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Revised Common Rule Sessions
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- Wednesday, November 14, 2018
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7:00 AM - 2:30 PMOn-Site Check-In
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7:00 AM - 2:30 PM
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8:30 AM - 4:30 PM2018 AER Conference: Preconference Programs
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8:30 AM - 4:30 PMBiobanking in an Era of Research Towards Precision Medicine: Approaches to the Ethical, Regulatory, and Practical Challenges
Location: Harbor Ballroom A
Marianna J. Bledsoe, MA – Marianna J. Bledsoe Consulting, LLC; Michele Russell-Einhorn, JD – Advarra; Mark Barnes, JD, LLM – Ropes & Gray Law Firm; William E. Grizzle, MD, PhD; Sarah Dry, MD – University of California Los AngelesMarianna J. Bledsoe, MA – Marianna J. Bledsoe Consulting, LLC ### 10569###Preconference Speaker @@@ Michele Russell-Einhorn, JD – Advarra ### 10144###Preconference Speaker @@@ Mark Barnes, JD, LLM – Ropes & Gray Law Firm ### 57669###Preconference Speaker @@@ William E. Grizzle, MD, PhD ### 112617###Preconference Speaker @@@ Sarah Dry, MD – University of California Los Angeles ### 618917###Preconference Speaker -
8:30 AM - 4:30 PMCritical Topics in SBER
Dean R. Gallant, AB – The HRP Consulting Group; Linda E. Petree, BA, CIP – The University of New MexicoDean R. Gallant, AB – The HRP Consulting Group ### 10127###Preconference Speaker @@@ Linda E. Petree, BA, CIP – The University of New Mexico ### 255981###Preconference Speaker -
8:30 AM - 12:30 PMEthical and Practical Issues in Global Human Research
Location: Old Town
Delia Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health; Karen M. Hansen – Fred Hutchinson Cancer Research Center; Byung-in (B.I.) Choe, PhD – The Catholic University of Korea; Susan M. Miller, MD, MPH, FACP; Okyere Boateng, MSc, MHSc – Noguchi Memorial Institute For Medical Research, University Of Ghana; Sharon C. Freitag, BSc – Providence St. Joseph's and St. Michael's Healthcare, TorontoDelia Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health ### 11119###Preconference Speaker @@@ Karen M. Hansen – Fred Hutchinson Cancer Research Center ### 10678###Preconference Speaker @@@ Byung-in (B.I.) Choe, PhD – The Catholic University of Korea ### 420089###Preconference Speaker @@@ Susan M. Miller, MD, MPH, FACP ### 418864###Preconference Speaker @@@ Okyere Boateng, MSc, MHSc – Noguchi Memorial Institute For Medical Research, University Of Ghana ### 618920###Preconference Speaker @@@ Sharon C. Freitag, BSc – Providence St. Joseph's and St. Michael's Healthcare, Toronto ### 42223###Preconference Speaker -
1:00 PM - 4:30 PMEthical and Regulatory Review of Research: Case Studies
Location: Old Town
Bruce G. Gordon, MD – University of Nebraska Medical Center; Ernest D. Prentice, PhD – Research EthicsBruce G. Gordon, MD – University of Nebraska Medical Center ### 11072###Preconference Speaker @@@ Ernest D. Prentice, PhD – Research Ethics ### 10693###Preconference Speaker -
1:00 PM - 4:30 PMEthical Study Design Is Good Science
Location: La Jolla
Susan S. Fish, PharmD, MPH – Boston University School of Public Health; Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus GroupSusan S. Fish, PharmD, MPH – Boston University School of Public Health ### 11071###Preconference Speaker @@@ Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus Group ### 10687###Preconference Speaker -
8:30 AM - 4:30 PMImplementing the Revised Common Rule
Location: Grand Hall B
Ada Sue Selwitz, MA – University of Kentucky; Ivor A. Pritchard, PhD – Office for Human Research ProtectionsAda Sue Selwitz, MA – University of Kentucky ### 11100###Preconference Speaker @@@ Ivor A. Pritchard, PhD – Office for Human Research Protections ### 10140###Preconference Speaker -
8:30 AM - 4:30 PMIRB 101sm
Location: Harbor Ballroom H
David H. Strauss, MD – Austen Riggs Center; Daniel K. Nelson, MSc, CIPDavid H. Strauss, MD – Austen Riggs Center ### 10147###Preconference Speaker @@@ Daniel K. Nelson, MSc, CIP ### 10137###Preconference Speaker -
8:30 AM - 4:30 PMIRB Chairs Boot Camp: Tools for Successful IRB Leadership
Location: Harbor Ballroom G
Francis J. DiMario, Jr., MD, MA, CIP; R. Peter Iafrate, PharmD – University of FloridaFrancis J. DiMario, Jr., MD, MA, CIP ### 25706###Preconference Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Preconference Speaker -
8:30 AM - 4:30 PMSingle IRBs: From Idea to Implementation
Location: Harbor Ballroom C
P. Pearl O'Rourke, MD; Susan Z. Kornetsky, MPH – Boston Children's Hospital; Nichelle Cobb, PhD – University of Wisconsin-Madison; Martha Jones, MA, CIP – Washington University in St. Louis; David G. Forster, JD, MA, CIP – WIRB-Copernicus GroupP. Pearl O'Rourke, MD ### 112647###Preconference Speaker @@@ Susan Z. Kornetsky, MPH – Boston Children's Hospital ### 10134###Preconference Speaker @@@ Nichelle Cobb, PhD – University of Wisconsin-Madison ### 173305###Preconference Speaker @@@ Martha Jones, MA, CIP – Washington University in St. Louis ### 59861###Preconference Speaker @@@ David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Preconference Speaker -
8:30 AM - 12:30 PMTips and Tools for Effective Education and Training
Location: La Jolla
Sharon Shriver, PhD – PRIM&R; Elizabeth Kipp Campbell, PhD, CIP – Council MemberSharon Shriver, PhD – PRIM&R ### 302147###Preconference Speaker @@@ Elizabeth Kipp Campbell, PhD, CIP – Council Member ### 584376###Preconference Speaker -
4:30 PM - 5:30 PM2018 AER Conference: Preconference Programs
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4:30 PM - 5:30 PMPreconference Programs Networking Reception
Location: Grand Hall A - Thursday, November 15, 2018
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7:00 AM - 8:00 AMContinental Breakfast to Welcome First-Time Attendees
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7:00 AM - 8:00 AMBreakfast to Welcome First-Time Attendees
Location: Ballroom 20A -
7:00 AM - 5:30 PMOn-Site Check-In
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7:00 AM - 5:30 PMOn-Site Check-In
Location: Exhibit Hall FG Foyer -
7:15 AM - 8:00 AMA Capella Musical Performance
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7:15 AM - 8:00 AMA Capella Musical Performance
Location: Exhibit Hall H -
8:00 AM - 9:00 AMConference Welcome Remarks
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8:00 AM - 9:00 AMMorning Welcomes and Announcements
Location: Exhibit Hall H -
9:00 AM - 10:00 AMKeynote Address
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9:00 AM - 10:00 AMKeynote Address by Timothy Caulfield, LLB, LLM, FRSC, FCAHS: Celebrities, Science-y, and Pseudoscience: Tackling Misinformation in the Era of Health Noise
Location: Exhibit Hall H
Timothy Caulfield, LLB, LLM, FRSC, FCAHS – University of AlbertaTimothy Caulfield, LLB, LLM, FRSC, FCAHS – University of Alberta ### 585102###Keynote Speaker -
10:00 AM - 10:30 AMBeverage Break Supported by Kinetiq
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10:00 AM - 10:30 AMBeverage Break With the Supporters and Exhibitors
Location: Exhibit Hall FG -
10:30 AM - 11:45 AMConcurrent Plenary Sessions
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10:30 AM - 11:45 AMPanel I: Gun Violence and Public Health: Facts, Fiction, and the Future
Location: Ballroom 20D
Harold D. Cox, MSSW – Boston University School of Public Health; Zoe Grover, JD – Stop Handgun Violence; Cynthia A. Gómez, PhD – San Francisco State University; Patrick M. Carter, MD – University of Michigan School of MedicineHarold D. Cox, MSSW – Boston University School of Public Health ### 606781###Panelist @@@ Zoe Grover, JD – Stop Handgun Violence ### 593626###Panelist @@@ Cynthia A. Gómez, PhD – San Francisco State University ### 10129###Moderator @@@ Patrick M. Carter, MD – University of Michigan School of Medicine ### 620259###Panelist -
10:30 AM - 11:45 AMPanel II: At the Crossroads of Hope and Hype: Recruiting the Desperately Ill for Clinical Trials
Location: Ballroom 20 BC
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Andrea Denicoff, MS, RN – Cancer Therapy Evaluation Program, National Cancer Institute; Betty R. Ferrell, PhD, RN, MA, FAAN, FPCN, CHPN – Beckman Research Institute of City of Hope; Jodi Halpern, MD, PhD – University of California Berkeley; Carol Juliet Weil, JD – National Cancer InstituteAlexander M. Capron, LLB, MA (Hon). – University of Southern California ### 10125###Moderator @@@ Andrea Denicoff, MS, RN – Cancer Therapy Evaluation Program, National Cancer Institute ### 585118###Panelist @@@ Betty R. Ferrell, PhD, RN, MA, FAAN, FPCN, CHPN – Beckman Research Institute of City of Hope ### 585140###Panelist @@@ Jodi Halpern, MD, PhD – University of California Berkeley ### 585141###Panelist @@@ Carol Juliet Weil, JD – National Cancer Institute ### 426710###Panelist -
10:30 AM - 11:45 AMPanel III: The New Rule's Identity Crisis: Should Identifiability Be Changed?
