- Wednesday, November 14, 2018
7:00 AM – 2:30 PM East Coast USA Time
On-Site Check-In
7:00 AM – 2:30 PM East Coast USA Time
Preconference Programs On-Site Check-In at the Manchester Grand Hyatt
8:30 AM – 4:30 PM East Coast USA Time
2018 AER Conference: Preconference Programs
8:30 AM – 12:30 PM East Coast USA Time
Ethical and Practical Issues in Global Human ResearchLocation: Old Town
Delia 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
8:30 AM – 12:30 PM East Coast USA Time
Tips and Tools for Effective Education and TrainingLocation: La Jolla
Sharon Shriver, PhD – PRIM&R ### 302147###Preconference Speaker @@@ Elizabeth Kipp Campbell, PhD, CIP – Council Member ### 584376###Preconference Speaker8:30 AM – 4:30 PM East Coast USA Time
Biobanking in an Era of Research Towards Precision Medicine: Approaches to the Ethical, Regulatory, and Practical ChallengesLocation: Harbor Ballroom A
Marianna 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 PM East Coast USA Time
Dean 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 – 4:30 PM East Coast USA Time
Implementing the Revised Common RuleLocation: Grand Hall B
Ada Sue Selwitz, MA – University of Kentucky ### 11100###Preconference Speaker @@@ Ivor A. Pritchard, PhD – Office for Human Research Protections ### 10140###Preconference Speaker8:30 AM – 4:30 PM East Coast USA Time
IRB 101smLocation: Harbor Ballroom H
David H. Strauss, MD – Austen Riggs Center ### 10147###Preconference Speaker @@@ Daniel K. Nelson, MSc, CIP ### 10137###Preconference Speaker
8:30 AM – 4:30 PM East Coast USA Time
IRB Chairs Boot Camp: Tools for Successful IRB LeadershipLocation: Harbor Ballroom G
Francis J. DiMario, Jr., MD, MA, CIP ### 25706###Preconference Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Preconference Speaker
8:30 AM – 4:30 PM East Coast USA Time
Single IRBs: From Idea to ImplementationLocation: Harbor Ballroom C
P. 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
1:00 PM – 4:30 PM East Coast USA Time
Ethical and Regulatory Review of Research: Case StudiesLocation: Old Town
Bruce 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 PM East Coast USA Time
Ethical Study Design Is Good ScienceLocation: La Jolla
Susan S. Fish, PharmD, MPH – Boston University School of Public Health ### 11071###Preconference Speaker @@@ Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus Group ### 10687###Preconference Speaker
4:30 PM – 5:30 PM East Coast USA Time
2018 AER Conference: Preconference Programs
4:30 PM – 5:30 PM East Coast USA Time
Preconference Programs Networking Reception
Location: Grand Hall A
- Thursday, November 15, 2018
7:00 AM – 8:00 AM East Coast USA Time
Continental Breakfast to Welcome First-Time Attendees
7:00 AM – 8:00 AM East Coast USA Time
Breakfast to Welcome First-Time AttendeesLocation: Ballroom 20A
7:00 AM – 5:30 PM East Coast USA Time
On-Site Check-In
7:00 AM – 5:30 PM East Coast USA Time
On-Site Check-In
Location: Exhibit Hall FG Foyer
7:15 AM – 8:00 AM East Coast USA Time
A Capella Musical Performance
7:15 AM – 8:00 AM East Coast USA Time
A Capella Musical Performance
Location: Exhibit Hall H
8:00 AM – 9:00 AM East Coast USA Time
Conference Welcome Remarks
8:00 AM – 9:00 AM East Coast USA Time
Morning Welcomes and AnnouncementsLocation: Exhibit Hall H
9:00 AM – 10:00 AM East Coast USA Time
Keynote Address
9:00 AM – 10:00 AM East Coast USA Time
Keynote Address by Timothy Caulfield, LLB, LLM, FRSC, FCAHS: Celebrities, Science-y, and Pseudoscience: Tackling Misinformation in the Era of Health NoiseLocation: Exhibit Hall H
Timothy Caulfield, LLB, LLM, FRSC, FCAHS – University of Alberta ### 585102###Keynote Speaker10:00 AM – 10:30 AM East Coast USA Time
Beverage Break Supported by Kinetiq
10:00 AM – 10:30 AM East Coast USA Time
Beverage Break With the Supporters and Exhibitors
Location: Exhibit Hall FG
10:30 AM – 11:45 AM East Coast USA Time
Concurrent Plenary Sessions
10:30 AM – 11:45 AM East Coast USA Time
Panel I: Gun Violence and Public Health: Facts, Fiction, and the FutureLocation: Ballroom 20D
Harold 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 AM East Coast USA Time
Panel II: At the Crossroads of Hope and Hype: Recruiting the Desperately Ill for Clinical TrialsLocation: Ballroom 20 BC
Alexander 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 AM East Coast USA Time
Panel III: The New Rule's Identity Crisis: Should Identifiability Be Changed?Location: Exhibit Hall H
William 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 PM East Coast USA Time
Lunch Sessions
