center ### 824687###Speaker -
2:45 PM - 4:00 PMB03 - Why Informed Consent Doesn't Work and Why the Revised Common Rule Won't Fix It
Location: Room 210Empirical Research Ethics Track
Quincy J. Byrdsong, EdD, CIP, CCRP – WellStar Health System ### 824449###Speaker @@@ Stephanie S. Cargill, PhD – Saint Louis University ### 11105###Speaker -
2:45 PM - 4:00 PMB04 - Investigational Device Exemptions (IDE) Mobile Medical Applications and IRB Review
Location: Room 311FDA-Regulated Research Track
Soma Kalb, PhD – US Food and Drug Administration ### 118703###Speaker @@@ Bakul Patel, MSEE, MBA – Center for Devices and Radiological Health (CDRH) Food and Drug Administration ### 838086###Speaker @@@ James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc. ### 10329###Speaker -
2:45 PM - 4:00 PMB05 - Foreign Influence in Research—Foreign Research Support, “Foreign Components,” and Personal Income from Foreign Entities
Location: Room 204Global Research Track
Susan Stayn, JD – Stanford University ### 11108###Speaker @@@ Nicholas A. Wallace, JD – Ropes & Gray LLP ### 821727###Speaker -
2:45 PM - 4:00 PMB06 - Use It or Lose It—Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 312Institutional Officials and HRPP Leadership Track
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University ### 284710###Speaker @@@ Michele Kennett, JD, MSN, CIP – University of Missouri ### 112633###Speaker -
2:45 PM - 4:00 PMB07 - You'll Know it When You See it, or Will You? Exploring the Regulatory Definitions for "Human Subjects Research"
Location: Room 309IRB Basics Track
Warren Capell, MD – University of Colorado Denver ### 263610###Speaker @@@ Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS ### 112639###Speaker @@@ Linda E. Petree, BA, CIP – The University of New Mexico ### 255981###Speaker -
2:45 PM - 4:00 PMB08 - The Revised Common Rule—Operational Considerations for IRB Chairs
Location: Room 310IRB Chairs Track
Jeremy J. Corsmo, MPH – Cincinnati Children's Hospital ### 58254###Speaker @@@ Barbara C. Engel, MD, PhD – Children's Hospital of Philadelphia ### 420099###Speaker -
2:45 PM - 4:00 PMB09 - Taking the Plunge—Transitioning Studies to the Revised Common Rule
Location: Room 306IRB Operations Advanced Track
Lauren Hartsmith, JD – OHRP ### 263718###Speaker @@@ John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus ### 10590###Speaker @@@ Nathalia Henry, MS, CHRC, CIP – Northwestern University ### 586792###Speaker -
2:45 PM - 4:00 PMB10 - Right to Try—Legal, Ethical, and Implementation Issues
Location: Room 203Pharma/Biotech Perspectives Track
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ### 420105###Speaker @@@ Richard Klein – GE2P2 Global ### 11087###Speaker @@@ Christine MacCracken, BSN, MSHEd – Janssen, Pharmaceutical Companies of Johnson & Johnson ### 824048###Speaker -
2:45 PM - 4:00 PMB11 - Navigating State Law Differences in the Era of Single IRB (sIRB) Review
Location: Room 202Legal Considerations for HRPPs Track
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker @@@ Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine ### 248446###Speaker -
2:45 PM - 4:00 PMB12 - Data and Biospecimens Across International Borders
Location: Room 102Research involving Data and Biospecimens Track
A. Roxana Lescano, JD, MS Bioethics (c ) – US Naval Medical Research Unit No. 6 ### 587331###Speaker @@@ Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories ### 10569###Speaker @@@ Marianne K. Henderson, MS, CPC – National Cancer Institute, NIH, DHHS ### 868040###Speaker @@@ Edward E. Bartlett, PhD – Office for Human Research Protections ### 10663###Speaker -
2:45 PM - 4:00 PMB13 - Engaging the Principal Investigators of Tomorrow With Research Ethics Today: Is It Possible?
Location: Room 101Responsible Conduct of Research Track
Charlotte H. Coley, MACT, CIP – University of North Carolina, Chapel Hill ### 112598###Speaker @@@ Leah R. Eisenberg, JD, MA – University of Arkansas for Medical Sciences ### 57700###Speaker -
2:45 PM - 4:00 PMB14 - Nuts and Bolts of Assessing IRB Compliance
Location: Room 103QA/QI and Postapproval Monitoring Track
Lisa Denney, n/a – Stanford University ### 10319###Speaker @@@ Keren R. Dunn, CIP – Cedars-Sinai Medical Center ### 10320###Speaker -
2:45 PM - 4:00 PMB15 - The Secrets of Big Data—Public, Private, or Something Else?
