Beginning in 1990, Arizona State University began a study using DNA from the Havasupai Tribe in Arizona. Read the articles at the links below. Discuss the importance of informed consent in human subjects research.
Indian tribe wins fight to limit research of its DNA
From the New York Times (04/22/2010)
Havasupai case highlights risks of DNA research
From the New York Times (04/23/2010)
Informed consent and the ethics of DNA research
From the New York Times (04/23/2010)
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Informed consent in human subject research appears to be both a legally and emotionally charged issue. While the process of screening DNA seems to be somewhat normal, as individuals we still desire some form of basic privacy and the right to say what can and what cannot be tested. There should be limits to what researchers can do with left over DNA. Such is the case of the Havasupai tribe of Arizona, whose DNA was collected for the express purpose of looking for genes involved in Type II diabetes, but wound up being used for a wide variety of genetic elements. The suit charged the storage and future research was a violation of the Fourth Amendment rights against unlawful search and seizure. The Havasupai tribe also feels that blood is sacred and that they gave their blood samples in faith that it would only be used for the purposes intended.
In addition, while the blood samples of the tribe were tested for Type II diabetes, they were also tested for many other issues including genetic origin, genetic inbreeding and schizophrenia. All of these issues are very personal as to the tribe as well as leaving them to feel betrayed and that their rights had been violated. In addition, due to the educational limits of many tribal members an advocate was used that led the tribe to believe that by allowing the diabetic testing they would prevent diabetes from forcing them to move from their tribal home to seek treatment.
Without conformed consent, the validity of research projects could also be in jeopardy. Informed consent is something that was created to protect the participants in a research study. What this means is that no researcher can include a person in a research project without getting approval from them first. Requiring informed consent protects many marginal groups from being forced to participate in medical studies without understanding the risks involved and requires that they be kept informed of what will happen with their DNA. This protects the individual from harm and protects the researchers from being sued or having their project deemed invalid or unethical. This prevents individuals from being subjected to testing that could be deemed harmful in the future and from being discriminated against. But without informed consent, abuses will inevitably follow.
The researchers at A.S.U. harmed the Havasupai tribe when they conducted research using their blood in ways in which they were unaware of. The important fact to keep in mind is that the Havasupai hold their blood (itself) to be sacred. The Havasupai members that participated in the DNA study for diabetes, obviously did not comprehend that their blood was also going to be used in other research. It is obvious they did not know because, the other types of research (mentioned in the articles) conducted was on schizophrenia, a stigmatizing illness in their culture, and about geographical origins of the tribe. The research being conducted about their geographical origins would discredit their own spiritual beliefs and legend. Although Dr. Markow had them sign a consent form, they obviously were not aware of all the types of research that their blood/DNA could be used for. I don’t find that a contract has much value when the people asked to sign it do not speak/comprehend the language fluently, are not educated enough to understand a complex contract, and seemingly (in this case) were not explained the wider ranging types of research that was to be conducted. Nor did A.S.U. researchers ever go back and inform them about testing being pursued regarding schizophrenia and whether their tribe could be traced ancestrally to others that crossed over the Bering Strait. From the articles it appears that the members involved in the tests were under the impression that their blood was going to be used for research on type II diabetes and to help the tribe with this disease. This is where it is important to remember that they feel there blood is sacred and has deep spiritual meaning. They would not have ever offered up their blood for the other types of research and I would suspect that someone at A.S.U. knew because, the results of the other research only became known to the Havasupai by accident. I do not feel that Dr. Markow acted within accepted moral principles in this research and that the court was correct in awarding the settlement to the Havasupai. I feel that the Havasupai’s trust was betrayed and that they may have been intentionally misled. I liken the use of their blood by A.S.U. to when a kid asks their asks their parents if they may have a few friends over. The parents go out of town for the weekend and come home to discover that their child has had a party and couple hundred people attend. The Havasupai did not have what amounts to “informed consent” in the use of their blood/DNA for research in the areas of mental illness and geographical origination. I feel that what “informed consent” truly means is that, the participants must be completely aware of what types of research their sample(s) will be used for. If a research team wants to study mental illness in a selected population, then that population must be completely aware of that. If the research team then wants to further their research into say sexually transmitted diseases or birth defects then, the research team must go back to the population and obtain specific permission to do so. It is not ethical to obtain permission for one kind of a study and translate that into open-ended permission to research whatever a team wants to. To have “informed consent” means to be fully aware of the ramifications of such study, and to give permission to allow the use of their sample within the grounds of the study.
