IRB Informational Teleconference on caBIG™ the ca ncer B iomedical I nformatics G rid

1. IRB Informational Teleconference on caBIG™the cancer Biomedical Informatics Grid caBIG an initiative of the National Cancer Institute, NIH, DHHS

2. Overview • Background and Goals of caBIG™ • caBIG™ Principles and Structure • caBIG™ Working Groups • Legal and Regulatory Issues within caBIG™: Patient Privacy, Consent and More • How to Get Involved/For More Information caBIG an initiative of the National Cancer Institute, NIH, DHHS

3. Current State at Cancer Centers:Informatics ‘Tower of Babel’ • Each cancer research community speaks its own scientific “dialect” • Overwhelming volume of data from a multitude of sources • Integration critical to achieve promise of molecular medicine caBIG an initiative of the National Cancer Institute, NIH, DHHS

4. caBIG™ Goal: To create a virtual web of interconnected data, individuals, and organizations redefining how research is conducted, care is provided, and patients/ participants interact with the biomedical research enterprise caBIG an initiative of the National Cancer Institute, NIH, DHHS

5. Cancer Biomedical Informatics Grid (caBIG™) • Common, widely distributed informatics platform • Shared vocabulary, data elements, data models • Common standard for developing applications caBIG an initiative of the National Cancer Institute, NIH, DHHS

6. caBIG™Principles • Open source • Open access • Open development • Federated caBIG an initiative of the National Cancer Institute, NIH, DHHS

7. caBIG™ grid will integrate diverse data within and across institutions caBIG an initiative of the National Cancer Institute, NIH, DHHS

8. caBIG™ infrastructure will facilitate sharing of tools, applications, and data caBIG an initiative of the National Cancer Institute, NIH, DHHS

9. DSIC Mission: Optimize data sharingacross Cancer Centers, while meeting all regulatory requirements such asIRB Assurances and HIPAA CTMS Mission: Facilitate thedesign, conduct,analysis andreporting ofclinical trials Data Sharing & Intellectual Capital Clinical Trial Management Systems V o c a b u a r y TissueSamples T r a n n g Tissue Banks & Pathology Tools Data Pipeline TBPT Mission:Deploy tools to enable Grid-based queries of biospecimen data within & across institutional specimen- based research Translational Research i i l Integrative Cancer Research TissueSamples Data Pipeline Architecture Strategic Planning ICR Mission: Facilitatetranslational research by collecting, storing & analyzingbasic-science data, linked toclinical trials where applicable Data Pipeline Overview of caBIG Infrastructure Po licy caBIG an initiative of the National Cancer Institute, NIH, DHHS

10. Goals of the caBIG™ Pilot • Illustrate that a spectrum of Cancer Centers with varying needs and capabilities can be joined in a common network of communications, shared data, applications, and technologies • Demonstrate that Cancer Centers, in collaboration with NCI, will develop new enabling tools and systems that could support multiple Cancer Centers • Demonstrate that Cancer Centers will actively use the grid and realize greater value in their cancer research endeavors by using the network • Create an extensible infrastructure that will continue to be expanded and extended to members of the cancer research community caBIG an initiative of the National Cancer Institute, NIH, DHHS

11. caBIG™ Deliverables:Clinical Trials Management Systems • Componentized, standards-based Clinical Trials Management System to handle, in an automated fashion, all aspects of developing, managing, conducting, and reporting Clinical Trials • e-IND filing/regulatory reporting with FDA • Electronic management of trials • Integration of diverse trials caBIG an initiative of the National Cancer Institute, NIH, DHHS

12. caBIG™ Deliverables:Tissue Banks and Pathology Tools • Tissue Management System • Systematic description and characterization of tissue resources – tools to inventory, track, mine, and visualize tissue samples from geographically dispersed repositories • Ability to link tissue resources to clinical and molecular correlative descriptions caBIG an initiative of the National Cancer Institute, NIH, DHHS

13. caBIG™ Deliverables:Integrative Cancer Research • “Plug and Play” analytic tool set • microarray • proteomics • pathways • data analysis and statistical methods • gene annotation • Diverse library of raw, structured data • Facilitate the integration of different types of data • Provide tools for the integration of clinical and basic research caBIG an initiative of the National Cancer Institute, NIH, DHHS

14. caBIG™ Strategic Workspaces • Mission, vision, and timelines guided by the Strategic Planning WS • Underlying key technologies guided by the Architecture WS • Standardization of terminologies ensured by the Vocabulary WS • Principles and regulations for sharing of data, tools, and applications overseen by the Data Sharing and Intellectual Capital WS caBIG an initiative of the National Cancer Institute, NIH, DHHS

15. Data Sharing and Intellectual Capital Workspace (DSIC WS) Goals: • Consider issues presented by caBIG™ activities related to data sharing, intellectual property, and intellectual capital • Recommend best practices, develop guidance, and draft white papers • Sponsor two Special Interest Groups (SIGs) • Regulatory SIG • Proprietary SIG caBIG an initiative of the National Cancer Institute, NIH, DHHS