Location: Exhibit Hall H
William E. Grizzle, MD, PhD; Laura Odwazny, JD, MA – DHHS; Suzanne M. Rivera, PhD, MSW – Case Western Reserve UniversityWilliam E. Grizzle, MD, PhD ### 112617###Panelist @@@ Laura Odwazny, JD, MA – DHHS ### 11092###Moderator @@@ Suzanne M. Rivera, PhD, MSW – Case Western Reserve University ### 10615###Panelist -
11:45 AM - 1:00 PMLunch Sessions
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11:45 AM - 1:00 PMLunch Session: A Dialogue With Patient-Centered Outcomes Research Institute (PCORI)
Location: Room 24A
Jason Gerson, PhD – Patient-Centered Outcomes Research InstituteJason Gerson, PhD – Patient-Centered Outcomes Research Institute ### 420114###Speaker -
11:45 AM - 1:00 PMLunch Session: A Dialogue With the Department of Energy (DOE)
Location: Room 24B
Elizabeth P. White, MBA, MPH, CIP – United States Department of Energy; Cheri Hautala-Bateman – Department of Energy/National Nuclear Security AdministrationElizabeth P. White, MBA, MPH, CIP – United States Department of Energy ### 10625###Speaker @@@ Cheri Hautala-Bateman – Department of Energy/National Nuclear Security Administration ### 593731###Speaker -
11:45 AM - 1:00 PMLunch Session: A Dialogue With the Office of Research Integrity (ORI)
Location: Room 24C
Scott J. Moore, PhD, JD – DHHS Office of Research IntegrityScott J. Moore, PhD, JD – DHHS Office of Research Integrity ### 593732###Speaker -
11:45 AM - 1:00 PMLunch Session: A Dialogue With the VA
Location: Room 25AB
Kristina C. Borror, PhD – Veterans Health Administration; Charlotte K. Jeans, PhD, CCRN, CIP; Mary M. Klote, MD, CIP – Veterans Health Administration; Richard D'Augusta, RPh, MPA – US Department of Veterans AffairsKristina C. Borror, PhD – Veterans Health Administration ### 10668###Speaker @@@ Charlotte K. Jeans, PhD, CCRN, CIP ### 426712###Speaker @@@ Mary M. Klote, MD, CIP – Veterans Health Administration ### 187333###Speaker @@@ Richard D'Augusta, RPh, MPA – US Department of Veterans Affairs ### 595174###Speaker -
11:45 AM - 1:00 PMMeet the Author Lunch and Book Signing
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11:45 AM - 1:00 PMResearch Ethics Discussion Luncheon : Fighting Health Myths with Stories, Art, and Fun
Location: Ballroom 20A
Timothy Caulfield, LLB, LLM, FRSC, FCAHS – University of Alberta; Melissa E. Abraham, PhD, MSTimothy Caulfield, LLB, LLM, FRSC, FCAHS – University of Alberta ### 585102###Panelist @@@ Melissa E. Abraham, PhD, MS ### 10021###Moderator -
11:45 AM - 1:00 PMNetworking Lunch Supported by CITI Program, a division of BRANY
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11:45 AM - 1:00 PMNetworking Lunch Supported by CITI Program, a division of BRANY
Location: Exhibit Hall FG -
12:15 PM - 12:35 PMOverview of the CIP Exam
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12:15 PM - 12:35 PMOverview of the CIP Exam
Location: Exhibit Hall FG -
12:30 PM - 1:00 PMFederal Agency/Accrediting Body Office Hours
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12:30 PM - 1:00 PMFederal Agency/Accrediting Body Office Hours
Location: Exhibit Hall FG -
12:30 PM - 1:00 PMMeet and Greet With the AER18 Supporters and Exhibitors
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12:30 PM - 1:00 PMMeet and Greet With the AER18 Supporters and Exhibitors
Location: Exhibit Hall FG -
12:40 PM - 1:00 PMeConsent: Modernize Your Consent Process—Don’t Change It
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12:40 PM - 1:00 PMeConsent: Modernize Your Consent Process—Don’t Change It
Location: Exhibit Hall FG -
1:15 PM - 2:30 PMBreakout Session Series A
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1:15 PM - 2:30 PMA01 - A Dialogue With OHRP
Location: Room 28ABC
Lisa R. Buchanan, BS, MAOM – DHHS, Office for Human Research Protections (OHRP); Ivor A. Pritchard, PhD – Office for Human Research Protections; Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP); Irene E. Stith-Coleman, PhD – Office for Human Research ProtectionsA Dialogue With the Feds Track
Lisa R. Buchanan, BS, MAOM – DHHS, Office for Human Research Protections (OHRP) ### 10669###Speaker @@@ Ivor A. Pritchard, PhD – Office for Human Research Protections ### 10140###Speaker @@@ Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP) ### 112580###Speaker @@@ Irene E. Stith-Coleman, PhD – Office for Human Research Protections ### 11110###Speaker -
1:15 PM - 2:30 PMA02 - Does Diversity Matter in the Conduct of a Clinical Trial?
Location: Room 23C
Owen Garrick, MD, MBA – Bridge Clinical Research; Barbara E. Bierer, MDHot Topics Track
Owen Garrick, MD, MBA – Bridge Clinical Research ### 262885###Speaker @@@ Barbara E. Bierer, MD ### 10123###Speaker -
1:15 PM - 2:30 PMA03 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)
Location: Room 29B
Micah H. Bass, MPH – Centers for Disease Control and Prevention; Julia G. Gorey, JD – OHRP; Laura Youngblood, MPH – Centers for Disease Control and Prevention (CDC)Boundaries and Balances Track
Micah H. Bass, MPH – Centers for Disease Control and Prevention ### 420018###Speaker @@@ Julia G. Gorey, JD – OHRP ### 11073###Speaker @@@ Laura Youngblood, MPH – Centers for Disease Control and Prevention (CDC) ### 10627###Speaker -
1:15 PM - 2:30 PMA04 - Stories Matter: The Use of Narrative in IRB Member Education
Location: Room 25C
Michael Leary, MA CIP – Lindenwood University; Gianna McMillan, MA – Loyola Marymount UniversityEducating and Training Track
Michael Leary, MA CIP – Lindenwood University ### 187411###Speaker @@@ Gianna McMillan, MA – Loyola Marymount University ### 11611###Speaker -
1:15 PM - 2:30 PMA05 - Empirical Research on Ethical Issues in Patient Centered Outcomes Research (PCOR): New Data to Inform Deliberations
Location: Room 22
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Stephanie Morain, PhD, MPH – Baylor College of Medicine; Jeremy Sugarman, MD, MPH, MA – Johns Hopkins UniversityEmpirical Research Ethics Track
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania ### 420145###Speaker @@@ Stephanie Morain, PhD, MPH – Baylor College of Medicine ### 429255###Speaker @@@ Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University ### 10037###Speaker -
1:15 PM - 2:30 PMA06 - Demystifying FDA 21 CFR Part 11
Location: Room 31C
James Riddle, MCSE, CIP, CPIA, CRQM – Kinetiq, a Division of Quorum IRB; Jan L. Hewett, BSN, JD – Food & Drug AdministrationFDA Regulations Track
James Riddle, MCSE, CIP, CPIA, CRQM – Kinetiq, a Division of Quorum IRB ### 10329###Speaker @@@ Jan L. Hewett, BSN, JD – Food & Drug Administration ### 43213###Speaker -
1:15 PM - 2:30 PMA07 - Different Models of Review: A Global Comparison
Location: Room 23A
Byung-in (B.I.) Choe, PhD – The Catholic University of Korea; Delia Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health; Rachel Zand, PhD – University of Toronto; Barthalomew Wilson – Partnership for Research on Ebola Virus in Liberia, Liberia - US Joint Clinical Research PartnershipGlobal Research Track
Byung-in (B.I.) Choe, PhD – The Catholic University of Korea ### 420089###Speaker @@@ Delia Wolf, MD, JD, MSCI, – Harvard T.H. Chan School of Public Health ### 11119###Speaker @@@ Rachel Zand, PhD – University of Toronto ### 171988###Speaker @@@ Barthalomew Wilson – Partnership for Research on Ebola Virus in Liberia, Liberia - US Joint Clinical Research Partnership ### 262891###Speaker -
1:15 PM - 2:30 PMA08 - The Certified IRB Professional (CIP®) Credential: How Do I Get Started?
Location: Room 29C
Hallie Kassan, MS, CIP – Northwell Health; Lori Roesch, CIM, CIP – Children's Hospital of Wisconsin; Michelle Francis Grienauer, JD, MPH, CIP – MicrosoftHot Topics Track
Hallie Kassan, MS, CIP – Northwell Health ### 57719###Speaker @@@ Lori Roesch, CIM, CIP – Children's Hospital of Wisconsin ### 57742###Speaker @@@ Michelle Francis Grienauer, JD, MPH, CIP – Microsoft ### 124795###Speaker -
1:15 PM - 2:30 PMA09 - Not Less Work, But Different: Re-Engineering for Single IRB Review
Location: Room 33AB
Nichelle Cobb, PhD – University of Wisconsin-Madison; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Kimberly K. Summers, PharmD – University of Texas Health Center San AntonioInstitutional Officials and HRPP Leadership Track
Nichelle Cobb, PhD – University of Wisconsin-Madison ### 173305###Speaker @@@ Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker @@@ Kimberly K. Summers, PharmD – University of Texas Health Center San Antonio ### 420574###Speaker -
1:15 PM - 2:30 PMA10 - Back to Basics: Does My Project Fall Within the Scope of the Revised Common Rule?
Location: Room 28DE
Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)IRB 101 Track
Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS) ### 251900###Speaker -
1:15 PM - 2:30 PMA11 - Meeting Management for IRB Chairs
Location: Room 29A
Francis J. DiMario, Jr., MD, MA, CIP; Luke Gelinas, PhD – Advarra IRBIRB Chairs Track
Francis J. DiMario, Jr., MD, MA, CIP ### 25706###Speaker @@@ Luke Gelinas, PhD – Advarra IRB ### 420113###Speaker -
1:15 PM - 2:30 PMA12 - It’s Not as New as You Think: Understanding How to Operationalize the Revised Common Rule
Location: Room 30AB
Jeffrey A. Cooper, MD, MMM – WIRB Copernicus Group; Kristin J. Craun, MPH, CIP – University of Southern California; Jessica Huening, JD – Yale University; Heather H. Pierce, JD, MPH – Association of American Medical CollegesIRB Operations Advanced Track
Jeffrey A. Cooper, MD, MMM – WIRB Copernicus Group ### 112600###Speaker @@@ Kristin J. Craun, MPH, CIP – University of Southern California ### 114622###Speaker @@@ Jessica Huening, JD – Yale University ### 187401###Speaker @@@ Heather H. Pierce, JD, MPH – Association of American Medical Colleges ### 10328###Speaker -
1:15 PM - 2:30 PMA13 - ClinicalTrials.gov: How Academic Institutions Can Respond to New Clinical Trial Disclosure Requirements
Location: Room 31A
Sarah A. White, MPH, CIP – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIHPharma/Biotech Perspectives Track
Sarah A. White, MPH, CIP – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard ### 10626###Speaker @@@ Rebecca J. Williams, PharmD, MPH – National Library of Medicine, NIH ### 112684###Speaker -
1:15 PM - 2:30 PMA14 - Legal and regulatory changes: A Year in Review
Location: Room 30D
Michele Russell-Einhorn, JD – Advarra; Mitchell Parrish, JD, RAC, CIP – Quorum ReviewLegal Track
Michele Russell-Einhorn, JD – Advarra ### 10144###Speaker @@@ Mitchell Parrish, JD, RAC, CIP – Quorum Review ### 25716###Speaker -
1:15 PM - 2:30 PMA15 - Defining Roles & Expectations for the Non-Scientist and Non-Affiliated IRB Member: Deconstructing Regulatory and Research Terminology
Location: Room 27B
Glenn Ellis, MPH, CHCE; Michelle M. Feige, MSW, LCSW-C – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP); Nancy A. Olson, JD – University of Mississippi Medical CenterNon-Scientist IRB Members Track
Glenn Ellis, MPH, CHCE ### 585128###Speaker @@@ Michelle M. Feige, MSW, LCSW-C – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 10675###Speaker @@@ Nancy A. Olson, JD – University of Mississippi Medical Center ### 11093###Speaker -
1:15 PM - 2:30 PMA16 - Implementing NIH’s Genomic Data Sharing Policy: Challenges and Solutions
Location: Room 25AB
Shannon Sewards, MA, CIP – Harvard University; Carrie D. Wolinetz, PhD – National Institutes of HealthResearch Involving Data and Biospecimens Track
Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker @@@ Carrie D. Wolinetz, PhD – National Institutes of Health ### 186124###Speaker -
1:15 PM - 2:30 PMA17 - Vulnerability Explored: Concepts and Applications
Location: Room 31B
Bruce G. Gordon, MD – University of Nebraska Medical Center; Robert E. Nobles, II, DrPH, MPH, CIP – University of Tennessee, Knoxville; David H. Strauss, MD – Austen Riggs CenterPopulations Requiring Additional Protections Track
Bruce G. Gordon, MD – University of Nebraska Medical Center ### 11072###Speaker @@@ Robert E. Nobles, II, DrPH, MPH, CIP – University of Tennessee, Knoxville ### 420157###Speaker @@@ David H. Strauss, MD – Austen Riggs Center ### 10147###Speaker -
1:15 PM - 2:30 PMA18 - Beyond Auditing and Monitoring of the IRB Towards Quality Improvement
Location: Room 30C
John R. Baumann, PhD – Indiana University; Cheryl L. Byers, MHA, CIP, CHRC – Moffitt Cancer Center and Research Institute; Mariette Marsh, MPA, CIP – University of ArizonaQA/QI and Post-Approval Monitoring Track
John R. Baumann, PhD – Indiana University ### 57670###Faculty @@@ Cheryl L. Byers, MHA, CIP, CHRC – Moffitt Cancer Center and Research Institute ### 248450###Speaker @@@ Mariette Marsh, MPA, CIP – University of Arizona ### 124813###Speaker -
1:15 PM - 2:30 PMA19 - IRB Review of Big Data Research
Location: Room 32AB
Laura Odwazny, JD, MA – DHHS; Stephen J. Rosenfeld, MD, MBA – Quorum IRB Review; Jacob Metcalf, PhD – Ethical Resolve, LLCResearch Conducted in the Digital World Track
Laura Odwazny, JD, MA – DHHS ### 11092###Speaker @@@ Stephen J. Rosenfeld, MD, MBA – Quorum IRB Review ### 420561###Speaker @@@ Jacob Metcalf, PhD – Ethical Resolve, LLC ### 425289###Speaker -
1:15 PM - 2:30 PMA20 - Preparing Research Misconduct Committees to Succeed
Location: Room 21
Kate Gallin Heffernan, JD – Verrill Dana LLP; Ross A. Hickey, JD, CIP, CPIA – University of Southern MaineResponsible Conduct of Research Track
Kate Gallin Heffernan, JD – Verrill Dana LLP ### 10588###Speaker @@@ Ross A. Hickey, JD, CIP, CPIA – University of Southern Maine ### 112622###Speaker -
1:15 PM - 2:30 PMA21 - Challenges and Opportunities for Institutions With Small Research Programs
Location: Room 23B
Andrea McDowell, PhD – Seattle University; John C. Smith, MSW, CIM, CIP – Morehouse School of MedicineSmall Research Programs Track
Andrea McDowell, PhD – Seattle University ### 175574###Speaker @@@ John C. Smith, MSW, CIM, CIP – Morehouse School of Medicine ### 587405###Speaker -
1:15 PM - 2:30 PMA22 - Different Minimal Risk Review Models
Location: Room 29D
Cecilia Brooke Cholka, MA, CIP – The University of New Mexico; Erik Williams, CIP – Arizona State University; Jeffrey M. Cohen, PhD – The HRP Consulting GroupSBER Track
Cecilia Brooke Cholka, MA, CIP – The University of New Mexico ### 585105###Speaker @@@ Erik Williams, CIP – Arizona State University ### 587413###Speaker @@@ Jeffrey M. Cohen, PhD – The HRP Consulting Group ### 11067###Speaker -
1:15 PM - 2:30 PMA23 - Risk Mitigation in Mixed SBER and Biomedical Research
Location: Room 30E
Matthew D. Stafford – Children's Hospital Boston; Lara N. Sloboda, PhD – Tufts UniversitySBER Track
Matthew D. Stafford – Children's Hospital Boston ### 57750###Speaker @@@ Lara N. Sloboda, PhD – Tufts University ### 181613###Speaker -
2:30 PM - 3:00 PMBeverage Break
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2:30 PM - 3:00 PMBeverage Break
Location: Room 23-27 Hallway -
3:00 PM - 4:15 PMBreakout Session Series B
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3:00 PM - 4:15 PMB01 - The Times, They Are a-Changing: Overview of the Latest NIH Changes and Their Implications on Research
Location: Room 32AB
Marylana Saadeh Helou, Esq. – Verrill Dana LLP; Carrie D. Wolinetz, PhD – National Institutes of HealthA Dialogue With the Feds Track
Marylana Saadeh Helou, Esq. – Verrill Dana LLP ### 587399###Speaker @@@ Carrie D. Wolinetz, PhD – National Institutes of Health ### 186124###Speaker -
3:00 PM - 4:15 PMB02 - The Generation and Utilization of Real-World Evidence (RWE): Ethical and Regulatory Considerations
Location: Room 31C
Jacqueline Corrigan-Curay, MD, JD – U.S. Food and Drug Administration; Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University; Robert (Skip) M. Nelson, MD, PhD – Johnson & Johnson; Diana T. Chingos, MS, MFA – Patient Representative, HHS Secretary Advisory Committee on Human Research Protections (SACHRP)FDA Regulations Track
Jacqueline Corrigan-Curay, MD, JD – U.S. Food and Drug Administration ### 585115###Speaker @@@ Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University ### 10037###Speaker @@@ Robert (Skip) M. Nelson, MD, PhD – Johnson & Johnson ### 25714###Speaker @@@ Diana T. Chingos, MS, MFA – Patient Representative, HHS Secretary Advisory Committee on Human Research Protections (SACHRP) ### 188200###Speaker -
3:00 PM - 4:15 PMB03 - You'll Know It When You See It, or Will You? Defining "Human Subjects Research"
Location: Room 28ABC
Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP); Warren Capell, MD – University of Colorado Denver; Dean R. Gallant, AB – The HRP Consulting GroupBoundaries and Balances Track
Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP) ### 112580###Speaker @@@ Warren Capell, MD – University of Colorado Denver ### 263610###Speaker @@@ Dean R. Gallant, AB – The HRP Consulting Group ### 10127###Speaker -
3:00 PM - 4:15 PMB04 - An Educational Map to Being a Great Research Ethicist (or Just a Better One)
Location: Room 31B
Robert Hood, PhD – AAHRPP, Inc.; Dane C. Joseph, PhD – George Fox UniversityEducating and Training Track
Robert Hood, PhD – AAHRPP, Inc. ### 251843###Speaker @@@ Dane C. Joseph, PhD – George Fox University ### 586811###Speaker -
3:00 PM - 4:15 PMB05 - Designing Trials for Completion
Location: Room 24A
Barbara E. Bierer, MD; Luke Gelinas, PhD – Advarra IRB; Spencer Hey – Harvard Center for BioethicsEmpirical Research Ethics Track
Barbara E. Bierer, MD ### 10123###Speaker @@@ Luke Gelinas, PhD – Advarra IRB ### 420113###Speaker @@@ Spencer Hey – Harvard Center for Bioethics ### 586794###Speaker -
3:00 PM - 4:15 PMB06 - When Is an Investigational Device Exemption (IDE) Needed for a Clinical Investigation of a Medical Device?
Location: Room 30E
Soma Kalb, PhD – US Food and Drug AdministrationFDA Regulations Track
Soma Kalb, PhD – US Food and Drug Administration ### 118703###Speaker -
3:00 PM - 4:15 PMB07 - Human Subjects Protections Across Borders
Location: Room 29B
Edward E. Bartlett, PhD; Byung-in (B.I.) Choe, PhD – The Catholic University of Korea; Karen M. Hansen – Fred Hutchinson Cancer Research CenterGlobal Research Track
Edward E. Bartlett, PhD ### 10663###Speaker @@@ Byung-in (B.I.) Choe, PhD – The Catholic University of Korea ### 420089###Speaker @@@ Karen M. Hansen – Fred Hutchinson Cancer Research Center ### 10678###Speaker -
3:00 PM - 4:15 PMB08 - Exploring and Enhancing Diversity Within Our Compliance Committees
Location: Room 23C
Tonya Ferraro, MEd – Harvard University; Owen Garrick, MD, MBA – Bridge Clinical Research; Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc.Hot Topics Track
Tonya Ferraro, MEd – Harvard University ### 420587###Speaker @@@ Owen Garrick, MD, MBA – Bridge Clinical Research ### 262885###Speaker @@@ Eric Allen, MA, CIP, CPIA – HRP Consulting Group, Inc. ### 11058###Speaker -
3:00 PM - 4:15 PMB09 - Top Considerations for Institutional and HRPP Leadership When Accepting Department of Defense (DOD) Support of Research
Location: Room 29D
Jean Barone, CIP – University of Pittsburgh; Kimberly Odam, MS, CIP – US Army Medical Research and Materiel Command; T. Howard Stone, JD, LLM, CIPInstitutional Officials and HRPP Leadership Track
Jean Barone, CIP – University of Pittsburgh ### 255824###Speaker @@@ Kimberly Odam, MS, CIP – US Army Medical Research and Materiel Command ### 448105###Speaker @@@ T. Howard Stone, JD, LLM, CIP ### 251909###Speaker -
3:00 PM - 4:15 PMB10 - Essential Documentation: IRB Records Documentation Requirements, Minutes, Written Procedures, and More
Location: Room 22
Lisa R. Buchanan, BS, MAOM – DHHS, Office for Human Research Protections (OHRP); Janet Donnelly, RAC – FDA; Ada Sue Selwitz, MA – University of KentuckyIRB 101 Track
Lisa R. Buchanan, BS, MAOM – DHHS, Office for Human Research Protections (OHRP) ### 10669###Speaker @@@ Janet Donnelly, RAC – FDA ### 10577###Speaker @@@ Ada Sue Selwitz, MA – University of Kentucky ### 11100###Speaker -
3:00 PM - 4:15 PMB11 - The Evolving Role of the IRB Chair in the World of Single IRBs
Location: Room 30D
David C. Christiani, MD, MPH, MS – Harvard University; Susan Sonne, PharmD, BCPPIRB Chairs Track
David C. Christiani, MD, MPH, MS – Harvard University ### 302150###Speaker @@@ Susan Sonne, PharmD, BCPP ### 587407###Speaker -
3:00 PM - 4:15 PMB12 - The After Party: Tools and Techniques for the Assessment of IRB Operations During and After Implementation of the Revised Common Rule
Location: Room 30AB
Meghan K. Scott – Fred Hutchinson Cancer Research Center; Jeanne Velders, JD, CIP – Washington University in St. LouisIRB Operations Advanced Track
Meghan K. Scott – Fred Hutchinson Cancer Research Center ### 587402###Speaker @@@ Jeanne Velders, JD, CIP – Washington University in St. Louis ### 112676###Speaker -
3:00 PM - 4:15 PMB13 - The European Union’s (EU) General Data Protection Regulation (GDPR) and US-Based Research: Implications, Problems, and Potential Solutions
Location: Room 33AB
Karla Childers, MSJ – Johnson & Johnson; Mark Barnes, JD, LLM – Ropes & Gray Law FirmPharma/Biotech Perspectives Track
Karla Childers, MSJ – Johnson & Johnson ### 418855###Speaker @@@ Mark Barnes, JD, LLM – Ropes & Gray Law Firm ### 57669###Speaker -
3:00 PM - 4:15 PMB14 - 1-800-RESEARCHLAWYER: Is Your Institution’s Legal Counsel on Speed Dial?
