Data must be used stored and secured according to the requirements of the VHA

Data must be used stored and secured according to the

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Data must be used, stored, and secured according to the requirements of the VHA series 1200 handbooks, other applicable VA and VHA requirements, and as described in the approved research protocolAny non-compliance with VA, VHA, or other applicable Federal regulations or the research protocol as approved by the IRB and R&D Committees, must be reported according to VA Connecticut policies and procedures and by VHA requirements. It must also be reported to the PI of VACS who will notifythe appropriate IRB.Any theft, loss, or copromise of the data must be immedicately reportedto VA Connecticut Information Security Officer, VA Connecticut Privacy Officer,the West Haven VAIRBand the PI of VACSas well as appropriate officials at the facility at which the theft, loss or compromise occurred.No effort will be made to re-identify data that are de-identified.Written approval from Chief Public Health and Environmental Hazards Officer authorizing release of 7332-protected information.Written approval from Chief R&D Officer authorizing release of research dataVA Form 10-0403 (Responsible Requestor and Project Information Sheet)VA Form 10-0403a (Data Use Agreement) – May need modification and Appendix signed by requestor and Chief Public Health and Environmental Hazards OfficerVA Form 10-0403b (Data Access List)VHA Data Use Agreement (VHA Handbook 1605.1 Appendix F)Yale Data Use Agreement (2 signed originals)Yale Assurance of Compliance with Data Use Agreement (included in Yale Data Use Agreement)The Chief Public Health and Environmental Hazards Officer signs for VHA. the Yale Grants & Contracts office signs for Yale, and requires a signed original for their files.In addition, copies of the IRB approvals for the extramural investigator must be on file with the VACS Coordinating Center.VACS Data Sharing PolicyPage 5 of 9
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Copies of all documents should be maintained by VACS Coordinating Center and another copy filed with the Office of the Chief Public Health and Environmental Hazards Officer.C) Fully Identified Data SetsIt is VACS Coordinating Center policy to not share fully identified data sets.4. Specifics Related to Release of Protected Health Information Including HIV Infection, Drug & Alcohol AbuseVeterans’ health information related to HIV, drug abuse, alcohol abuse and sickle cell disease is specifically protected by 38 USC 7332, restricting release without consent specifically related to these classes of information. However, under 38 USC 7332 (b)(2)(B), information related to HIV infection (including information related to testing regardless of the test results), drug abuse, alcohol abuse and sickle cell disease may be released for purposes of research. In addition, 38 CFR 1.488, allows for the release of HIV-related information for the purposes of research when the recipient:Is qualified to conduct the researchHas a research protocol under which the information:oWill be maintained in accordance with the security requirements of 38 CFR 1.466, andoWill redisclose only back to the VAoWill not identify any individual patient in any research report or otherwise disclose patient identities
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  • Fall '19
  • Health Insurance Portability and Accountability Act, Social Security number, Social Security Administration

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