11:45 AM – 1:00 PM East Coast USA Time
Lunch Session: A Dialogue With Patient-Centered Outcomes Research Institute (PCORI)Location: Room 24A
Jason Gerson, PhD – Patient-Centered Outcomes Research Institute ### 420114###Speaker11:45 AM – 1:00 PM East Coast USA Time
Lunch Session: A Dialogue With the Department of Energy (DOE)Location: Room 24B
Elizabeth 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 PM East Coast USA Time
Lunch Session: A Dialogue With the Office of Research Integrity (ORI)Location: Room 24C
Scott J. Moore, PhD, JD – DHHS Office of Research Integrity ### 593732###Speaker11:45 AM – 1:00 PM East Coast USA Time
Lunch Session: A Dialogue With the VA Location: Room 25AB
Kristina 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 PM East Coast USA Time
Meet the Author Lunch and Book Signing
11:45 AM – 1:00 PM East Coast USA Time
Research Ethics Discussion Luncheon : Fighting Health Myths with Stories, Art, and FunLocation: Ballroom 20A
Timothy Caulfield, LLB, LLM, FRSC, FCAHS – University of Alberta ### 585102###Panelist @@@ Melissa E. Abraham, PhD, MS ### 10021###Moderator11:45 AM – 1:00 PM East Coast USA Time
Networking Lunch Supported by CITI Program, a division of BRANY
11:45 AM – 1:00 PM East Coast USA Time
Networking Lunch Supported by CITI Program, a division of BRANY
Location: Exhibit Hall FG
12:15 PM – 12:35 PM East Coast USA Time
Overview of the CIP Exam
12:15 PM – 12:35 PM East Coast USA Time
Overview of the CIP Exam
Location: Exhibit Hall FG
12:30 PM – 1:00 PM East Coast USA Time
Federal Agency/Accrediting Body Office Hours
12:30 PM – 1:00 PM East Coast USA Time
Federal Agency/Accrediting Body Office HoursLocation: Exhibit Hall FG
12:30 PM – 1:00 PM East Coast USA Time
Meet and Greet With the AER18 Supporters and Exhibitors
12:30 PM – 1:00 PM East Coast USA Time
Meet and Greet With the AER18 Supporters and Exhibitors
Location: Exhibit Hall FG
12:40 PM – 1:00 PM East Coast USA Time
eConsent: Modernize Your Consent Process—Don’t Change It
12:40 PM – 1:00 PM East Coast USA Time
eConsent: Modernize Your Consent Process—Don’t Change It
Location: Exhibit Hall FG
1:15 PM – 2:30 PM East Coast USA Time
Breakout Session Series A
1:15 PM – 2:30 PM East Coast USA Time
A01 - A Dialogue With OHRPLocation: Room 28ABCA 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 PM East Coast USA Time
A02 - Does Diversity Matter in the Conduct of a Clinical Trial? Location: Room 23CHot Topics Track
Owen Garrick, MD, MBA – Bridge Clinical Research ### 262885###Speaker @@@ Barbara E. Bierer, MD ### 10123###Speaker
1:15 PM – 2:30 PM East Coast USA Time
A03 - Distinguishing Public Health Surveillance from Public Health Research at the Centers for Disease Control and Prevention (CDC)Location: Room 29BBoundaries 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 PM East Coast USA Time
A04 - Stories Matter: The Use of Narrative in IRB Member EducationLocation: Room 25CEducating and Training Track
Michael Leary, MA CIP – Lindenwood University ### 187411###Speaker @@@ Gianna McMillan, MA – Loyola Marymount University ### 11611###Speaker
1:15 PM – 2:30 PM East Coast USA Time
A05 - Empirical Research on Ethical Issues in Patient Centered Outcomes Research (PCOR): New Data to Inform DeliberationsLocation: Room 22Empirical 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 PM East Coast USA Time
A06 - Demystifying FDA 21 CFR Part 11Location: Room 31CFDA 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 PM East Coast USA Time
A07 - Different Models of Review: A Global ComparisonLocation: Room 23AGlobal 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 PM East Coast USA Time
A08 - The Certified IRB Professional (CIP®) Credential: How Do I Get Started?Location: Room 29CHot 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 PM East Coast USA Time
A09 - Not Less Work, But Different: Re-Engineering for Single IRB ReviewLocation: Room 33ABInstitutional 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 PM East Coast USA Time
A10 - Back to Basics: Does My Project Fall Within the Scope of the Revised Common Rule?Location: Room 28DEIRB 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 PM East Coast USA Time
A11 - Meeting Management for IRB ChairsLocation: Room 29AIRB Chairs Track
Francis J. DiMario, Jr., MD, MA, CIP ### 25706###Speaker @@@ Luke Gelinas, PhD – Advarra IRB ### 420113###Speaker
1:15 PM – 2:30 PM East Coast USA Time
A12 - It’s Not as New as You Think: Understanding How to Operationalize the Revised Common RuleLocation: Room 30ABIRB 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 PM East Coast USA Time
