After DNA Misuse, Researchers Banished From Havasupai Reservation 332
bbsguru writes "A court settlement has ended a controversial case of medical privacy abuse. From the NYTimes: 'Seven years ago, the Havasupai Indians, who live in the deepest part of the Grand Canyon, issued a 'banishment order' to keep Arizona State University employees from setting foot on their reservation, an ancient punishment for what they regarded as a genetic-era betrayal. Members of the tiny tribe had given DNA samples to university researchers starting in 1990, hoping they might provide genetic clues to the tribe's high rate of diabetes. But members learned their blood samples also had been used to study many other things, including mental illness and theories of the tribe's geographical origins that contradict their traditional stories.'"
This isn't a new issue... (Score:2, Informative)
Quick google search turned up http://www.dddmag.com/intellectual-property-and-biological-materials.aspx [dddmag.com] which is a summary of some of the important cases.
http://en.wikipedia.org/wiki/Moore_v._Regents [wikipedia.org] is one of the "big" cases, and worth reading the wikipedia summary of, " The California Supreme Court ruled that Moore had no right to any share of the profits realized from the commercialization of anything developed from his discarded body parts."
beautiful place (Score:3, Informative)
I've camped down there a few times. It's a great hike in and out and just a beautiful place to spend some time. Reserve your spots early, the space is limited.
Re:Get it Back (Score:5, Informative)
Acknowledging a desire to “remedy the wrong that was done,” the university’s Board of Regents on Tuesday agreed to pay $700,000 to 41 of the tribe’s members, return the blood samples and provide other forms of assistance to the impoverished Havasupai — a settlement that legal experts said was significant because it implied that the rights of research subjects can be violated when they are not fully informed about how their DNA might be used.
Re:here comes a relativist conundrum. (Score:5, Informative)
Go to a reservation public school like I did.
Second year of High School there was a year long course, mandatory for graduation call "Tribal Government", except it wasn't tribal government it was a year of Lakota mythology and religion. Even though I'm not a member of the tribe, I had to take it, as did folks who weren't American Indian, the school board which was 4/5th white would not allow kids to opt out because BIA funding was dependent on it being taught. A non-tribal member could not get a grade better than B+ because "they weren't capable of understanding it fully".
In biology classes we had a day during evolution of "Lakota creation myth". Again, BIA funding mandated it.
IRBs ???? (Score:1, Informative)
If the Arizona State University research group violated their IRBs (Federal Title 45 CFR Part 46) by performing tests not specified in those documents, they can be in significantly deeper doo doo than being banished from one reservation. This can result in the loss of Federal research funding not just for a particular research group but for an entire institution - to say nothing of disciplinary action within the University itself. That's why, at least at our University, if you're doing research involving human subjects you have to be certified yearly on the rules and regs related to IRBs.
Re:Damn them! (Score:3, Informative)
Collecting data for purposes A, then later using them without permission for B, C and D should be illegal. I know that is at least the case here in Norway, the law on use of personal information is quite strict. Consider it a form of fraud if you will, that's the issue here not the research itself.
Told but didn't understand..... (Score:5, Informative)
From the looks of the article, it seems more like a case where the people were told but didn't understand the ramifications of their decision:
The consent form was purposely simple, Dr. Markow said, given that English was a second language for many Havasupai, and few of the tribe’s 650 members had graduated from high school. They were always given the opportunity to ask questions, she said, and students were also instructed to explain the project and get written and verbal consent from donors.
So, were they mislead, or is this more of a type of "buyers remorse"? There are plenty of places where the local population is uneducated and unlikely to fully understand genetic testing, should we stop studying them, and in the process deny them the good (potential treatments for disease that they suffer from) to protect them from "the bad" (the possibility that their world-view will be challenged, or that the data will be applied to larger studies)?
Also, one of the big issues here seems to be that the findings contradict their folklore:
Another article, suggesting that the tribe’s ancestors had crossed the frozen Bering Sea to arrive in North America, flew in the face of the tribe’s traditional stories that it had originated in the canyon and was assigned to be its guardian.
Listening to the investigators, Ms. Tilousi felt a surge of anger, she recalled. But in Supai, the initial reaction was more of hurt. Though some Havasupai knew already that their ancestors most likely came from Asia, “when people tell us, ‘No, this is not where you are from,’ and your own blood says so — it is confusing to us,” Rex Tilousi said. “It hurts the elders who have been telling these stories to our grandchildren.”
So science showed that their fable about springing from the ground in this canyon was, at best, unlikely. So what. We don't accept that the Earth is the center of the universe, that sex with virgins cures disease, that human sacrifice improves crop yield, or that it's turtles all the way down, why should we care about this story either. I'm not inclined to "turn off" science just because results show that a stone-age story is just a story.
Live from Arizona (Score:5, Informative)
I live not too far from the Havasupai reservation and I have to tell you that these Indians are not playing with a full deck.
For example, they try to license the air space over the reservation, regardless of the fact that the FAA has told them many times that only the FAA may do that.
