The Havasupai Indians, Genetic Research and the Problem of Informed Consent
posted by Gaia Bernstein
Researchers can gain significant genetic information by studying indigenous and preferably isolated populations. Although both researchers and indigenous populations can gain from this collaboration, the two groups often do not see eye to eye. This was the case of the collaboration between the Havasupai Indians and researchers from Arizona State University, which resulted in a long legal fight. The Havasupai Indians were suffering from high prevalence of diabetes and agreed to give their blood samples for genetic research on Diabetes. The members of the tribe were infuriated when they found out later that their blood samples were used for other purposes, among them genetic research on schizophrenia.
The New York Times reported yesterday that this conflict resulted in a settlement in which Arizona State University agreed to pay $700,000 to the tribe members and also return the blood samples. The Havasupai Indians’ main legal claim was of violation of informed consent. Informed consent requires that patients and research subjects receive full information that will enable them to decide whether to adopt a certain medical treatment plan or participate in research. Here, the Havasupai Indians argued that the informed consent principle was violated because they were told that their blood samples will be used for one purpose while, in fact, they were used for another.
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.
April 23, 2010 at 11:23 am
Tags: genetics, informed consent, medical research, native americans, Privacy
Posted in: Health Law, Privacy, Privacy (Medical)
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Responses (5)
Glenn Cohen - April 28, 2010 at 4:53 pm
Interesting post (as always) Gaia, but I wasn’t clear what you thought about the question of whether the individual donor of genetic tissue’s right of donation should be stymied by the interests of others’ from his or her ethnic/racial group who may object to possible inferences from about them based on any research that results.
Granted that is perhaps a somewhat shaded way of putting the matter, but it stems from my skepticism that such a rights claim on the part of others carrying similar genetic information is well-founded.
Let me give two tentative reasons why I am skeptical (but I want to hear more on your thoughts):
(1) The identical twin case. It seems unlikely that we would restrict the participation in genetic research of one identical twin if the other objects, say genetic schizophrenia research (to match the Havasupi worry). That is so even if though the resulting research is much much more revealing about the party whose consent was not sought than in the Havasupi case (where only some genetic information is in common between consenting and not consenting tribe members). If so, and this case fails to raise a worry, it seems the claim of non-consenting tribe members should fail even more forcefully.
(2) Is there unwarranted genetic exceptionalism here? Suppose (and this is purely hypothetical) a researcher wanted to study the prevalence of schizophrenia in Havasupi versus Navajo tribes by observation of behavior in a controlled environment, or non-genetic medical histories. 1000 members of each tribe consent. The researcher publishes results suggesting that schizophrenia is more common among the Havasupi by a factor of 3. Does a tribe member who was asked to participate but refused doing so have a valid source of complaint? It seems to me not. If that is correct, what difference does the genetic nature of the research make? It seems the objection is instead to the research project (studying the prevalence of stigmatic diseases in specific populations), but that worry is quite divorced from anything to do with consent.
This is not to say the actual question of what counts as sufficient informed consent as to research purposes is irrelevant, or a research ethics violation did not take place based on the answer to that question, but I took your post to suggest that wasn’t the hard/interesting consent issue raised by the Havasupi case. Again, I haven’t thought too deeply about this so I am curious to hear your thoughts….
Gaia Bernstein - April 29, 2010 at 10:01 am
Glenn,
Thank you for your very interesting comments. There is a lot to say to address your comments, but I will try to be short here.
My sense is that the principle of informed consent that works well in other areas of medical practice and research, falls apart in genetics. If we really tried to apply informed consent to this genetic research scenario the result would be that some members of the tribe should be able to block research. To avoid this result I would apply a different principle, perhaps even a democratic vote to determine whether the research should be executed.
Specifically to answer your identical twins hypothetical. Since these scenarios have many participants and the results will be relevant on a group basis I don’t think an identical twin can affect a decision more than any other member of the tribe.
As for genetic exceptionalism, the problem is that genetic determinism does exist and we can’t deny it. A research finding a genetic mutation for Schizophrenia among members of the tribe is likely to be more stigmatizing than a research only finding a high incidence of Schizophrenia. I would rather use genetic exceptionalism to address genetic determinism than avoid addressing the issue.
Glenn Cohen - April 29, 2010 at 10:40 am
Thanks Gaia for the thoughtful response.
On identical twins I (in a poorly phrased hypo) meant to raise a different kind of case, not tribe members per se but rather just two identical twins out there in the world, and whether you thought that I (as one twin) should be able to object to my identical twin’s participation in research that may reveal things about both of us. Since your response suggests the fear is specifically related to stigma more than privacy, it may be that you would distinguish this case on that ground, but I wasn’t sure.
