Presenter: Sharon C. Freitag, BSc – Unity Health Toronto
Speaker: Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research
Moderator: Jada Bussey-Jones, MD, FACP – Emory University
Panelist: Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University
Panelist: Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Speaker: Elisa A. Hurley, PhD – Public Responsibility in Medicine & Research
@@@ Jada Bussey-Jones, MD, FACP – Emory University ### 1153798###Moderator###Chief of General Medicine and Geriatrics, Emory at Grady Memorial Hospital; Director of Education, Emory Urban Health Initiative; Assistant Dean of Professional Development, Emory School of Medicine###Emory University###Moderator: Jada Bussey-Jones, MD, FACP – Emory University
@@@ Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University ### 284710###Panelist###Director, Human Research Protection Program###Yale University###Panelist: Linda M. Coleman, JD, CIP, CHC, CHRC, CCEP-I – Yale University
@@@ Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School ### 585128###Panelist###President###Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School###Panelist: Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Moderator: Albert J. Allen, MD, PhD – Eli Lilly and Company
Panelist: Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus Group
Panelist: Mitchell Klopfenstein, M.A. – Eli Lilly & Company
Panelist: Mary L. Gray, PhD – Microsoft Research
Panelist: Susan Z. Kornetsky, MPH – Boston Children's Hospital
Moderator: Albert J. Allen, MD, PhD – Eli Lilly and Company
@@@ Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus Group ### 10687###Panelist###Chief Medical Officer###WIRB-Copernicus Group###Panelist: Lindsay McNair, MD, MPH, MSB – WIRB-Copernicus Group
@@@ Mitchell Klopfenstein, M.A. – Eli Lilly & Company ### 863993###Panelist###Consultant-Bioethics###Eli Lilly & Company###Panelist: Mitchell Klopfenstein, M.A. – Eli Lilly & Company
@@@ Mary L. Gray, PhD – Microsoft Research ### 284648###Panelist###Senior Principal Researcher###Microsoft Research###Panelist: Mary L. Gray, PhD – Microsoft Research
@@@ Susan Z. Kornetsky, MPH – Boston Children's Hospital ### 10134###Panelist###Senior Director Clinical Research Compliance###Boston Children's Hospital###Panelist: Susan Z. Kornetsky, MPH – Boston Children's Hospital
Speaker: Paul Elliot – Axiom Mentor
Speaker: Curt Naser – Axiom Mentor
.png)
Speaker: Paul Elliot – Axiom Mentor
@@@ Curt Naser – Axiom Mentor ### 1165480###Speaker###Founder and Chief Product Officer###Axiom Mentor###Speaker: Curt Naser – Axiom Mentor
Speaker: Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Speaker: Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.
Speaker: Nancy A. Olson, JD – University of Nebraska Medical Center
Resource Person: Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Education and Training Track
Speaker: Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
@@@ Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc. ### 10675###Speaker###Executive Vice President###AAHRPP, Inc.###Speaker: Michelle M. Feige, MSW, LCSW-C – AAHRPP, Inc.
