1. MGH Clinical Research Council Meeting Wednesday, February 4, 2015 12:00-1:00 p.m. MEETING AGENDA NIH Genomic Data Sharing (GDS) policy Dr. Pearl O'Rourke, PHS IRB Health On-line for Patient Enrichment (HOPE) initiative Joshua Di Frances, BWH Research Institute Updates and enhancements to the eIRB Scott McNeal and Daniel Hernandez, PHS Research Applications and Analytics

2. NIH Genome Data Sharing Policy (GDS) MGH February 4, 2015 Pearl O’Rourke, MD

3. Agenda GDS Policy – what is new PHS Implementation – NOW – Eye on the future Challenges and Risks

4. Context GDS Policy is an expansion of the existing GWAS policy which: – Requires submission of de-identified genotype/phenotype pairs into dbGaP for NIH- funded GWAS research. Increasing number of non-NIH entities requiring submission of raw research data to accessible databases – EU – USAID

5. GDS Policy Went into effect January 25, 2015 Expands the existing GWAS policy: – Scope: (Increased): “all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research.” Note: this is the floor – ICs can require more

6. Large Scale Genomic Research

7. GDS Policy Requires: – Plan for data sharing at time of grant submission – Prior to grant award (JIT): IO certification re: the data sharing plan c/w data sharing policy – Informed consent for specimens collected after January 25, 2015 See next slide

8. Informed Consent Requirements Content: – Broad future sharing – Unrestricted or controlled access Note: default of controlled access at PHS When required – For any tissue collected after 1/25/15 Research and/or clinical Identifiable and de-identified – For any cells used for cell line derivation after 1/25/15 Uncertainty – Type of consent/permission

9. Research Clinical Care The Regs: Why the Tissue Was Initially Obtained IRB action Informed Consent

10. Research Clinical Care The Regs: Why the Tissue Was Initially Obtained Is There Excess Tissue? YES NO Is It Identifiable? YES NO Secondary Research Uses IRB action Informed Consent IRB action: Consent or Waiver

11. Research Clinical Care The Regs: Why the Tissue Was Initially Obtained Is There Excess Tissue? YES NO Is It Identifiable? YES NO Secondary Research Uses IRB action Informed Consent IRB action: Consent or Waiver IRB action Consent or Waiver YES NO Is It Identifiable?

12. Research Clinical Care GDS policy: Why the Tissue Was Initially Obtained Is There Excess Tissue? YES NO Secondary Research Uses Must have consent for future use and sharing IRB action Informed Consent Consent (new or initial) must include broad sharing and future use

13. Two policy options were considered Option 1: Single policy for all tissue research. Option 2: Separate policy for NIH-funded large-scale genomic research that is within the scope of the GDS Policy.

14. PHS Implementation TWO POLICIES – Policy for NIH funded research in scope – Policy for all else Notice posted on Research Portal eIRB amended with specific questions to identify studies within scope Consent template amended

15. PHS Implementation IRB working with Grants and Contracts and Research Compliance re: – Template data sharing plans for grant application – Language for IO certification – Logistics of working around JIT – Non-human research in scope

16. PHS Implementation – FUTURE? Possibility of going to one policy with consent for all specimens – Await ANPRM* and NIH GDS guidance – HUGE undertaking – not for the timid * ANPRM = Advanced Notice of Proposed Rule Making for the Common Rule (IRB federal regs) Propose that all tissue is identifiable

17. Risks and challenges of current implementation Difficulty of two tissue policies Inconsistent NIH funding over the life of a grant Power of NIH IC Program Officers: – ‘Raising the floor’ Limits future use of tissue specimens that were obtained without adequate consent

19. Local effect: Insight query (5 yr) 769 distinct protocols using excess clinical specimens 130 (17%) with NIH funding – 72 protocols requesting de-id excess clinical 14 (20%) with NIH funding – 81 protocols requesting identifiable with consent 24 (30%) with NIH funding – 682 requesting identifiable with waiver of consent 103 (15%) with NIH funding

