Genetic Data: Use, Storage and Benefit Sharing

In one line

What may be done with the data afterwards, how long it may be kept, when two databases may be joined, and what the people who gave it are owed.

In the wording a student can write in an exam: article 16 prohibits use for a different purpose incompatible with the original consent unless fresh consent is obtained or domestic law provides for an important public interest reason; article 19 requires that benefits from the use of the data be shared with society as a whole and the international community, listing seven forms; article 21 requires destruction when no longer necessary, including of samples taken from a suspect in a criminal investigation; and article 22 makes consent essential for cross-matching data stored for different purposes.

Article 16: change of purpose

16(a). Data and samples collected for one of the purposes in article 5 should not be used for a different purpose that is incompatible with the original consent, unless:

• the prior, free, informed and express consent of the person is obtained under article 8(a); or
• the proposed use, decided by domestic law, corresponds to an important public interest reason and is consistent with international human rights law.

Where the person lacks capacity, article 8(b) and (c) apply mutatis mutandis.

16(b). Where such consent cannot be obtained, or in the case of data irretrievably unlinked, the data may be used in accordance with domestic law or following the consultation procedures set out in article 6(b), that is, consultation of an independent, multidisciplinary and pluralist ethics committee.

This article is the answer to the problem article 4(a)(iii) identifies: the significance of genetic data is not necessarily known at the time of collection, so a consent given for one purpose cannot be informed about a use that becomes possible later. The Declaration does not solve that by making consent perpetual, which would be fiction, nor by prohibiting further use, which would sterilise every archive. It requires fresh consent, or a law serving an important public interest, or, where neither is available, a committee.

Note the drafting of the prohibition: not any different purpose, but a different purpose incompatible with the original consent. A purpose that is different but compatible does not require the machinery, which leaves room for research that develops naturally from what was agreed.

Article 17: stored samples collected for other purposes

17(a). Stored biological samples collected for purposes other than those in article 5 may be used to produce genetic or proteomic data with the prior, free, informed and express consent of the person. However, domestic law may provide that where such data have significance for medical and scientific research purposes, for example epidemiological studies, or public health purposes, they may be used for those purposes following the consultation procedures in article 6(b).