Location: Room 304Research Conducted in the Digital World Track
Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker -
2:45 PM - 4:00 PMB16 - Agents and Rogues—The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 107Responsible Conduct of Research Track
Robert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University ### 261880###Speaker @@@ Joseph Crossno, MS, CPIA – Central Michigan University ### 597578###Speaker -
2:45 PM - 4:00 PMB17 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 201Small Research Programs Track
Melissa McGee, J.D. – University of New Hampshire ### 824599###Speaker @@@ Heather H. Pierce, JD, MPH – Association of American Medical Colleges ### 10328###Speaker -
2:45 PM - 4:00 PMB18 - A Comparison of Human Subjects Protections Auditing Between Biomedical and Social-Behavioral Human Subjects Research
Location: Room 313SBER Track
Narayan A. Escolin, MBS, CCRP – Rutgers University ### 824458###Speaker @@@ Kate Sasamoto, JD – Office of Research Compliance Review, University of Michigan ### 609545###Speaker -
2:45 PM - 4:00 PMB19 - Research With Native American and Indigenous Populations: Ethical and Regulatory Perspectives
Location: Room 300Populations Requiring Additional Protections Track
Jyoti Angal, MPH CIP – Avera Research Institute ### 420581###Speaker @@@ Heather L. Larsen, MEd – Sisseton-Wahpeton Oyate (Sioux Tribe) ### 420595###Speaker @@@ Anita B. Frederick, MS Management – Tribal Nations Research Group ### 418856###Speaker -
2:45 PM - 4:00 PMB20 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 104Flexibility and Innovation in IRB Processes Track
Irene E. Stith-Coleman, PhD – Office for Human Research Protections ### 11110###Speaker @@@ Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention ### 10627###Speaker -
2:45 PM - 4:00 PMB21 - ClinicalTrials.gov—How Academic Institutions Can Meet Clinical Trial Disclosure Requirements
Location: Room 206Pharma/Biotech Perspectives Track
Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard ### 609692###Speaker @@@ Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIH ### 112684###Speaker -
2:45 PM - 4:00 PMB22 - Ethical Considerations in Vaccine Development and Use
Location: Room 108Pharma/Biotech Perspectives Track
Walter L. Straus, MD, MPH – Merck Co., Inc. ### 11111###Speaker @@@ Jennifer E. Gerber, MSc – Johns Hopkins Bloomberg School of Public Health ### 824049###Speaker @@@ Jason L. Schwartz, PhD, MBE – Yale School of Public Health ### 824640###Speaker -
2:45 PM - 4:00 PMB23 - Flexible Strategies to Manage Unregulated Research in the Era of the Revised Common Rule
Location: Room 111Flexibility and Innovation in IRB Processes Track
Jeffrey A. Cooper, MD, MMM – WIRB-Copernicus Group ### 112600###Speaker -
4:00 PM - 5:00 PMBreakout Session Series B
-
4:00 PM - 5:00 PMAER19 Welcome Reception Supported by CITI Program
Location: Exhibit Hall C -
4:10 PM - 4:30 PMIndustry Expert Theater: Overview and Demonstration of PRIM&R’s Ethical Research Oversight Course (EROC)
-
4:10 PM - 4:30 PMIndustry Expert Theater: Overview and Demonstration of PRIM&R’s Ethical Research Oversight Course (EROC)
Location: Exhibit Hall C -
5:00 PM - 6:00 PMYoung Professionals Networking Reception
-
5:00 PM - 6:00 PMYoung Professionals Networking Reception
Location: Trident Booksellers and Café (off-site) - Tuesday, November 19, 2019
-
7:00 AM - 6:00 PMA Capella Musical Performance
-
7:00 AM - 8:00 AMA Capella Musical Performance
Location: Pre-Function Hall C/ Veterans Memorial Auditorium -
7:00 AM - 6:00 PMNetworking Breakfast
-
7:00 AM - 8:00 AMNetworking Breakfast
Location: Exhibit Halls C and D -
7:00 AM - 5:00 PMOn-Site Check-In Open
-
7:00 AM - 5:00 PMOn-Site Check-In Open
Location: Pre-Function Hall C -
7:15 AM - 7:35 AMIndustry Expert Theater: AER19 Poster Presentation
-
7:15 AM - 7:35 AMIndustry Expert Theater: AER19 Poster Presentation—Accelerating Clinical Coordinator Excellence (ACCE): Building for Excellence, Success and Empowerment
Location: Exhibit Hall CAbby Keeley, MS, CIP – Washington University School of Medicine in St. Louis ### 255930###Speaker -
7:40 AM - 8:00 AMIndustry Expert Theater: SkyiRIS Research Network for the NIH Single IRB of Use
-
7:40 AM - 8:00 AMIndustry Expert Theater: SkyiRIS Research Network for the NIH Single IRB of Use
Location: Exhibit Hall CWilliam Schroeder – iMedRIS ### 906915###Speaker -
8:00 AM - 8:05 AMWelcome from the Conference Co-Chairs
-
8:00 AM - 8:05 AMWelcome from the Conference Co-Chairs
Location: Veterans Memorial Auditorium -
8:05 AM - 8:10 AMPresentation of PRIM&R’s Distinguished Service Award to Robert S. Bienkowski, PhD, Central Michigan University
-
8:05 AM - 8:10 AMPresentation of PRIM&R’s Distinguished Service Award to Robert S. Bienkowski, PhD, Central Michigan University
Location: Veterans Memorial Auditorium -
8:10 AM - 8:15 AMPresentation of PRIM&R’s Applied Research Ethics National Association Legacy Award to Susan Z. Kornetsky, MPH, Boston Children's Hospital
-
8:10 AM - 8:15 AMPresentation of PRIM&R’s Applied Research Ethics National Association Legacy Award to Susan Z. Kornetsky, MPH, Boston Children's Hospital
Location: Veterans Memorial Auditorium -
8:15 AM - 8:40 AMRemarks from PRIMR’s Chair of Board of Directors, Heather H. Pierce, JD, MPH
-
8:15 AM - 8:40 AMRemarks from PRIM&R’s Board of Directors Chair, Heather H. Pierce, JD, MPH
Location: Veterans Memorial Auditorium -
8:40 AM - 9:45 AMKeynote Address by Scott D. Halpern, MD, PhD, Professor of Medicine, Epidemiology, and Medical Ethics and Health Policy, University of Pennsylvania: Financial Incentives and Nudges for Research Participation—Undue, Unjust, or Uncertain?
-
8:40 AM - 9:45 AMKeynote Address by Scott D. Halpern, MD, PhD, Professor of Medicine, Epidemiology, and Medical Ethics and Health Policy, University of Pennsylvania: Financial Incentives and Nudges for Research Participation—Undue, Unjust, or Uncertain?