20. Factors considered For a single policy Maximizes compliance Maximizes use of specimens Most research includes genetics ANPRM Promotes efficiency for IRB, grants and contracts For two policies Unnecessary for research not in scope Consenting infrastructure would be costly The consented Biobank should be adequate Evolving regulations: – NIH Guidance in GDS pending – ANPRM

21. Problem: Clinical trial recruitment is a difficult task for all biomedical researchers. Many trials (nearly 80%) do not meet enrollment timelines and patient recruitment is very costly. Opportunity: Partners has over 300,000 patients on Patient Gateway. Research indicates that many more patients would participate in clinical trials if they knew how to find/access them. HOPE: An on-line patient community connected to Patient Gateway that will eliminate many of the current barriers to clinical trial recruitment enabling Partners researchers to more successfully recruit for clinical trials and better engage the Partners patient community in the research process.

22. How HOPE works: Patient Actions: Easily join focused health areas (arthritis, depression, diabetes, heart disease) relevant to their health from Patient Gateway See all current IRB-approved research studies relevant to their health and be able request participation in these studies Receive useful targeted health information (e.g. educational materials, summaries of relevant research articles) and learn about upcoming focused events Clinical Investigator Actions: List trials on HOPE platform (open to researchers at all sites) Directly reach out to patients that “opt-in” to one of the HOPE health areas and recruit them to relevant human research studies Distribute one time surveys/longitudinal questionnaires (only IRB approved protocols)

23. Impact on clinical practice: Reduced recruitment burden Reduced email traffic from researchers Fewer posted signs in practices Fewer patient recruiters in practices Streamlined clinical recruitment Impact on patients: Patients will be more aware of the research opportunities at Partners Patients will have easier access to research studies Patients will be more educated about their health conditions

24. HOPE Patient Gateway Quicklink

25. HOPE Introductory Welcome Page *Note: HOPE platform will have language on the introductory welcome page that communicates that this is a pilot and, though it only focuses on a few health conditions initially, it will likely expand to additional health conditions in the future. Current copy on page is not final.

26. HOPE Home Page

27. HOPE Community Page

28. HOPE Example Research Study

29. HOPE Research Study Search

30. Updates Platform design and development finished. Testing currently underway Scheduled to be available in production on February 26, 2015 Platform content will be populated in late February/early March Planning to launch a soft roll out and begin patient outreach in March Currently recruiting arthritis, depression, diabetes and heart disease human research protocols. Please inform your colleagues.

31. Protocol Submission Go to the PCERC website*: o Google “PCERC” or o Go to the following url: brighamandwomens.org/research/centers/pcercbrighamandwomens.org/research/centers/pcerc Click on “Partners HOPE” on the left hand navigation Click on “HOPE Protocol Submission Form” Submit your protocol *Instructions also on distributed handout

32. Department Name 2014 Accomplishments Insight 4.0

33. Department Name 2014 Year in Review  Study Staff Automation – Based on predefined criteria, Study staff amendments can be automatically approved  Estimated Time to Review – Based on historical data, Review time and Approval time are estimated and presented to submitter on application submission. (Next slide for screen)  eCOI update – At the point of PI or Staff certification, users are able to complete their eCOI disclosure form.  Insight 4.0 kick off  IRB Business Drivers  Design Review Insight 4.0

34. Department Name Estimated Time to Review 34 Submission: Submission History:

35. Department Name 2014 Statistics Insight Development Tasks – 265 Tickets (IRB Only) IRB Helpdesk volume – 1608 Tickets/Calls (or roughly 31 calls per week) IRB Transactions Received – 35

36. Department Name IRB Business Drivers  Consistent overall navigation  Streamlined application process (Wizard)  Continuous and intuitive review process  Easier Submission Tracking  More intuitive Attachments management process  Easily accessible activity list Insight 4.0

37. Department Name Overall Navigation Insight 4.0

38. Department Name Overall Navigation Ctd.. Insight 4.0

39. Department Name Application Process 39 Insight 4.0

40. Department Name Staff page 40 Insight 4.0

41. Department Name Attachments 41 Insight 4.0

42. Department Name Response process 42 Insight 4.0