A13 - ClinicalTrials.gov: How Academic Institutions Can Respond to New Clinical Trial Disclosure RequirementsLocation: Room 31APharma/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 PM East Coast USA Time
A14 - Legal and regulatory changes: A Year in ReviewLocation: Room 30DLegal Track
Michele Russell-Einhorn, JD – Advarra ### 10144###Speaker @@@ Mitchell Parrish, JD, RAC, CIP – Quorum Review ### 25716###Speaker
1:15 PM – 2:30 PM East Coast USA Time
A15 - Defining Roles & Expectations for the Non-Scientist and Non-Affiliated IRB Member: Deconstructing Regulatory and Research TerminologyLocation: Room 27BNon-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 PM East Coast USA Time
A16 - Implementing NIH’s Genomic Data Sharing Policy: Challenges and SolutionsLocation: Room 25ABResearch 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 PM East Coast USA Time
A17 - Vulnerability Explored: Concepts and ApplicationsLocation: Room 31BPopulations 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 PM East Coast USA Time
A18 - Beyond Auditing and Monitoring of the IRB Towards Quality ImprovementLocation: Room 30CQA/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 PM East Coast USA Time
A19 - IRB Review of Big Data ResearchLocation: Room 32ABResearch 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 PM East Coast USA Time
A20 - Preparing Research Misconduct Committees to SucceedLocation: Room 21Responsible 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 PM East Coast USA Time
A21 - Challenges and Opportunities for Institutions With Small Research ProgramsLocation: Room 23BSmall 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 PM East Coast USA Time
A22 - Different Minimal Risk Review ModelsLocation: Room 29DSBER 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 PM East Coast USA Time
A23 - Risk Mitigation in Mixed SBER and Biomedical ResearchLocation: Room 30ESBER Track
Matthew D. Stafford – Children's Hospital Boston ### 57750###Speaker @@@ Lara N. Sloboda, PhD – Tufts University ### 181613###Speaker
2:30 PM – 3:00 PM East Coast USA Time
Beverage Break
2:30 PM – 3:00 PM East Coast USA Time
Beverage Break
Location: Room 23-27 Hallway
3:00 PM – 4:15 PM East Coast USA Time
Breakout Session Series B
3:00 PM – 4:15 PM East Coast USA Time
B01 - The Times, They Are a-Changing: Overview of the Latest NIH Changes and Their Implications on ResearchLocation: Room 32ABA 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 PM East Coast USA Time
B02 - The Generation and Utilization of Real-World Evidence (RWE): Ethical and Regulatory ConsiderationsLocation: Room 31CFDA 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 PM East Coast USA Time
B03 - You'll Know It When You See It, or Will You? Defining "Human Subjects Research"Location: Room 28ABCBoundaries 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 PM East Coast USA Time
B04 - An Educational Map to Being a Great Research Ethicist (or Just a Better One)Location: Room 31BEducating and Training Track
Robert Hood, PhD – AAHRPP, Inc. ### 251843###Speaker @@@ Dane C. Joseph, PhD – George Fox University ### 586811###Speaker
3:00 PM – 4:15 PM East Coast USA Time
B05 - Designing Trials for CompletionLocation: Room 24AEmpirical 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 PM East Coast USA Time
B06 - When Is an Investigational Device Exemption (IDE) Needed for a Clinical Investigation of a Medical Device?Location: Room 30EFDA Regulations Track
Soma Kalb, PhD – US Food and Drug Administration ### 118703###Speaker
3:00 PM – 4:15 PM East Coast USA Time
B07 - Human Subjects Protections Across BordersLocation: Room 29BGlobal 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 PM East Coast USA Time
B08 - Exploring and Enhancing Diversity Within Our Compliance CommitteesLocation: Room 23CHot 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 PM East Coast USA Time
B09 - Top Considerations for Institutional and HRPP Leadership When Accepting Department of Defense (DOD) Support of ResearchLocation: Room 29DInstitutional 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 PM East Coast USA Time
B10 - Essential Documentation: IRB Records Documentation Requirements, Minutes, Written Procedures, and MoreLocation: Room 22IRB 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 PM East Coast USA Time
B11 - The Evolving Role of the IRB Chair in the World of Single IRBs Location: Room 30DIRB Chairs Track