Location: Veterans Memorial AuditoriumScott D. Halpern, MD, PhD – University of Pennsylvania Perelman School of Medicine ### 824498###Keynote Speaker -
9:45 AM - 10:15 AMBeverage Break With Supporters and Exhibitors
-
9:45 AM - 10:15 AMBeverage Break With Supporters and Exhibitors
Location: Exhibit Hall C -
10:15 AM - 12:45 PMBreakout Session Series C
-
10:15 AM - 12:45 PMC01 - HRPP Innovation Showcase—Creative Approaches to IRB Challenges
Location: Room 203Flexibility and Innovation in IRB Processes Track
Madelon V. Baranoski, PhD, CIP – Yale University ### 433404###Speaker @@@ Jeri Burr, RN-BC, MS, CCRC, FACRP – University of Utah ### 824448###Speaker @@@ Martha Jones, MA, CIP – Partners HealthCare System, Inc. ### 59861###Speaker @@@ Christine Suver, PhD – Sage Bionetworks ### 262889###Speaker -
10:15 AM - 12:45 PMC02 - I Love My Job!? Perspectives Throughout a Career in Human Research Protections
Location: Room 312Educating and Training Track
Tonya Ferraro, MEd – Boston Children's Hospital ### 420587###Speaker @@@ Danielle A. Griffin, Ed.D., CIP – University of Houston ### 824496###Speaker @@@ Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention ### 10627###Speaker @@@ Ada Sue Selwitz, MA – University of Kentucky ### 11100###Speaker -
10:15 AM - 11:30 AMC03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Ballroom AResearch involving Data and Biospecimens Track
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center ### 112649###Speaker @@@ Nicholas A. Wallace, JD – Ropes & Gray LLP ### 821727###Speaker @@@ Carol Juliet Weil, JD – National Cancer Institute ### 10624###Speaker -
10:15 AM - 11:30 AMC04 - Bioresearch Monitoring (BIMO) Inspections—Regulatory Violations Observed in IRB and Clinical Investigator Inspections
Location: Room 101FDA-Regulated Research Track
Kavita C. Dada, Pharm, D. RAC – Food and Drug Administration ### 824454###Speaker @@@ Jan L. Hewett, BSN, JD – Food & Drug Administration ### 43213###Speaker -
10:15 AM - 11:30 AMC05 - European Union (EU) General Data Protection Regulation (GDPR)
Location: Room 302Global Research Track
Kristin J. Craun, MPH, CIP – University of California Los Angeles ### 114622###Speaker @@@ Michael A. DiMaio – Ropes & Gray LLP ### 825251###Speaker -
10:15 AM - 11:30 AMC06 - Not Less Work, but Different—Re-Engineering for Single IRB (sIRB) Review
Location: Room 210Institutional Officials and HRPP Leadership Track
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker @@@ Kimberly K. Summers, PharmD – University of Texas Health San Antonio ### 420574###Speaker -
10:15 AM - 12:45 PMC07 - Covering All Your Bases: Considerations and Tips for How to Identify and Apply the Appropriate Federal Regulations for IRB Review
Location: Room 304IRB Basics Track
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University ### 609634###Speaker @@@ Warren Capell, MD – University of Colorado Denver ### 263610###Speaker @@@ Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health ### 187400###Speaker -
10:15 AM - 12:45 PMLuke Gelinas, PhD – Advarra ### 420113###Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Speaker @@@ Brenda J. Klement – Morehouse School of Medicine ### 824524###Speaker
-
10:15 AM - 12:45 PMC09 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 306IRB Operations Advanced Track
Holly Bante, PhD, MPH – University of Cincinnati ### 824368###Speaker @@@ Ann Johnson, PhD, MPH, CIP – University of Utah ### 298549###Speaker @@@ Hallie Kassan, MS, CIP – Northwell Health ### 57719###Speaker @@@ Janelle A. Maddox-Regis, MS – Johns Hopkins University SOM ### 609637###Speaker -
10:15 AM - 11:30 AMC10 - A Case-Based Assessment of Post-Trial Access to Investigational Medicines
Location: Room 107Pharma/Biotech Perspectives Track
Karla Childers, MSJ – Johnson & Johnson ### 418855###Speaker @@@ Ariella Kelman, MD – Genentech, a member of the Roche Group ### 420841###Speaker -
10:15 AM - 12:45 PMC11 - Risky Business—Defining Research Risks and Who Faces Them in the Age of Comparative Effectiveness Research and Alternative Trial Design
Location: Room 103Legal Considerations for HRPPs Track
Kate Gallin Heffernan, JD – Verrill Dana LLP ### 10588###Speaker @@@ Todd W. Rice, MD – Vanderbilt University Medical Center ### 821446###Speaker -
10:15 AM - 11:30 AMC12 - Considerations for Return of Results and Incidental Findings
Location: Room 102Research involving Data and Biospecimens Track
Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories ### 10569###Speaker @@@ P. Pearl O'Rourke, MD – Harvard Medical School ### 112647###Speaker -
10:15 AM - 12:45 PMC13 - IRB Review of Research With Children
Location: Room 309Populations Requiring Additional Protections Track
Ran Goldman, MD – University of British Columbia ### 824461###Speaker @@@ Bethany Johnson, JD, CIP – Indiana University ### 609633###Speaker @@@ Andrew Neel, CIP – Indiana University ### 824618###Speaker -
10:15 AM - 11:30 AMC14 - Nuts and Bolts of Investigator Site Audits
Location: Room 202QA/QI and Postapproval Monitoring Track
Stephanie deRijke, RN, MSN – Emory University ### 256471###Speaker @@@ Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh ### 10578###Speaker -
10:15 AM - 11:30 AMC15 - Social Media in Research—Recruitment, Subject Communication, and Data Source
Location: Ballroom CResearch Conducted in the Digital World Track
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania ### 420145###Speaker @@@ Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ### 420105###Speaker @@@ Stephanie Morain, PhD, MPH – Baylor College of Medicine ### 429255###Speaker -
10:15 AM - 11:30 AMC16 - Conducting Research Misconduct Investigations When Human Subjects Research Is Involved—Case Studies and Best Practices
Location: Room 300Responsible Conduct of Research Track
Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services ### 261881###Speaker @@@ David J. Hudson, PhD – University of Virginia ### 824510###Speaker -
10:15 AM - 11:30 AMC17 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 201Small Research Programs Track
Sharon C. Freitag, BSc – Unity Health Toronto Providence St. Joseph's and St. Michael's Healthcare ### 42223###Speaker @@@ Jennifer L. Pacheco, MPH, CIM, CIP – Baystate Health ### 594020###Speaker -
10:15 AM - 11:30 AMEmily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine ### 21622###Speaker @@@ Cecilia Brooke Cholka, MA, CIP – University of Nevada, Reno ### 585105###Speaker
-
10:15 AM - 11:30 AMLara N. Sloboda, PhD – Dana Farber Cancer Insititute ### 181613###Speaker @@@ Matt D. Stafford, MPH – Boston Children's Hospital ### 57750###Speaker
-
10:15 AM - 12:45 PMC20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches
Location: Room 311IRB Operations Advanced Track
Susan Z. Kornetsky, MPH – Boston Children's Hospital ### 10134###Speaker @@@ Sariah Fuller – University of Utah ### 843617###Speaker @@@ Holly A. Taylor, PhD, MPH – NIH ### 57753###Speaker -
10:15 AM - 12:45 PMC21 - A Look into the Crystal Ball—The HRPP of the Future
Location: Room 310Institutional Officials and HRPP Leadership Track
John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ Nichelle Cobb, PhD – University of Wisconsin-Madison ### 173305###Speaker @@@ Rachel A. Wenzl, MPH, CIP – Research Compliance Services, University of Nebraska - Lincoln ### 825254###Speaker -
10:15 AM - 12:45 PMC22 - Scientific Aspects of Study Design—A Primer for Non-Scientists
Location: Room 108Educating and Training Track
Susan S. Fish, PharmD, MPH – Boston University School of Public Health ### 11071###Speaker @@@ Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus Group ### 10687###Speaker -
10:15 AM - 12:45 PMC23 - Exempt Human Subjects Research Case Studies— Implementing Changes to the Exemption Categories Under the Revised Common Rule
Location: Room 206IRB Operations Advanced Track
Christine DeLussey, MS, CIP – Children's Hospital of Philadelphia ### 830299###Speaker @@@ Julie M. Eiserman, MA, CCRP – National Institutes of Health ### 830300###Speaker @@@ Caitlin Alcorn, MPA, CIP – University of Oregon ### 840256###Speaker -
11:30 AM - 11:45 AMBreak
-
11:30 AM - 11:45 AM
-
11:45 AM - 12:05 PMIndustry Expert Theater: AER19 Poster Presentation
-
11:45 AM - 12:05 PMIndustry Expert Theater: AER19 Poster Presentation—IRB Members' Assessment of Minimal Risk Procedures in Pregnancy
Location: Exhibit Hall CAmina A. White, MD, MA – University of North Carolina at Chapel Hill ### 847720###Speaker -
11:45 AM - 12:45 PMFederal Agency and Accrediting Body Dialogue Sessions
-
11:45 AM - 12:45 PMA Dialogue With AAHRPP, Inc.