16. DSIC WS Participation • Representation from 14 cancer centers and other private entities, including: City of Hope Cold Spring Harbor Labs Fox Chase Fred Hutchinson Jackson Labs Oregon Health and Sciences U. Sloan Kettering Thomas Jefferson U./ Kimmel UNC/ Chapel Hill U. Pittsburgh U. Pennsylvania/ Abramson U. Iowa/ Holden U. Michigan Washington U./ Siteman Patient Advocates in Research (PAIR) caBIG an initiative of the National Cancer Institute, NIH, DHHS

17. DSIC WS Methodology: The “Problem Scenario” Approach • Problem scenarios are solicited from members of the DSIC and throughout the caBIG community • After they submitted, they are fielded by member of the appropriate team (either the Proprietary or Regulatory SIG). caBIG an initiative of the National Cancer Institute, NIH, DHHS

18. Problem Scenario Workflow • Scenario is fielded to subject matter experts • Proposed solutions submitted; discussed amongst group members • Adopted as policy/ recommendation caBIG an initiative of the National Cancer Institute, NIH, DHHS

19. Some Current DSIC WS Problem Scenarios • Are dates on which tissue samples are processed or transferred considered PHI? • How can unique patient identifiers be used to prevent data duplication across studies? • Is HIPAA violated if a researcher learns only that a patient records exists in a research database? • Can a patient compel sharing of research data with another researcher? caBIG an initiative of the National Cancer Institute, NIH, DHHS

20. One Approach to Addressing Regulatory Issues What is the business case for developing an IRB Applications Technical Assistance Service? • This service would aid researchers in delivering complete, clear applications for IRB approval. caBIG an initiative of the National Cancer Institute, NIH, DHHS

21. DSIC WS Sponsors Two Special Interest Groups (SIGs) • The Regulatory SIG is focused on legal and policy issues relating to study participant consent, IRB and HIPAA authorization, and confidentiality and data security. • The Proprietary SIG is concerned with intellectual property matters such as software licensing, data sharing and biospecimen resources and “intellectual capital” (e.g., authorship and attribution). caBIG an initiative of the National Cancer Institute, NIH, DHHS

22. Regulatory SIG: Issues Addressed • HIPAA Compliance • IRB Compliance • De-Identification • Use of Patient Identifiers • Patient Consent for Inclusion in Databases • Expedited IRB Review caBIG an initiative of the National Cancer Institute, NIH, DHHS

23. Activities of the Regulatory SIG • caBIG™ Publication Policy • Documents process for review and provides guidelines for authorship, attribution, and acknowledgement in caBIG™ Publications • Security Program • Will develop authorization, authentication, horizontal trust, and other security policies and procedures • Conflict of Interest Statement • Requires disclosure of financial interests in matters under discussion • Industry Partners Statement • Restricts activities on teleconferences and at meetings to those related to conducting the mission or business of caBIG™ caBIG an initiative of the National Cancer Institute, NIH, DHHS

24. Activities of the Proprietary SIG • Open Source Software (OSS) Licensing Guidelines and Model Agreement • Source code for all caBIG™ software tools will be available to end-users; no restrictions on how source code modified by end users is distributed • Use of model agreement is not mandatory; guidance document will assist caBIG institutions in formulating alternatives • White paper on data sharing • Problem scenarios • Research on other data sharing initiatives caBIG an initiative of the National Cancer Institute, NIH, DHHS

25. Proprietary SIG: Other Initiatives currently being researched • Cooperative Breast Cancer Tissue Resource • The BIRN initiative • The DNA/Autism-related project • NCI Cooperative Group Specimen Banks • Other biospecimens sharing initiatives caBIG an initiative of the National Cancer Institute, NIH, DHHS

26. Do you have answers, ideas, or suggestions to contribute? • We would love to have you! caBIG an initiative of the National Cancer Institute, NIH, DHHS

27. How to Get Involved • DSIC WS will hold a face-to-face in meeting to discuss progress to date, to hold educational sessions on IRB and HIPAA related topics • March 6&7, Philadelphia PA • Others to follow! • Learn more about caBIG™ and DSIC WS activities: • http://caBIG.nci.nih.gov/ caBIG an initiative of the National Cancer Institute, NIH, DHHS

28. How to Get Involved • DSIC WS welcomes participation by experienced IRB staff and HIPAA specialists • Teleconferences are open to all interested parties • Regulatory SIG teleconferences are on the 2nd and 4th Thursday of each month, 2 PM EST caBIG an initiative of the National Cancer Institute, NIH, DHHS

29. DSIC Communications: • Workspace Facilitator (NCI) Wendy Patterson, J.D. (301) 435-3110 pattersw@mail.nih.gov • Workspace Coordinator (BAH) Dan Steinberg, J.D. (703) 377- 1261 steinberg_daniel@bah.com caBIG an initiative of the National Cancer Institute, NIH, DHHS

30. Questions? caBIG an initiative of the National Cancer Institute, NIH, DHHS