1. The Million Veteran Program: Strategies for Consent & Sample Collection Gerry Higgins, M.D., Ph.D. and the ‘Genomics Advisory Panel’ of OSEHRA

2. TOPICS 1.Consent and Re-Consent: → Proposed use of a PGP (Personal Genomes Project) Consent Form that has been adopted by NIST’s ‘Genome- in-a-bottle’ program, including the FDA. 2. Obtaining samples for use in a CLIA-accredited laboratory for sequencing. → If it were necessary, could we ‘re-consent’ the ~200K Veterans that have already donated samples without having to re-draw another blood sample? 3. Why the use of a CLIA-accredited laboratory is vital: → The individual Veteran can access his or her own data. → A clinician can use the data for healthcare of the Veteran.

3. CONSENT AND RE-CONSENT → In the original survey conducted by the Veteran’s Health Administration, participants raked the use of genomic data as the “highest priority for their own healthcare.” → In the various ‘Consent’ forms 1, it was made clear that the data collected would not be used for the individual Veteran’s healthcare, but for larger public health studies. → However, since that time, genome analysis is proving to be of tremendous clinical benefit, and it is anticipated that by the time the MVP finishes data collection, the era of ‘Clinical Genomic Medicine’ will be well underway. 1 All versions of existing MVP consent forms can be found at: www.oshera.org/genomicswww.oshera.org/genomics

4. CONSENT AND RE-CONSENT 1. The members of the ‘Genomics Advisory Panel’ recommend that all future sample collections be performed in such a manner to be allow any data collected from an individual Veteran be used for that individual’s healthcare, as well as for larger studies. 2. We recommend that a modified version of the Personal Genomes Project (PGP) consent form, adopted by NIST and the FDA, be used for all future sample collections. 3.We recommend that all future sample collections meet CLIA standards, so that they can be used for the individualized healthcare from the Veteran from which that sample was obtained. 4.If possible, we recommend re-consenting of individual Veterans from which samples have already be collected, in a manner which meets CLIA guidelines, but does not require the re-collection of a blood sample.

5. The Value of a Modified PGP Consent Form → It ensures that the Veteran signing the Consent Form is completely aware of his or her legal rights. → It explicitly provides a statement about that data collected from that Veteran can be used for that Veteran’s own healthcare. → It provides privacy protection, compliant with HIPAA guidelines. → It has been adopted by federal agencies such as the FDA for participants in clinical trials whose samples will be processed using next generation sequencing.

6. A view from a Veteran: Rick Williams, J.D., OIF/OEF Veteran (This view is supported by Rick Maguire, Ph.D., a member of the Genomics Advisory Panel, and a former Navy Seal, retired Admiral, who fought in the in the Vietnam era, the First Gulf War, the Second Gulf War and Operation Enduring Freedom. It is also supported by all of the other Veterans who are on the ‘Genomics Advisory Panel’)

7. CLINICAL LABORATORY IMPROVEMENT ADMENDMENTS (CLIA) → It establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. → A laboratory is any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. → The Centers for Medicare & Medicaid Services (CMS) assumes primary responsibility for the CLIA program. → For clinicians who perform next generation sequencing & analysis, it essential that samples be collected & processed following CLIA guidelines.

8. CLINICAL LABORATORY IMPROVEMENT ADMENDMENTS (CLIA) – THE BIG QUESTIONS FOR THE MVP → Since the initial ~200K samples collected for the Million Veteran Program only contained a single identifier, would it be necessary to obtain another sample for next generation sequencing & analysis? → Or…Is it possible to only have to re-consent those Veterans that have provided samples? → The provisional answer from CMS is that it is not necessary to re-draw blood samples, if the initial samples were collected in a manner that ensures sample tracking, integrity and reproducibility…We need to follow-up on this issue…

9. END OF PART TWO: Questions?Discussion?ghiggins@assurerxhealth.com