@@@ Nancy A. Olson, JD – University of Nebraska Medical Center ### 11093###Speaker###IRB Administrator###University of Nebraska Medical Center###Speaker: Nancy A. Olson, JD – University of Nebraska Medical Center
@@@ Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS ### 112639###Resource Person###Director, Division of Education and Development###HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS###Resource Person: Yvonne Lau, MBBS, MBHL, PhD – HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Speaker: Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention
Speaker: Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Flexibility and Innovation in IRB Processes Track
Speaker: Laura Youngblood, MPH, CIP – Centers for Disease Control and Prevention
@@@ Irene E. Stith-Coleman, PhD – Office for Human Research Protections ### 11110###Speaker###Director, Division of Policy and Assurances###Office for Human Research Protections###Speaker: Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Speaker: Jan L. Hewett, BSN, JD – Food & Drug Administration
Speaker: Deborah Barnard, MS – University of Colorado Denver
FDA Regulated Research Track
Speaker: Jan L. Hewett, BSN, JD – Food & Drug Administration
@@@ Deborah Barnard, MS – University of Colorado Denver ### 10565###Speaker###Director, Clinical Research Administration###University of Colorado Denver###Speaker: Deborah Barnard, MS – University of Colorado Denver
Speaker: Scott J. Lipkin, DPM, CIP – Miami Cancer Institute; Baptist Health South Florida
Speaker: Liz Michaels, MS, CIP – Meriter Hospital
Speaker: Cheryl L. Byers, MHA, CIP, CHRC – Advarra
Institutional Officials and HRPP Leadership Track
Speaker: Scott J. Lipkin, DPM, CIP – Miami Cancer Institute; Baptist Health South Florida
@@@ Liz Michaels, MS, CIP – Meriter Hospital ### 1095768###Speaker###IRB Coordinator###Meriter Hospital###Speaker: Liz Michaels, MS, CIP – Meriter Hospital
@@@ Cheryl L. Byers, MHA, CIP, CHRC – Advarra ### 248450###Speaker###Vice President, Institutional Partnerships###Advarra###Speaker: Cheryl L. Byers, MHA, CIP, CHRC – Advarra
Speaker: John Heldens, RAC, CIP – University of Colorado Denver, Anschutz Medical Campus
Speaker: Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis
Resource Person: Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
IRB Operations Advanced Track
Speaker: John Heldens, RAC, CIP – University of Colorado Denver, Anschutz Medical Campus
@@@ Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis ### 426680###Speaker###Manager of Single IRB Services###Washington University in St. Louis###Speaker: Carissa Minder, RN, BSN, MS, CIP, CCRP – Washington University in St. Louis
@@@ Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP) ### 112580###Resource Person###Senior Advisor for Public Health Education###Office for Human Research Protections (OHRP)###Resource Person: Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Speaker: Seema K. Shah, J.D. – NIH Clinical Center
Speaker: Luke Gelinas, PhD – Advarra
Resource Person: Jerry A. Menikoff, MD, JD – Office for Human Research Protections
Speaker: Richard Gorman – Biodefense Advanced Research and Development Authority
Pharma/Biotech Perspectives Track
Speaker: Seema K. Shah, J.D. – NIH Clinical Center
@@@ Luke Gelinas, PhD – Advarra ### 420113###Speaker###Chairperson###Advarra###Speaker: Luke Gelinas, PhD – Advarra
@@@ Jerry A. Menikoff, MD, JD – Office for Human Research Protections ### 11091###Resource Person###Director###Office for Human Research Protections###Resource Person: Jerry A. Menikoff, MD, JD – Office for Human Research Protections
@@@ Richard Gorman – Biodefense Advanced Research and Development Authority ### 1123283###Speaker######Biodefense Advanced Research and Development Authority###Speaker: Richard Gorman – Biodefense Advanced Research and Development Authority
Speaker: Maysa Al-Hussaini, MD FRCPath CIP – King Hussein Cancer Center
Speaker: Colleen Kohashi, MA, CIP – UC Berkeley
Speaker: Melissa McGee, J.D. – University of New Hampshire
