Over on Concurring Opinions, Gaia Bernstein discusses the Havasupai case discussed here previously in several posts, and makes the following statement:
No doubt, the Havasupai Indians informed consent argument resulted in their victorious settlement. But, the harder question is whether informed consent principle can be feasibly applied in the area of genetics. Genetic information is not just individual information it also provides information about groups and families. For example, assume there is a tribe in which some members agree to participate in genetic research investigating Manic Depression. Other members of the tribe refuse because they are concerned that a result showing that there is a prevalent genetic mutation for Manic Depression among them could stigmatize them and even lead to discrimination against the tribe. The researchers collect samples only from the members of the group who agree to the research. But, the results still provide genetic information on all members of the tribe even those who refused to participate because of their genetic connection to those who participated.
The result in the Havasupai settlement cannot be seen then as a victory for the principle of informed consent in the area of genetics. Restricting genetic researchers to use of samples only for the purpose for which they were collected only partly resolves the informed consent problem. The group nature of genetic information makes the application of informed consent to genetic research much more complicated than that.
With all due respect to Professor Bernstein, I disagree with her strongly. Although a court ruling would have been preferable (in my opinion) in terms of precedent, I think the case is a victory for the principle of informed consent in the area of genetics and demonstrates that individuals do and should have a say in how their own genetic material is used if they volunteer for research.
Professor Bernstein raises a somewhat different question in asking about how genetic research might reveal information about someone who has not consented to participate in research. The types of studies she alludes to — including large kindred studies — have been around for decades. And while it is true that a kindred study of rare genetic disorders might suggest genetic information about someone who did not participate in the study, unless the genetic condition has a 100% heritability and a penetrance of 100%, then all the researchers would actually be revealing is a likelihood that another family member or group member who did not participate in the research has a particular genetic condition. While that might be of concern to non-volunteer family or group members, I do not think it confers any obligation on the researchers to obtain their consent. Although researchers need to be mindful of the impact of such research on those who do not consent to participate, the rights of those who do not consent to participate do not trump the rights of those who do volunteer and give their informed consent to participate. Informed consent relates to the right to control what happens to your genetic material and does not give you rights over someone else’s genetic material.
Taken to an extreme, Professor Bernstein’s argument might lead one to argue that we should never diagnose anyone with a genetic condition as we might be potentially revealing something about another family member who might experience stigma or discrimination because of it.
The principle of informed consent not only can, but needs to be applied in genetic research. Certainly if one claims to be concerned about non-volunteers having information about them possibly revealed, then the argument for obtaining informed consent from those who do volunteer genetic material becomes even more compelling. As to non-volunteers, I would argue that informed consent does not even apply, but that researchers need to be mindful of the impact of their research on others and make clear what one can and cannot conclude from group or family membership. But that’s just my personal take on the ethics of the situation and others may certainly have strong countervailing views.
Update: The NY Times has an interesting article on the ethics of DNA research.
it is true that a group or family could be stigmatized, but this should not hinder research and the growth of knowledge. As long as those that participate in the genetic research, voluntarily do so.