Location: Room 25C
Emily Chi Fogler, JD – Verrill Dana LLP; Kate Gallin Heffernan, JD – Verrill Dana LLP; Jessica A. Ripton, MPH, CIP – Beth Israel Deaconess Medical CenterLegal Track
Emily Chi Fogler, JD – Verrill Dana LLP ### 42688###Speaker @@@ Kate Gallin Heffernan, JD – Verrill Dana LLP ### 10588###Speaker @@@ Jessica A. Ripton, MPH, CIP – Beth Israel Deaconess Medical Center ### 124834###Speaker -
3:00 PM - 4:15 PMB15 - New Data on Single IRBs: Implications for the Future
Location: Room 30C
Robert Klitzman, MD – Columbia University; Charles W. Lidz, PhD – University of Massachusetts Medical SchoolHot Topics Track
Robert Klitzman, MD – Columbia University ### 284672###Speaker @@@ Charles W. Lidz, PhD – University of Massachusetts Medical School ### 585145###Speaker -
3:00 PM - 4:15 PMB16 - Research with Data and Biospecimens Under the Revised Common Rule: An Overview of Changes and Challenges
Location: Ballroom 20A
Marianna J. Bledsoe, MA – Marianna J. Bledsoe Consulting, LLC; Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout; Lauren Hartsmith, JD – HHSResearch Involving Data and Biospecimens Track
Marianna J. Bledsoe, MA – Marianna J. Bledsoe Consulting, LLC ### 10569###Speaker @@@ Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout ### 10572###Speaker @@@ Lauren Hartsmith, JD – HHS ### 263718###Speaker -
3:00 PM - 4:15 PMB17 - Conducting Research With Children: Complexities in Practice
Location: Room 25AB
Bruce G. Gordon, MD – University of Nebraska Medical Center; Susan Z. Kornetsky, MPH – Boston Children's HospitalPopulations Requiring Additional Protections Track
Bruce G. Gordon, MD – University of Nebraska Medical Center ### 11072###Speaker @@@ Susan Z. Kornetsky, MPH – Boston Children's Hospital ### 10134###Speaker -
3:00 PM - 4:15 PMB18 - Ideas and Practices for Compliance and Auditing of Single IRB Studies
Location: Room 31A
Nichelle Cobb, PhD – University of Wisconsin-Madison; Sarah A. White, MPH, CIP – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and HarvardQA/QI and Post-Approval Monitoring Track
Nichelle Cobb, PhD – University of Wisconsin-Madison ### 173305###Speaker @@@ Sarah A. White, MPH, CIP – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard ### 10626###Speaker -
3:00 PM - 4:15 PMB19 - Privacy and Security Risks in Research With Wearable Technology
Location: Room 28DE
Megan Doerr – Sage Bionetworks; Sara Meeder, CIP – Maimonides Medical CenterResearch Conducted in the Digital World Track
Megan Doerr – Sage Bionetworks ### 427699###Speaker @@@ Sara Meeder, CIP – Maimonides Medical Center ### 589958###Speaker -
3:00 PM - 4:15 PMB20 - Case Studies in Research Misconduct
Location: Room 29C
Ross A. Hickey, JD, CIP, CPIA – University of Southern Maine; Fariba Houman, PhD, CIP – Boston Children's HospitalResponsible Conduct of Research Track
Ross A. Hickey, JD, CIP, CPIA – University of Southern Maine ### 112622###Speaker @@@ Fariba Houman, PhD, CIP – Boston Children's Hospital ### 598447###Speaker -
3:00 PM - 4:15 PMB21 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research Organization
Location: Room 24C
Heather H. Pierce, JD, MPH – Association of American Medical Colleges; Elizabeth A. Boyd, PhD – Fred Hutchinson Cancer Research CenterSmall Research Programs Track
Heather H. Pierce, JD, MPH – Association of American Medical Colleges ### 10328###Speaker @@@ Elizabeth A. Boyd, PhD – Fred Hutchinson Cancer Research Center ### 597542###Speaker -
3:00 PM - 4:15 PMB22 - College Students and Research: Challenges and Issues for IRBs
Location: Room 29A
Andrea McDowell, PhD – Seattle University; Linda E. Petree, BA, CIP – The University of New MexicoSBER Track
Andrea McDowell, PhD – Seattle University ### 175574###Speaker @@@ Linda E. Petree, BA, CIP – The University of New Mexico ### 255981###Speaker -
3:00 PM - 4:15 PMB23 - Assessing and Mitigating Risk in SBER Research: A Case Study Approach
Location: Room 24B
Amy Ben-Arieh, JD MPH – The Fenway Institute at Fenway Community Health; Alyssa Speier, MS, CIPSBER Track
Amy Ben-Arieh, JD MPH – The Fenway Institute at Fenway Community Health ### 420065###Speaker @@@ Alyssa Speier, MS, CIP ### 428263###Speaker -
4:15 PM - 5:30 PMAER18 Welcome Reception
-
4:15 PM - 5:30 PMAER18 Welcome Reception
Location: Exhibit Hall FG -
4:45 PM - 5:05 PMForte eReg: Ensure Compliance and Streamline Your Regulatory Processes
-
4:45 PM - 5:05 PM
-
5:45 PM - 7:15 PMYoung Professionals Networking Reception
-
5:45 PM - 7:15 PM
- Friday, November 16, 2018
-
7:00 AM - 5:00 PMOn-Site Check-In
-
7:00 AM - 5:00 PMOn-Site Check-In
Location: Exhibit Hall FG Foyer -
7:15 AM - 8:00 AMA Capella Musical Performance
-
7:15 AM - 8:00 AMA Capella Musical Performance
Location: Exhibit Hall H -
8:00 AM - 8:30 AMWelcome and Award Presentations
-
8:00 AM - 8:30 AMWelcome and Award Presentations
Location: Exhibit Hall H -
8:30 AM - 9:30 AMKeynote Address by Michelle M. Mello, JD, PhD: Clinical Trial Data Sharing: Perspectives From Participants
-
8:30 AM - 9:30 AMKeynote Address by Michelle M. Mello, JD, PhD: Clinical Trial Data Sharing: Perspectives From Participants
Location: Exhibit Hall H
Michelle M. Mello, JD, PhD – Stanford Law SchoolMichelle M. Mello, JD, PhD – Stanford Law School ### 585137###Keynote Speaker -
9:30 AM - 10:00 AMBeverage Break With the Supporters and Exhibitors
-
9:30 AM - 10:00 AMBeverage Break With the Supporters and Exhibitors
Location: Exhibit Hall FG -
10:00 AM - 11:00 AMExplorations in… Panel Series
-
10:00 AM - 11:00 AMExplorations A: Explorations in Optimizing Informed Consent and Assent
Location: Exhibit Hall H
Ryan Spellecy, PhD – Medical College of Wisconsin; Kristen Sullivan, PhD, MSW, MBA – Center for Bioethics, Department of Social Medicine, University of North Carolina at Chapel Hill; Moore Rhys, CIP; Jessica Macha, CIP – Ann & Robert H. Lurie Children's Hospital of ChicagoRyan Spellecy, PhD – Medical College of Wisconsin ### 11106###Moderator @@@ Kristen Sullivan, PhD, MSW, MBA – Center for Bioethics, Department of Social Medicine, University of North Carolina at Chapel Hill ### 426805###Speaker @@@ Moore Rhys, CIP ### 172058###Speaker @@@ Jessica Macha, CIP – Ann & Robert H. Lurie Children's Hospital of Chicago ### 255986###Speaker -
10:00 AM - 11:00 AMExplorations B: Explorations in Navigating the Single IRB Mandate
Location: Ballroom 20BC
Adrianne Haggins, MD, MS – University of Michigan Medical School; Jeanette Bailey, BS, MT(ASCP), CIP – Cincinnati Children's Hospital Medical Center; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Michael J. Linke, PhD, CIPAdrianne Haggins, MD, MS – University of Michigan Medical School ### 586790###Speaker @@@ Jeanette Bailey, BS, MT(ASCP), CIP – Cincinnati Children's Hospital Medical Center ### 172027###Speaker @@@ Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker @@@ Michael J. Linke, PhD, CIP ### 248446###Moderator -
10:00 AM - 11:00 AMExplorations C: Explorations in Engaging Communities to Promote Ethical Research
Location: Ballroom 20D
Bethany Hansen, MA – University of Minnesota; Shira Goldenberg – Centre for Gender and Sexual Health Equity, Simon Fraser University; Lauren Hartsmith, JD – HHS; Katie Huber, PhD, CIP – 23andMe, Inc.Bethany Hansen, MA – University of Minnesota ### 426755###Speaker @@@ Shira Goldenberg – Centre for Gender and Sexual Health Equity, Simon Fraser University ### 586787###Speaker @@@ Lauren Hartsmith, JD – HHS ### 263718###Moderator @@@ Katie Huber, PhD, CIP – 23andMe, Inc. ### 586798###Speaker -
11:15 AM - 1:30 PMBreakout Session Series C
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11:15 AM - 12:30 PMC01 - A Dialogue With the Department of Defense (DOD): Updates for DOD and DOD-Sponsored Research Protections Personnel
Location: Room 30C
T. Howard Stone, JD, LLM, CIP; Monique E. Hawkins, MS, CIP – Office of Naval Research; Stephanie Bruce, CIP, CPIA – Department of Defense; Kim London, JD, MPH – United States Air Force, Air Force Research Laboratory, OhioA Dialogue With the Feds Track
T. Howard Stone, JD, LLM, CIP ### 251909###Speaker @@@ Monique E. Hawkins, MS, CIP – Office of Naval Research ### 595814###Speaker @@@ Stephanie Bruce, CIP, CPIA – Department of Defense ### 255575###Speaker @@@ Kim London, JD, MPH – United States Air Force, Air Force Research Laboratory, Ohio ### 595816###Speaker -
11:15 AM - 12:30 PMC02 - A Dialogue With the Secretary's Advisory Committee on Human Research Protections (SACHRP)
Location: Room 29C
Julia G. Gorey, JD – OHRP; Nancy M. P. King, JD – Wake Forest School of Medicine; David A. Borasky, Jr., MPH, CIP – WIRB-Copernicus Group; David G. Forster, JD, MA, CIP – WIRB-Copernicus GroupA Dialogue With the Feds Track
Julia G. Gorey, JD – OHRP ### 11073###Speaker @@@ Nancy M. P. King, JD – Wake Forest School of Medicine ### 586820###Speaker @@@ David A. Borasky, Jr., MPH, CIP – WIRB-Copernicus Group ### 10124###Speaker @@@ David G. Forster, JD, MA, CIP – WIRB-Copernicus Group ### 10581###Speaker -
11:15 AM - 12:30 PMC03 - Standard of Care, Medical Innovation, or Research: How Should We Decide?