Resource Person: Julia G. Gorey, JD – OHRP
Populations Requiring Additional Protections Track
Speaker: Maysa Al-Hussaini, MD FRCPath CIP – King Hussein Cancer Center
@@@ Colleen Kohashi, MA, CIP – UC Berkeley ### 118172###Speaker###IRB Administrator###UC Berkeley###Speaker: Colleen Kohashi, MA, CIP – UC Berkeley
@@@ Melissa McGee, J.D. – University of New Hampshire ### 824599###Speaker###Compliance Officer###University of New Hampshire###Speaker: Melissa McGee, J.D. – University of New Hampshire
@@@ Julia G. Gorey, JD – OHRP ### 11073###Resource Person###Public Health Analyst###OHRP###Resource Person: Julia G. Gorey, JD – OHRP
Speaker: Aaron J. Goldenberg, PhD, MA, MPH – Case Western Reserve University
Speaker: A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6
Speaker: Kyle B. Brothers, MD, PhD – University of Louisville
Resource Person: Julie Kaneshiro, MA – Office for Human Research Protections
Research Involving Data and Biospecimens Track
Speaker: Aaron J. Goldenberg, PhD, MA, MPH – Case Western Reserve University
@@@ A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6 ### 587331###Speaker###Head, Research Administration, NAMRU-6###US Naval Medical Research Unit No. 6###Speaker: A. Roxana Lescano, JD, MS Bioethics – US Naval Medical Research Unit No. 6
@@@ Kyle B. Brothers, MD, PhD – University of Louisville ### 1095772###Speaker###Endowed Chair of Pediatric Clinical and Translational Research###University of Louisville###Speaker: Kyle B. Brothers, MD, PhD – University of Louisville
@@@ Julie Kaneshiro, MA – Office for Human Research Protections ### 11084###Resource Person###Deputy Director###Office for Human Research Protections###Resource Person: Julie Kaneshiro, MA – Office for Human Research Protections
Speaker: Kele Piper, CHRC, CIP, MS – Massachusetts General Hospital
Speaker: Monika S. Markowitz, PhD – Virginia Commonwealth University
Responsible Conduct of Research Track
Speaker: Kele Piper, CHRC, CIP, MS – Massachusetts General Hospital
@@@ Monika S. Markowitz, PhD – Virginia Commonwealth University ### 10602###Speaker###Director, Office of Research Integrity and Ethics###Virginia Commonwealth University###Speaker: Monika S. Markowitz, PhD – Virginia Commonwealth University
Speaker: John D. Horigan, MA, CIP – National Institutes of Health
Speaker: Elicia Preslan, MS, CIP – Virginia Commonwealth University
Speaker: Michelle C. Stickler, DEd, CIP – The University of Texas at Austin
Resource Person: Ivor A. Pritchard, PhD – OHRP
SBER Track
Speaker: John D. Horigan, MA, CIP – National Institutes of Health
@@@ Elicia Preslan, MS, CIP – Virginia Commonwealth University ### 124830###Speaker###IRB Operations QA/QI Manager###Virginia Commonwealth University###Speaker: Elicia Preslan, MS, CIP – Virginia Commonwealth University
@@@ Michelle C. Stickler, DEd, CIP – The University of Texas at Austin ### 25451###Speaker###Assistant Vice President for Research Support and Compliance###The University of Texas at Austin###Speaker: Michelle C. Stickler, DEd, CIP – The University of Texas at Austin
@@@ Ivor A. Pritchard, PhD – OHRP ### 10140###Resource Person###Senior Advisor to the Director###OHRP###Resource Person: Ivor A. Pritchard, PhD – OHRP
Presenter: Danielle Giltner, JD, CIP – Indiana University
Presenter: Warren H. Capell, MD – CPC Clinical Research University of Colorado Anschutz Medical Campus
Presenter: Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
IRB Basics Track
Presenter: Danielle Giltner, JD, CIP – Indiana University
@@@ Warren H. Capell, MD – CPC Clinical Research University of Colorado Anschutz Medical Campus ### 263610###Presenter###Associate Professor of Medicine###CPC Clinical Research University of Colorado Anschutz Medical Campus###Presenter: Warren H. Capell, MD – CPC Clinical Research University of Colorado Anschutz Medical Campus
@@@ Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS) ### 251900###Presenter###Management and Program Analyst###Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)###Presenter: Jaime O. Hernandez, JD, M.Be. – Office for Human Research Protections (OHRP), Department of Health and Human Services (HHS)
