Office of Research Oversight Summary of ORO Interim
Office of Research Oversight Summary of ORO Interim Guidance on Research Data Disclosures for Collaborative Studies July 27, 2011* * Supersedes all previous ORO guidance on this subject (slides updated: September 8, 2011) Office of Research Oversight Challenges & Opportunities Related to Collaborative Research with Affiliates
Challenges Federal Records Retention Requirements Privacy/Confidentiality Requirements Privacy Act, HIPAA Privacy Rule, etc Data Ownership Issues VA Data Security Requirements Dual Appointment Investigator Issues Slide 2 Office of Research Oversight Challenges & Opportunities Related to Collaborative Research with Affiliates Opportunities AAMC Working Group on Information Technology Security and
Privacy in VA and NIH-Sponsored Research The Working Group report describes: Disclosure of PHI Pursuant to a request from the affiliate For use in non-VA research conducted by the affiliate OROs Interim Guidance Assumes (pending clarification in VA policy) that the Working Group report also applies to collaborative research in which VA data are combined with affiliate data Slide 3 Office of Research Oversight Working Group Report
Slide 4 Office of Research Oversight Record Retention Requirements VA research data must be maintained per Federal records retention and other requirements A Records Control Schedule approved by National Archives and Records Administration (NARA) is required to destroy Federal records Records Control Schedule for VA facility-level research records is currently under development VA facilities must retain data from VA research pending approval of an applicable Records Control Schedule
Slide 5 Office of Research Oversight Working Group Report Disclosure Under HIPAA Authorization (Appendix A) Slide 6 Office of Research Oversight Disclosure Under HIPAA Authorization Subjects HIPAA authorization permits VA to disclose subjects data for research as described in the authorization
No Data Use Agreement required per Working Group Authorization, informed consent document, study protocol, and CRADA (where applicable) must be consistent as to data and purpose Authorization and consent must include all required elements and permit informed decision by subject Research data repository (per VHA Handbook 1200.12) must be established if use or disclosure by VA for future research (ie, outside study for which the data were collected) is anticipated Slide 7 Office of Research Oversight
Disclosure Under HIPAA Authorization Data Ownership & Information Security Valid informed consent and HIPAA authorization are required Informed consent and HIPAA authorization requirements apply to all VA PHI and individually identifiable private information that are used/disclosed for research Includes clinical data used in research for control or comparison groups VA must retain a complete record (original or copy) of the disclosed data Slide 8
Office of Research Oversight Disclosure Under HIPAA Authorization Data Ownership & Information Security The record retained by VA is: Owned by VA Subject to VA information security requirements Once the disclosed copy is held by the Affiliate, VA may no longer be able to: Control the disclosed copy Enforce VA information security requirements Slide 9
Office of Research Oversight Disclosure Under HIPAA Authorization Policy Clarification Desirable Working Group describes disclosure pursuant to a request from the affiliate vs collaborative research Not clear that disclosure under a HIPAA authorization necessarily transfers ownership Without a DUA or other legal agreement, it would seem problematic, for VA to exert ownership of the disclosed copy of any data provided to the affiliate/collaborator A DUA or other legal agreement would seem to be advisable if VA wishes to exercise ownership or control of disclosed data
Slide 10 Office of Research Oversight Working Group Report Disclosure without Authorization and Consent (Appendix A) Slide 11 Office of Research Oversight Working Group Report Disclosure Without HIPAA Authorization and/or Informed Consent Requirements are fact-specific
ORO strongly recommends consulting ORD, the VHA Privacy Office, and Regional Counsel prior to such disclosures Slide 12 Office of Research Oversight VA Information Security Requirements Apply to all research data owned by VA If maintained electronically and containing VA Sensitive Information (VASI) must reside on VA-owned equipment unless: A waiver has been approved by the VA CIO or A valid Memorandum of Understanding / System