Location: Ballroom 20D
Jeremy J. Corsmo, MPH; Stephanie S. Cargill, PhD – Center for Health Care Ethics, Saint Louis UniversityBoundaries and Balances Track
Jeremy J. Corsmo, MPH ### 58254###Speaker @@@ Stephanie S. Cargill, PhD – Center for Health Care Ethics, Saint Louis University ### 11105###Speaker -
11:15 AM - 12:30 PMC04 - Advancing Yourself as a Regulatory Professional: Education, Cooperation, and Self-Advocacy
Location: Room 30D
Charlotte H. Coley, MACT, CIP; Karen M. Hansen – Fred Hutchinson Cancer Research Center; Margaret Rankovic, BA, MEd, CIP – CITI ProgramEducating and Training Track
Charlotte H. Coley, MACT, CIP ### 112598###Speaker @@@ Karen M. Hansen – Fred Hutchinson Cancer Research Center ### 10678###Speaker @@@ Margaret Rankovic, BA, MEd, CIP – CITI Program ### 587392###Speaker -
11:15 AM - 12:30 PMC05 - The Pressing Need for IRB Precedent
Location: Room 30E
Barbara E. Bierer, MD; Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Stephen J. Rosenfeld, MD, MBA – Quorum IRB ReviewLegal Track
Barbara E. Bierer, MD ### 10123###Speaker @@@ Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ### 420105###Speaker @@@ Stephen J. Rosenfeld, MD, MBA – Quorum IRB Review ### 420561###Speaker -
11:15 AM - 12:30 PMC06 - The Rise of the Patient Voice at FDA
Location: Room 23A
Andrea Furia-Helms, MPH – US Food and Drug Administration; Salina P. Miller, MS, MBA – Food and Drug AdministrationFDA Regulations Track
Andrea Furia-Helms, MPH – US Food and Drug Administration ### 586783###Speaker @@@ Salina P. Miller, MS, MBA – Food and Drug Administration ### 587391###Speaker -
11:15 AM - 12:30 PMC07 - Research Passport: Regulatory and Ethics Review Implications for International Participants in US-Based Clinical Trials
Location: Room 23C
Jessica Huening, JD – Yale University; Aarthi Iyer, JD, MPH – Kinetiq, a Division of Quorum Review, Inc.Global Research Track
Jessica Huening, JD – Yale University ### 187401###Speaker @@@ Aarthi Iyer, JD, MPH – Kinetiq, a Division of Quorum Review, Inc. ### 586799###Speaker -
11:15 AM - 12:30 PMC08 - Developments Regarding the Federal "Right-to-Try" Law and its Impact on the FDA's Expanded Access Program
Location: Room 30AB
Richard Klein; Marylana Saadeh Helou, Esq. – Verrill Dana LLP; Marjorie A. Speers, PhD – Clinical Research Pathways; Walter L. Straus, MD, MPH – Merck Co., Inc.Hot Topics Track
Richard Klein ### 11087###Speaker @@@ Marylana Saadeh Helou, Esq. – Verrill Dana LLP ### 587399###Speaker @@@ Marjorie A. Speers, PhD – Clinical Research Pathways ### 420568###Speaker @@@ Walter L. Straus, MD, MPH – Merck Co., Inc. ### 11111###Speaker -
11:15 AM - 1:30 PMC09 - Use It or Lose It: Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory Climate
Location: Room 33AB
Ann Johnson, PhD, MPH, CIP – University of Utah; Michele Kennett, JD, MSN, CIP – University of Missouri; Robert E. Nobles, II, DrPH, MPH, CIP – University of Tennessee, KnoxvilleInstitutional Officials and HRPP Leadership Track
Ann Johnson, PhD, MPH, CIP – University of Utah ### 298549###Speaker @@@ Michele Kennett, JD, MSN, CIP – University of Missouri ### 112633###Speaker @@@ Robert E. Nobles, II, DrPH, MPH, CIP – University of Tennessee, Knoxville ### 420157###Speaker -
11:15 AM - 1:30 PMC10 - Let's Review A Protocol: Reviewing Research that Requires Expedited or Full Board Review
Location: Room 28ABC
Warren Capell, MD – University of Colorado Denver; Andrew Hedrick, MPA, CIP – University of Kentucky; Amy C. Waltz, JD, CIPIRB 101 Track
Warren Capell, MD – University of Colorado Denver ### 263610###Speaker @@@ Andrew Hedrick, MPA, CIP – University of Kentucky ### 172015###Speaker @@@ Amy C. Waltz, JD, CIP ### 248436###Speaker -
11:15 AM - 1:30 PMC11 - IRB Chairs Forum: A Structured Discussion for IRB Chairs
Location: Room 22
Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; R. Peter Iafrate, PharmD – University of Florida; Geeta K. Swamy, MD – Duke UniversityIRB Chairs Track
Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center ### 57704###Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Speaker @@@ Geeta K. Swamy, MD – Duke University ### 420576###Speaker -
11:15 AM - 1:30 PMC12 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 29B
Joseph Datko, CIP – University of Miami; P. Pearl O'Rourke, MD; Michael J. Linke, PhD, CIP; Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center; Susan Sonne, PharmD, BCPPIRB Operations Advanced Track
Joseph Datko, CIP – University of Miami ### 426868###Speaker @@@ P. Pearl O'Rourke, MD ### 112647###Speaker @@@ Michael J. Linke, PhD, CIP ### 248446###Speaker @@@ Julie Ozier, MHL, CHRC, CIP – Vanderbilt University and Medical Center ### 112649###Speaker @@@ Susan Sonne, PharmD, BCPP ### 587407###Speaker -
11:15 AM - 12:30 PMC13 - Scientific and Ethical Considerations in Choosing a Study Control Group
Location: Room 23B
Robert (Skip) M. Nelson, MD, PhD – Johnson & Johnson; Albert J. Allen, MD, PhD – Eli Lilly and CompanyPharma/Biotech Perspectives Track
Robert (Skip) M. Nelson, MD, PhD – Johnson & Johnson ### 25714###Speaker @@@ Albert J. Allen, MD, PhD – Eli Lilly and Company ### 22648###Speaker -
11:15 AM - 1:30 PMC14 - Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996 (HIPAA): What’s New and What We Still Need to Worry About
Location: Ballroom 20A
Marissa Gordon-Nguyen, JD, MPH – HHS; Susie R. Hoffman, RN, BSN, CIP – University of Virginia; Nadine Peters, JD, MPH – Verrill Dana LLPLegal Track
Marissa Gordon-Nguyen, JD, MPH – HHS ### 441562###Speaker @@@ Susie R. Hoffman, RN, BSN, CIP – University of Virginia ### 10681###Speaker @@@ Nadine Peters, JD, MPH – Verrill Dana LLP ### 600716###Speaker -
11:15 AM - 1:30 PMC15 - Scientific Aspects of Study Design: A Primer for Non-Scientists
Location: Room 21
Susan S. Fish, PharmD, MPH – Boston University School of Public Health; Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus GroupNon-Scientist IRB Members Track
Susan S. Fish, PharmD, MPH – Boston University School of Public Health ### 11071###Speaker @@@ Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus Group ### 10687###Speaker -
11:15 AM - 1:30 PMC16 - Considerations for Return of Results Under the Revised Common Rule
Location: Room 28DE
Michelle Francis Grienauer, JD, MPH, CIP – Microsoft; Jody M. Shoemaker Roberts, MS, CCRP, CIP – Mind Research Network; Angela Bradbury, MD – University of Pennsylvania Perelman School of MedicineResearch Involving Data and Biospecimens Track
Michelle Francis Grienauer, JD, MPH, CIP – Microsoft ### 124795###Speaker @@@ Jody M. Shoemaker Roberts, MS, CCRP, CIP – Mind Research Network ### 171980###Speaker @@@ Angela Bradbury, MD – University of Pennsylvania Perelman School of Medicine ### 594043###Speaker -
11:15 AM - 1:30 PMC17 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior
Location: Room 29A
Amy Ben-Arieh, JD MPH – The Fenway Institute at Fenway Community Health; Mary L. Gray, PhD – Microsoft Research/Indiana University; Jeanette BowlesPopulations Requiring Additional Protections Track
Amy Ben-Arieh, JD MPH – The Fenway Institute at Fenway Community Health ### 420065###Speaker @@@ Mary L. Gray, PhD – Microsoft Research/Indiana University ### 284648###Speaker @@@ Jeanette Bowles ### 620402###Speaker -
11:15 AM - 1:30 PMC18 - Advanced Investigator Post-Approval Monitoring Issues
Location: Room 25C
Mary-Tara Roth, RN, MSN, MPH – Boston University Medical Campus/Boston Medical Center; Alyssa Speier, MS, CIPQA/QI and Post-Approval Monitoring Track
Mary-Tara Roth, RN, MSN, MPH – Boston University Medical Campus/Boston Medical Center ### 587396###Speaker @@@ Alyssa Speier, MS, CIP ### 428263###Speaker -
11:15 AM - 1:30 PMC19 - The Intersections of Data Security, Privacy, Confidentiality, and Compliance in Digital Health and Mobile Health (mHealth) Research
Location: Room 32AB
Jeremy N. Block, PhD, MPP – Venture Catalyst; Brenda L. Curtis, PhD, MSPH – Perelman School of Medicine, University of PennsylvaniaResearch Conducted in the Digital World Track
Jeremy N. Block, PhD, MPP – Venture Catalyst ### 21626###Speaker @@@ Brenda L. Curtis, PhD, MSPH – Perelman School of Medicine, University of Pennsylvania ### 57690###Speaker -
11:15 AM - 12:30 PMC20 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Location: Room 31B
Lisa R. Buchanan, BS, MAOM – DHHS, Office for Human Research Protections (OHRP); Kate Gallin Heffernan, JD – Verrill Dana LLP; Scott J. Moore, PhD, JD – DHHS Office of Research IntegrityResponsible Conduct of Research Track
Lisa R. Buchanan, BS, MAOM – DHHS, Office for Human Research Protections (OHRP) ### 10669###Speaker @@@ Kate Gallin Heffernan, JD – Verrill Dana LLP ### 10588###Speaker @@@ Scott J. Moore, PhD, JD – DHHS Office of Research Integrity ### 593732###Speaker -
11:15 AM - 1:30 PMC21 - Flying Solo: A Moderated Discussion on Challenges Encountered by Single Staff IRB Offices
Location: Room 24C
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago; Andrea McDowell, PhD – Seattle University; Rachel Zand, PhD – University of TorontoSmall Research Programs Track
April V. Baker, BGS – National Opinion Research Center (NORC) at the University of Chicago ### 263607###Speaker @@@ Andrea McDowell, PhD – Seattle University ### 175574###Speaker @@@ Rachel Zand, PhD – University of Toronto ### 171988###Speaker -
11:15 AM - 12:30 PMC22 - Research in K-12 Settings
Location: Room 31A
Shannon Sewards, MA, CIP – Harvard University; Julie Slayton, JD, PhD – University of Southern CaliforniaSBER Track
Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker @@@ Julie Slayton, JD, PhD – University of Southern California ### 112668###Speaker -
11:15 AM - 12:30 PMC23 - Understanding and Applying Family Educational Rights and Privacy Act (FERPA) Guidelines
Location: Room 29D
Bethany L. Johnson, JD, CIP – Indiana University; Nalinee D. Patin, CIP – Clemson UniversitySBER Track
Bethany L. Johnson, JD, CIP – Indiana University ### 586803###Speaker @@@ Nalinee D. Patin, CIP – Clemson University ### 587337###Speaker -
12:30 PM - 1:30 PMNetworking Lunch
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12:30 PM - 1:30 PMNetworking Lunch
Location: Exhibit Hall FG -
1:00 PM - 1:20 PMOverview and Demonstration of PRIM&R’s NEW Ethical Research Oversight Course (EROC)
-
1:00 PM - 1:20 PMOverview and Demonstration of PRIM&R’s New Ethical Research Oversight Course (EROC)
Location: Exhibit Hall FG -
1:45 PM - 3:00 PMConcurrent Plenary Sessions
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1:45 PM - 3:00 PMPanel IV: What Do Patients Want: Does Majority Rule?