Location: Room 202Mary L. Fields, BA (Psychology), CIP – Association for the Accreditation of Human Research Protection Programs ### 284711###Speaker @@@ Robert Hood – AAHRPP, Inc. ### 251843###Speaker @@@ Lori Kravchick – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 641618###Speaker @@@ Elyse I. Summers, JD – Association for the Accreditation of Human Research Protection Programs, Inc. ### 10699###Speaker @@@ Kate Vulakovich – The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 587411###Speaker @@@ Jemelle Williams – AAHRPP ### 857461###Speaker -
11:45 AM - 12:45 PMA Dialogue With DHHS Office for Civil Rights (OCR)
Location: Room 107Marissa Gordon-Nguyen, JD, MPH – HHS ### 441562###Speaker @@@ Linda Sanches, MPH – HHS ### 879286###Speaker @@@ Nick Heesters, JD – HHS ### 879287###Speaker -
11:45 AM - 12:45 PMA Dialogue with DoD
Location: Room 313Laura R. Brosch, RN, PhD – Uniformed Services University of the Health Sciences ### 10143###Speaker @@@ Stephanie Bruce, CIP, CPIA – Department of Defense ### 255575###Speaker @@@ John Lee Melton, PhD, CDR, MSC, USN – Department of Navy ### 429110###Speaker -
11:45 AM - 12:45 PMA Dialogue With DOE
Location: Room 204Cheri Hautala-Bateman – Department of Energy/National Nuclear Security Administration ### 593731###Speaker @@@ James E. Morris – Department of Energy ### 824045###Speaker @@@ Elizabeth P. White, MBA, MPH, CIP – United States Department of Energy ### 10625###Speaker -
11:45 AM - 12:45 PMA Dialogue With FDA
Location: Ballroom CJoanne R. Less, PhD – US Food and Drug Administration ### 10597###Speaker @@@ Diane M. Maloney, JD – Food and Drug Administration ### 10601###Speaker @@@ Kevin A. Prohaska, DO, MPH – Food and Drug Administration ### 10694###Speaker @@@ Soma Kalb, PhD – US Food and Drug Administration ### 118703###Speaker @@@ Kavita C. Dada, Pharm, D. RAC – Food and Drug Administration ### 824454###Speaker @@@ Patrick J. McNeilly, PhD – Food and Drug Administration ### 10688###Speaker -
11:45 AM - 12:45 PMA Dialogue with NIH
Location: Room 101Carrie D. Wolinetz, PhD – National Institutes of Health ### 186124###Speaker -
11:45 AM - 12:45 PMA Dialogue With OHRP
Location: Ballroom BLisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP) ### 10669###Speaker @@@ Julie Kaneshiro, MA – Office for Human Research Protections ### 11084###Speaker @@@ Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS ### 112639###Speaker @@@ Irene E. Stith-Coleman, PhD – Office for Human Research Protections ### 11110###Speaker @@@ Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker -
11:45 AM - 12:45 PMA Dialogue With ORI
Location: Room 109Yvette M. Carter, MD – Office of Research Integrity, Department of Health and Human Services ### 261881###Speaker -
11:45 AM - 12:45 PMA Dialogue With Patient Centered Outcomes Research Institute (PCORI)
Location: Room 111Jason Gerson, PhD – Patient-Centered Outcomes Research Institute ### 420114###Speaker -
11:45 AM - 12:45 PMA Dialogue With SACHRP
Location: Room 201Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems ### 420561###Speaker @@@ Nancy M.P King, JD – Wake Forest School of Medicine ### 586820###Speaker @@@ Julia G. Gorey, JD – OHRP ### 11073###Speaker @@@ David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker -
11:45 AM - 12:45 PMA Dialogue With the VA
Location: Room 302Kristina C. Borror, PhD – Veterans Health Administration ### 10668###Speaker @@@ Cynthia L. Boudreaux, M.Ed – Department of Veterans Affairs ### 824372###Speaker @@@ Charlotte K. Jeans, PhD, CCRN, CIP – Department of Veterans Affairs ### 426712###Speaker @@@ Mary M. Klote, MD, CIP – Veterans Health Administration ### 187333###Speaker -
11:45 AM - 12:45 PMMeet and Greet With the Supporters and Exhibitors, View the AER19 Posters
-
11:45 AM - 12:45 PMMeet and Greet With the Supporters and Exhibitors, View the AER19 Posters
Location: Exhibit Hall C -
11:45 AM - 12:45 PMPRIM&R’s Guide to Speaking at the AER Conference
-
11:45 AM - 12:45 PMPRIM&R’s Guide to Speaking at the AER Conference
Location: Room 300Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc. ### 10675###Speaker @@@ Kelly Unsworth, MS, CCRP, CIP – University of Rochester ### 187438###Speaker @@@ Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker -
11:45 AM - 12:45 PMThe Certified IRB Professional (CIP®) Credential—How Do I Get Started?
-
11:45 AM - 12:45 PMThe Certified IRB Professional (CIP®) Credential—How Do I Get Started?
