Big Data and the IRB Conference
October 24, 2014 | 8:00am – 5:00pm Eastern Time
Boston Marriott Cambridge, Cambridge MA | or via Webcast
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.
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.
David W. Kaufman, Sc.D.
Slone Epidemiology Center at Boston University
Professor of Epidemiology
Boston University School of Public Health
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 7.25 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.
Dietary Considerations and Special Services
The CME staff will work to accommodate dietary requests (including, but not limited to: vegetarian, kosher, and low-sodium menus) received in writing at least one week prior to the conference. To request reasonable accommodations for a disability, please notify the Boston University CME Office, in writing, at least two weeks prior to the start of the conference.
It is the policy of Boston University School of Medicine Department of Continuing Medical Education, that faculty disclose to program participants any real or apparent conflict of interest. In addition, the faculty is asked to disclose any discussion pertaining to the unapproved use of pharmaceuticals and devices. Complete disclosure information will be available on site in the printed course materials.
Substitutions may be made at any time without an additional charge. Refunds, less an $50 administrative fee, will be issued for all cancellations received two weeks prior to the start of the conference. Should cancellation occur within the two-week window, a credit will be issued, not a refund. Credits will be honored for up to two years. “No shows” are subject to the full course fee. Cancellations/substitution(s) must be made in writing. Refunds or credits will not be issued once the conference has started. This course is subject to change or cancellation.
Education program is co-sponsored by: