This section addresses collaborations between VA and non-VA investigators. Collaboration is encouraged when VA investigators have a substantive role in the design, conduct, and/or analysis of the research. VA may also serve as a Coordinating Center for collaborative studies. NOTE: Collaborative studies do not include studies conducted under a CRADA with pharmaceutical companies or other for-profit entities.

IRB of Record Approval

Each institution is responsible for safeguarding the rights and welfare of human subjects and providing oversight of the research activities conducted at that institution.

• Each collaborating institution engaged in human subjects research must obtain approval from its IRB of Record and hold a FWA or another assurance acceptable to VA, e.g., DoD assurance.
• VA investigators must submit a protocol or other documentation to their VA IRB of Record that delineates which research activities will be conducted by VA.
• Each institution engaged in the collaborative research must use the informed consent document and HIPAA authorization required by their respective institutional policies for subjects recruited from that institution, or procedures requiring participation of the subject at that institution. The informed consent document may contain information on the project as a whole as long as the document clearly describes which procedures will be performed at VA and which will be performed at other institutions.
  • The VA informed consent document must clearly state when procedures mentioned at other institutions are part of the VA’s portion of the study.
  • The informed consent document and HIPAA authorization must be consistent and include information describing the following:
    • PHI to be collected and/or used by the VA research team;
    • PHI to be disclosed to the other institutions; and
    • Purpose for which the PHI may be used.

Waivers

PHI obtained in research for which the IRB of Record has waived the requirements to obtain a HIPAA authorization and a signed informed consent document may not be disclosed outside VA unless the VA facility Privacy Officer ensures and documents VA’s authority to disclose the PHI to another institution. A waiver of HIPAA authorization is not sufficient to fulfill the requirements of other applicable privacy regulations such as the Privacy Act of 1974 (5 U.S.C. 552a).

Research Data

The protocol, addendum, and/or IRB of Record application must describe the data to be disclosed to collaborators, the entity(ies) to which the data are to be disclosed, and how the data are to be transmitted. This includes data from individual subjects as well as other data developed during the research such as the analytic data and the aggregate data.

• Each VA facility must retain a complete record of all data obtained during the VA portion of the research in accordance with privacy requirements, the Federal Records Act, and VHA Records Control Schedule (RCS) 10-1.
• All disclosures and data transmission must meet privacy and security requirements per VA Directive 6500, VHA Handbook 6500, and VHA Handbook 1605.1.

Written Agreements

Collaborative research involving non-VA institutions may not be undertaken without a signed written agreement (e.g., a CRADA or a Data Use Agreement (DUA)) that addresses such issues as the responsibilities of each party, the ownership of the data and the reuse of the data for other research.

NOTE: Any reuse must be consistent with the protocol, the informed consent document, and the HIPAA authorization.