They (the Havasupai's) bend the laws to their own will and then when someone tries to go after them, they hide on their reservation where you can't serve them with any notices and even if you did, they would ignore them.
Re:Live from Arizona (Score:3, Informative)
Oh and the Havasupai don't live in "the deepest part of the Grand Canyon" that would be the Supai Tribe. The Havasupai live on top and is where they charge $75 for the sky walk over the GC.
Also mades it harder for legitimate research (Score:5, Informative)
There was already fallout from cases like this when it was first discovered in the mid-nineties. I grew up more or less on the Navajo reservation, and remember sitting in on a PTO meeting as a high school student. There was a doctor there who was explaining the diabetes screening that was going to be taking place in the coming months.
She was a Navajo gal who had returned to the res after getting her degree (despite the fact that she could have got a much better job elsewhere), and had managed to secure a government grant to perform free diabetes screening of every native student in the district. I thought this was a great thing given the high rate of diabetes on the res, the low health care coverage, and the importance of detecting diabetes early.
However, one of the school board members, who also held a tribal government post, kept railing on her and accusing her of all kinds of crap, including asking why she hadn't gotten permission from her as a tribal officer first (in fact the doctor had, and even had papers signed by the board member with her). At first I thought it was just because she was a territorial bitch (she was). However, after later hearing about this case, I understood why she was so sensitive to this particular issue, and agreed that her concerns (although not her behavior) were absolutely justified.
Re:Damn them! (Score:5, Informative)
That would be true, but TFA says:
Roughly 100 tribe members who gave blood from 1990 to 1994 signed a broad consent that said the research was to “study the causes of behavioral/medical disorders.”
Yes, Diabetes was their primary motivation, but they signed on for more than that. The problem seems to be that they didn't like what happened later and regretted that decision.
Re:Interesting... (Score:5, Informative)
I'm torn here. On the one hand, I would not want research on tissue samples being done outside of the scope of the informed consent permissions document under which the samples were collected. If that did, indeed, occur, the researchers lied to their test subjects. That is all kinds of unethical.
And it should have been blocked by the local Institute Review Board (IRB) who is supposed to oversee research involving samples of human tissue for this very reason (shades of Tuskege and vulnerable populations come immediately to mind). Either the researchers didn't get IRB approval, which is a career-ending mistake, or the IRB gave approval for what seems to be unethical use of the samples.
Neither of those seem likely so I'm betting there's more to the story here.
For those who are interested in understanding more about regulations concerning human research, the basis for current theory and practice is something called The Belmont Report (use Google). Also, for Federally Funded research, DHHS has specific guidelines (based on The Belmont Report recommendations): http://www.hhs.gov/ohrp/irb/irb_guidebook.htm [hhs.gov]
Re:here comes a relativist conundrum. (Score:3, Informative)
"Based on the Native American Graves Protection and Repatriation Act (NAGPRA), five Native American groups (the Nez Perce, Umatilla, Yakama, Wanapum, and Colville) claimed the remains as theirs, to be buried by traditional means. Only the Umatilla tribe continued further court proceedings. In February 2004, the United States Court of Appeals for the Ninth Circuit ruled that a cultural link between the tribes and the skeleton was not met, allowing scientific study of the remains to continue."
"Robson Bonnichsen and seven other anthropologists sued the United States for the right to conduct tests on the skeleton. On February 4, 2004, the United States Court of Appeals for the Ninth Circuit panel rejected the appeal brought by the U.S. Army Corps of Engineers and the Umatilla, Colville, Yakama, Nez Perce and other tribes on the grounds that they were unable to show any evidence of kinship."
Go back and research the stance of the Department of Interior and Army Corps of Engineers, the Clinton administration pushed the NAGPRA onto these remains to keep the American Indian votes.
The Federal Government tried to suppress the science by claiming 8000 year old remains were linked to the tribes in the region.
"As expected, the scientists' documents allege the Corps and Department of the Interior agencies mishandled the case in other ways - from failing to preserve the bones' scientific integrity to being biased in favor of American Indian tribes from the beginning, topics that have long been part of the legal banter while the case was on hold."
http://www.tri-cityherald.com/2001/01/03/136458/scientists-say-corps-destroyed.html [tri-cityherald.com]
In the waning days of the Clinton administration the site destroyed. Ultimately the scientists won in Federal Court and the remains were not suppressed.
Re:Live from Arizona (Score:3, Informative)
It is probably unrelated but worth knowing, that in a village of 450 people that is 8 miles from the nearest road, they have a very nice modern diabetes clinic and exercise center.
Re:Get it Back (Score:3, Informative)
Researcher Behaving Correctly (Score:5, Informative)
Re:Damn them! (Score:3, Informative)
That's just nonsense. The consent form said the samples were to be used for medical research. That's what they were used for. Your examples would be applicable if the samples were used for criminal checks, or market-research, but that's not the case.
In Sony's case, OtherOS was a feature that was present, and in some cases motivated people to purchase the unit. There is no comparison here.
Clauses that say a contract can be unilaterally modified at any time are generally invalid on their face, and since that's again not what happened here, not relevant.