Presenter: Keren R. Dunn, CIP – Cedars-Sinai Medical Center
Presenter: Heather Savage, CIP – University of New Mexico
Presenter: Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
QA/QI and Post-Approval Monitoring Track
Presenter: Keren R. Dunn, CIP – Cedars-Sinai Medical Center
@@@ Heather Savage, CIP – University of New Mexico ### 1095777###Presenter###Sr. IRB Analyst-Compliance Specialist###University of New Mexico###Presenter: Heather Savage, CIP – University of New Mexico
@@@ Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP) ### 10669###Presenter###Director, Division of Compliance Oversight###DHHS, Office for Human Research Protections (OHRP)###Presenter: Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
Presenter: Sarah B. Ware, PhD – BioBlaze Community Bio Lab
Presenter: Camille Nebeker, EdD, MS – University of California, San Diego, Herbert Wertheim School of Public Health
Presenter: Martin Codyre, BEng, MS – Giantleap Biotechnology
Research Conducted in the Digital World Track
Presenter: Sarah B. Ware, PhD – BioBlaze Community Bio Lab
@@@ Camille Nebeker, EdD, MS – University of California, San Diego, Herbert Wertheim School of Public Health ### 59110###Presenter###Associate Professor###University of California, San Diego, Herbert Wertheim School of Public Health###Presenter: Camille Nebeker, EdD, MS – University of California, San Diego, Herbert Wertheim School of Public Health
@@@ Martin Codyre, BEng, MS – Giantleap Biotechnology ### 1166984###Presenter###Neuroscientist, Engineer###Giantleap Biotechnology###Presenter: Martin Codyre, BEng, MS – Giantleap Biotechnology
Presenter: Shana Sonbolian – PRIM&R
Presenter: Scott Rule, MAT – PRIM&R
Presenter: Scott Rule, MAT – PRIM&R
Moderator: Nancy M.P King, JD – Wake Forest School of Medicine
Panelist: Jonathan Moreno, PhD – University of Pennsylvania
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Moderator: Nancy M.P King, JD – Wake Forest School of Medicine
@@@ Jonathan Moreno, PhD – University of Pennsylvania ### 10034###Panelist###Professor of Biomedical Ethics and Health Policy and of History and Sociology of Science###University of Pennsylvania###Panelist: Jonathan Moreno, PhD – University of Pennsylvania
Presenter: David C. Matesanz, JD, CIP – Kaiser Permanente - Northern California
Presenter: Lori Roesch, CIP – Children's Wisconsin
Presenter: Andrew Hedrick, MPA, CIP – The Ohio State University
Presenter: David C. Matesanz, JD, CIP – Kaiser Permanente - Northern California
@@@ Lori Roesch, CIP – Children's Wisconsin ### 57742###Presenter###Research Integrity Manager, HRPP/IRB Office###Children's Wisconsin###Presenter: Lori Roesch, CIP – Children's Wisconsin
@@@ Andrew Hedrick, MPA, CIP – The Ohio State University ### 172015###Presenter###Senior IRB Protocol Analyst###The Ohio State University###Presenter: Andrew Hedrick, MPA, CIP – The Ohio State University
Moderator: R. Peter Iafrate, PharmD – University of Florida
Moderator: Sharon Ellison, PharmD – Duke University Health System, Inc.
Moderator: Ilene F. Wilets, PhD, CIP – Program for the Protection of Human Subjects
Moderator: Debra D. Roberts, PhD – Howard University
Moderator: R. Peter Iafrate, PharmD – University of Florida
@@@ Sharon Ellison, PharmD – Duke University Health System, Inc. ### 10674###Moderator###Lead IRB Chair###Duke University Health System, Inc.###Moderator: Sharon Ellison, PharmD – Duke University Health System, Inc.
@@@ Ilene F. Wilets, PhD, CIP – Program for the Protection of Human Subjects ### 64126###Moderator###IRB Chair###Program for the Protection of Human Subjects###Moderator: Ilene F. Wilets, PhD, CIP – Program for the Protection of Human Subjects
@@@ Debra D. Roberts, PhD – Howard University ### 1170632###Moderator###Professor and Chair Department of Psychology###Howard University###Moderator: Debra D. Roberts, PhD – Howard University
