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Click on an individual session to read more about it. To search the program by date, title, target audience, or to do a keyword search, click on "Conference Agenda" in the left hand navigation, and select the desired sort type.
- Sunday, November 17, 2019
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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 B
Katie Shilton, MLIS, PhD – University of Maryland College ParkKatie Shilton, MLIS, PhD – University of Maryland College Park ### 10146###Keynote Speaker -
9:15 AM - 10:30 AMBreakout Session Series A
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9:15 AM - 10:30 AMA03 - Scientific Merit and SBER
Location: Room 311
Julie Slayton, JD, PhD – University of Southern California; Matt D. Stafford, MPH – Boston Children's HospitalAdvanced Track (SBER)
Julie Slayton, JD, PhD – University of Southern California ### 112668###Speaker @@@ Matt D. Stafford, MPH – Boston Children's Hospital ### 57750###Speaker -
9:15 AM - 10:30 AMA07 - Continuing Review or No Continuing Review, That Is the Question
Location: Room 302
Andrew Hedrick, MPA, CIP – The Ohio State University; Sharon L. Zack, MS – WestatIRB Policy/Operations Track (SBER)
Andrew Hedrick, MPA, CIP – The Ohio State University ### 172015###Speaker @@@ Sharon L. Zack, MS – Westat ### 124855###Speaker -
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 311
Rebecca D. Armstrong, DVM, PhD – University of California, Berkeley; Cecilia Brooke Cholka, MA, CIP – University of Nevada, RenoAdvanced 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 PMB06 - Reliance—SBER Specific Issues
Location: Room 302
Robleinscky Isabel Dominguez, BS, CIP – Boston Children's Hospital; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis; Ashley D. Hicks, CIP – Tufts UniversityHot Topics Track (SBER)
Robleinscky 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 -
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 B
Andrew Hedrick, MPA, CIP – The Ohio State University; RoseAnn Fleming, CIP – University of Southern California Institutional Review Board; Julie Slayton, JD, PhD – University of Southern California; Jessica R. Williams, MA, MS, CIP – University of KentuckyAndrew 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 -
3:15 PM - 4:30 PMBreakout Session Series C
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3:15 PM - 4:30 PMC05 - Benign Behavioral Interventions (BBI) in Practice
Location: Room 302
Alma Castro, MA, CIP – Harvard T.H. Chan School of Public Health; Matt D. Stafford, MPH – Boston Children's Hospital; Ivor A. Pritchard, PhD – OHRPHot Topics Track (SBER)
Alma 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 -
3:15 PM - 4:30 PMC06 - College Students and Research—Challenges and Issues for IRBs
Location: Room 311
Andrea R. McDowell, PhD – Seattle University; Julie F. Simpson, PhD – University of New HampshireBasic Track (SBER)
Andrea R. McDowell, PhD – Seattle University ### 175574###Speaker @@@ Julie F. Simpson, PhD – University of New Hampshire ### 57933###Speaker - Monday, November 18, 2019
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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 Auditorium
Janine Austin Clayton, MD – NIHJanine Austin Clayton, MD – NIH ### 825084###Keynote Speaker -
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 B
Barbara E. Bierer, MD – Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard; Denise Anne Dillard, PhD – Southcentral Foundation; Tesheia Johnson, MBA, MHS – Yale University; Paul Underwood, MD FACC – Boston Scientific CorporationBarbara 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 Auditorium
Kimberly M. Nelson, PhD, MPH – Boston University School of Public Health; Teresa Doksum, PhD, MPH – Abt Associates Inc.; Luke Gelinas, PhD – Advarra; Julie Slayton, JD, PhD – University of Southern CaliforniaKimberly 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 C
