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CARe Program's Balancing Act for Patient Privacy and Open Access


One project making headway on the slippery slope of patient privacy versus free data access is the National Heart, Lung, and Blood Institute's Candidate Gene Association Resource project, known as CARe. The goal of the program is to provide a hosted resource for investigators where nine separate national heart, lung, and blood cohorts are combined to provide meta-analysis of clinical data from more than 50,000 patients together with genome-type data. The project's leaders had the hair-pulling task of striking a balance between how openly accessible they could make the data without compromising the patients' identity.

"By definition, when someone has been genotyped or has received whole genome scans, they're identified," says Marcia Nizzari, director of the informatics development program in the medical and population genetics group at the Broad Institute. "So there's an issue of how do you handle security and yet at the same time make things open enough to really make it a resource to the research community that's valuable."

To address the issue, Nizzari had initially constructed two different data distribution models for CARe: portal and enclave. "Portal" was the freer of the two, allowing investigators to download patient data to their own computers and analyze it with their own tools. Users are required to sign a legally binding agreement stipulating that they would be responsible if the data was compromised in any way. The "enclave" model is much more secure, but also much more restrictive for the researcher. Instead of being able to download the data, users could only access and analyze the data on the Broad's servers.

Aside from the more limited usability, Nizzari says the daunting task of building and vetting the source code required to port researchers' favorite apps to run on the Broad server was another reason why the CARe steering committee decided to go with the portal approach instead of enclave. Still, reaching a consensus among the CARe team was no walk in the park, and it wasn't arguing over the technical details, but rather, the policy debates at the heart of patient privacy versus the need for access that made it a challenge.

"It took us about five or six months to finally decide on the portal model, and a lot of it was around their completely understandable reluctance to do anything that would expose their cohort patient population to some sort of study that those people had not consented to," Nizzari says. "But on the other hand, they wanted to be able to do the studies, so it was really the ground-zero issue of policy."

Another big consideration was the various ways in which people were consented or not consented to do these studies. But regardless of which side of the data distribution debate the researchers were on, all agreed upon the importance of CARe's goals. "There is tremendous value in being able to do these meta-analysis-type studies," Nizzari says. "By having these vast number of patients that can be brought together from individual studies, you get such tremendous power from the statistical significance."

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