Moderator: Eric Allen, MA, CIP, CPIA – University of South Florida
Moderator: Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
Moderator: Danielle A. Griffin, Ed.D., CIP – University of Houston
Moderator: Eric Allen, MA, CIP, CPIA – University of South Florida
@@@ Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School ### 585128###Moderator###President###Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School###Moderator: Glenn Ellis, MPH, CHCE – Strategies for Well-Being, LLC; Harvard Research Bioethics Fellow, Harvard Medical School
@@@ Danielle A. Griffin, Ed.D., CIP – University of Houston ### 824496###Moderator###Associate Director of Research Integrity and Oversight###University of Houston###Moderator: Danielle A. Griffin, Ed.D., CIP – University of Houston
Speaker: Tonya Ferraro, MEd – Boston Children's Hospital
Speaker: Eunice Yim Newbert, MPH – Boston Children's Hospital
Speaker: Tonya Ferraro, MEd – Boston Children's Hospital
@@@ Eunice Yim Newbert, MPH – Boston Children's Hospital ### 25441###Speaker###Program Manager###Boston Children's Hospital###Speaker: Eunice Yim Newbert, MPH – Boston Children's Hospital
Speaker: Ada Sue Selwitz, MA – University of Kentucky
Speaker: David H. Strauss, MD – Columbia University
Resource Person: Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Speaker: Ada Sue Selwitz, MA – University of Kentucky
@@@ David H. Strauss, MD – Columbia University ### 10147###Speaker###Special Lecturer, Department of Psychiatry###Columbia University###Speaker: David H. Strauss, MD – Columbia University
@@@ Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP) ### 112580###Resource Person###Senior Advisor for Public Health Education###Office for Human Research Protections (OHRP)###Resource Person: Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Moderator: Emily E. Anderson, PhD, MPH – Neiswanger Institute for Bioethics, Loyola University Chicago
Poster Presenter: Jessica Blackburn, MPH, CIP – Emory University
Poster Presenter: Kathryn M. Porter, JD, MPH – Seattle Children's Hospital and Research Institute
Poster Presenter: Brandon J. Brown, MPH, PhD – University of California, Riverside
Moderator: Emily E. Anderson, PhD, MPH – Neiswanger Institute for Bioethics, Loyola University Chicago
@@@ Jessica Blackburn, MPH, CIP – Emory University ### 1095794###Poster Presenter###Senior Education and QA Research Protocol Analyst###Emory University###Poster Presenter: Jessica Blackburn, MPH, CIP – Emory University
@@@ Kathryn M. Porter, JD, MPH – Seattle Children's Hospital and Research Institute ### 863997###Poster Presenter###Research Scientist###Seattle Children's Hospital and Research Institute###Poster Presenter: Kathryn M. Porter, JD, MPH – Seattle Children's Hospital and Research Institute
@@@ Brandon J. Brown, MPH, PhD – University of California, Riverside ### 122577###Poster Presenter###Associate Professor, Department of Social Medicine, Population and Public Health###University of California, Riverside###Poster Presenter: Brandon J. Brown, MPH, PhD – University of California, Riverside
Moderator: Nancy E. Kass, ScD – The Johns Hopkins University
Panelist: E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO)
Panelist: Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada
Panelist: Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Moderator: Nancy E. Kass, ScD – The Johns Hopkins University
@@@ E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO) ### 1156067###Panelist###Chief of Programs and Services###National Association of County and City Health Officials (NACCHO)###Panelist: E. Oscar Alleyne, DrPH, MPH – National Association of County and City Health Officials (NACCHO)
@@@ Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada ### 11339###Panelist###Associate Professor###Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada###Panelist: Jonathan Kimmelman – Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, Montreal, Canada
