Whose Blood Is It?
The basic concept of informed consent in research is straightforward: People being studied should understand the research enough to know the risks and benefits and be able to make an intelligent decision on whether to participate. For anthropologists, whose discipline for decades studied native groups around the world without using the modern ideas of informed consent, the ethics involved are particularly sensitive.
Those ethics issues may be about to get a legal airing, following a decision Friday by an Arizona appeals court to revive a lawsuit by a small Indian tribe against the Arizona Board of Regents and some researchers involved in the use of blood collected from the tribe. Tribe members consented to the blood being used for research on why they may have been experiencing high rates of diabetes.
But they charge that some of the studies conducted with their blood -- in some cases by researchers who played no role in the original study, or its informed consent protocols -- violated their rights. Some of the additional research challenged the tribe's religious beliefs and members say they never would have contributed to such studies.
Notably, this dispute involves not research that took place in anthropology's early days, but in the 1990s, when protections for research subjects were at least theoretically in place.
The suit was initially dismissed on grounds related to whether the briefs appropriately outlined damages done to the tribe and how the litigation would prove those claimed harms. And it was revived based on the view of the appeals court that the tribe had in fact filed appropriately. Neither the dismissal nor the revival of the suit were based on the merits of the case -- but those issues should now take center stage, and some think that's a good thing.
"This is a really interesting case because it opens up some questions of the reasonableness of practices that have been flying under the bioethical radar," said Jonathan Marks, a professor of anthropology at the University of North Carolina at Charlotte and an expert on informed consent and bioethics. Marks said that while he did not know the specifics of what happened in Arizona, he sees a widespread problem of anthropologists collecting blood for one purpose (with informed consent) and then having other scholars use the blood (without consent). Ethics issues abound, he said, because some of the subsequent research is potentially lucrative and because of the realities that these interactions do not take place on a two-way street.
"There's historical context here," Marks said. "You've always got scientists taking the blood of Hopis or some other tribe and not Hopis taking the blood of scientists."
The suit in Arizona is being brought by the Havasupai Tribe, many of whose members live at the bottom of the Grand Canyon. As a group that has lived largely by itself for generations, the tribe has long been of interest to scholars. One of the scholars who gained the trust of tribe leaders, over several decades of research, was John F. Martin, now a professor emeritus of anthropology at Arizona State University. As outlined in the appeals court's decision, Martin was approached by tribe members in 1989 about an apparent rise in the incidence of diabetes.
He developed an informed consent procedure and, between 1990 and 1992, collected blood samples from about 200 tribe members. That research is not being questioned, but a series of other studies are. One was by Therese Markow, an Arizona State professor of genetics who has since moved to the University of California at San Diego, and concerned schizophrenia. Other studies with the blood, both at Arizona State and the University of Arizona, were used in four doctoral dissertations and several journal papers.
Significantly, several of the studies shifted from direct medical uses of genetics to evolutionary uses of genetics, and some of the work concerned theories about how Native Americans came to inhabit North America, including work to support theories that they migrated from Asia. Havasupai believe that they originated in the Grand Canyon, so as a matter of principle, their leaders say that they would never, under any circumstances, consent to the use of their blood to try to question that belief.
Martin, the original researcher, objected when he learned of the way the blood was being used, and he also informed tribal leaders. That makes him a hero to some -- although some tribe members who have filed individual suits have sued him, too. The suits followed an Arizona State study of the situation and failed attempts to reach a settlement out of court.
"This case is about principle, and about how things with research on Native Americans haven't changed since the 1700s," said Robert A. Rosette, lawyer for the Havasupai. "This case is about researchers who knew what they were doing, and were trying to advance their careers and themselves, and who took advantage."
Rosette said that the knowledge that their blood was used against their wishes has had a devastating emotional impact on tribe members, who feel that they have been lured into violating their most sacred beliefs by giving up their blood and who also have lost trust in Western medicine. "Now we have people who won't even see a doctor. We have plaintiffs in this case dying and losing limbs because they are afraid of doctors."
The case has the potential to go well beyond these studies on the blood obtained by one tribe. Rosette said that, through discovery, he wants to document other instances in which blood has been used inappropriately. "We've only scratched the surface," he said. "If I can depose these researchers and go into their laboratories, who knows what I'm going to find. We want to create real change in how scientists conduct research on indigenous populations."
The outcome could be expensive to Arizona State in all kinds of ways. Rosette's suit is seeking $50 million in damages, although he said the universities could have avoided all of this by returning the blood and apologizing. "This was never about the money," he said. (A Web site produced by Rosette and supporters, with documents and details about the case, is here.)
On Friday, the Arizona attorney general's office, which represents the Board of Regents in the case, told local reporters that officials there hadn't had time to review the decision and so could not comment on it.
Markow, the genetics professor in the case, said via e-mail that she was on the road and couldn't comment at length about the case, but she said (without specifying them) that there have been mistakes in the description of the course of events. She also pointed to a 2004 article in Nature as a better representation of the issues than that found in the court's decision on Friday.
That article stressed the difficulties posed for researchers by the dispute, particularly since the Havasupai have stopped cooperating with most studies, and some other Indian groups have expressed similar reluctance. Markow noted that the research to which the tribe objects could help many of its members. “What concerns me deeply is that the allegations have resulted in a moratorium on biomedical research on the Havasupai reservation, excluding this and other communities from discoveries with the potential to address their health concerns,” Markow told Nature.
The promise of medical breakthroughs, however, should not get scientists a free pass on issues of informed consent, said Marks of UNC-Charlotte. "We've always got this carrot at the end of the stick," in terms of the promise of a medical advance. "I'm not saying people shouldn't participate, but we also have now a cultural setting in which the human body is becoming increasing commodified," such that a medical breakthrough may lead to financial windfalls for researchers and universities. If they are going to boast to Native Americans and the public about how research may help cure diseases, they also should be open with everyone about potential financial benefits, he said, stressing that he was talking about the issues generally and not with regard to the Arizona dispute.
"Blood, especially the blood of Native people, has some not just scientific value, but possible financial value," he said.
Martin, the professor originally involved in the diabetes studies and the one who set up the informed consent with the Havasupai, said that while some of the additional research done might have been covered by the presentations he made to the tribe, it is "undeniable" that some of the studies went beyond what the tribe members agreed to.
He also agreed with the suggestions of others that this case represents a set of ethical issues that are likely to need more attention from researchers. "The issue of secondary use [of samples] is of great significance because of its implication to people doing genetic work," he said. Many people -- Native Americans or otherwise -- would give blood to anthropologists or to public health workers, but might have concerns about the use of blood for genetic studies, he said.
The reality, Martin said, is that most work by anthropologists or public health workers doesn't have the potential "to make money for anyone," and so the ethical issues involved are different -- although the same blood samples may be being used in potentially lucrative genetic research. "This doesn't make it easy for anthropologists," he said.
Marks said flatly that what the genetic research should mean is "accepting a larger burden of responsibility," with researchers making sure that no material from an individual is used for studies they didn't agree to. He said that this would be a huge change for many researchers, but one that is necessary -- especially for anthropologists, who rely on the cooperation of the groups they study.
He added: "If we treat people contemptuously, anthropology disappears."