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Privacy Overviewfor VHA ORDStephania H Griffin JD RHIADirector Information Access and PrivacyVeterans Health Administration.
Office of Health InformaticsMay 4 2020 Privacy Topics General Privacy Efforts with Research Component VA Form 10 250 VHA Research Protocol Privacy.
Review Checklist Combined Research ICF with HIPAA Authorization Waiver of HIPAA Authorizations General Privacy Efforts Updating VHA facility Privacy Policy Template.
Facility level Privacy Policies are required butbeing revised to remove duplicate language PCA Audits include Research Privacy Component Mandated and Consultative Review compliance with Privacy requirements and.
use the completed VA Form 10 250 to assist inthat review VA Form 10 250 VA Form 10 250 VHA Research Protocol Privacy ReviewChecklist is required by VHA Directive 1605 03.
Must incorporate completed form into the protocol May be maintained in facility protocol documentation ifusing Affiliate IRB Only documents the Privacy Officer review ISSO review is nolonger documented on the Privacy Officer Checklist and may.
be performed as the facility determines Both the Preliminary and Final review sections must becompleted Completing VA Form 10 250 Privacy Officer Preliminary review begins on pg 2.
Conducted to ensure that all privacy concerns areaddressed prior to approval Privacy Officer Final Review begins on pg 5 Conduct a final review after the IRB or R DCommittee when acting as Privacy Board has.
approved the study to see if any changes weremade that would affect the privacy interest of the Did the approval documents include all thenecessary components Combined ICF and HIPAA Authorization.
VHA Directive 1200 05 no longer prohibits combininginformed consent forms and HIPAA authorizations into one There are however certain situations when it is not advised tocombine the two documents due to requirements inherent inthe Privacy Act or HIPAA Privacy Rule Specifically it is best.
not to combine the informed consent form with a HIPAAAuthorization when either The subject has diminished decision making capacity or When the research study contains optional componentsthat the subject can choose to participate in or not e g .
optional data or tissue banking or genetic testing Combined ICF and HIPAA Authorization For subjects that have diminished decision making capacity the individual who is authorized to provide informed consenton the subject s behalf may not be the same individual who is.
authorized to sign a HIPAA Authorization for the subject If a combined document was used and the individualsigning the form met the qualifications of the subject s LARbut was not appointed as their personal representative the HIPAA authorization would not be valid .
The scenario would require the subject s PersonalRepresentative to sign a separate HIPAA Authorization orfor the IRB or R D Committee to approve a waiver ofHIPAA Authorization for the subjects without a PersonalRepresentative .
Combined ICF and HIPAA Authorization Where the study includes an optional component such as dataor tissue banking or genetic testing in order to meet therequirements specified in the HIPAA Privacy Rule the HIPAAauthorization must clearly differentiate between the.
conditioned mandatory and unconditioned optional components and provide the subject with an opportunity toopt in to the research activities described in theunconditioned part of the authorization In order to sufficiently show that the subject opted into the.
unconditioned optional component of the study a signatureis required for that component as opposed to just a check boxwithin the Informed Consent Waiver of HIPAA Authorizations IRB or Privacy Board approved waivers of HIPAA.
Authorizations may be for an entire study a single aspect of the study such as recruitment or a specific situation such as consenting subjects withdiminished decision making capacity with a LAR .
Waivers are a balance of generalities with specificity The IRB or Privacy Board has sole authority for determining ifHIPAA Privacy Rule criteria have been meet to grant a waiver However concerns raised by the PO around what the waiverdoes and does not cover as written should be heeded as a PO.
in many cases may have to approve access to the data suchas with CDW VINCI and CAPRI Q A Discussion ADDITIONAL INFORMATIONContact Stephania Griffin Director.
Information Access and Privacy704 245 2492 Stephania griffin va govCombined ICF and HIPAA Authorization. VHA Directive 1200.05 no longer prohibits combining informed consent forms and HIPAA authorizations into one document.

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