@@@ Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health ### 1179525###Panelist###Director, Institute for Vaccine Safety; Professor, International Health###Johns Hopkins Bloomberg School of Public Health###Panelist: Daniel Salmon, PhD, MPH – Johns Hopkins Bloomberg School of Public Health
Moderator: Melissa E. Abraham, PhD, MS
Panelist: Joan Albert Camprodon, MD, PhD – Massachusetts General Hospital
Panelist: Kate Gallin Heffernan, JD – Epstein Becker & Green PC
Panelist: Benjamin C. Silverman, MD – Mass General Brigham
Moderator: Melissa E. Abraham, PhD, MS
@@@ Joan Albert Camprodon, MD, PhD – Massachusetts General Hospital ### 1166912###Panelist###Chief, Division of Neuropsychiatry; Director, Transcranial Magnetic Stimulation Clinical Service; Director, Laboratory for Neuropsychiatry & Neuromodulation###Massachusetts General Hospital###Panelist: Joan Albert Camprodon, MD, PhD – Massachusetts General Hospital
@@@ Kate Gallin Heffernan, JD – Epstein Becker & Green PC ### 10588###Panelist###Member###Epstein Becker & Green PC###Panelist: Kate Gallin Heffernan, JD – Epstein Becker & Green PC
@@@ Benjamin C. Silverman, MD – Mass General Brigham ### 824672###Panelist###Senior IRB Chair###Mass General Brigham###Panelist: Benjamin C. Silverman, MD – Mass General Brigham
Speaker: Daniel Kavanagh, PhD, RAC – WCG
Speaker: Daniel Kavanagh, PhD, RAC – WCG
Speaker: Bridget Foltz – FDA
Speaker: Joanne R. Less, PhD – US Food and Drug Administration
Speaker: Laurie Muldowney, MD – FDA
Speaker: Kevin A. Prohaska, DO, MPH – Food and Drug Administration
Speaker: Minerva Hughes, JD, PhD – FDA
Speaker: Diane M. Maloney, JD – Food and Drug Administration
A Dialogue With the Feds Track
Speaker: Bridget Foltz – FDA
@@@ Joanne R. Less, PhD – US Food and Drug Administration ### 10597###Speaker###Director, Office of Good Clinical Practice###US Food and Drug Administration###Speaker: Joanne R. Less, PhD – US Food and Drug Administration
@@@ Laurie Muldowney, MD – FDA ### 1097124###Speaker###Deputy Director, Office of Scientific Investigations###FDA###Speaker: Laurie Muldowney, MD – FDA
@@@ Kevin A. Prohaska, DO, MPH – Food and Drug Administration ### 10694###Speaker###Senior Medical Policy Advisor/Bioethics Consultant###Food and Drug Administration###Speaker: Kevin A. Prohaska, DO, MPH – Food and Drug Administration
@@@ Minerva Hughes, JD, PhD – FDA ### 1140826###Speaker###Regulatory Counsel###FDA###Speaker: Minerva Hughes, JD, PhD – FDA
@@@ Diane M. Maloney, JD – Food and Drug Administration ### 10601###Speaker###Associate Director for Policy###Food and Drug Administration###Speaker: Diane M. Maloney, JD – Food and Drug Administration
Speaker: Linnea A. Anderson, BA, CIP – University of Minnesota
Speaker: Kimberly K. Summers, PharmD – University of Texas Health San Antonio
Speaker: Suzanne Stone, MA, CIP – UC Berkeley
Institutional Officials and HRPP Leadership Track
Speaker: Linnea A. Anderson, BA, CIP – University of Minnesota
@@@ Kimberly K. Summers, PharmD – University of Texas Health San Antonio ### 420574###Speaker###Director, Research Protection Programs###University of Texas Health San Antonio###Speaker: Kimberly K. Summers, PharmD – University of Texas Health San Antonio
@@@ Suzanne Stone, MA, CIP – UC Berkeley ### 57886###Speaker###Research Compliance Analyst/Administrator###UC Berkeley###Speaker: Suzanne Stone, MA, CIP – UC Berkeley
Speaker: Brenda J. Klement – Morehouse School of Medicine
Speaker: Susan Sonne, PharmD, BCPP – Medical University of South Carolina
IRB Chairs Track
Speaker: Brenda J. Klement – Morehouse School of Medicine
@@@ Susan Sonne, PharmD, BCPP – Medical University of South Carolina ### 587407###Speaker###Chair, IRB II; Associate Director, Regulatory Knowledge and Support Core, SCTR Institute###Medical University of South Carolina###Speaker: Susan Sonne, PharmD, BCPP – Medical University of South Carolina
Speaker: Edye Edens, JD, MA, CIP, CCRP – First Class Solutions, Inc.
Speaker: Daniel A. Perez, BS, CCRP – MACRO Trials
Leadership Track
Speaker: Edye Edens, JD, MA, CIP, CCRP – First Class Solutions, Inc.