Jeremy Sugarman, MD, MPH, MA – Johns Hopkins University; Josephine M. Johnston, LLB, MBHL – The Hastings Center; Haley K. Sullivan – Duke University; Ingrid A. Holm, MD, MPH – Boston Children's HospitalJeremy 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 -
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 304
John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. LouisIRB 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 PMA11 - Legal and Regulatory Changes: A Year in Review
Location: Room 302
Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Michele Russell-Einhorn, JD – Advarra; Laura Odwazny, JD, MA – US DHHSLegal 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 311
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 -
1:00 PM - 2:15 PMA19 - Fundamental Issues in Qualitative Research
Location: Room 306
Julie F. Simpson, PhD – University of New Hampshire; Patricia B. Condon, PhD – University of New HampshireSBER Track
Julie F. Simpson, PhD – University of New Hampshire ### 57933###Speaker @@@ Patricia B. Condon, PhD – University of New Hampshire ### 855130###Speaker -
1:00 PM - 2:15 PMA23 - Making Limited Review Work Without Reinventing the Wheel
Location: Room 313
David A. Borasky, Jr., MPH, CIP – WCG; Teresa Doksum, PhD, MPH – Abt Associates Inc.IRB Operations Advanced Track
David A. Borasky, Jr., MPH, CIP – WCG ### 10124###Speaker @@@ Teresa Doksum, PhD, MPH – Abt Associates Inc. ### 21633###Speaker -
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 302
Alexander M. Capron, LLB, MA (Hon). – University of Southern California; Robert W. Frenck, Jr., MD – Cincinnati Children’s Medical Center; Michele Russell-Einhorn, JD – AdvarraFlexibility 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 PMB04 - Investigational Device Exemptions (IDE) Mobile Medical Applications and IRB Review
Location: Room 311
Soma Kalb, PhD – US Food and Drug Administration; Bakul Patel, MSEE, MBA – Center for Devices and Radiological Health (CDRH) Food and Drug Administration; James Riddle, MCSE, CIP, CPIA, CRQM – Advarra, Inc.FDA-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 PMB09 - Taking the Plunge—Transitioning Studies to the Revised Common Rule
Location: Room 306
Lauren Hartsmith, JD – OHRP; John Heldens, CIP, CCRP – University of Colorado Denver, Anschutz Medical Campus; Nathalia Henry, MS, CHRC, CIP – Northwestern UniversityIRB 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 PMB15 - The Secrets of Big Data—Public, Private, or Something Else?
Location: Room 304
Ivor A. Pritchard, PhD – OHRPResearch Conducted in the Digital World Track
Ivor A. Pritchard, PhD – OHRP ### 10140###Speaker -
2:45 PM - 4:00 PMB18 - A Comparison of Human Subjects Protections Auditing Between Biomedical and Social-Behavioral Human Subjects Research
Location: Room 313
Narayan A. Escolin, MBS, CCRP – Rutgers University; Kate Sasamoto, JD – Office of Research Compliance Review, University of MichiganSBER Track
Narayan A. Escolin, MBS, CCRP – Rutgers University ### 824458###Speaker @@@ Kate Sasamoto, JD – Office of Research Compliance Review, University of Michigan ### 609545###Speaker - Tuesday, November 19, 2019
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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: Veterans Memorial Auditorium -
8:05 AM - 8:10 AMPresentation of PRIM&R’s Distinguished Service Award to Robert S. Bienkowski, PhD, Central Michigan University
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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
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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
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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?
