Genetic Data: Collection and Consent

In one line

Consent to give a sample, the right to take that consent back, and the right to decide whether you want to be told what the sample said.

In the wording a student can write in an exam: article 8 requires prior, free, informed and express consent, without inducement by financial or other personal gain, for the collection of genetic data, proteomic data or biological samples and for their subsequent processing, use and storage, whether by public or private institutions; article 9 governs withdrawal, which is available unless the data are irretrievably unlinked to an identifiable person; article 10 extends the right to decide whether or not to be informed of research results, and where appropriate to identified relatives who may be affected; article 11 requires non-directive genetic counselling; and article 12 governs collection for forensic and legal proceedings.

Article 8: consent

8(a). Prior, free, informed and express consent, without inducement by financial or other personal gain, should be obtained for the collection of human genetic data, human proteomic data or biological samples, whether through invasive or non-invasive procedures, and for their subsequent processing, use and storage, whether carried out by public or private institutions. Limitations on this principle should be prescribed only for compelling reasons by domestic law consistent with the international law of human rights.

Four features of that sentence are examinable.

"Without inducement by financial or other personal gain." No other consent provision in this book contains this. It excludes payment for a sample outright, which is the genetic counterpart of the prohibitions on payment for organs and gametes, and it extends beyond money to other personal gain, so an offer of preferential treatment or of access to a service is equally excluded.

"Whether through invasive or non-invasive procedures." A cheek swab requires the same consent as a blood draw. The consent is to the taking of genetic information, not to a physical intrusion, which is why the manner of collection does not lower the standard.

"And for their subsequent processing, use and storage." The consent covers the whole life of the sample, not the moment of collection, which is what makes the change-of-purpose rule in article 16 necessary rather than optional.

"Public or private institutions." A private sequencing company is bound as a State laboratory is.

8(b) to (d) deal with those who cannot consent. Where a person is incapable of giving informed consent, authorization should be obtained from the legal representative, who should have regard to the best interest of the person concerned. An adult not able to consent should as far as possible take part in the authorization procedure, and the opinion of a minor should be taken into consideration as an increasingly determining factor in proportion to age and degree of maturity. And in diagnosis and health care, genetic screening and testing of minors and adults not able to consent will normally only be ethically acceptable when they have important implications for the health of the person and have regard to their best interest.