David C. Christiani, MD, MPH, MS – Harvard University ### 302150###Speaker @@@ Susan Sonne, PharmD, BCPP ### 587407###Speaker
3:00 PM – 4:15 PM East Coast USA Time
B12 - The After Party: Tools and Techniques for the Assessment of IRB Operations During and After Implementation of the Revised Common RuleLocation: Room 30ABIRB 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 PM East Coast USA Time
B13 - The European Union’s (EU) General Data Protection Regulation (GDPR) and US-Based Research: Implications, Problems, and Potential SolutionsLocation: Room 33ABPharma/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 PM East Coast USA Time
B14 - 1-800-RESEARCHLAWYER: Is Your Institution’s Legal Counsel on Speed Dial? Location: Room 25CLegal 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 PM East Coast USA Time
B15 - New Data on Single IRBs: Implications for the Future Location: Room 30CHot Topics Track
Robert Klitzman, MD – Columbia University ### 284672###Speaker @@@ Charles W. Lidz, PhD – University of Massachusetts Medical School ### 585145###Speaker3:00 PM – 4:15 PM East Coast USA Time
B16 - Research with Data and Biospecimens Under the Revised Common Rule: An Overview of Changes and ChallengesLocation: Ballroom 20AResearch 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 PM East Coast USA Time
B17 - Conducting Research With Children: Complexities in PracticeLocation: Room 25ABPopulations 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 PM East Coast USA Time
B18 - Ideas and Practices for Compliance and Auditing of Single IRB Studies Location: Room 31AQA/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 PM East Coast USA Time
B19 - Privacy and Security Risks in Research With Wearable TechnologyLocation: Room 28DEResearch 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 PM East Coast USA Time
B20 - Case Studies in Research MisconductLocation: Room 29CResponsible 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 PM East Coast USA Time
B21 - How to Identify, Navigate, and Manage Conflicts of Interest (COI) at a Small Research OrganizationLocation: Room 24CSmall 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 PM East Coast USA Time
B22 - College Students and Research: Challenges and Issues for IRBsLocation: Room 29ASBER 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 PM East Coast USA Time
B23 - Assessing and Mitigating Risk in SBER Research: A Case Study ApproachLocation: Room 24BSBER 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 PM East Coast USA Time
AER18 Welcome Reception
4:15 PM – 5:30 PM East Coast USA Time
AER18 Welcome ReceptionLocation: Exhibit Hall FG
4:45 PM – 5:05 PM East Coast USA Time
Forte eReg: Ensure Compliance and Streamline Your Regulatory Processes
4:45 PM – 5:05 PM East Coast USA Time
Forte eReg: Ensure Compliance and Streamline Your Regulatory Processes
5:45 PM – 7:15 PM East Coast USA Time
Young Professionals Networking Reception
5:45 PM – 7:15 PM East Coast USA Time
Young Professionals Networking Reception
- Friday, November 16, 2018
7:00 AM – 5:00 PM East Coast USA Time
On-Site Check-In
7:00 AM – 5:00 PM East Coast USA Time
On-Site Check-In
Location: Exhibit Hall FG Foyer
7:15 AM – 8:00 AM East Coast USA Time
A Capella Musical Performance
7:15 AM – 8:00 AM East Coast USA Time
A Capella Musical Performance
Location: Exhibit Hall H
8:00 AM – 8:30 AM East Coast USA Time
Welcome and Award Presentations
8:00 AM – 8:30 AM East Coast USA Time
Welcome and Award PresentationsLocation: Exhibit Hall H
8:30 AM – 9:30 AM East Coast USA Time
Keynote Address by Michelle M. Mello, JD, PhD: Clinical Trial Data Sharing: Perspectives From Participants
8:30 AM – 9:30 AM East Coast USA Time
Keynote Address by Michelle M. Mello, JD, PhD: Clinical Trial Data Sharing: Perspectives From ParticipantsLocation: Exhibit Hall H
Michelle M. Mello, JD, PhD – Stanford Law School ### 585137###Keynote Speaker9:30 AM – 10:00 AM East Coast USA Time
Beverage Break With the Supporters and Exhibitors
9:30 AM – 10:00 AM East Coast USA Time
Beverage Break With the Supporters and Exhibitors
Location: Exhibit Hall FG
10:00 AM – 11:00 AM East Coast USA Time
Explorations in… Panel Series
10:00 AM – 11:00 AM East Coast USA Time
Explorations A: Explorations in Optimizing Informed Consent and AssentLocation: Exhibit Hall H
Ryan 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 AM East Coast USA Time
Explorations B: Explorations in Navigating the Single IRB Mandate Location: Ballroom 20BC