Location: Room 102Lori Roesch, CIM, CIP – Children's Hospital of Wisconsin ### 57742###Speaker @@@ Andrew Hedrick, MPA, CIP – The Ohio State University ### 172015###Speaker @@@ David C. Matesanz, JD, CIP – Kaiser Permanente - Northern California ### 880506###Speaker -
12:10 PM - 12:30 PMIndustry Expert Theater: AER19 Poster Presentation
-
12:10 PM - 12:30 PMIndustry Expert Theater: AER19 Poster Presentation—What Ethical Challenges Do Pragmatic Trials Pose for the Oversight of Human Subjects Research? An Interview Study With Key Stakeholders
Location: Exhibit Hall CStuart G. Nicholls, PhD – Clinical Epidemiology Program, Ottawa Hospital Research Institute ### 847723###Speaker -
12:45 PM - 1:45 PMAttendee Open Lunch Period
-
12:45 PM - 1:45 PM
-
2:00 PM - 3:15 AMConcurrent Plenary Sessions
-
2:00 PM - 3:15 PMPanel IV: Identifying and Avoiding the Conduct of Low Value Clinical Trials
Location: Ballroom BJohn R. Baumann, PhD – Indiana University ### 57670###Moderator @@@ Laura Odwazny, JD, MA – US DHHS ### 11092###Moderator @@@ Eileen M. O'Reilly, MD – Memorial Sloan Kettering Cancer Center ### 824620###Panelist @@@ Deborah Zarin, MD – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Medical School ### 10628###Panelist @@@ Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems ### 420561###Panelist -
2:00 PM - 3:15 PMPanel V: Bioethics Turns 50—Reflections from The Hastings Center
Location: Ballroom CMildred Z. Solomon, EdD – The Hastings Center ### 57748###Moderator @@@ Steven Joffe, MD, MPH – University of Pennsylvania Perelman School of Medicine ### 10030###Panelist @@@ Nancy M.P King, JD – Wake Forest School of Medicine ### 586820###Panelist @@@ Alex John London, PhD – Carnegie Mellon University ### 418860###Panelist @@@ Karen J. Maschke, PhD – The Hastings Center ### 114629###Panelist -
2:00 PM - 3:15 PMConcurrent Plenary Sessions
-
2:00 PM - 3:15 PMPanel VI: Studying Suicide and Subjects at Risk for Suicide—Identifying and Minimizing Risk to Promote Necessary Research
Location: Veterans Memorial AuditoriumDavid H. Strauss, MD – Columbia University ### 10147###Moderator @@@ Celia B. Fisher, PhD – Fordham University ### 57702###Panelist @@@ Samantha Marquez McKetchnie, LCSW – Massachusetts General Hospital ### 829354###Panelist -
3:15 PM - 3:45 PMBeverage Break With the Supporters and Exhibitors
-
3:15 PM - 3:45 PMBeverage Break With the Supporters and Exhibitors
Location: Exhibit Hall C -
3:45 PM - 5:00 PMBreakout Session Series D
-
3:45 PM - 5:00 PMD01 - Lost in Transition? Flexible and Innovative Approaches to the Revised Common Rule
Location: Room 210Flexibility and Innovation in IRB Processes Track
Charles Brightbill, CIM, CIP – Geisinger Health System ### 824373###Speaker @@@ Cynthia S. Shindledecker, B.A., CIP – University of Michigan ### 25718###Speaker -
3:45 PM - 5:00 PMD02 - Paving the Road to Success—Meeting the Challenges of Investigator and Study Team Education
Location: Room 200Educating and Training Track
Kelly Unsworth, MS, CCRP, CIP – University of Rochester ### 187438###Speaker @@@ Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital ### 10574###Speaker -
3:45 PM - 5:00 PMD03 - Looking Through the Bars—Responsible Research With Prisoners
Location: Room 203Populations Requiring Additional Protections Track
Julia G. Gorey, JD – OHRP ### 11073###Speaker @@@ Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc. ### 429992###Speaker -
3:45 PM - 5:00 PMD04 - FDA’s Oversight of ClinicalTrials.gov Requirements
Location: Room 309FDA-Regulated Research Track
Anthony Keyes, MBA, PMP – Johns Hopkins University ### 586819###Speaker @@@ Patrick J. McNeilly, PhD – Food and Drug Administration ### 10688###Speaker -
3:45 PM - 5:00 PMRobert S. Bienkowski, PhD, CIP, CHRC, ECoP – Central Michigan University ### 261880###Speaker @@@ Lisa A. Griffin, JD, MPH – Brigham and Women's Healthcare, Inc. ### 114626###Speaker
-
3:45 PM - 5:00 PMD06 - Complex Institutional Relationships—Going Beyond the Multi-site Model
Location: Room 202Institutional Officials and HRPP Leadership Track
Kristin J. Craun, MPH, CIP – University of California Los Angeles ### 114622###Speaker @@@ Sara Chandros Hull, PhD – NIH ### 10593###Speaker @@@ Mary M. Klote, MD, CIP – Veterans Health Administration ### 187333###Speaker @@@ Theresa M. Straut, RAC, CIP – US Army, Combat Capabilities Development Command, Army Research Laboratory ### 609630###Speaker -
3:45 PM - 5:00 PMD07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule
Location: Room 306IRB Basics Track
Elizabeth A. Bankert, MA – Dartmouth College ### 57668###Speaker @@@ Lauren Hartsmith, JD – OHRP ### 263718###Speaker @@@ Cheryl A. Savini – The HRP Consulting Group ### 21651###Speaker -
3:45 PM - 5:00 PMD08 - The Role of IRBs Chairs in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 311IRB Chairs Track
Francis J. DiMario, MD, MA, CIP – University of Connecticut ### 112602###Speaker @@@ Michael J. Linke, PhD, CIP – University of Cincinnati College of Medicine ### 248446###Speaker -
3:45 PM - 5:00 PMD09 - Ensuring IRB Compliance in a Hybrid World—Strategies for Operating in a World Where Multiple Regulatory Frameworks Apply
Location: Room 310IRB Operations Advanced Track
Martha Jones, MA, CIP – Partners HealthCare System, Inc. ### 59861###Speaker @@@ Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker -
3:45 PM - 5:00 PMD10 - Returning Research Results to Participants—Whose Job Is It?
