VA healthcare research halted

Seven research sites were shut down indefinitely last month by the US Department of Veterans Affairs after an employee at the Birmingham, Alabama, site reported an external hard drive was missing. All seven sites, where researchers use medical records to evaluate healthcare quality, have each been inspected but research remains closed until the VA decides how to proceed.

An employee at Birmingham's Deep South Center for Effectiveness reported on January 22 the missing hard drive, used as backup storage for research data. Researchers at the Deep South Center for Effectiveness study the VA's medical database for large scale trends in healthcare, using the information to improve patient care.

An investigation by the VA's inspector general determined that the hard drive contained medical records from 535,000 veterans and 1.3 million non-VA physicians. On February 6, VA secretary James Nicholson suspended research at all seven VA sites performing records-based studies, called Research Enhancement Award Programs (REAPs).

In addition to the Birmingham center, other closed REAP sites are located in Oregon, Colorado, New Jersey, California, Vermont, and Texas.

"We wanted to make sure that procedures for security would be followed for all of [the sites]," Josephine Schuda, spokesperson for VA, told The Scientist. "We don't know if there was data that applied to centers across the country, [or just to Birmingham]."

According to Joel Kupersmith, chief research and development officer of VA's veteran's health administration, the suspended studies will remain so until the VA technology and security personnel visit each to ensure that security procedures are being followed. He told The Scientist in an Email that "security for VA biomedical research has been greatly enhanced" as a result of the lost hard drive and data breach in Birmingham.

"It has been confusing and demoralizing for everybody," Linda Ganzini, chief researcher at the Columbia Center for the Study of Chronic, Comorbid Mental and Physical Disorders in Portland, Ore, one of the closed REAP sites, told The Scientist. She added that she's been frustrated by conflicting information from the VA about what new policies will be implemented, and there's no word when she and her colleagues will be allowed to continue with research using the VA database. Ganzini said her group has tried to work with previously analyzed data, but they are not allowed to enter new patients into studies.

Other chief investigators at the suspended sites did not respond to requests for comment.

Kupersmith said the suspended studies do not directly impact patient care -- which is a good thing, according to David Lobach, Chief of the Division of Clinical Informatics at Duke University Medical Center. If the research is being immediately applied to clinical practice, Lobach told The Scientist, there could be serious repercussions from the halted studies.

The House Veterans Affairs subcommittee held a hearing on February 28 and heard testimony on this latest and largest case of security misconduct, one of several currently under investigation by the VA inspector general. Testimonial by counsel to the inspector general said that the VA lacks basic encryption techniques for sensitive material, and a registry of who has access to the data and uses external hard drives.

The missing Birmingham hard drive has yet to be found. The US Federal Bureau of Investigation (FBI) has issued a $25,000 reward for its recovery.

Andrea Gawrylewski
mail@the-scientist.com

Links within this article:

REAPs
http://www.hsrd.research.va.gov/about/centers/reap.cfm

D. Wilkie, "USVA scientists vexed," The Scientist, January 19, 2004.
http://www.the-scientist.com/article/display/14377

JL Goulet, "Measuring performance directly using the veterans health administration electronic medical record: a comparison with external peer review," Medical Care 45: 73-79.
http://www.the-scientist.com/pubmed/17279023

Joel Kupersmith
http://www1.va.gov/directory/guide/manager.asp?pnum=30125

A. Harding, "Fraud earns researcher time in jail," The Scientist, December 13, 2005.
http://www.the-scientist.com/article/display/22859

David Lobach
http://www.dukehealth.org/physicians/6B431DF8C63CB77785256DFD006A93D7