Adrianne 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 AM East Coast USA Time
Explorations C: Explorations in Engaging Communities to Promote Ethical ResearchLocation: Ballroom 20D
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 PM East Coast USA Time
Breakout Session Series C
11:15 AM – 12:30 PM East Coast USA Time
C01 - A Dialogue With the Department of Defense (DOD): Updates for DOD and DOD-Sponsored Research Protections PersonnelLocation: Room 30CA 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###Speaker11:15 AM – 12:30 PM East Coast USA Time
C02 - A Dialogue With the Secretary's Advisory Committee on Human Research Protections (SACHRP)Location: Room 29CA 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 PM East Coast USA Time
C03 - Standard of Care, Medical Innovation, or Research: How Should We Decide?Location: Ballroom 20DBoundaries 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 PM East Coast USA Time
C04 - Advancing Yourself as a Regulatory Professional: Education, Cooperation, and Self-AdvocacyLocation: Room 30DEducating 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 PM East Coast USA Time
C05 - The Pressing Need for IRB PrecedentLocation: Room 30ELegal 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 PM East Coast USA Time
C06 - The Rise of the Patient Voice at FDALocation: Room 23AFDA 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 PM East Coast USA Time
C07 - Research Passport: Regulatory and Ethics Review Implications for International Participants in US-Based Clinical TrialsLocation: Room 23CGlobal 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 PM East Coast USA Time
C08 - Developments Regarding the Federal "Right-to-Try" Law and its Impact on the FDA's Expanded Access ProgramLocation: Room 30ABHot 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 – 12:30 PM East Coast USA Time
C13 - Scientific and Ethical Considerations in Choosing a Study Control GroupLocation: Room 23BPharma/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 – 12:30 PM East Coast USA Time
C20 - The Regulatory Intersection of Research Misconduct and Human Subjects ProtectionsLocation: Room 31BResponsible 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 – 12:30 PM East Coast USA Time
C22 - Research in K-12 SettingsLocation: Room 31ASBER Track
Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker @@@ Julie Slayton, JD, PhD – University of Southern California ### 112668###Speaker
11:15 AM – 12:30 PM East Coast USA Time
C23 - Understanding and Applying Family Educational Rights and Privacy Act (FERPA) GuidelinesLocation: Room 29DSBER Track
Bethany L. Johnson, JD, CIP – Indiana University ### 586803###Speaker @@@ Nalinee D. Patin, CIP – Clemson University ### 587337###Speaker
11:15 AM – 1:30 PM East Coast USA Time
C09 - Use It or Lose It: Re-Calibrating and Re-Engineering the HRPP/IRB Office in Response to the Changing Regulatory ClimateLocation: Room 33ABInstitutional 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 PM East Coast USA Time
C10 - Let's Review A Protocol: Reviewing Research that Requires Expedited or Full Board ReviewLocation: Room 28ABCIRB 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 PM East Coast USA Time
C11 - IRB Chairs Forum: A Structured Discussion for IRB ChairsLocation: Room 22IRB 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###Speaker11:15 AM – 1:30 PM East Coast USA Time
C12 - Creative Solutions for Serving as a Reviewing IRBLocation: Room 29BIRB 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 – 1:30 PM East Coast USA Time
C14 - 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 AboutLocation: Ballroom 20ALegal 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 PM East Coast USA Time
C15 - Scientific Aspects of Study Design: A Primer for Non-ScientistsLocation: Room 21Non-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 PM East Coast USA Time
C16 - Considerations for Return of Results Under the Revised Common RuleLocation: Room 28DEResearch 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 PM East Coast USA Time
C17 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk BehaviorLocation: Room 29APopulations 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 PM East Coast USA Time
C18 - Advanced Investigator Post-Approval Monitoring IssuesLocation: Room 25CQA/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###Speaker11:15 AM – 1:30 PM East Coast USA Time