Location: Ballroom 20BC
Neal W. Dickert, MD, PhD – Emory University School of Medicine, Department of Medicine, Division of Cardiology; Diana T. Chingos, MS, MFA – Patient Representative, HHS Secretary Advisory Committee on Human Research Protections (SACHRP); Matthew S. McCoy, PhD; Jonathan D. Jackson, PhD – Community Access, Recruitment, and Engagement (CARE) Research CenterNeal W. Dickert, MD, PhD – Emory University School of Medicine, Department of Medicine, Division of Cardiology ### 57694###Moderator @@@ Diana T. Chingos, MS, MFA – Patient Representative, HHS Secretary Advisory Committee on Human Research Protections (SACHRP) ### 188200###Panelist @@@ Matthew S. McCoy, PhD ### 585146###Panelist @@@ Jonathan D. Jackson, PhD – Community Access, Recruitment, and Engagement (CARE) Research Center ### 593622###Panelist -
1:45 PM - 3:00 PMPanel V: Ethical Challenges in HIV Cure Research
Location: Ballroom 20D
Rowena Johnston – amfAR; Stephanie S. Cargill, PhD – Center for Health Care Ethics, Saint Louis University; Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University; Nir Eyal, DPhil – Harvard T.H. Chan School of Public HealthRowena Johnston – amfAR ### 585144###Panelist @@@ Stephanie S. Cargill, PhD – Center for Health Care Ethics, Saint Louis University ### 11105###Moderator @@@ Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University ### 10037###Panelist @@@ Nir Eyal, DPhil – Harvard T.H. Chan School of Public Health ### 591962###Panelist -
1:45 PM - 3:00 PMPanel VI: To Participate or Not to Participate, That Is the Question
Location: Exhibit Hall H
Celia B. Fisher, PhD – Fordham University; Jonathan M. Green, MD, MBA – National Institutes of Health; Ivor A. Pritchard, PhD – Office for Human Research Protections; Ada Sue Selwitz, MA – University of KentuckyCelia B. Fisher, PhD – Fordham University ### 57702###Panelist @@@ Jonathan M. Green, MD, MBA – National Institutes of Health ### 420116###Panelist @@@ Ivor A. Pritchard, PhD – Office for Human Research Protections ### 10140###Moderator @@@ Ada Sue Selwitz, MA – University of Kentucky ### 11100###Panelist -
3:00 PM - 3:30 PMBeverage Break Supported by CITI Program, a division of BRANY
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3:00 PM - 3:30 PMBeverage Break
Location: Room 23-27 Hallway -
3:30 PM - 4:45 PMBreakout Session Series D
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3:30 PM - 4:45 PMD01 - A Dialogue With the FDA
Location: Room 30C
Soma Kalb, PhD – US Food and Drug Administration; Joanne R. Less, PhD – US Food and Drug Administration; Diane M. Maloney, JD – Food and Drug Administration; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Jan L. Hewett, BSN, JD – Food & Drug AdministrationA Dialogue With the Feds Track
Soma Kalb, PhD – US Food and Drug Administration ### 118703###Speaker @@@ Joanne 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 @@@ Jan L. Hewett, BSN, JD – Food & Drug Administration ### 43213###Speaker -
3:30 PM - 4:45 PMD02 - Pharmacogenetics and Precision Medicine: Partnering to Enable DNA Research in Global Clinical Trials
Location: Room 24AB
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Feng Hong, PhD – BioMarin Pharmaceutical, Inc.; Anita J. Nelsen – PAREXEL InternationalPharma/Biotech Perspectives Track
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University ### 284710###Speaker @@@ Feng Hong, PhD – BioMarin Pharmaceutical, Inc. ### 586797###Speaker @@@ Anita J. Nelsen – PAREXEL International ### 594022###Speaker -
3:30 PM - 4:45 PMD03 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Location: Room 30AB
Mark Barnes, JD, LLM – Ropes & Gray Law Firm; Julie Kaneshiro, MA – Office for Human Research Protections; Susan Stayn, JD – Stanford UniversityBoundaries and Balances Track
Mark Barnes, JD, LLM – Ropes & Gray Law Firm ### 57669###Faculty @@@ Julie Kaneshiro, MA – Office for Human Research Protections ### 11084###Speaker @@@ Susan Stayn, JD – Stanford University ### 11108###Speaker -
3:30 PM - 4:45 PMD04 - Paving the Road to Success: Meeting the Challenges of Investigator and Study Team Education
Location: Room 29B
Kelly Unsworth, MS, CCRP, CIP – University of Rochester; Michael Voth, MSc, CQA – University Health Network (UHN)Educating and Training Track
Kelly Unsworth, MS, CCRP, CIP – University of Rochester ### 187438###Speaker @@@ Michael Voth, MSc, CQA – University Health Network (UHN) ### 587410###Speaker -
3:30 PM - 4:45 PMD05 - Promises and Perils of HIV Phylogenetics Research
Location: Room 31B
Susan J. Little, MD – University of California San Diego; Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University; A. Cornelius Baker – U.S. Department of State’s Office of the U.S. Global AIDS CoordinatorEmpirical Research Ethics Track
Susan J. Little, MD – University of California San Diego ### 587332###Speaker @@@ Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University ### 10037###Speaker @@@ A. Cornelius Baker – U.S. Department of State’s Office of the U.S. Global AIDS Coordinator ### 10121###Speaker -
3:30 PM - 4:45 PMD06 - FDA’s Oversight of ClinicalTrials.gov Requirements
Location: Room 29A
Anthony Keyes, MBA, PMP – Johns Hopkins University School of Medicine; Patrick J. McNeilly, PhD – Food and Drug AdministrationFDA Regulations Track
Anthony Keyes, MBA, PMP – Johns Hopkins University School of Medicine ### 586819###Speaker @@@ Patrick J. McNeilly, PhD – Food and Drug Administration ### 10688###Speaker -
3:30 PM - 4:45 PMD07 - Lessons From the Trenches: Avoiding Legal and Operational Pitfalls in International Research Studies
Location: Room 31C
David A. Borasky, Jr., MPH, CIP – WIRB-Copernicus Group; Andrew P. Rusczek, JD, MBioethics – Verrill Dana LLPGlobal Research Track
David A. Borasky, Jr., MPH, CIP – WIRB-Copernicus Group ### 10124###Speaker @@@ Andrew P. Rusczek, JD, MBioethics – Verrill Dana LLP ### 58355###Speaker -
3:30 PM - 4:45 PMD08 - Public Health Emergencies, Research, and Bioethics
Location: Room 31A
Nicole (Nicky) J. Cohen, MD, MS – Centers for Disease Control and Prevention; Christine Grady, RN, PhD – National Institutes of Health Clinical CenterHot Topics Track
Nicole (Nicky) J. Cohen, MD, MS – Centers for Disease Control and Prevention ### 585107###Speaker @@@ Christine Grady, RN, PhD – National Institutes of Health Clinical Center ### 10026###Speaker -
3:30 PM - 4:45 PMD09 - How to Investigate, Mitigate, Report, and Learn from Noncompliance: Avoiding Pitfalls and Seizing Opportunities for Improvement
Location: Room 30D
Kate Gallin Heffernan, JD – Verrill Dana LLP; Scott J. Lipkin, DPM, CIPInstitutional Officials and HRPP Leadership Track
Kate Gallin Heffernan, JD – Verrill Dana LLP ### 10588###Speaker @@@ Scott J. Lipkin, DPM, CIP ### 10598###Speaker -
3:30 PM - 4:45 PMD10 - Writing and Updating Standard Operating Procedures (SOPs) With the Revised Common Rule in Mind
Location: Room 33AB
Elizabeth A. Bankert, MA – Dartmouth College; Lauren Hartsmith, JD – HHS; Cheryl A. Savini, CIP – The HRP Consulting GroupIRB 101 Track
Elizabeth A. Bankert, MA – Dartmouth College ### 57668###Faculty @@@ Lauren Hartsmith, JD – HHS ### 263718###Speaker @@@ Cheryl A. Savini, CIP – The HRP Consulting Group ### 21651###Speaker -
3:30 PM - 4:45 PMD11 - The Revised Common Rule: Operational Considerations for the IRB Chair
Location: Room 28DE
Jeremy J. Corsmo, MPH; R. Peter Iafrate, PharmD – University of FloridaIRB Chairs Track
Jeremy J. Corsmo, MPH ### 58254###Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Speaker -
3:30 PM - 4:45 PMD12 - Single IRB: The Next Generation
Location: Room 32AB
Jenni Beadles, MEd, CIP – Vanderbilt University Medical Center; Aaron Kirby, MSc – Harvard Catalyst; Daniel Alderson, MS, CIP – Boston Children's HospitalIRB Operations Advanced Track
Jenni Beadles, MEd, CIP – Vanderbilt University Medical Center ### 10567###Speaker @@@ Aaron Kirby, MSc – Harvard Catalyst ### 586821###Speaker @@@ Daniel Alderson, MS, CIP – Boston Children's Hospital ### 251905###Speaker -
3:30 PM - 4:45 PMD13 - Post-Trial Access: A Look at the Challenges of Ensuring Continued Access to Investigational Medicine
Location: Room 21
Robert Klitzman, MD – Columbia University; Walter L. Straus, MD, MPH – Merck Co., Inc.; Ariella Kelman, MD – GenentechPharma/Biotech Perspectives Track