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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 Auditorium
Scott D. Halpern, MD, PhD – University of Pennsylvania Perelman School of MedicineScott D. Halpern, MD, PhD – University of Pennsylvania Perelman School of Medicine ### 824498###Keynote Speaker -
10:15 AM - 12:45 PMBreakout Session Series C
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10:15 AM - 11:30 AMC05 - European Union (EU) General Data Protection Regulation (GDPR)
Location: Room 302
Kristin J. Craun, MPH, CIP – University of California Los Angeles; Michael A. DiMaio – Ropes & Gray LLPGlobal 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 - 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 304
Danielle Giltner, JD, CIP – Human Research Protection Program, Indiana University; Warren Capell, MD – University of Colorado Denver; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public HealthIRB 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 PMC09 - Creative Solutions for Serving as a Reviewing IRB
Location: Room 306
Holly Bante, PhD, MPH – University of Cincinnati; Ann Johnson, PhD, MPH, CIP – University of Utah; Hallie Kassan, MS, CIP – Northwell Health; Janelle A. Maddox-Regis, MS – Johns Hopkins University SOMIRB 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 AMC15 - Social Media in Research—Recruitment, Subject Communication, and Data Source
Location: Ballroom C
Emily Largent, RN, JD, PhD – Perelman School of Medicine, University of Pennsylvania; Holly Fernandez Lynch, JD, MA-Bioethics – Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania; Stephanie Morain, PhD, MPH – Baylor College of MedicineResearch 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 - 12:45 PMC20 - Implementing the Key Information Requirements of the Revised Common Rule—Perspectives on Early Approaches
Location: Room 311
Susan Z. Kornetsky, MPH – Boston Children's Hospital; Sariah Fuller – University of Utah; Holly A. Taylor, PhD, MPH – NIHIRB 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 -
11:45 AM - 12:45 PMFederal Agency and Accrediting Body Dialogue Sessions
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11:45 AM - 12:45 PMA Dialogue with DoD
Location: Room 313
Laura R. Brosch, RN, PhD – Uniformed Services University of the Health Sciences; Stephanie Bruce, CIP, CPIA – Department of Defense; John Lee Melton, PhD, CDR, MSC, USN – Department of NavyLaura 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 FDA
Location: Ballroom C
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; Soma Kalb, PhD – US Food and Drug Administration; Kavita C. Dada, Pharm, D. RAC – Food and Drug Administration; Patrick J. McNeilly, PhD – Food and Drug AdministrationJoanne 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 OHRP
Location: Ballroom B
Lisa R. Buchanan, MAOM – DHHS, Office for Human Research Protections (OHRP); Julie Kaneshiro, MA – Office for Human Research Protections; Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS; Irene E. Stith-Coleman, PhD – Office for Human Research Protections; Ivor A. Pritchard, PhD – OHRPLisa 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 the VA
Location: Room 302
Kristina C. Borror, PhD – Veterans Health Administration; Cynthia L. Boudreaux, M.Ed – Department of Veterans Affairs; Charlotte K. Jeans, PhD, CCRN, CIP – Department of Veterans Affairs; Mary M. Klote, MD, CIP – Veterans Health AdministrationKristina 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 -
2:00 PM - 3:15 AMConcurrent Plenary Sessions
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2:00 PM - 3:15 PMPanel IV: Identifying and Avoiding the Conduct of Low Value Clinical Trials
Location: Ballroom B
John R. Baumann, PhD – Indiana University; Laura Odwazny, JD, MA – US DHHS; Eileen M. O'Reilly, MD – Memorial Sloan Kettering Cancer Center; Deborah Zarin, MD – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Medical School; Stephen J. Rosenfeld, MD, MBA – Freeport Research SystemsJohn 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 C
Mildred Z. Solomon, EdD – The Hastings Center; Steven Joffe, MD, MPH – University of Pennsylvania Perelman School of Medicine; Nancy M.P King, JD – Wake Forest School of Medicine; Alex John London, PhD – Carnegie Mellon University; Karen J. Maschke, PhD – The Hastings CenterMildred 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
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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 Auditorium
David H. Strauss, MD – Columbia University; Celia B. Fisher, PhD – Fordham University; Samantha Marquez McKetchnie, LCSW – Massachusetts General HospitalDavid H. Strauss, MD – Columbia University ### 10147###Moderator @@@ Celia B. Fisher, PhD – Fordham University ### 57702###Panelist @@@ Samantha Marquez McKetchnie, LCSW – Massachusetts General Hospital ### 829354###Panelist -
