by Wendy Tate, PSM, CIP
On June 1, 2011, I descended upon Washington, DC, with about 660 of my Department of Veteran’s Affairs (VA) and university colleagues responsible for the conduct of research at a VA hospital or health care system.
Simply put, human subjects research at the VA must improve the status of veterans. The purpose of this conference was to discuss the role of privacy and information security in human research projects within the VA system. Each VA institution that holds a Federalwide Assurance (FWA) was invited to have it’s assistant chief of staff, research, administrative officer, IRB administrator, information security officer, privacy officer, and research compliance officer in attendance.
If you have never worked with VA human subjects research, you may not realize how many additional requirements exist. The VA has codified the Common Rule (45 CFR 46) in 38 CFR 16. In addition to the Common Rule, the VA provides handbooks full of other requirements. The handbooks relevant to human subjects are 1200.05 (Requirements for the Protection of Human Subjects in Research), 1058.01 (Research Compliance Reporting Requirements), 1058.03 (Assurance of Protection for Human Subjects in Research), 1108.04 (Investigational Drugs and Supplies), and 1200.12 (Use of Data and Data Repositories in VHA Research).
Like every other institution, the VA must apply FDA regulations in 21 CFR parts 50, 56, 312, and 812 when dealing with FDA regulated products. As a federal agency and treatment facility, in addition to the HIPAA regulations, the VA has to apply 38 USC 7332 and the Privacy Act of 1974. The agency’s definition of VA Sensitive Information is found in Public Law 109-461. The VA handbooks related to privacy and information security are 1605.1 (Privacy and Release of Information), 1907.01 (Health Information Management and Health Records), and 6500 (Information Security Program).
Several top officials from both the Office of Research Oversight (ORO) and the Office of Research and Development (ORD) were at the meeting. They shared many interesting details, including that the VA is the fifth most trusted agency in the United States and a major recipient of research funds. ORO also shared findings from oversight visits and helpful hints to avoid preventable citations. There was a significant discussion about the records retention schedule. Unlike HHS and FDA, the VA does not in its regulations define how long research records must be held. This has resulted in a VA requirement stating that research records must be held forever, which includes the retention of any identifiers, making it difficult to protect human subjects through de-identification.
On the second day, there was a spirited discussion about collaborative research. In what may have been the most tense session of the conference, the VA leadership insisted that there must be separate consent forms for the VA site and any affiliate site (e.g., university), even if the two sites share a subject population. This was followed by a discussion of ethics as they relate to respecting the individual and whether the agency format exists to inform potential subjects or to protect institutions from liability. It reminded me of many AER Conference sessions spent discussing ethical standards versus institutional protections and the role of the IRB.
I also had the opportunity to network with about 75 fellow IRB administrators from VA institutions, universities, and the Central VA IRB. It was a fantastic group of colleagues with great questions, deep insight, and a passion for the ethical treatment of veterans participating in research.
In many ways, the large number of VA requirements makes the agency’s research overly paternalistic with respect to subjects and burdensome for researchers. While HHS is allowing institutions to “uncheck the box,” and AAHRPP is promoting the practice of using flexibility in the regulations, the VA should be a leader, adapting to the changing landscape of research oversight. I urge both ORO and ORD to invite their university affiliates HHS, and AAHRPP to the table as they continue to review their regulations and guidance. In this way, the VA can continue to garner the respect of veterans and the academic world.