Robert Klitzman, MD – Columbia University ### 284672###Speaker @@@ Walter L. Straus, MD, MPH – Merck Co., Inc. ### 11111###Speaker @@@ Ariella Kelman, MD – Genentech ### 420841###Speaker -
3:30 PM - 4:45 PMD14 - Wrangling IRB Reliance Agreements: How to Implement Flexible Terms and Addenda and Execute Necessary Agreements
Location: Room 25AB
Nichelle Cobb, PhD – University of Wisconsin-Madison; Ann Johnson, PhD, MPH, CIP – University of Utah; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of MedicineLegal Track
Nichelle Cobb, PhD – University of Wisconsin-Madison ### 173305###Speaker @@@ Ann Johnson, PhD, MPH, CIP – University of Utah ### 298549###Speaker @@@ Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker -
3:30 PM - 4:45 PMD15 - Recruiting, Educating, and Retaining Non-Scientist and Unaffiliated IRB Members
Location: Room 24C
Charlotte H. Coley, MACT, CIP; Glenn Ellis, MPH, CHCENon-Scientist IRB Members Track
Charlotte H. Coley, MACT, CIP ### 112598###Speaker @@@ Glenn Ellis, MPH, CHCE ### 585128###Speaker -
3:30 PM - 4:45 PMD16 - Assessing Plans to Maintain Confidentiality: How IRBs Can Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 28ABC
Gretchen L. J Anding, MA – University of Wisconsin-Madison; John R. Baumann, PhD – Indiana University; Elizabeth A. Buchanan, PhD – University of Wisconsin-StoutResearch Involving Data and Biospecimens Track
Gretchen L. J Anding, MA – University of Wisconsin-Madison ### 418825###Speaker @@@ John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout ### 10572###Speaker -
3:30 PM - 4:45 PMD17 - Looking Through the Bars: Responsible Research With Prisoners
Location: Room 29D
Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc.; Julia G. Gorey, JD – OHRPPopulations Requiring Additional Protections Track
Wayne Carriker, MA, CADC-II – Hopequest Ministry Group, Inc. ### 429992###Speaker @@@ Julia G. Gorey, JD – OHRP ### 11073###Speaker -
3:30 PM - 4:45 PMD18 - Nuts and Bolts of Assessing IRB Compliance
Location: Room 22
Lisa Denney, MPH, CIP – Stanford University; Keren R. Dunn, CIP – Cedars-Sinai Medical CenterQA/QI and Post-Approval Monitoring Track
Lisa Denney, MPH, CIP – Stanford University ### 10319###Speaker @@@ Keren R. Dunn, CIP – Cedars-Sinai Medical Center ### 10320###Speaker -
3:30 PM - 4:45 PMD19 - Social Media in Research: Recruitment, Subject Communication, and Data Source
Location: Ballroom 20A
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Michelle N. Meyer, PhD, JD – Union Graduate College-Icahn School of Medicine at Mount Sinai Bioethics ProgramResearch Conducted in the Digital World Track
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ### 420105###Speaker @@@ Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania ### 420145###Speaker @@@ Michelle N. Meyer, PhD, JD – Union Graduate College-Icahn School of Medicine at Mount Sinai Bioethics Program ### 114619###Speaker -
3:30 PM - 4:45 PMD20 - Agents and Rogues: The Limits of Agency, Institutional Engagement, and Institutional Responsibility
Location: Room 29C
Robert S. Bienkowski, PhD, CIP, CHRC – Central Michigan University; Lynn E. Smith, JD – Huron Consulting Group; Joseph Crossno, MS, CPIA – Central Michigan UniversityResponsible Conduct of Research Track
Robert S. Bienkowski, PhD, CIP, CHRC – Central Michigan University ### 57675###Speaker @@@ Lynn E. Smith, JD – Huron Consulting Group ### 21652###Speaker @@@ Joseph Crossno, MS, CPIA – Central Michigan University ### 597578###Speaker -
3:30 PM - 4:45 PMD21 - How to Maintain Institutional Memory at a Small Research Program
Location: Room 23C
Sharon C. Freitag, BSc – Providence St. Joseph's and St. Michael's Healthcare, Toronto; Jennifer L. Pacheco, MPH, CIM, CIPSmall Research Programs Track
Sharon C. Freitag, BSc – Providence St. Joseph's and St. Michael's Healthcare, Toronto ### 42223###Speaker @@@ Jennifer L. Pacheco, MPH, CIM, CIP ### 594020###Speaker -
3:30 PM - 4:45 PMD22 - Clinical Trials in the SBER Context
Location: Room 25C
Cynthia S. Shindledecker, CIP – University of Michigan; Wendy J. Weber, ND, PhD, MPH; Melissa E. Abraham, PhD, MSSBER Track
Cynthia S. Shindledecker, CIP – University of Michigan ### 25718###Speaker @@@ Wendy J. Weber, ND, PhD, MPH ### 587412###Speaker @@@ Melissa E. Abraham, PhD, MS ### 10021###Speaker -
3:30 PM - 4:45 PMD23 - Navigating Uncertainty: Research With Undocumented/Unauthorized Immigrants
Location: Room 30E
Gene Gloeckner, PhD – School of Education, Colorado State University; Elizabeth Jach, MA – University of Wisconsin-Madison; Colleen Kohashi, MA, CIP – UC BerkeleySBER Track
Gene Gloeckner, PhD – School of Education, Colorado State University ### 586786###Speaker @@@ Elizabeth Jach, MA – University of Wisconsin-Madison ### 586800###Speaker @@@ Colleen Kohashi, MA, CIP – UC Berkeley ### 118172###Speaker -
4:45 PM - 6:00 PMFederal Agency Office Hours
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4:45 PM - 6:00 PMFederal Agency/Accrediting Body Office Hours
Location: Exhibit Hall FG -
4:45 PM - 6:00 PMMeet the AER18 Poster Authors
-
4:45 PM - 6:00 PMMeet the AER18 Poster Authors
Location: Exhibit Hall FG -
4:45 PM - 6:00 PMNetworking Reception With the Supporters and Exhibiters
-
4:45 PM - 6:00 PMNetworking Reception With the Supporters and Exhibiters
Location: Exhibit Hall FG -
4:50 PM - 5:15 PMSimplifying Research Compliance With Cayuse IRB
-
4:50 PM - 5:15 PMSimplifying Research Compliance With Cayuse IRB
Location: Exhibit Hall FG - Saturday, November 17, 2018
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7:00 AM - 12:30 PMOn-Site Check-In
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7:00 AM - 12:30 PMOn-Site Check-In
Location: Exhibit Hall FG Foyer -
8:00 AM - 8:30 AMWelcome and PRIM&R Membership and CIP Updates
-
8:00 AM - 8:30 AMWelcome and PRIM&R Membership and CIP® Updates
Location: Exhibit Hall H -
8:30 AM - 9:30 AMKeynote Address by Vickie M. Mays, PhD, MSPH
-
8:30 AM - 9:30 AMKeynote Address by Vickie M. Mays, PhD, MSPH
Location: Exhibit Hall H
Vickie M. Mays, PhD, MSPH – University of California, Los AngelesVickie M. Mays, PhD, MSPH – University of California, Los Angeles ### 291708###Keynote Speaker -
9:30 AM - 10:00 AMBeverage Break With Supporters and Exhibitors
-
9:30 AM - 10:00 AMBeverage Break With Supporters and Exhibitors
Location: Exhibit Hall FG -
10:00 AM - 11:15 AMConcurrent Plenary Sessions
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10:00 AM - 11:15 AMPanel IX: Is a Misconception Always a Misconception?
Location: Ballroom 20D
John D. Lantos, MD – Children's Mercy Hospital; Monica Mita, MD, MDSc; Sally Okun, RN, BSN, MMHSJohn D. Lantos, MD – Children's Mercy Hospital ### 10032###Moderator @@@ Monica Mita, MD, MDSc ### 594021###Panelist @@@ Sally Okun, RN, BSN, MMHS ### 418866###Panelist -
10:00 AM - 11:15 AMPanel VII: IRB Decision-Making From a Behavioral Economics Perspective
Location: Ballroom 20BC
Christine Grady, RN, PhD – National Institutes of Health Clinical Center; Charles W. Lidz, PhD – University of Massachusetts Medical School; Michele Russell-Einhorn, JD – Advarra; Ivor A. Pritchard, PhD – Office for Human Research ProtectionsChristine Grady, RN, PhD – National Institutes of Health Clinical Center ### 10026###Moderator @@@ Charles W. Lidz, PhD – University of Massachusetts Medical School ### 585145###Panelist @@@ Michele Russell-Einhorn, JD – Advarra ### 10144###Panelist @@@ Ivor A. Pritchard, PhD – Office for Human Research Protections ### 10140###Panelist -
10:00 AM - 11:15 AMPanel VIII: Big Data: Who's Minding the Store?
Location: Exhibit Hall H
Brenda L. Curtis, PhD, MSPH – Perelman School of Medicine, University of Pennsylvania; Mark MacCarthy, MA, PhD; Matthew J. Bietz, PhD – Department of Informatics, University of California, Irvine; Mary L. Gray, PhD – Microsoft Research/Indiana UniversityBrenda L. Curtis, PhD, MSPH – Perelman School of Medicine, University of Pennsylvania ### 57690###Moderator @@@ Mark MacCarthy, MA, PhD ### 593723###Panelist @@@ Matthew J. Bietz, PhD – Department of Informatics, University of California, Irvine ### 594495###Panelist @@@ Mary L. Gray, PhD – Microsoft Research/Indiana University ### 284648###Panelist -
11:30 AM - 12:45 PMBreakout Session Series E
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11:30 AM - 12:45 PME01 - A Dialogue With AAHRPP, Inc.