C19 - The Intersections of Data Security, Privacy, Confidentiality, and Compliance in Digital Health and Mobile Health (mHealth) ResearchLocation: Room 32ABResearch 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 – 1:30 PM East Coast USA Time
C21 - Flying Solo: A Moderated Discussion on Challenges Encountered by Single Staff IRB OfficesLocation: Room 24CSmall 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
12:30 PM – 1:30 PM East Coast USA Time
Networking Lunch
12:30 PM – 1:30 PM East Coast USA Time
Networking Lunch
Location: Exhibit Hall FG
1:00 PM – 1:20 PM East Coast USA Time
Overview and Demonstration of PRIM&R’s NEW Ethical Research Oversight Course (EROC)
1:00 PM – 1:20 PM East Coast USA Time
Overview and Demonstration of PRIM&R’s New Ethical Research Oversight Course (EROC)
Location: Exhibit Hall FG
1:45 PM – 3:00 PM East Coast USA Time
Concurrent Plenary Sessions
1:45 PM – 3:00 PM East Coast USA Time
Panel V: Ethical Challenges in HIV Cure ResearchLocation: Ballroom 20D
Rowena 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 PM East Coast USA Time
Panel 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 ### 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 PM East Coast USA Time
Panel VI: To Participate or Not to Participate, That Is the QuestionLocation: Exhibit Hall H
Celia 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 PM East Coast USA Time
Beverage Break Supported by CITI Program, a division of BRANY
3:00 PM – 3:30 PM East Coast USA Time
Beverage Break
Location: Room 23-27 Hallway
3:30 PM – 4:45 PM East Coast USA Time
Breakout Session Series D
3:30 PM – 4:45 PM East Coast USA Time
D01 - A Dialogue With the FDALocation: Room 30CA 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###Speaker3:30 PM – 4:45 PM East Coast USA Time
D02 - Pharmacogenetics and Precision Medicine: Partnering to Enable DNA Research in Global Clinical TrialsLocation: Room 24ABPharma/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 PM East Coast USA Time
D03 - Tissue Repositories and Data Banks in the Era of the Revised Common RuleLocation: Room 30ABBoundaries 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 PM East Coast USA Time
D04 - Paving the Road to Success: Meeting the Challenges of Investigator and Study Team EducationLocation: Room 29BEducating 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 PM East Coast USA Time
D05 - Promises and Perils of HIV Phylogenetics ResearchLocation: Room 31BEmpirical 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 PM East Coast USA Time
D06 - FDA’s Oversight of ClinicalTrials.gov RequirementsLocation: Room 29AFDA 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 PM East Coast USA Time
D07 - Lessons From the Trenches: Avoiding Legal and Operational Pitfalls in International Research StudiesLocation: Room 31CGlobal 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 PM East Coast USA Time
D08 - Public Health Emergencies, Research, and BioethicsLocation: Room 31AHot 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 PM East Coast USA Time
D09 - How to Investigate, Mitigate, Report, and Learn from Noncompliance: Avoiding Pitfalls and Seizing Opportunities for ImprovementLocation: Room 30DInstitutional 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 PM East Coast USA Time
D10 - Writing and Updating Standard Operating Procedures (SOPs) With the Revised Common Rule in MindLocation: Room 33ABIRB 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 PM East Coast USA Time
D11 - The Revised Common Rule: Operational Considerations for the IRB ChairLocation: Room 28DEIRB Chairs Track
Jeremy J. Corsmo, MPH ### 58254###Speaker @@@ R. Peter Iafrate, PharmD – University of Florida ### 112628###Speaker
3:30 PM – 4:45 PM East Coast USA Time
D12 - Single IRB: The Next GenerationLocation: Room 32ABIRB 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 PM East Coast USA Time
D13 - Post-Trial Access: A Look at the Challenges of Ensuring Continued Access to Investigational MedicineLocation: Room 21Pharma/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###Speaker3:30 PM – 4:45 PM East Coast USA Time
D14 - Wrangling IRB Reliance Agreements: How to Implement Flexible Terms and Addenda and Execute Necessary Agreements Location: Room 25ABLegal 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 PM East Coast USA Time
D15 - Recruiting, Educating, and Retaining Non-Scientist and Unaffiliated IRB Members Location: Room 24CNon-Scientist IRB Members Track
Charlotte H. Coley, MACT, CIP ### 112598###Speaker @@@ Glenn Ellis, MPH, CHCE ### 585128###Speaker
3:30 PM – 4:45 PM East Coast USA Time