Location: Room 201Pharma/Biotech Perspectives Track
Gianna McMillan, DBe – Loyola Marymount University ### 11611###Speaker @@@ Carol Juliet Weil, JD – National Cancer Institute ### 10624###Speaker @@@ Karla Childers, MSJ – Johnson & Johnson ### 418855###Speaker -
3:45 PM - 5:00 PMD11 - Is Your HRPP Due for a Policy Refresh? Re-Thinking Policies and Processes Related to Conflicts of Interest and Research Integrity
Location: Room 206Legal Considerations for HRPPs Track
Heather H. Pierce, JD, MPH – Association of American Medical Colleges ### 10328###Speaker @@@ Emily M.Q Schriver, JD – The Ohio State University ### 824639###Speaker @@@ Michael J. Vernick, JD – Hogan Lovells US LLP ### 828346###Speaker -
3:45 PM - 5:00 PMD12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 304Research involving Data and Biospecimens Track
Gretchen L. J Anding, MA – University of Wisconsin-Madison ### 418825###Speaker @@@ Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout ### 10572###Speaker -
3:45 PM - 5:00 PMD13 - Inclusion of Pregnant Women in Clinical Trials
Location: Room 101Populations Requiring Additional Protections Track
Kristine Shields, MSN, DRPH – Shields Medical Writing and Consulting ### 824642###Speaker @@@ Leyla Sahin, MD – FDA ### 857460###Speaker -
3:45 PM - 5:00 PMD14 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Room 302QA/QI and Postapproval Monitoring Track
Nichelle Cobb, PhD – University of Wisconsin-Madison ### 173305###Speaker @@@ Neala Lane, MS, CCRC – Indiana University ### 824565###Speaker @@@ Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard ### 609692###Speaker -
3:45 PM - 5:00 PMD15 - Mobile Health Research: Regulatory and Ethical Challenges
Location: Ballroom AResearch Conducted in the Digital World Track
Luke Gelinas, PhD – Advarra ### 420113###Speaker @@@ Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard ### 10123###Speaker @@@ Laura Odwazny, JD, MA – US DHHS ### 11092###Speaker -
3:45 PM - 5:00 PMD16 - Responsible Conduct of Research (RCR) for Research Leaders—Integrating Research Administration for a Successful Collaborative Framework
Location: Room 107Responsible Conduct of Research Track
John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc. ### 10329###Speaker @@@ Jane Strasser – University of Cincinnati ### 824683###Speaker -
3:45 PM - 5:00 PMD17 - Flying Solo—A Moderated Discussion on Opportunities Available for Single Staff IRB Offices
Location: Room 204Small Research Programs Track
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago ### 263607###Speaker @@@ Andrea R. McDowell, PhD – Seattle University ### 175574###Speaker @@@ Rachel Zand, PhD – University of Toronto ### 171988###Speaker -
3:45 PM - 5:00 PMD18 - Reviewing SBER—A Guide for the Non-Scientist, Unaffiliated IRB Member
Location: Room 108SBER Track
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine ### 21622###Speaker @@@ Amy Corneli, PhD, MPH – Duke University ### 112601###Speaker -
3:45 PM - 5:00 PMD19 - IRBs and Ethnographers—Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding
Location: Room 313SBER Track
Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker @@@ Montana Miller, PhD – Bowling Green State University ### 830142###Speaker -
3:45 PM - 5:00 PMJ. Andrew Bertolatus, MD – University of Iowa ### 112581###Speaker @@@ Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center ### 57704###Speaker @@@ Kerry A. Agnitsch, PhD – Iowa State University ### 855362###Speaker
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3:45 PM - 5:00 PMD21 - Situational Vulnerability—Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Room 312Populations Requiring Additional Protections Track
John A. Guidry, PhD – TRX Development Soutions ### 112618###Speaker @@@ Matan Benyishay, MPP – AIDS Action Committee/Fenway Health ### 837945###Speaker @@@ Dana J. Pardee, BS – The Fenway Institute ### 850368###Speaker -
3:45 PM - 5:00 PMD22 - The Keys to Key Information—An Interactive Workshop
Location: Room 103IRB Operations Advanced Track
Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS ### 112639###Speaker @@@ Jerry A. Menikoff, MD, JD – Office for Human Research Protections ### 11091###Speaker -
3:45 PM - 5:00 PMD23 - Challenges and Lessons for Implementing New Exemption 4(iii)—Secondary Research Involving Only Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule-Protected Identifiable Health Information
Location: Room 102Research involving Data and Biospecimens Track
Kim Fowler, CIP, CIM – University of Georgia ### 843740###Speaker @@@ Megan McFarland, MS, CIP, CCRP – Army Human Research Protections Office (AHRPO) ### 843741###Speaker -
5:00 PM - 6:00 PMFederal Agency Office Hours
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5:00 PM - 6:00 PMFederal Agency Office Hours
Location: Exhibit Hall C -
5:00 PM - 6:00 PMMeet the AER19 Poster Authors
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5:00 PM - 6:00 PMMeet the AER19 Poster Authors
Location: Exhibit Hall C -
5:00 PM - 6:00 PMNetworking Reception With the Supporters and Exhibitors
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5:00 PM - 6:00 PMNetworking Reception With the Supporters and Exhibitors
Location: Exhibit Hall C -
5:10 PM - 5:30 PMIndustry Expert Theater: AER19 Poster Presentation
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5:10 PM - 5:30 PMIndustry Expert Theater: AER19 Poster Presentation—Novice Researcher Confidence Before and After the Implementation of an Informed Consent Simulation Workshop Enlisting the Feedback of Former Research Volunteers
Location: Exhibit Hall CSusan Garrow-Sloan, RN, BSN, CCRP – Baystate Health ### 864103###Speaker @@@ Judith Pride, RN, MSHS, CCRC, CCRP, CIP – Baystate Health ### 864102###Speaker -
5:35 PM - 5:55 PMIndustry Expert Theater: AER19 Poster Presentation
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5:35 PM - 5:55 PMIndustry Expert Theater: AER19 Poster Presentation—The Consent Language Explicit and Reasonable (CLEAR) Initiative
Location: Exhibit Hall CMarilyn Eshikena, MS, CIP – Icahn School of Medicine at Mount Sinai ### 847719###Speaker - Wednesday, November 20, 2019
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7:00 AM - 6:00 PMA Capella Musical Performance
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7:00 AM - 8:00 AMA Capella Musical Performance
Location: Pre-Function Hall C/ Veterans Memorial Auditorium -