On genetic determinism, here I think we reach a very interesting question: does your claim rest on the truth of genetic determinism (or perhaps genetic essentialism) or only its perceived truth, and what exactly do you mean by the term? In particular I was unsure whether you meant by the term a descriptive claim (some portion of our phenotypic characteristics is determined by genotype) or a normative one (it is fitting and proper for individuals to make judgments about us based on our genotype). The descriptive thesis seems clearly true (if put in a moderate way that respects gene-environment interaction), but the normative one is something many would argue against, so I wondered whether your claim was premised on the idea that some may WRONGLY accept the normative claim and that was the thing the non-consenting Havasupi tribe members are entitled to guard against by blocking this kind of research.
To press a little bit, I am not sure why you think the genetic link is more stigmatizing than high incidence. In some ways, it seems to me worse in terms of stigma if we thought there was high incidence of a psychopathology without a genetic link, to the extent we would then be blaming things like rearing behavior by the tribe. In a weird way, the genetic connection might be more excusing and preferable.
More generally, I think I need to know more about your theory of stigma in this case. If it is discrimination, that people will hold the following view “X is Havasupi, therefore X is likely to be schizophrenic,” then again I am not sure the genetic piece is doing the work. To wit, imagine two possible research findings – (1) a large sampling of the Havasupi tribe not using genetic testing shows that 8 in 10 meet the DSM-IV diagnostic criteria for schizophrenia. (2) A genetic research program determines that a particular hereditary gene carried by the Havasupi makes them 3% more likely to develop schizophrenia than the non-Havasupi population. If stigma means what I think you mean by it — susceptibility to discriminatory judgments — it seems to me that research finding 1 is much more likely to cause stigma than 2. If that is right, it is the research project and the finding that is the problem, not the genetics aspect.
I’m really enjoying this exchange (as always when we ‘talk’) but fear it may bore the blog’s readers so don’t feel obliged to respond.
Gaia Bernstein - April 29, 2010 at 12:51 pm
Glenn,
You have raised many important challenges. I will address some of them and hopefully we could continue the conversation at another time or forum:
- As for the twins’ scenario – as long as the goal of the research is a statistical result, the research would not reveal individual results and therefore the twin would not be affected more than anyone else in the group. If the twin requests to get his personal result and the research allows that – I still do not believe the other twin can block him. But now the situation is more similar to genetic testing in a medical scenario and not a research scenario. And although I do not believe one twin could block another, this is another example of where informed consent as a principle collapses.
- As for genetic determinism – my claim rests on people’s perceptions that genes matter a lot. I personally do not espouse this view. But I think that perceptions should be addressed as well as truths. Genetics has a huge cultural force and people tend to overestimate its impact. And even if you and I know that its impact is less than usually believed I think there is still a need to address the effects of this common perception.
- As for your two examples of the findings – in the examples you gave there is a big gap in the percentages but if the percentages were more similar, I think the genetic study would be more stigmatizing. In addition, I think that a finding of a very high prevalence of a disease raises the genetic factor in people’s mind even if the study itself did not involve genetics.
Joan - July 2, 2010 at 1:38 pm
I think this discussion is totally off topic for this case, researchers did get consent so the issue is not where they allowed to do this research.
http://www.nature.com/neuro/journal/v13/n7/full/nn0710-777.html
in short the form these people signed stated that their samples could be used for the ““study [of] the causes of behavioral/medical disorders.””
The issue here is that the Havasupai where unhappy with the findings based on research they authorized when signing their consent forms. (mainly incest frequency and results not in line with religious and other non-rational based beliefs about their origins and the nature of mental diseases). Possibly this is also an issue of simple short sighted greed.
This fear/miss-understanding/distrust is not dissimilar to what you see in the American population at large when confronted with any issue related genetics (GMOs,Testing etc)
and the bigger issues here is the generic distrust of science, a distrust breed by the ignorance that comes from a systemically poor science education, and a lack of government support (hence the judgment in favor of the Havasupai’s case).
I think this is the fault of the scientific community for failing to effectively communicate to the public who’s support and trust they need. And for this case and others, I also blame the courts who’s ruling in this case was not in the interest of truth or justice but political pressures.
Communication and getting informed consent is to important! but in this case even though scientist employed anthropologist to help communicate to these people and worked with/in the community that was apparently insufficient. It would be really nice to discuss what is sufficient and how to enforce protocols to ensure people don’t feel disenfranchised in light of scientific findings.
Also, Cherry picking in genomic is a terrible idea, limiting what people study to a democratic vote by a group of ill informed people is detrimental to science (I do not say this as a insult, just to point out that at least 8 years of college/graduate study goes into getting the Ph.d. the bare minimum needed to run this research).
This whole case is the equivalent of authorizing your surgeon to remove a tumor and getting angry when he finds you also have an abscess. Asking for a vote would be like the surgeon asking you and your family to vote on what tools and techniques he/she should use when removing a tumor and also that he can’t look at anything else in your body.
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