Richard L. Roudebush VA Collaborative VA Research Project Guidance Implementation 1/1/2012 VA research Per VHA Handbook 1200.01 & 1058.01, VA research is:  Research (regardless of funding) conducted by VA investigator effort, that is: Compensated, WithOut Compensation (WOC), or Intergovernmental Personnel Agreement (IPA))  While on: a. VA time, b. Utilizing VA resources (e.g., equipment, personnel), or c. On VA property (including space leased to or used by VA) Collaborative Research Collaborative Research is considered any VA Research activity which includes any property or resources of a non - VA entity (individuals or institutions). VA research activities (time, resources, and property) should be clearly separated from non-VA activities. IRB approval of these distinctions must be provided to the VA R&D. The IRB documentation must clearly state which research procedures and activities (including effort, resources, and location) are VA or non-VA. VA considers collaborative research to be multi-site, requiring IRB clarification & VA approval (only for the VA Research portion).

Time - Principal Investigator The PI’s VA time may be compensated at x/8ths, WithOut Compensation (WOC), or via an IPA (inter-personnel agreement) by which VA salary is provided to the non VA entity. The PI’s clinical & research time may be VA only, non-VA only, or a dual appointment (both VA & Non VA). The PI may be asked to clarify only the VA portion related to duties, duty locations, tours of duty, and VA research percent effort across all studies.

Coordinating Center Research data collected from both the VA and a non-VA site (ie: IU, RG, IU Health, Meth) may be coordinated either at the VA or the non-VA site. If the PI is on a dual appointment, using VA time, with a non-VA site as the coordinating center then special approval is required. Contact the VA Research office for more information.

Data Disclosure (outside the VA or to a non-VA entity) If the research data is collected under an IRB-approved VA consent and VA HIPAA authorization then a DUA (Data Use Agreement) or DTA (Data Transfer Agreement) is NOT required. Otherwise, a DUA and/or a DTA are required, even if the data is deidentified or the IRB has approved a waiver of consent and/or authorization or the study is IRB exempt. If data is collected without a VA consent and VA HIPAA authorization, the Privacy Officer may approve the disclosure and allow collection without a DUA/DTA if all other applicable approvals have been obtained. Consult the VA R&D office.

Record Retention VA must retain a complete record of data (original or a copy) including any data that is shared (disclosed). This is true regardless of whether the data is deidentified or collected under a DUA, waiver of consent, or waiver of HIPAA authorization, or if the study is exempt. An exception may apply if the VA has a contract with the non-VA entity to store its electronic data (which remains owned by the VA) on the non-VA entity’s server. This is not common. The VA Research Office should be consulted.

A complete record of VA Research data (either an original or a copy) must be retained/stored at the VA indefinitely (REQUIRED), or until redefined by NARA (National Archives & Records Administration)

Electronic - Data Ownership & Information Security Electronic data that is retained by the VA, which is sensitive information (ie: PHI/identifiable), must reside on VA-owned equipment. If it does not, the VA CIO must provide a waiver or a MOU/SIA or a contract. Contact the VA R&D office.

The electronic data that is disclosed to the non-VA entity, under proper HIPAA authorization or DUA, is not required to reside on VA-owned equipment and is not subject to VA-specific information security requirements; however, appropriate security measures should be followed per the non-VA entity. Collaborative Research_12 14 11 (5).docx Page 1 Richard L. Roudebush VA Collaborative VA Research Project Guidance Implementation 1/1/2012

The PI will document protocol-specific procedures on the VA research Privacy, Confidentiality & Information Security - Checklist form. IRB and VA R&DC Submission The new IRB form Request Form for VA Research must be utilized and approved by the IRB for any VA research. The form must be included with all initial IRB submissions made on or after 1/1/2012. Ongoing research submissions must submit the form at the next IRB continuing review or at the applicable amendment in which VA research is initiated on an existing project. Provide the VA with a copy of all IRB approvals.

IRB Submission Documents The IRB submission should include a single protocol and the Request Form for VA Research, in which VA research is clearly separated from non-VA research activities.

There will be > 2 informed consents, 1 for VA research & 1 for non-VA research, unless there is an IRB Waiver of Consent.

There will be > 2 HIPAA authorizations, 1 for VA research & 1 for non-VA research, unless there is an IRB Waiver of HIPPA Authorization.

The VA consent and VA HIPAA authorization should include:  Only the VA-related subject intervention/interaction/data review that is performed (on VA data, property, resources and/or by VA personnel).  That the subject’s collected data will be used in a multi-site study which combines VA data with non- VA data, listing the name of the non-VA entity.  That collected/combined data are disclosed to the Coordinating Center, listing the name & location of the Coordinating Center.  The activities of the Coordinating Center should be listed if the VA is the Coordinating Center.

CONTACT INFORMATION: R&DC Submission: Katalina Gullins 988-2525 [email protected] VA Regulatory: Marta Sears 988-4202 [email protected] Compliance (Consent Review): Laura Gibson 988-4219 [email protected]

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