Location: Room 29B
Michelle M. Feige, MSW, LCSW-C – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP); Robert Hood, PhD – AAHRPP, Inc.; Elyse I. Summers, JD – Association for the Accreditation of Human Research Protection Programs, Inc.; Kate Vulakovich – The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP); Lori Kravchick – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)A Dialogue With the Feds Track
Michelle M. Feige, MSW, LCSW-C – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 10675###Speaker @@@ Robert Hood, PhD – AAHRPP, Inc. ### 251843###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 @@@ Lori Kravchick – Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) ### 641618###Speaker -
11:30 AM - 12:45 PME02 - Two Offices Divided by a Common Goal: Conflict of Interest (COI) and IRB
Location: Room 22
John R. Baumann, PhD – Indiana University; Heather H. Pierce, JD, MPH – Association of American Medical CollegesInstitutional Officials and HRPP Leadership Track
John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ Heather H. Pierce, JD, MPH – Association of American Medical Colleges ### 10328###Speaker -
11:30 AM - 12:45 PME03 - The Seven Habits of Highly Effective and Flexible IRBs
Location: Room 30AB
Cecilia Brooke Cholka, MA, CIP – The University of New Mexico; Jeffrey A. Cooper, MD, MMM – WIRB Copernicus Group; Jonathan M. Green, MD, MBA – National Institutes of HealthBoundaries and Balances Track
Cecilia Brooke Cholka, MA, CIP – The University of New Mexico ### 585105###Speaker @@@ Jeffrey A. Cooper, MD, MMM – WIRB Copernicus Group ### 112600###Speaker @@@ Jonathan M. Green, MD, MBA – National Institutes of Health ### 420116###Speaker -
11:30 AM - 12:45 PME04 - Building Bridges Through IRB Education Outreach
Location: Room 31A
Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital Medical Center; Colleen P. Gilrane, PhD – The University of Tennessee, Knoxville; Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research IntegrityEducating and Training Track
Mina P. Busch, MS, CCRP, CIP – Cincinnati Children's Hospital Medical Center ### 10574###Speaker @@@ Colleen P. Gilrane, PhD – The University of Tennessee, Knoxville ### 420115###Speaker @@@ Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research Integrity ### 619387###Speaker -
11:30 AM - 12:45 PME05 - Correcting and Avoiding Noncompliance: Examining Real-life Cases
Location: Room 32AB
Martha Jones, MA, CIP – Washington University in St. Louis; Charlotte H. Coley, MACT, CIPQA/QI and Post-Approval Monitoring Track
Martha Jones, MA, CIP – Washington University in St. Louis ### 59861###Speaker @@@ Charlotte H. Coley, MACT, CIP ### 112598###Speaker -
11:30 AM - 12:45 PME06 - FDA Clinical Holds and 21 CFR 50 Subpart D
Location: Room 29A
David G. Forster, JD, MA, CIP – WIRB-Copernicus Group; Kevin A. Prohaska, DO, MPH – Food and Drug Administration; Donna L. Snyder, MD – Food and Drug AdministrationFDA Regulations Track
David 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 -
11:30 AM - 12:45 PME07 - Applying US Human Research Protections Regulations and Embedded Cultural Values to Research Conducted in Different Cultures: Challenges, Cultural Considerations, Collaborations, and Experiences
Location: Room 30D
Edward E. Bartlett, PhD; Derek Englis, MBA, EdS, CIP – Department of the Navy Human Research Protection Program (DON HRPP)/Armed Forces Services Corporation; A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6; Sophea Sout – U.S Naval Medical Research Unit TWO, Phnom Penh, CambodiaGlobal Research Track
Edward E. Bartlett, PhD ### 10663###Speaker @@@ Derek Englis, MBA, EdS, CIP – Department of the Navy Human Research Protection Program (DON HRPP)/Armed Forces Services Corporation ### 585129###Speaker @@@ A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6 ### 587331###Speaker @@@ Sophea Sout – U.S Naval Medical Research Unit TWO, Phnom Penh, Cambodia ### 587408###Speaker -
11:30 AM - 12:45 PME08 - User Agreements in Human Subjects Research During the Burgeoning Technology Age
Location: Room 25AB
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University; Megan Doerr – Sage BionetworksResearch Conducted in the Digital World Track
Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University ### 284710###Speaker @@@ Megan Doerr – Sage Bionetworks ### 427699###Speaker -
11:30 AM - 12:45 PME09 - Ethical and Operational Issues Related to Clinical Trial Billing: What HRPPs and IRBs Should Consider
Location: Room 25C
Keren R. Dunn, CIP – Cedars-Sinai Medical Center; F. Lisa Murtha, Esq., CHC, CHRC – FTI Consulting; Ann Rodavitch, MA – Memorial Sloan Kettering Cancer CenterInstitutional Officials and HRPP Leadership Track
Keren R. Dunn, CIP – Cedars-Sinai Medical Center ### 10320###Speaker @@@ F. Lisa Murtha, Esq., CHC, CHRC – FTI Consulting ### 25713###Speaker @@@ Ann Rodavitch, MA – Memorial Sloan Kettering Cancer Center ### 248442###Speaker -
11:30 AM - 12:45 PME10 - IRB Review of Informed Consent: Moving Beyond the Form
Location: Room 33AB
Elizabeth A. Bankert, MA – Dartmouth College; Joshua Fedewa, CIP – University of Texas Southwestern Medical Center; Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)IRB 101 Track
Elizabeth A. Bankert, MA – Dartmouth College ### 57668###Speaker @@@ Joshua Fedewa, CIP – University of Texas Southwestern Medical Center ### 112607###Speaker @@@ Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS) ### 251900###Speaker -
11:30 AM - 12:45 PME11 - The Role of the IRB Chair in Protocol Exceptions, Violations, Noncompliance, and Unanticipated Problems
Location: Room 28DE
Jeremy J. Corsmo, MPH; Madelon V. Baranoski, PhD, CIP – Yale UniversityIRB Chairs Track
Jeremy J. Corsmo, MPH ### 58254###Speaker @@@ Madelon V. Baranoski, PhD, CIP – Yale University ### 433404###Speaker -
11:30 AM - 12:45 PME12 - Overlapping Roles of Data Safety Monitoring Boards (DSMBs) and IRBs in the Protection of Human Subjects
Location: Room 30C
Michael J. Linke, PhD, CIP; Robert Silbergleit, MD – University of Michigan Medical School; Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine; Roger J. Lewis, MD, PhDIRB Operations Advanced Track
Michael J. Linke, PhD, CIP ### 248446###Speaker @@@ Robert Silbergleit, MD – University of Michigan Medical School ### 254860###Speaker @@@ Megan Kasimatis Singleton, JD, MBE, CIP – Johns Hopkins University School of Medicine ### 112632###Speaker @@@ Roger J. Lewis, MD, PhD ### 21641###Speaker -
11:30 AM - 12:45 PME13 - Designing and Implementing Expanded Access Programs
Location: Room 31C
Richard Klein; Marjorie A. Speers, PhD – Clinical Research Pathways; Walter L. Straus, MD, MPH – Merck Co., Inc.; Erika L. Segear, PhD, RAC – Duke University School of MedicinePharma/Biotech Perspectives Track
Richard Klein ### 11087###Speaker @@@ Marjorie A. Speers, PhD – Clinical Research Pathways ### 420568###Speaker @@@ Walter L. Straus, MD, MPH – Merck Co., Inc. ### 11111###Speaker @@@ Erika L. Segear, PhD, RAC – Duke University School of Medicine ### 628387###Speaker -
11:30 AM - 12:45 PME14 - From Shield to Sword? How the 21st Century Cures Act and NIH Policy Have Altered Certificates of Confidentiality (CoCs)
Location: Room 24AB
Leslie E. Wolf, JD, MPH – Georgia State University College of Law; Carrie D. Wolinetz, PhD – National Institutes of Health; Catherine Sutherland – University of Colorado, Denver - Anschutz Medical CampusLegal Track
Leslie E. Wolf, JD, MPH – Georgia State University College of Law ### 11120###Speaker @@@ Carrie D. Wolinetz, PhD – National Institutes of Health ### 186124###Speaker @@@ Catherine Sutherland – University of Colorado, Denver - Anschutz Medical Campus ### 594779###Speaker -
11:30 AM - 12:45 PME15 - Considerations and Strategies for Maximizing Contributions and Promoting Effective Communication for Non-Scientist and Unaffiliated IRB Members
Location: Room 24C
Nathalia Henry, MS, CHRC, CIP – Northwestern University; Stephen Poppel, PhD, CFANon-Scientist IRB Members Track
Nathalia Henry, MS, CHRC, CIP – Northwestern University ### 586792###Speaker @@@ Stephen Poppel, PhD, CFA ### 593616###Speaker -
11:30 AM - 12:45 PME16 - Building a Better Biobank: Promise and Challenges of the National Cancer Institute Cancer Moonshot Biobank
Location: Room 29C
Helen M. Moore, PhD – NIH/NCI; Janet Freeman-Daily, MS, ENG – GrayConnections.netResearch Involving Data and Biospecimens Track
Helen M. Moore, PhD – NIH/NCI ### 593597###Speaker @@@ Janet Freeman-Daily, MS, ENG – GrayConnections.net ### 593739###Speaker -
11:30 AM - 12:45 PME17 - Tribal Research Futures: Resources to Strengthen Governance, Trust, and Culture in Research Partnerships
Location: Room 23A
Yvette Roubideaux, MD, MPH – National Congress of American Indians; Amber Emerson, MPH – School of Community Health Sciences, University of Nevada, RenoPopulations Requiring Additional Protections Track
Yvette Roubideaux, MD, MPH – National Congress of American Indians ### 587398###Speaker @@@ Amber Emerson, MPH – School of Community Health Sciences, University of Nevada, Reno ### 645727###Speaker -
11:30 AM - 12:45 PME18 - Nuts and Bolts of Investigator Site Audits
Location: Room 29D
David A. Borasky, Jr., MPH, CIP – WIRB-Copernicus Group; Stephanie deRijke, RN, MSN – Emory University; Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of PittsburghQA/QI and Post-Approval Monitoring Track
David A. Borasky, Jr., MPH, CIP – WIRB-Copernicus Group ### 10124###Speaker @@@ Stephanie deRijke, RN, MSN – Emory University ### 256471###Speaker @@@ Kelly Dornin-Koss, MPPM, RN, CIP, CCRC – University of Pittsburgh ### 10578###Speaker -
11:30 AM - 12:45 PME19 - Intersection of Research and Electronic Health Records With Privacy and Confidentiality Concerns: Considerations for IRB Review
Location: Ballroom 20A
Gretchen L. J Anding, MA – University of Wisconsin-Madison; Judith Birk, JD – University of MichiganResearch Conducted in the Digital World Track
Gretchen L. J Anding, MA – University of Wisconsin-Madison ### 418825###Speaker @@@ Judith Birk, JD – University of Michigan ### 11062###Speaker -
11:30 AM - 12:45 PME20 - Data Acquisition and Management: Concepts Every Researcher and Research Administrator Should Know
Location: Room 23C
Carolyn Broccardo, PhD, PMP – University of Wyoming; Bradley R. Woods, PhD – Colorado State UniversityResponsible Conduct of Research Track
Carolyn Broccardo, PhD, PMP – University of Wyoming ### 420073###Speaker @@@ Bradley R. Woods, PhD – Colorado State University ### 302148###Speaker -
11:30 AM - 12:45 PME21 - Managing Small Research Programs in Healthcare Settings
Location: Room 31B
Delilah Ofosu-Barko, BMSc – Trillium Health Partners; Jennifer L. Pacheco, MPH, CIM, CIPSmall Research Programs Track
Delilah Ofosu-Barko, BMSc – Trillium Health Partners ### 420160###Speaker @@@ Jennifer L. Pacheco, MPH, CIM, CIP ### 594020###Speaker -
11:30 AM - 12:45 PME22 - How to Create an Undergraduate Research Training Program
Location: Room 30E
Jonathan M. Girard – Harvard University; Shannon Sewards, MA, CIP – Harvard UniversitySBER Track
Jonathan M. Girard – Harvard University ### 586785###Speaker @@@ Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker -
11:30 AM - 12:45 PME23 - You Want to Do What? Developing Best Practices for IRB Review of Research Investigating Illegal/Illicit Behaviors
Location: Room 28ABC
Dean R. Gallant, AB – The HRP Consulting Group; Sarah Trautz – Beth Israel Deaconess Medical Center; Jeffrey M. Cohen, PhD – The HRP Consulting GroupSBER Track
Dean R. Gallant, AB – The HRP Consulting Group ### 10127###Speaker @@@ Sarah Trautz – Beth Israel Deaconess Medical Center ### 12697###Speaker @@@ Jeffrey M. Cohen, PhD – The HRP Consulting Group ### 11067###Speaker -
12:45 PM - 2:30 PMClosing General Session Luncheon
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12:45 PM - 2:30 PMClosing General Session Luncheon: Research Ethics, Race, and Opioids—The Evolution of the Perfect Epidemic
Location: Exhibit Hall H
Elizabeth A. Buchanan, PhD – University of Wisconsin-Stout; Brenda L. Curtis, PhD, MSPH – Perelman School of Medicine, University of Pennsylvania; Alexis Roth, MPH, PhD – Dornsife School of Public Health, Drexel University; Ekow N. Yankah, BA, JD, BCL – Yeshiva UniversityElizabeth A. Buchanan, PhD – University of Wisconsin-Stout ### 10572###Moderator @@@ Brenda L. Curtis, PhD, MSPH – Perelman School of Medicine, University of Pennsylvania ### 57690###Panelist @@@ Alexis Roth, MPH, PhD – Dornsife School of Public Health, Drexel University ### 593618###Panelist @@@ Ekow N. Yankah, BA, JD, BCL – Yeshiva University ### 593619###Panelist