7:00 AM - 12:30 PMOn-Site Check-In Open
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7:00 AM - 12:30 PMOn-Site Check-In Open
Location: Pre-Function Hall C -
8:00 AM - 8:10 AMWelcome from the Conference Co-Chairs
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8:00 AM - 8:10 AMWelcome from the Conference Co-Chairs
Location: Veterans Memorial Auditorium -
8:10 AM - 8:20 AMPRIM&R Membership Update
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8:10 AM - 8:20 AMPRIM&R Membership Update
Location: Veterans Memorial Auditorium -
8:20 AM - 8:30 AMPRIM&R CIP® Update
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8:20 AM - 8:30 AMPRIM&R CIP® Update
Location: Veterans Memorial Auditorium -
8:30 AM - 9:30 AMKeynote Address by Mary Elizabeth Williams, BA, Writer, Speaker, Consultant: Keeping the Humanity in Human Subjects Trials
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8:30 AM - 9:30 AMKeynote Address by Mary Elizabeth Williams, BA, Writer, Speaker, Consultant: Keeping the Humanity in Human Subjects Trials
Location: Veterans Memorial AuditoriumMary Elizabeth Williams, BA – maryelizabethwilliams.net ### 824690###Speaker -
9:30 AM - 10:00 AMBeverage Break With Supporters and Exhibitors
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9:30 AM - 10:00 AMBeverage Break With Supporters and Exhibitors
Location: Exhibit Hall C -
9:30 AM - 10:00 AMBook Signing With Keynote Speaker Mary Elizabeth Williams, BA, Writer, Speaker, Consultant
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9:30 AM - 10:00 AMBook Signing With Keynote Speaker Mary Elizabeth Williams, BA, Writer, Speaker, Consultant
Location: Exhibit Hall CMary Elizabeth Williams, BA – maryelizabethwilliams.net ### 824690###Speaker -
10:00 AM - 11:15 AMConcurrent Plenary Sessions
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10:00 AM - 11:15 AMPanel VII: From Fortnite to Facebook—Data Security and Breaches, Downstream Harms, and the (Precarious) Role of IRBs
Location: Ballroom BJacob Metcalf, PhD – Ethical Resolve, LLC ### 425289###Panelist @@@ James R. Foulds, PhD – University of Maryland, Baltimore County ### 829349###Panelist @@@ Stephen J. Rosenfeld, MD, MBA – Freeport Research Systems ### 420561###Panelist -
10:00 AM - 11:15 AMPanel VIII: The Challenges of Studying Marijuana Use in the United States
Location: Ballroom CAlbert J. Allen, MD, PhD – Eli Lilly and Company ### 22648###Moderator @@@ Benjamin C. Silverman, MD – Partners HealthCare System, Inc. ### 824672###Panelist @@@ Juliette Roddy, PhD – University of Michigan Dearborn ### 828547###Panelist @@@ Beth Watters, JD – Partners HealthCare System, Inc. ### 856030###Panelist -
10:00 AM - 11:15 AMFive Repeat Breakout Sessions from AER19 Breakout Series A Through E
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10:00 AM - 11:15 AMRepeat Breakout Session (A9): The Etiquette and Necessity of Communication in the Single IRB World
Location: Room 302IRB Operations Advanced Track
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus ### 10590###Speaker @@@ Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis ### 426680###Speaker -
10:00 AM - 11:15 AMRepeat Breakout Session (B15): The Secrets of Big Data—Public, Private, or Something Else?
Location: Room 306Research Conducted in the Digital World Track
Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker -
10:00 AM - 11:15 AMRepeat Breakout Session (C3): Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Room 312Research involving Data and Biospecimens Track
Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center ### 112649###Speaker @@@ Nicholas A. Wallace, JD – Ropes & Gray LLP ### 821727###Speaker @@@ Carol Juliet Weil, JD – National Cancer Institute ### 10624###Speaker -
10:00 AM - 11:15 AMRepeat Breakout Session (D1): Lost in Transition? Flexible and Innovative Approaches to the Revised Common Rule
Location: Room 210Flexibility and Innovation in IRB Processes Track
Cynthia S. Shindledecker, B.A., CIP – University of Michigan ### 25718###Speaker @@@ Charles Brightbill, CIM, CIP – Geisinger Health System ### 824373###Speaker -
10:00 AM - 11:15 AMRepeat Breakout Session (E2): Strategies for IRB Member Education
Location: Room 304Educating and Training Track
Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine ### 21622###Speaker @@@ Toby L. Schonfeld, PhD – Prime Review Board ### 112660###Speaker -
11:15 AM - 11:30 AMBreak
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11:15 AM - 11:30 AM
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11:30 AM - 12:45 PMBreakout Session Series E
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11:30 AM - 12:45 PME01 - Innovations in IRB Evaluation and Improvement
Location: Room 210Flexibility and Innovation in IRB Processes Track
Holly A. Taylor, PhD, MPH – NIH ### 57753###Speaker @@@ Ilene F. Wilets, PhD, CIP – Program for the Protection of Human Subjects ### 64126###Speaker -
11:30 AM - 12:45 PMToby L. Schonfeld, PhD – Prime Review Board ### 112660###Speaker @@@ Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of Medicine ### 21622###Speaker
-
11:30 AM - 12:45 PME03 - Integrating Empirical Research Ethics into IRB Decisions for Studies Involving Vulnerable Populations
Location: Room 104Empirical Research Ethics Track
Celia B. Fisher, PhD – Fordham University ### 57702###Speaker @@@ Nicole M. Overstreet, PhD – Clark University ### 843744###Speaker -
11:30 AM - 12:45 PME04 - Assessing the Prospect of Direct Benefit in Early-Phase Pediatric Studies
Location: Room 202FDA-Regulated Research Track
Melanie Bhatnagar, MD – Food & Drug Administration ### 824369###Speaker @@@ Donna L. Snyder, MD – Food and Drug Administration ### 587406###Speaker @@@ Albert J. Allen, MD, PhD – Eli Lilly and Company ### 22648###Speaker -
11:30 AM - 12:45 PME05 - Applying US Human Research Protections Regulations and Embedded Cultural Values to Research Conducted in Different Cultures
Location: Room 302Global Research Track
A. Roxana Lescano, JD, MS Bioethics (c ) – US Naval Medical Research Unit No. 6 ### 587331###Speaker @@@ Derek Englis, MBA, EdS, CIP – Armed Forces Services Corp./Magellan Federal ### 585129###Speaker @@@ Bussara Sukpanichnant, BS (Nursing), M.Ed., CIP – Armed Forces Research Institute of Medical Sciences (AFRIMS) ### 903008###Speaker @@@ Edward E. Bartlett, PhD – Office for Human Research Protections ### 10663###Moderator -
