Wednesday, March 26, 2008

NIH laptop theft raises questions about help for clinical trials

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The theft last month of a laptop carrying personal information for about 2,500 participants in a National Institutes of Health study has raised questions about recruitment for future clinical trials.

‘‘When volunteers enroll in a clinical study, they place great trust in the researchers and study staff, expecting them to act both responsibly and ethically,” Elizabeth G. Nabel, director of the National Heart, Lung and Blood Institute said in a prepared statement Monday. ‘‘We at the NHLBI take that trust very seriously and we deeply regret that this incident may cause those who have participated in one of our studies to feel that we have violated that trust.”

The laptop was taken from an institute researcher’s car trunk during a ‘‘random” theft outside of the Bethesda NIH campus, the statement said.

Unencrypted information stored on the laptop included names, birth dates, hospital medical record numbers and MRI data of participants in a cardiac MRI study running from 2001 to 2007.

No social security numbers or participants’ financial or contact information were on the laptop, the institute said.

‘‘We want to assure the participants in this and every other NHLBI study that we are taking several steps to increase data security and ensure that similar incidents do not occur in the future,” Nabel said.

All NHLBI research staff laptops are being checked for the proper encryption software, and the institute said it reminded staff that participants’ identifying information is not to be stored on researchers’ laptops.

The institute sent letters earlier this month to participants whose information was on the laptop to notify them of the security breach.

Charlotte Reineck, a regular NIH study participant who lives near Springfield, Va., said she isn’t worried about volunteering for future research. Reineck takes part in NIH studies every six months or so but was not involved in the MRI study.

‘‘I’m not imperfectly healthy, and don’t feel like I have anything to hide,” Reineck said Tuesday. ‘‘I guess if I had received a letter, I would have been concerned in the broader sense, but I am probably less worried about identity theft than I should be.”

The NIH is currently recruiting volunteers for more than 5,000 studies.

The NHLBI’s ongoing research relies on participants in several categories — asthma, coronary artery disease and leukemia among them — and is actively seeking volunteers in 374 studies.

‘‘The NHLBI is committed to ensuring that no future security breaches will occur,” the institute said.

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