Interconnection Agreement (MUA/SIA) has been approved or Where appropriate, a valid contract with VAs security clause and security requirements has been established to permit alternate arrangements. Slide 13 Office of Research Oversight Investigators Holding Dual Appointments Critical to separate and document: VA activities on VA time vs Affiliate activities on affiliate time Documentation should clarify: VA duties
VA duty locations VA tours of duty or time allocations Data ownership issues Data security requirements Separation of VA activities/research from affiliate activities/research is critical for studies combining VA data with affiliate data Slide 14 Office of Research Oversight Combining VA Data with Affiliate Data for Collaborative Studies VA data are data collected:
By a VA investigator On VA time Under a protocol approved by the VA IRB of Record and the VA R&D Committee Affiliate data are data collected: By an Affiliate investigator On affiliate time Under a protocol approved by the affiliate IRB Slide 15 Office of Research Oversight Combining VA Data with Affiliate Data for Collaborative Studies -Separate Activities Defined for Each Site
The collaborative study should be implemented as a multi-site study with activities clearly defined for each site Critical factors: Data collection should typically take place at the VA site on VA time and at the affiliate/collaborator site on affiliate/collaborator time as separate activities that can be clearly distinguished by the IRB and the R&DC The status off-site VA research taking place at an affiliate site on VA time should be clarified through a written agreement with the affiliate addressing data ownership and responsibility for research-related injury The R&D Committee must only approve the VA research Slide 16
Office of Research Oversight Combining VA Data with Affiliate Data for Collaborative Studies When Affiliate IRB is VA IRB of Record Each facility exercises latitude in administrative management of its research projects If the Affiliate IRB serves as the VA IRB of Record, the IRB may either: Approve two separate protocols one for the VA research and one for the Affiliate research or Approve a single protocol under which the VA research
activities are clearly separated from the affiliate research activities Slide 17 Office of Research Oversight Combining VA Data with Affiliate Data for Collaborative Studies When Affiliate IRB is VA IRB of Record For existing collaborative studies with a single protocol, ORO suggests: Separation of VA vs Affiliate research at applicable continuing reviews occurring after December 31, 2011 By appropriately amending the informed consent
documents and HIPAA authorizations Slide 18 Office of Research Oversight Combining VA Data with Affiliate Data for Collaborative Studies When Affiliate IRB is VA IRB of Record For new collaborative studies with a single protocol, ORO suggests: Separation of VA vs Affiliate research at initial reviews occurring after December 31, 2011 In addition to informed consent documents and HIPAA authorizations, relevant areas of separation may include:
Recruitment procedures/strategies/advertisements Research related procedures Data collection/storage/uses/disclosures VA researchers/personnel/staff VA Clinics/Units/Labs/Locations involved Slide 19 Results of VA ISO and PO reviews Office of Research Oversight Combining VA Data with Affiliate Data for Collaborative Studies Protocols, consent documents, and authorizations for both sites must include: Use of data in a multi-site study combining
VA data and affiliate data Data will be disclosed to study Coordinating Center Location of Coordinating Center Slide 20 Office of Research Oversight Combining VA Data with Affiliate Data for Collaborative Studies If Coordinating Center is at the VA site, the VA research described in the protocol must include: Interaction/intervention and data collection
activities at VA Activities of the Coordinating Center Slide 21 Office of Research Oversight Combining VA Data with Affiliate Data for Collaborative Studies If Coordinating Center is at the Affiliate Site : A dual appointment investigator should not conduct research using the combined data set while on VA time unless data ownership issues have been clarified in writing ORO strongly recommends consultation with
ORD and Regional Counsel regarding data ownership clarifications Slide 22 Office of Research Oversight Combining VA Data with Affiliate Data for Collaborative Studies Related Documents ORO Interim Guidance on Research Data Disclosures for Collaborative Studies (July 27, 2011) AAMC Working Group on Information Technology Security and Privacy in VA and NIH-Sponsored Research Available at:
http://vaww.vha.vaco.portal.va.gov/sites/ORO/RCO/default.aspx (click on: Memoranda, Clarifications, and Guidance) Slide 23
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