@@@ Daniel A. Perez, BS, CCRP – MACRO Trials ### 1095805###Speaker###Chief Operating Officer###MACRO Trials###Speaker: Daniel A. Perez, BS, CCRP – MACRO Trials
Speaker: David G. Forster, JD, MA, CIP – WIRB-Copernicus Group
Speaker: Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Legal Considerations in HRPPs Track
Speaker: David G. Forster, JD, MA, CIP – WIRB-Copernicus Group
@@@ Irene E. Stith-Coleman, PhD – Office for Human Research Protections ### 11110###Speaker###Director, Division of Policy and Assurances###Office for Human Research Protections###Speaker: Irene E. Stith-Coleman, PhD – Office for Human Research Protections
Speaker: Ran Goldman, MD – University of British Columbia
Speaker: Mary Cataletto, MD – NYU Long Island School of Medicine
Speaker: Casey Mumaw, MA, CIP – Indiana University
Resource Person: Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Populations Requiring Additional Protections Track
Speaker: Ran Goldman, MD – University of British Columbia
@@@ Mary Cataletto, MD – NYU Long Island School of Medicine ### 57687###Speaker###IRB Member###NYU Long Island School of Medicine###Speaker: Mary Cataletto, MD – NYU Long Island School of Medicine
@@@ Casey Mumaw, MA, CIP – Indiana University ### 420597###Speaker###Assistant Director###Indiana University###Speaker: Casey Mumaw, MA, CIP – Indiana University
@@@ Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP) ### 112580###Resource Person###Senior Advisor for Public Health Education###Office for Human Research Protections (OHRP)###Resource Person: Misti Ault Anderson, MS, MA – Office for Human Research Protections (OHRP)
Speaker: Michele Russell-Einhorn, JD – Advarra
Speaker: Jason M. Malone, MPA, CIP – University of Washington
Speaker: Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
QA/QI and Post-Approval Monitoring Track
Speaker: Michele Russell-Einhorn, JD – Advarra
@@@ Jason M. Malone, MPA, CIP – University of Washington ### 1135091###Speaker###Assistant Director, Regulatory Affairs Human Subjects Division###University of Washington###Speaker: Jason M. Malone, MPA, CIP – University of Washington
@@@ Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP) ### 10669###Speaker###Director, Division of Compliance Oversight###DHHS, Office for Human Research Protections (OHRP)###Speaker: Lisa R. Buchanan, MAOM, CIP – DHHS, Office for Human Research Protections (OHRP)
Speaker: Danielle A. Griffin, Ed.D., CIP – University of Houston
Speaker: Lorraine R. Reitzel, PhD, FAAHB, FSRNT – University of Houston
Research Conducted in the Digital World Track
Speaker: Danielle A. Griffin, Ed.D., CIP – University of Houston
@@@ Lorraine R. Reitzel, PhD, FAAHB, FSRNT – University of Houston ### 1095815###Speaker###IRB Chair and Professor###University of Houston###Speaker: Lorraine R. Reitzel, PhD, FAAHB, FSRNT – University of Houston
Speaker: John C. Smith, MSW, CIM, CIP – Morehouse School of Medicine
Speaker: Elizabeth Carroll, MPH, CIP – Adventist Healthcare, Inc.
Small Research Programs Track
Speaker: John C. Smith, MSW, CIM, CIP – Morehouse School of Medicine
@@@ Elizabeth Carroll, MPH, CIP – Adventist Healthcare, Inc. ### 1095816###Speaker###Ethics Program Director###Adventist Healthcare, Inc.###Speaker: Elizabeth Carroll, MPH, CIP – Adventist Healthcare, Inc.
Speaker: Julie F. Simpson, PhD – University of New Hampshire
Speaker: Andrea R. McDowell, PhD – Seattle University
Resource Person: Ivor A. Pritchard, PhD – OHRP
SBER Track
Speaker: Julie F. Simpson, PhD – University of New Hampshire
@@@ Andrea R. McDowell, PhD – Seattle University ### 175574###Speaker###IRB Administrator; Lecturer, Business Communication###Seattle University###Speaker: Andrea R. McDowell, PhD – Seattle University
@@@ Ivor A. Pritchard, PhD – OHRP ### 10140###Resource Person###Senior Advisor to the Director###OHRP###Resource Person: Ivor A. Pritchard, PhD – OHRP
Presenter: Charlotte K. Jeans, PhD, CCRN, CIP – Department of Veterans Affairs
Presenter: Mary M. Klote, MD, CIP – Veterans Health Administration
Presenter: Kristina C. Borror, PhD – Veterans Health Administration
Presenter: Yen B. Nguyen, PharmD, CCRC – Office of Research Oversight, Veterans Health Administration
Presenter: Charlotte K. Jeans, PhD, CCRN, CIP – Department of Veterans Affairs
