Big Data and the IRB Conference
Big data and biorepositories are key to today’s research initiatives, especially efforts to identify the genetic underpinnings of disease. But can we conduct this research successfully in the current regulatory environment?
Join leading experts on October 24, 2014 as they explore solutions and identify best practices to collecting, storing and using large data and biospecimen collections with IRB approval.
Chief Executive Officer
Quorum Review IRB
Pearl O'Rourke, MD
Director of Human Research Affairs
Partners Healthcare System
Jerry Menikoff, MD, JD
Director, Office of Human Research Protections
US Department of Health and Human Services
Director, Genetic Sample and Data Sciences/RD Projects Clinical Platforms & Sciences
Glaxo Smith Kline
Director, Human Research Protocol Office, U.S. EPA
Adjunct Professor, Center for Bioethics, University of North Carolina at Chapel Hill
Director, Biorepository Regulatory Support
University of Texas, MD Anderson Cancer Center
Member, Genetic Alliance Council
Co-Founder, Allurion Technologies
Independent Researcher & Consultant
Adjunct Assistant Professor, George Washington University School of Medicine
Michelle Ann Penny
Senior Director, Head of Genetics and Bioinformatics, Tailored Theraputics
Eli Lilly and Company
Senior Program Officer
Patient-Centered Outcomes Research Institute
|CE Hours||Time||Presentation Topic||Speaker(s)|
|0.0||8:00-8:15||Welcome||Cami Gearhart, JDnCEOnQuorum Review IRB|
|0.75||8:15 u2013 9:00||Keynote: History and Context of IRB Review of Biorepositories and Biospecimen Research||Pearl Ou2019Rourke, MDnDirector of Human Research AffairsnPartners Healthcare System|
|0.5||9:00-9:30||Topic: OHRP and Big Data||Jerry Menikoff, MD, JDnDirector, Office for Human Research ProtectionsnUS Department of Health and Human Services|
|9:30 u2013 9:45||BREAK|
|1.0||9:45 u2013 10:45||Topic: Megatrends Impacting Biospecimen Management and Ethical Considerations||Ken WilkenPrincipalnBioStrategy Solutions, LLC|
|0.75||10:45 u2013 11:30||Topic: PCORnet u2013 A Laboratory for Developing and Using Big Data u2013 with IRB Approval||Sarah Greene, MPHnSenior Program OfficernPatient-Centered Outcomes Research Institute|
|0.75||11:30 u2013 12:15||Topic: SACHRP Recommendations Regarding Informed Consent and Research Use of Biospecimens||Daniel Nelson, MScnDirector Human Research Protocol OfficenNational Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency (EPA)nAdjunct Professor of Social Medicine and PediatricsnFaculty Associate, Center for BioethicsnUniversity of North Carolina at Chapel Hill|
|12:15 u2013 01:15||Lunch|
|0.0||1:15 u2013 1:30||Introduction to Afternoon Session||Cami Gearhart, JDnChief Executive OfficernQuorum Review IRB|
|2.0||1:30 u2013 3:30||Topic: The u201cWhyu201d and the u201cHowu201d of Pharmacogenomics Research and Repository Management.||Moderator: Stephen Rosenfeld, MD, MBAnIRB ChairnQuorum Review IRB nnFabio Nunes, MD, MMScnAssociate Medical AdvisornTailored TherapeuticsnEli Lilly and CompanynnMarianna Bledsoe, MAnIndependent Research Professional/ConsultantnAdjunct Assistant Professor, George Washington Univ. School of Medicine nnAnita NelsennDirector, Genetic Sample and Data SciencesnGenetics nRD Projects Clinical Platforms & SciencesnGSKn|
|3:30 u2013 3:45||BREAK|
|1.25||3:45 u2013 5:00||Topic: Informed Consent Approaches||Moderator: Marianna Bledsoe, MAnIndependent Research Professional/ConsultantnAdjunct Assistant Professor, George Washington University School of MedicinennTy Hoover, MD, JD, FCLM, FCAPnDirector, Biorepository Regulatory SupportnUniversity of Texas, MD Anderson Cancer CenternnShantanu Gaur, MDnMember, Genetic Alliance Council and Co-Founder, Allurion Technologiesnn|
|5:00 u2013 6:00||SOCIAL HOUR|
Upon completion of this activity, participants will be able to:
- Discuss regulatory requirements for evaluating IRB approvability.
- Explain how pharmacogenetics contributes to advances in clinical care.
- Explain the importance of biorepositories for advancing current research initiatives.
- Analyze key forces shaping the health care industry and how they will influence clinical trials and biospecimen management.
- Discuss governance models and ethics frameworks used by those designing biospecimen repositories.
- Identify the ethical, legal and social policy implications relating to the collection, storage and use of biospecimens.
- Summarize the key regulatory authorities that guide an ethics committee’s review of repositories.
- Identify innovative informed consent approaches.
- Describe participant perceptions regarding informed consent and the concept of privacy and confidentiality.
Sponsors, contract research organizations, institutions, IRB members, researchers, regulatory personnel, and individuals who design and manage repositories.
Educational Needs Addressed
Big data and biorepositories are key to today’s research initiatives, especially efforts to identify the genetic underpinnings of disease. It is difficult (and some say impossible) to conduct this research successfully in today’s regulatory environment. This conference will explore current solutions and best practices to successfully collect, store and use large data and biospecimen collections . . . with the approval of the IRB.
David W. Kaufman, Sc.D.
Slone Epidemiology Center at Boston University
Professor of Epidemiology
Boston University School of Public Health
Attend Live Conference
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Boston University School of Medicine and Quorum Review IRB. Boston University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
Boston University School of Medicine designates this live activity for a maximum of 7.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This educational activity has been provided by Continuing Nursing Education Provider Unit, Boston University School of Medicine and co-provided by Quorum Review IRB.
Continuing Nursing Education Provider Unit, Boston University School of Medicine is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
Attendance at this event has been pre‐approved for up 7.0 points of research-related education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CCTI® or CPI® certification designations.
Conference sessions that meet the criteria in the Certified IRB Professional (CIP) recertification guidelines are eligible for accredited CIP continuing education credits.
The Compliance Certification Board (CCB) has approved this event for up to [ 8.4 ] CCB CEUs. Continuing Education Units are awarded based on individual attendance records. Granting of prior approval in no way constitutes endorsement by CCB of this program content or of the program sponsor.
The conference will be held at the beautiful Boston Marriott Cambridge located at:
Two Cambridge Center, 50 Broadway
Cambridge, MA 02142 USA
A block of rooms has been reserved at the Boston Marriott Cambridge with an arrival date of 10/23/14 and a departure date of 10/26/14. The room rate is $299, single or double, plus applicable taxes. The rate is available until 10/2/14 or until it sells out, whichever is first. Click here to book a room.
Big Data and the IRB Conference Tuition
Live Conference Tuition
MD or DO
Allied Healthcare Professional
Resident or Student
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