To facilitate clinical research, Vanderbilt University has constructed a biobank that contains DNA specimens derived from leftover blood remaining after clinical tests have been carried out, together with information extracted from the electronic medical record. The blood would be discarded if not used for research. All information is de-identified by the biobank before it is provided to researchers. See article.
The Vanderbilt IRB has determined that because researchers receive only de-identified information, specific projects carried out with biobank data and materials are not human subjects research, and therefore no consent is required. Researchers who use the biobank must sign a data use agreement promising not to try to re-identify patients. As an additional safeguard, patients may opt-out of having their blood and data placed in the biobank; about 5% of patients have done so. Provisions to opt-out of the biobank are contained in a separate section of the Consent to Treatment / Agreement to Pay form that patients sign every year. The program has been publicized through posters at the medical center, information pamphlets given to patients, and newspaper advertisements.
- Do you believe that the arrangements for this biobank are ethically acceptable? In other words, should the federal regulations permit such arrangements?
- In particular, should research that involves sequencing of an entire genome be permitted on leftover blood without active, explicit consent from participants?