New Frequently Asked Questions (FAQs) Available (March 12, 2012)
The Office of Research Oversight (ORO) and the Office of Research and Development (ORD) have jointly developed a series of FAQs on Human Research Protection Programs (HRPPs). The FAQs can be found here.
Interim ORO Guidance On Data Disclosure For Collaborative Studies (July 27, 2011)
The Office of Research Oversight (ORO) has developed interim guidance on data disclosures for collaborative research studies. The guidance clarifies current requirements for the disclosure of VA research data to academic affiliates and other non-VA entities for “collaborative” human subject research, including requirements related to the retention of VA research records, disclosure of data under the Health Insurance Portability and Accountability Act (HIPAA), data ownership, information security, “dual appointment” research investigators, and combining data collected at a VA site and an affiliate/collaborator site.
An accompanying PowerPoint presentation can be found here.
December 12, 2011: The Office of Research Oversight released an IMPLEMENTATION UPDATE on the July 2011 Interim Guidance on Research Data Disclosures for “Collaborative” Studies.
**UPDATE (December 21, 2011): The Office of Research Oversight has released a SAMPLE SOP AND SAMPLE PROTOCOL APPLICATION FORM for implementing the July 2011 Interim Guidance on Research Data Disclosures for “Collaborative” Studies.
Waiver of Requirement for Full Time Research Compliance Officer (RCO) (January 12, 2011)
VHA Handbook 1058.01 §6c(1) requires that each VA research facility designate at least one full-time RCO unless a waiver for a part-time RCO is approved by the Under Secretary for Health. Click here for information on how to obtain such a waiver.
ORO - ORD Guidance on VA Access to Meeting Minutes of Affiliate Research Review Committees
This document, date January 7, 2011 gives joint Office of Research Oversight and Office of Research and Development guidance on VA access to meeting minutes of affiliate research review committes designated for oversight of VA research.
Memo on RCO Role with Regard to VA-affiliated Non-Profit Corporations
This memo, dated 7/26/10, from the Chief Research and Development Officer (CRADO) and the Chief Officer of the Office of Research Oversight to Network and Facility Directors, addresses the role and authority of the Research Compliance Officer (RCO) with regard to VA-affiliated Nonprofit Research and Education Corporations (NPCs). Any questions related to this memo should be addressed to Dr. Bob Brooks at Robert.Brooks7@va.gov or Dr. Yen Nguyen at Yen.Nguyen8@va.gov.
VHA and CMS Data Agreement Signed
VHA and the Center for Medicare and Medicaid Services (CMS) within the Department of Health and Human Services signed an Information Exchange Agreement (IEA) to allow for the exchange, use, and distribution of CMS data within VHA for research and administrative purposes. Please see the attached memorandum from the Acting Under Secretary for Health (dated 10/01/09) for details.
Memo to Clarify RCO Audit Requirements for
2010 and 2011
This guidance clarifies and supersedes previous guidance on the requirements for RCO informed consent and regulatory audits during (i) the June 1, 2009, through May 31, 2010, reporting period and (ii) the June 1, 2010, through May 31, 2011, reporting period.
Clarification: VHA Policy is More Restrictive than NIH Guidance on Recruitment of Study Subjects under HIPAA Privacy Rule
Under VHA Policy, accessing patient records for recruitment into research requires prior Institutional Review Board (IRB) approval, IRB waiver of HIPAA Privacy Rule Authorization, IRB waiver of informed consent, and Research and Development (R&D) Committee approval. These steps are required even when records of one's own patients are accessed for recruitment purposes. See full Clarification . . . (Sept. 05, 2007).
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