Anonymous samples do not have identifiers that enable the samples to be linked with individuals. As an example, Kenneth Pass described the use of such samples in a blinded seroprevalence study for HIV in New York. The only identifiers retained with the samples were the mother’s age, the gender of the child, and the ZIP code. “Using those three pieces of information, it would be literally impossible to go back and identify an individual specimen,” he said. By the same token, however, anonymized data would, at least theoretically, make it impossible to find a subject who needs to be treated for a life-threatening disease.
By contrast, de-identified samples are coded and separated from identifiers. These identifiers are not held by the researchers themselves, but are instead kept by an “honest broker.” In this case, the identifier can be retrieved and linked to a sample if necessary, allowing the person who donated the sample to be re-contacted if something is discovered that could be beneficial to his or her health.
Fleischman and several other speakers raised the issue of whether anonymous samples containing DNA could be linked to individuals. They acknowledged that this could occur. For example, Terry pointed out that additional data could be obtained to link the DNA in an anonymized sample to a particular person and such identification will become increasingly possible in the future. Fleischman observed, however, that creating such linkages would require the use of other databases. Careful data and sample access agreements with researchers can make it inappropriate and unethical for people to make such linkages. Other speakers pointed out that legal provisions can also be used to prohibit the identification of anonymized samples.
Public health programs are the stewards of newborn screening samples, Kelly Edwards said, in the sense that these programs are responsible and accountable for the fair use of samples and for follow-up with the public. Stewardship implies program-level decisions about who has access to samples, for what purpose, and relative to what expenditures of resources. Stewardship is also related to accountability for fair use, ethical practices, and follow-up with dissemination where appropriate, Edwards said.
More broadly, stewardship means taking responsibility for the care and well-being of something that is valued, Edwards added. It entails the science, art, and skill of responsible and accountable management of resources. A steward assumes responsibility for the donor’s intent, the manner in which resources are used, and the outcomes from their use. Achieving these objectives requires that stewardship be built into governance strategies, Edwards said.