@@@ Mary M. Klote, MD, CIP – Veterans Health Administration ### 187333###Presenter###Director, Office of Research Protections, Policy, and Education###Veterans Health Administration###Presenter: Mary M. Klote, MD, CIP – Veterans Health Administration
@@@ Kristina C. Borror, PhD – Veterans Health Administration ### 10668###Presenter###Director of Policy and Education, Office of Research Oversight###Veterans Health Administration###Presenter: Kristina C. Borror, PhD – Veterans Health Administration
@@@ Yen B. Nguyen, PharmD, CCRC – Office of Research Oversight, Veterans Health Administration ### 1095819###Presenter###Director, Informatics and Data Analytics###Office of Research Oversight, Veterans Health Administration###Presenter: Yen B. Nguyen, PharmD, CCRC – Office of Research Oversight, Veterans Health Administration
Speaker: Cecilia Brooke Cholka, PhD, CIP – University of Nevada, Reno
Speaker: Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research Integrity
Speaker: Cecilia Brooke Cholka, PhD, CIP – University of Nevada, Reno
@@@ Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research Integrity ### 619387###Speaker###Research Education Specialist###University of Kentucky Office of Research Integrity###Speaker: Belinda M. Smith, M.S., R.D., CCRC – University of Kentucky Office of Research Integrity
Moderator: James M. DuBois, PhD, DSc – Washington University School of Medicine
Moderator: Bryan A. Sisk, MD, MSCI – Washington University School of Medicine
Moderator: James M. DuBois, PhD, DSc – Washington University School of Medicine
@@@ Bryan A. Sisk, MD, MSCI – Washington University School of Medicine ### 1159124###Moderator###Assistant Professor in Pediatric Hematology and Oncology, Bioethics Research Center###Washington University School of Medicine###Moderator: Bryan A. Sisk, MD, MSCI – Washington University School of Medicine
Moderator: Polly Goodman, BS, CIP – Harvard University
Moderator: Robleinscky Isabel Dominguez, BS, CIP – Boston Children's Hospital
Moderator: Jenni Beadles, MEd, CIP – Vanderbilt University Medical Center
Moderator: Polly Goodman, BS, CIP – Harvard University
@@@ Robleinscky Isabel Dominguez, BS, CIP – Boston Children's Hospital ### 824456###Moderator###IRB Reliance Specialist###Boston Children's Hospital###Moderator: Robleinscky Isabel Dominguez, BS, CIP – Boston Children's Hospital
@@@ Jenni Beadles, MEd, CIP – Vanderbilt University Medical Center ### 10567###Moderator###Assistant Director External Partners###Vanderbilt University Medical Center###Moderator: Jenni Beadles, MEd, CIP – Vanderbilt University Medical Center
Speaker: Quincy J. Byrdsong, EdD, CIP, CCRP – Lipscomb University
Speaker: Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Speaker: Quincy J. Byrdsong, EdD, CIP, CCRP – Lipscomb University
@@@ Allecia A. Harley, MPH, CRA – Lake Shore Strategy ### 1095821###Speaker###CEO and Chief Strategy Officer###Lake Shore Strategy###Speaker: Allecia A. Harley, MPH, CRA – Lake Shore Strategy
Moderator: Warren H. Capell, MD – CPC Clinical Research University of Colorado Anschutz Medical Campus
Poster Presenter: Julie Wijesooriya, MPA – Cincinnati Children's Hospital/University of Cincinnati - CCTST
Poster Presenter: Deneil Harney, MPH, MSW – University of Michigan Medical School
Poster Presenter: Courtney Jarboe, MS, MA, CIP – University of Minnesota
Moderator: Warren H. Capell, MD – CPC Clinical Research University of Colorado Anschutz Medical Campus
@@@ Julie Wijesooriya, MPA – Cincinnati Children's Hospital/University of Cincinnati - CCTST ### 864187###Poster Presenter###Research Community Liaison###Cincinnati Children's Hospital/University of Cincinnati - CCTST###Poster Presenter: Julie Wijesooriya, MPA – Cincinnati Children's Hospital/University of Cincinnati - CCTST
@@@ Deneil Harney, MPH, MSW – University of Michigan Medical School ### 609722###Poster Presenter###NETT/SIREN Human Subjects Protection Specialist in the Department of Emergency Medicine###University of Michigan Medical School###Poster Presenter: Deneil Harney, MPH, MSW – University of Michigan Medical School
@@@ Courtney Jarboe, MS, MA, CIP – University of Minnesota ### 112630###Poster Presenter###Assistant Director, HRPP Education and Outreach###University of Minnesota###Poster Presenter: Courtney Jarboe, MS, MA, CIP – University of Minnesota