D16 - Assessing Plans to Maintain Confidentiality: How IRBs Can Determine Whether Data Security and Management Plans Are SufficientLocation: Room 28ABCResearch 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 PM East Coast USA Time
D17 - Looking Through the Bars: Responsible Research With PrisonersLocation: Room 29DPopulations 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 PM East Coast USA Time
D18 - Nuts and Bolts of Assessing IRB ComplianceLocation: Room 22QA/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 PM East Coast USA Time
D19 - Social Media in Research: Recruitment, Subject Communication, and Data SourceLocation: Ballroom 20AResearch 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 PM East Coast USA Time
D20 - Agents and Rogues: The Limits of Agency, Institutional Engagement, and Institutional ResponsibilityLocation: Room 29CResponsible 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 PM East Coast USA Time
D21 - How to Maintain Institutional Memory at a Small Research ProgramLocation: Room 23CSmall 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 PM East Coast USA Time
D22 - Clinical Trials in the SBER ContextLocation: Room 25CSBER 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 PM East Coast USA Time
D23 - Navigating Uncertainty: Research With Undocumented/Unauthorized ImmigrantsLocation: Room 30ESBER 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 PM East Coast USA Time
Federal Agency Office Hours
4:45 PM – 6:00 PM East Coast USA Time
Federal Agency/Accrediting Body Office HoursLocation: Exhibit Hall FG
4:45 PM – 6:00 PM East Coast USA Time
Meet the AER18 Poster Authors
4:45 PM – 6:00 PM East Coast USA Time
Meet the AER18 Poster Authors
Location: Exhibit Hall FG
4:45 PM – 6:00 PM East Coast USA Time
Networking Reception With the Supporters and Exhibiters
4:45 PM – 6:00 PM East Coast USA Time
Networking Reception With the Supporters and Exhibiters
Location: Exhibit Hall FG
4:50 PM – 5:15 PM East Coast USA Time
Simplifying Research Compliance With Cayuse IRB
4:50 PM – 5:15 PM East Coast USA Time
Simplifying Research Compliance With Cayuse IRB
Location: Exhibit Hall FG
- Saturday, November 17, 2018
7:00 AM – 12:30 PM East Coast USA Time
On-Site Check-In
7:00 AM – 12:30 PM East Coast USA Time
On-Site Check-In
Location: Exhibit Hall FG Foyer
8:00 AM – 8:30 AM East Coast USA Time
Welcome and PRIM&R Membership and CIP Updates
8:00 AM – 8:30 AM East Coast USA Time
Welcome and PRIM&R Membership and CIP® UpdatesLocation: Exhibit Hall H
8:30 AM – 9:30 AM East Coast USA Time
Keynote Address by Vickie M. Mays, PhD, MSPH
8:30 AM – 9:30 AM East Coast USA Time
Keynote Address by Vickie M. Mays, PhD, MSPHLocation: Exhibit Hall H
Vickie M. Mays, PhD, MSPH – University of California, Los Angeles ### 291708###Keynote Speaker9:30 AM – 10:00 AM East Coast USA Time
Beverage Break With Supporters and Exhibitors
9:30 AM – 10:00 AM East Coast USA Time
Beverage Break With Supporters and Exhibitors
Location: Exhibit Hall FG
10:00 AM – 11:15 AM East Coast USA Time
Concurrent Plenary Sessions
10:00 AM – 11:15 AM East Coast USA Time
Panel VIII: Big Data: Who's Minding the Store?Location: Exhibit Hall H
Brenda 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
10:00 AM – 11:15 AM East Coast USA Time
Panel IX: Is a Misconception Always a Misconception?Location: Ballroom 20D
John 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 AM East Coast USA Time
Panel VII: IRB Decision-Making From a Behavioral Economics PerspectiveLocation: Ballroom 20BC
Christine 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
11:30 AM – 12:45 PM East Coast USA Time
Breakout Session Series E
11:30 AM – 12:45 PM East Coast USA Time
E01 - A Dialogue With AAHRPP, Inc.Location: Room 29BA 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###Speaker11:30 AM – 12:45 PM East Coast USA Time
E02 - Two Offices Divided by a Common Goal: Conflict of Interest (COI) and IRBLocation: Room 22Institutional Officials and HRPP Leadership Track
John R. Baumann, PhD – Indiana University ### 57670###Speaker @@@ Heather H. Pierce, JD, MPH – Association of American Medical Colleges ### 10328###Speaker11:30 AM – 12:45 PM East Coast USA Time
E03 - The Seven Habits of Highly Effective and Flexible IRBsLocation: Room 30ABBoundaries 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 PM East Coast USA Time
E04 - Building Bridges Through IRB Education OutreachLocation: Room 31AEducating 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 PM East Coast USA Time
