Open Access News

News from the open access movement

Wednesday, August 29, 2007

Balancing access, privacy, discoverer-priority, and IP in a new NIH

Jeffrey Brainard, NIH Releases Final Policy on Centralized Database of Human Genetic Data, Chronicle of Higher Education, August 29, 2007 (accessible only to subscribers).  Excerpt:

The National Institutes of Health announced on Tuesday the final version of a policy governing a powerful, central repository of human genetic data that the agency will establish for the study of diseases.

Among other provisions, the policy will give scientists who contribute data to the repository exclusive rights for up to 12 months to publish scholarly analyses based on the data.

In other respects, the final policy, published in the Federal Register, is similar to a draft version published last year for comment (The Chronicle, August 31, 2006). The agency said it received nearly 200 comments, a large response reflecting controversy over some aspects of the new database, including privacy protections and controls over publishing and intellectual property.

The NIH and biomedical researchers are viewing the database as a promising tool that will help bring about the next phase in the development of medicine: new understanding of the contribution of genes to many common diseases. Scientists have already begun such research using smaller databases. Such work aims to correlate, for example, conditions like heart disease and diabetes with variations in particular genes.

The success of such studies, called genome-wide association studies, depends on having data from large-enough populations to yield statistically significant results. The NIH's data repository will allow the pooling of smaller databases containing similar information. Scientists financed by the agency to conduct such studies will be required to contribute their data to the repository....

The agency will also require scientists who want to study the database to agree not to publicly distribute it. Privacy advocates have worried that health insurers, for example, might obtain information from the database that identified individuals as having a genetic susceptibility to certain diseases and deny them coverage as a result....

The final policy also clarified the original proposal to specify that publication encompasses forms of public dissemination besides peer-reviewed journals, including meeting abstracts, oral presentations, and Web sites and blogs.

As for intellectual property, the NIH's policy says that it will expect users of the database not to use patents to block other researchers from using the data.

The policy will take effect in January.

PS:  For background, see my August 2006 post on the call for public comments and my December 2006 post on the NIH launch of the dbGaP database.