HIPAA has nothing to do with this. Patient confidentiality was not broken during any of the studies. If you're aware of some other state or federal law you feel is applicable, go ahead and cite it, but good luck searching, 'cause I don't think you'll find anything.
Re:LOL (Score:2, Informative)
Nope, not cultural genocide, your mileage may vary, I spent 20 years on the Cheyenne Indian Reservation which is Minnecojou, Sans Arc, Blackfoot and Two Kettle.
There is much more cultural history in the people there today than there are of Europeans who have come to the US over the last 200 years. Tribal music, dancing, language, arts and crafts are all strongly remembered and participated in.
A. - The livelihood of the Plains Indians was not destroyed by settlers, the Great Plains west of the Missouri River were and still are greatly unsettled by the Europeans. My Reservation did have homesteading which brought Germans and Dutch there, but that extra economic boost has made it a stronger reservation that those like Pine Ridge and Rosebud.
B. - Pitiful existence because of cradle to grave welfare. If you know you'll get a house when you let yours fall apart from neglect for free, why keep your home up? If you know you'll get a check for doing nothing, why get a job? If you are an American Indian you can get free 2 and 4 year college educations, in my high school class of 50, 5 of us made it off the Reservation and stayed off.
Re:Damn them! (Score:4, Informative)
If you read a bit further: Carletta Tilousi, one of the few Havasupai to attend college, stopped by Professor Martin's office one day in 2003, and he invited her to the student's doctoral presentation. Ms. Tilousi understood little of the technical aspect, but what she heard bore no resemblance to the diabetes research she had pictured when she had given her own blood sample years earlier.
I realize that "[t]he consent form was purposely simple, Dr. Markow said, given that English was a second language for many Havasupai," but when you explain it as diabetes research and the consent form says something different, there's a problem. After the above question, the following happened.
Bottom line is, if they were told it was one purpose, and the contract said something else, then you would have to prove that everyone who signed was capable of understanding that the contract did not match the verbal description. the sentence right before what you quoted was "I went and told people, if they have their blood taken, it would help them," said Floranda Uqualla, 46, whose parents and grandparents suffered from diabetes. "And we might get a cure so that our people won't have to leave our canyon." Does that sound like someone who thought the consent form was more broad than just diabetes?
"Doesn't matter, you signed a contract" is not bulletproof.
Re:Interesting... (Score:1, Informative)
Part of me wants to LOL at your post, and part of me is professionally embarrassed.
I work with IRB's. Our interaction with them is essentially "how much do we have to tell you about what we are doing for you to say that its ok?". Researchers fib on Protocol and Site Renewal submissions all the time; the less they have to tell IRB's the better. It is wildly unethical, and is a major violations of Participants rights, but it happens. It is very common for Researchers to submit a Protocol just to get the "ok" to begin recruiting Participants, and then try to sort out the study design later
Either the researchers didn't get IRB approval, which is a career-ending mistake, or the IRB gave approval for what seems to be unethical use of the samples.
Neither of those seem likely so I'm betting there's more to the story here.
I think you are absolutely spot on. Seems likely to me that someone realized that they had these samples and wanted to do some analysis to "see if there is anything there". When working with Human Subjects data, you just can't do that.
Re:Damn them! (Score:3, Informative)
Roughly 100 tribe members who gave blood from 1990 to 1994 signed a broad consent that said the research was to “study the causes of behavioral/medical disorders.” The consent form was purposely simple, Dr. Markow said, given that English was a second language for many Havasupai, and few of the tribe’s 650 members had graduated from high school. They were always given the opportunity to ask questions, she said, and students were also instructed to explain the project and get written and verbal consent from donors.
So yes. They did.
Jackass.
Re:Damn them! (Score:4, Informative)
Yes, Diabetes was their primary motivation, but they signed on for more than that. The problem seems to be that they didn't like what happened later and regretted that decision.
http://en.wikipedia.org/wiki/Informed_consent [wikipedia.org]
Especially when it comes to medical ethics, the wording of the contract is far less less relevant than the meeting of the minds [wikipedia.org] that precedes it.
As context, if you look at how our laws are interpreted, the Supreme Court spends a lot of time delving into the intent of Congress, not just the final product.
Re:i'm going to come take your dna (Score:1, Informative)
Except they DID get the consent for that exact thing.
"Roughly 100 tribe members who gave blood from 1990 to 1994 signed a broad consent that said the research was to “study the causes of behavioral/medical disorders.” The consent form was purposely simple, Dr. Markow said, given that English was a second language for many Havasupai, and few of the tribe’s 650 members had graduated from high school. They were always given the opportunity to ask questions, she said, and students were also instructed to explain the project and get written and verbal consent from donors."
OOPS THERE GOES YOUR ENTIRE ARGUMENT.
Idiot.
Re:Damn them! (Score:2, Informative)
It is illegal to decode digital satellite signals without the permission of the broadcaster, even though they are indiscriminately irradiating most of the United States. If you don't want me to decode it, you shouldn't be so sloppy with your EM, not go running to the government.