E05 - Correcting and Avoiding Noncompliance: Examining Real-life Cases Location: Room 32ABQA/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 PM East Coast USA Time
E06 - FDA Clinical Holds and 21 CFR 50 Subpart D Location: Room 29AFDA 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 PM East Coast USA Time
E07 - Applying US Human Research Protections Regulations and Embedded Cultural Values to Research Conducted in Different Cultures: Challenges, Cultural Considerations, Collaborations, and ExperiencesLocation: Room 30DGlobal 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 PM East Coast USA Time
E08 - User Agreements in Human Subjects Research During the Burgeoning Technology AgeLocation: Room 25ABResearch 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 PM East Coast USA Time
E09 - Ethical and Operational Issues Related to Clinical Trial Billing: What HRPPs and IRBs Should ConsiderLocation: Room 25CInstitutional 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 PM East Coast USA Time
E10 - IRB Review of Informed Consent: Moving Beyond the FormLocation: Room 33ABIRB 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 PM East Coast USA Time
E11 - The Role of the IRB Chair in Protocol Exceptions, Violations, Noncompliance, and Unanticipated ProblemsLocation: Room 28DEIRB Chairs Track
Jeremy J. Corsmo, MPH ### 58254###Speaker @@@ Madelon V. Baranoski, PhD, CIP – Yale University ### 433404###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E12 - Overlapping Roles of Data Safety Monitoring Boards (DSMBs) and IRBs in the Protection of Human SubjectsLocation: Room 30CIRB 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 PM East Coast USA Time
E13 - Designing and Implementing Expanded Access ProgramsLocation: Room 31CPharma/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 PM East Coast USA Time
E14 - From Shield to Sword? How the 21st Century Cures Act and NIH Policy Have Altered Certificates of Confidentiality (CoCs)Location: Room 24ABLegal 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 PM East Coast USA Time
E15 - Considerations and Strategies for Maximizing Contributions and Promoting Effective Communication for Non-Scientist and Unaffiliated IRB MembersLocation: Room 24CNon-Scientist IRB Members Track
Nathalia Henry, MS, CHRC, CIP – Northwestern University ### 586792###Speaker @@@ Stephen Poppel, PhD, CFA ### 593616###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E16 - Building a Better Biobank: Promise and Challenges of the National Cancer Institute Cancer Moonshot BiobankLocation: Room 29CResearch 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 PM East Coast USA Time
E17 - Tribal Research Futures: Resources to Strengthen Governance, Trust, and Culture in Research PartnershipsLocation: Room 23APopulations 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 PM East Coast USA Time
E18 - Nuts and Bolts of Investigator Site AuditsLocation: Room 29DQA/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 PM East Coast USA Time
E19 - Intersection of Research and Electronic Health Records With Privacy and Confidentiality Concerns: Considerations for IRB ReviewLocation: Ballroom 20AResearch 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 PM East Coast USA Time
E20 - Data Acquisition and Management: Concepts Every Researcher and Research Administrator Should KnowLocation: Room 23CResponsible Conduct of Research Track
Carolyn Broccardo, PhD, PMP – University of Wyoming ### 420073###Speaker @@@ Bradley R. Woods, PhD – Colorado State University ### 302148###Speaker11:30 AM – 12:45 PM East Coast USA Time
E21 - Managing Small Research Programs in Healthcare SettingsLocation: Room 31BSmall 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 PM East Coast USA Time
E22 - How to Create an Undergraduate Research Training ProgramLocation: Room 30ESBER Track
Jonathan M. Girard – Harvard University ### 586785###Speaker @@@ Shannon Sewards, MA, CIP – Harvard University ### 172040###Speaker
11:30 AM – 12:45 PM East Coast USA Time
E23 - You Want to Do What? Developing Best Practices for IRB Review of Research Investigating Illegal/Illicit BehaviorsLocation: Room 28ABCSBER 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 PM East Coast USA Time
Closing General Session Luncheon
12:45 PM – 2:30 PM East Coast USA Time
Closing General Session Luncheon: Research Ethics, Race, and Opioids—The Evolution of the Perfect EpidemicLocation: Exhibit Hall H
Elizabeth 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