3:45 PM - 5:00 PMBreakout Session Series D
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3:45 PM - 5:00 PMD07 - Writing and Updating Standard Operating Procedures (SOPs) for the Revised Common Rule
Location: Room 306
Elizabeth A. Bankert, MA – Dartmouth College; Lauren Hartsmith, JD – OHRP; Cheryl A. Savini – The HRP Consulting GroupIRB 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 311
Francis J. DiMario, MD, MA, CIP – University of Connecticut; Michael J. Linke, PhD, CIP – University of Cincinnati College of MedicineIRB 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 PMD12 - Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient
Location: Room 304
Gretchen L. J Anding, MA – University of Wisconsin-Madison; Elizabeth A. Buchanan, PhD – University of Wisconsin-StoutResearch 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 PMD14 - Ideas and Practices for Compliance and Auditing of Single IRB (sIRB) Studies
Location: Room 302
Nichelle Cobb, PhD – University of Wisconsin-Madison; Neala Lane, MS, CCRC – Indiana University; Sarah A. White, MPH – Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and HarvardQA/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 PMD19 - IRBs and Ethnographers—Unpacking the Dimensions of a Challenging Relationship to Increase Mutual Understanding
Location: Room 313
Shannon Sewards, MA, CIP – Harvard University; Montana Miller, PhD – Bowling Green State UniversitySBER Track
Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker @@@ Montana Miller, PhD – Bowling Green State University ### 830142###Speaker - Wednesday, November 20, 2019
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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 Auditorium
Mary Elizabeth Williams, BA – maryelizabethwilliams.netMary 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 B
Jacob Metcalf, PhD – Ethical Resolve, LLC; James R. Foulds, PhD – University of Maryland, Baltimore County; Stephen J. Rosenfeld, MD, MBA – Freeport Research SystemsJacob 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 C
Albert J. Allen, MD, PhD – Eli Lilly and Company; Benjamin C. Silverman, MD – Partners HealthCare System, Inc.; Juliette Roddy, PhD – University of Michigan Dearborn; Beth Watters, JD – Partners HealthCare System, Inc.Albert 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 -
11:30 AM - 12:45 PMBreakout Session Series E
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11:30 AM - 12:45 PME02 - Strategies for IRB Member Education
Location: Room 304
Toby L. Schonfeld, PhD – Prime Review Board; Emily E. Anderson, PhD, MPH – Loyola University Chicago Stritch School of MedicineEducating and Training Track
Toby 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 PME05 - Applying US Human Research Protections Regulations and Embedded Cultural Values to Research Conducted in Different Cultures
Location: Room 302
A. Roxana Lescano, JD, MS Bioethics (c ) – US Naval Medical Research Unit No. 6; Derek Englis, MBA, EdS, CIP – Armed Forces Services Corp./Magellan Federal; Bussara Sukpanichnant, BS (Nursing), M.Ed., CIP – Armed Forces Research Institute of Medical Sciences (AFRIMS); Edward E. Bartlett, PhD – Office for Human Research ProtectionsGlobal 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 PME14 - Impact of the Revised Common Rule on the Work of a QA/QI Program
Location: Room 311
Mary-Tara Roth, RN, MSN, MPH – Boston University Medical Campus/Boston Medical Center; Leslie M. Howes, MPH, CIP – Harvard T.H. Chan School of Public HealthQA/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 PME19 - Navigating Uncertainty—Developing Best Practices for Review of Research on the Edge
Location: Room 306
Jeffrey M. Cohen, PhD – Department of Bioethics, Clarkson University; Juliette Roddy, PhD – University of Michigan DearbornSBER 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 PME22 - Implementation of a System to Promote Compliance With 45 CFR 46.116(h)—Posting Consent Forms
Location: Room 313
Matthew Ogrodnik, MS, CIP – Boston Medical Center and Boston University Medical Campus; Lauren Hartsmith, JD – OHRPInstitutional 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 -
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 Auditorium
Neal W. Dickert, MD, PhD – Emory University School of Medicine; Marshall Chin, MD, MPH – University of Chicago; David Magnus, PhD – Stanford University; Tamiko Eto, MS, CIP – Stanford Research Institute (SRI) InternationalNeal 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