Richard L. Roudebush VA

Collaborative VA Research Project Guidance

Implementation 1/1/2012

VA research

Per VHA Handbook 1200.011058.01, 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 anyVA Researchactivitywhich includesany property or resources of anon - 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-VAsite (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 centerthen 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 collectedunder an IRB-approved VA consent and VA HIPAA authorizationthen 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. Consultthe VA R&D office.

Record Retention

VA must retain a complete record of data(original or a copy) including any data that isshared (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 ora copy) must be retained/stored at the VAindefinitely (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 isdisclosed to the non-VA entity, under proper HIPAA authorization or DUA, isnot 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.

ThePI will document protocol-specific procedures on the VA research Privacy, Confidentiality & Information Security - Checklistform.

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 submissionsmust 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 submissionshould includea 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 authorizationshouldinclude:

  • Onlythe VA-related subject intervention/interaction/datareviewthat 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, listingthe name & location of the Coordinating Center.
  • The activities of the Coordinating Centershould be listedifthe VA is the Coordinating Center.

CONTACT INFORMATION:
R&DC Submission:

VA Regulatory:Marta

Compliance (Consent Review):Laura

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