11:30 AM - 12:45 PME06 - Making Your HRPP Distinct and Organized in a Single IRB World
Location: Room 102Institutional Officials and HRPP Leadership Track
Ann Johnson, PhD, MPH, CIP – University of Utah ### 298549###Speaker @@@ Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center ### 112649###Speaker -
11:30 AM - 12:45 PME07 - Essential Documentation—IRB Record Keeping, Written Procedures, Minutes, and More
Location: Room 309IRB Basics Track
Janet C. Donnelly, RAC – FDA ### 10577###Speaker @@@ Irene E. Stith-Coleman, PhD – Office for Human Research Protections ### 11110###Speaker @@@ Ada Sue Selwitz, MA – University of Kentucky ### 11100###Speaker -
11:30 AM - 12:45 PMFrancis J. DiMario, MD, MA, CIP – University of Connecticut ### 112602###Speaker @@@ Robert H. Romanchuk, CCRC, CIP – Advarra, Inc. ### 826173###Speaker
-
11:30 AM - 12:45 PME09 - How IRBs Identify Research vs. Non-Research Risks—The Impact of the “Standard of Care” Concept
Location: Ballroom AIRB Operations Advanced Track
Sharon Ellison, PharmD – Duke University Health System, Inc. ### 10674###Speaker @@@ Anthony E. Magit, MD, MPH – University of California, San Diego ### 293357###Speaker -
11:30 AM - 12:45 PM
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11:30 AM - 12:45 PME11 - Protecting Privacy in an Era of Shifting Requirements for Privacy and Concepts of Identifiability
Location: Room 312Legal Considerations for HRPPs Track
Theresa J. Colecchia – Johns Hopkins University ### 825253###Speaker @@@ Valerie H. Bonham, JD – Ropes & Gray LLP ### 11362###Speaker -
11:30 AM - 12:45 PME12 - Operationalizing Research Databases and Biobanks at Your Institution
Location: Room 200Research involving Data and Biospecimens Track
Marylana Saadeh Helou, Esq. – Verrill LLP ### 587399###Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Speaker @@@ Marianna J. Bledsoe, MA – International Society for Biological and Environmental Repositories ### 10569###Speaker -
11:30 AM - 12:45 PME13 - Under the Influence—Capacity and Consent
Location: Room 203Populations Requiring Additional Protections Track
Amy Ben-Arieh, JD MPH – The Fenway Institute at Fenway Health ### 420065###Speaker @@@ Lara N. Sloboda, PhD – Dana Farber Cancer Insititute ### 181613###Speaker -
11:30 AM - 12:45 PME14 - Impact of the Revised Common Rule on the Work of a QA/QI Program
Location: Room 311QA/QI and Postapproval Monitoring Track
Mary-Tara Roth, RN, MSN, MPH – Boston University Medical Campus/Boston Medical Center ### 587396###Speaker @@@ Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public Health ### 187400###Speaker -
11:30 AM - 12:45 PME15 - The Regulatory and Ethical Implications of Melding Consumer "Big Data" With Medical "Big Data"
Location: Room 310Research Conducted in the Digital World Track
Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout ### 10572###Speaker @@@ James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc. ### 10329###Speaker -
11:30 AM - 12:45 PME16 - IRBs and Conflict of Interest (COI) Oversight—Mind the Gaps
Location: Room 206Responsible Conduct of Research Track
John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ Scott J. Lipkin, DPM, CIP – Ankura Consulting ### 10598###Speaker @@@ Shelby Moench, BA – Intermountain Healthcare ### 187417###Speaker -
11:30 AM - 12:45 PME17 - Building Models for Hospital and Practice-Based Research Programs—Agony and Ecstasy
Location: Room 107Small Research Programs Track
Paul Papagni, JD, CIP – Holy Cross Hospital/Trinity Health ### 11610###Speaker @@@ Patricia Seymour, CCRC, MA, CIP – WCG Clinical ### 420598###Speaker -
11:30 AM - 12:45 PME18 - Beyond Auditing and Monitoring of the IRB Towards Quality Improvement
Location: Room 103QA/QI and Postapproval Monitoring Track
Cheryl L. Byers, MHA, CIP, CHRC – Moffitt Cancer Center and Research Institute ### 248450###Speaker @@@ Mariette Marsh, MPA, CIP, CHPC – University of Arizona ### 124813###Speaker @@@ Kristen Connal – The Fenway Institute at Fenway Health ### 829038###Speaker -
11:30 AM - 12:45 PME19 - Navigating Uncertainty—Developing Best Practices for Review of Research on the Edge
Location: Room 306SBER Track
Jeffrey M. Cohen, PhD – Department of Bioethics, Clarkson University ### 11067###Speaker @@@ Juliette Roddy, PhD – University of Michigan Dearborn ### 828547###Speaker -
11:30 AM - 12:45 PME20 - Who's Minding the Store? Local Oversight of Research Without an IRB
Location: Room 201Institutional Officials and HRPP Leadership Track
Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker @@@ Hallie Kassan, MS, CIP – Northwell Health ### 57719###Speaker @@@ Greg E. Manship, DBe, MDiv, CIP, CIM – OSF HealthCare ### 10325###Speaker -
11:30 AM - 12:45 PME21 - Strategies for Conducting an Effective Local Context Review as a Relying Organization
Location: Room 101Institutional Officials and HRPP Leadership Track
Sarah Mumford, MBA, CIP – University of Utah ### 826186###Speaker @@@ Kimberly K. Summers, PharmD – University of Texas Health San Antonio ### 420574###Speaker -
11:30 AM - 12:45 PME22 - Implementation of a System to Promote Compliance With 45 CFR 46.116(h)—Posting Consent Forms
Location: Room 313Institutional Officials and HRPP Leadership Track
Matthew Ogrodnik, MS, CIP – Boston Medical Center and Boston University Medical Campus ### 426722###Speaker @@@ Lauren Hartsmith, JD – OHRP ### 263718###Speaker -
11:30 AM - 12:45 PME23 - Implementing Key Information in Multi-Site Research
Location: Room 108IRB Operations Advanced Track
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker @@@ Jeanne Velders, JD, CIP – Washington University in St. Louis ### 112676###Speaker @@@ Joan Affleck, M.A., M.B.A. – Merck & Co., Inc. ### 844800###Speaker -
12:45 PM - 2:30 PMClosing Session
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12:45 PM - 2:30 PMClosing General Session Luncheon—Designing Ethical Cars and Computing Clinicians: Research and the Ethics of Artificial Intelligence (AI) Programming
Location: Veterans Memorial AuditoriumNeal W. Dickert, MD, PhD – Emory University School of Medicine ### 57694###Moderator @@@ Marshall Chin, MD, MPH – University of Chicago ### 859611###Panelist @@@ David Magnus, PhD – Stanford University ### 874905###Panelist @@@ Tamiko Eto, MS, CIP – Stanford Research Institute (SRI) International ### 864327###Panelist