The Havasupai, Privacy and Medical Research

I learned that the Havasupai of the Grand Canyon recently won a lawsuit against the University of Arizona. They claimed that the university had misused DNA samples that had been obtained from them for what they thought was research on diabetes. And, in fact, the researchers had studied the genetics of diabetes using samples from the Havasupai, but they had subsequently expanded their project to study the genetics of schizophrenia and ethnic origins of Native American tribes. In defense, the University investigators pointed out that the subjects of the study had signed consent forms that allowing use of the DNA samples for other studies. However, the consent form was very general. It did not speak to the possibility that the Havasupai people could be embarrassed by the findings or could have their myths of origin contested. The Havasupai people therefore sued the university claiming misuse of the samples, and they won.

I am sympathetic to concerns of the Havasupai, but I do not feel the question is as black and white as it sounds. True, in the United States, we give very high priority to privacy. The problem is with the definition of the word privacy. Our regulations, and our usual sense of the word, means individual, not group, privacy. The distinction is an ambiguity that needs to be clarified.

It is very common these days for medical research projects to bank DNA samples from individuals — genetic origin of disease is the hottest thing going in medical research right now. Investigators should do this work under very tight restrictions that require that "personal identifiers," such as birth dates, addresses, Social Security numbers, and any information that could allow someone outside the study to identify a specific individual blood donor, be kept under the strictest secrecy — locked cabinets, limited access, etc. The results of the study must be presented only in "de-identified" form, that is, no public information can lead back to a specific person.

Investigators have another requirement. If the National Institutes of Health or any other federal agency study funded the study, because tax dollars paid for the research, the investigators must provide de-identified samples to other legitimate researchers. The samples are considered public because they were paid for by public funds. The point is that the samples are very valuable, and cannot be obtained over and over again, so they should not be wasted.

In other words, the investigators who banked DNA for the Havasupai study of diabetes had to provide samples to a legitimate request of another investigator who thinks that the samples will be valuable for his or her research. Or, should other questions arise, the investigators are expected to use the samples already obtained and not go out and try to get new samples. By federal requirement, research projects that involve DNA banks have outside boards of experts to judge the legitimacy and the feasibility of a request and to decide whether or not it is legitimate to use the specimens for another study. The investigators can not make such a decision themselves. The point of the board is to protect the samples and to protect the dignity of the patients who gave the samples.

The researcher who asks for consent from the person donating the blood will usually not know the possible future uses of those samples, so the researcher uses a very general consent form that says something like "and for future studies as we may determine." The alternative is that the researcher can refuse to release samples until he or she goes back to the subject to obtain additional consents as each applications to use the DNA for other purposes arises. This is very cumbersome. Years elapse, people move or cannot be found. The feasibility of doing the second line of research thus becomes nil. This is not to say that researchers should be freed from onerous duties necessary to protect people's privacy, but rather to point out that the more restraints are placed on research, the less research will be done.

The Havasupai complaint introduces a larger question: the concept of individual privacy versus group privacy. The Havasupai were angered because they perceived group (not individual) stigmatization in the studies on schizophrenia. The privacy laws that researchers now operate under focus on individual privacy and do not think very deeply about group privacy. Nor do the federal regulations decide what might constitute an insult and what might not. Not everyone would consider a study on schizophrenia to stigmatize the group. Some people might be thrilled to learn their origins. Several years ago a study documenting that the Jewish priestly tribe (the Cohanim) could be identified through genetic tracking caused great excitement among the people involved.

I suggest that one cannot do genetic studies ("find the gene for a disease") without studying groups. If this suggestion is correct, any study of any gene could potentially stigmatize the group — it depends on what people may be embarrassed by. Should Greeks disallow studies on thalassemia (Mediterranean anemia), or blacks on sickle cell disease ? Or Jews on Tay-Sachs disease? How do you ask why Kenyans are great marathoners without identifying the group? What about the Long Islanders whose concerns led to the finding of the breast cancer gene — not, as they supposed, because of an environmental contaminant but because a group of ethnically related people lived nearby? Is one person's embarrassment another's clue to the origin of a problem? Whose rights prevail? Those who would be embarrassed? Or those who would benefit from the knowledge?

I do not know how to conflate the rules for individual and for group privacy. I don't think they are the same, and I don't know that prohibitions for the former apply to the latter. It seems to me that extreme restrictions on studies of groups, as we already have on studies of individuals, would inhibit research on the nature of disease, or on the nature of humankind. It seems to me that that privacy rules must be different for groups than for individuals. I suspect the distinction is not so clear and that discussions about where we should draw the line are due.

This conundrum is an opportunity for negotiation between researchers and subjects regarding about priorities. Personal privacy is a priority for some. Group privacy is a priority for others. Scientific advance is a priority for still others. These priorities conflict. There must be a negotiable position that distinguishes the rights of individuals from the rights of groups. Studies on schizophrenia, or on distant past origins of groups, are not intrinsically wrong.

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