I don’t think, and know it’s not ok at all to collect ones DNA without the right to know how or where it will be used. In this case and matter the Havasupai Tribe were told that their DNA was supposed to be used in a study in finding clues to “Type 2 Diabetes”, since it is something that a lot of Native American tribes suffer from at an extraordinarily high rate. Other cases have shown that people involved in medical trials and research want to be asked before their donated DNA is used for different purposes. Everyone has a right to their own privacy… and the right to say what can and cannot be tested. I am a Native American myself “Navajo” that is, and to see and hear something like this happen to a Native American tribe, and community as a whole, is both sad and wrong! It’s misleading and mistrusting! I think that the research group thought they could get away with the studies, thinking that the tribe won’t know what’s going on with the research since there are limited uses of technology in some areas of their reservation. In other words, it seems like they were taken advantage of. Carletta Tilousi who is a member of the Havasupai Tribe said: “I’m not against scientific research; I just want it to be done right. They used our blood for all these studies, people got degrees and grants, and they never asked our permission.” If the DNA samples were used for its intended use and study, this lawsuit wouldn’t have resulted.
When communication in a relationship is lacking or not present it is going to suffer. How can a person know what the other person thinks or feels without any communication? This applies with the relationship between the researcher and the subject. Communication allows the person who is the subject of research to make an informed decision about any aspect of their involvement with the research being conducted.
When a human is participating in research where certain aspects of the research could harm them, they need to know. Withholding this information could be exposing a person to possible harm that they do not want to be exposed to. The story of the Tuskegee Syphilis Study is an extreme example but a valid one. These men were deceived but the idea is the same. During the study, information that was important for them to know was withheld from them. Much harm was done to them and their families because of this.
With research done on the Havasupai Indian Tribe’s blood samples, there is still the need to clearly explain what will be done with their samples. They have the right to decide what kind of studies will be done with their blood samples. Some of the information gained from these studies that the Tribe was not informed of was very hurtful to their culture. When you don’t fully inform your research subjects of your intent, serious harm can be done to the trust you develop with them. You are also imposing on their right to make decisions about their own body. Since this blood was drawn from their bodies they have the right to decide what is done with it.
I feel with further DNA research that if a sample is going to be used for a new project the person who gave the sample should be informed and consent from them should be obtained. There may be information uncovered that could be harmful to that person or it may be something they don’t want to know. There might be information uncovered that would make them feel uncomfortable if the researchers know. If subjects are informed it will foster a better relationship for future researchers. The actions researchers in the past have taken have caused mistrust and skepticism to arise in public opinion. This damages the credibility of those now who are trying to engage in ethical research. It causes people to feel that researchers are intentionally trying to deceive them and take advantage of them. If the subjects are informed clearly and specifically about what research will be involved and communication stays, it is a better situation for all. Peoples’ rights are respected, research can continue on and there are no ethically questionable actions involved.
I believe that it’s very important to get consent in human subject research. In the case of the Havasupai Indian tribe; ASU researchers told the tribe that they would only be using their blood samples in diabetic research to help or hopefully find a way to end the rapid devastating toll that diabetes has on this tribe. Unfortunately, ASU not only used the tribe’s blood samples in researching diabetes, but the researchers also used the tribe’s blood samples according to the New York times in mental illness and theories of the tribe’s geographical origins that contradict their traditional stories. With all this being said I think what ASU researchers did to the tribe without getting their consent to do other studies other than the diabetic research, was unethical.
Everyone has a say as to what their DNA is used for, when given. ASU should have gotten all consent for the other research that was being done as well. I think that there should have been more involved in what was really being said that day as to what the DNA was used for. The Havasupai tribe should have been more educated as to what the process of DNA research is and as to how it was going to be researched. Another thing is that the Havasupai Indian blood is sacred to the tribe. So the ASU researchers should have honored their word as to what the blood samples were being used for. As researchers and with their resources to understanding the tribe, they should have known that if they didn’t comply with what the research was intended for, then the tribe wouldn’t trust them anymore. This might complicate any future studies that other researchers might want to do with the tribe.
When I read the article I was very upset to read that some of the blood samples were being used in research just prove that what the tribes initial thoughts of their upbringing was, was wrong. The ASU’s researchers mislead the tribe and no one’s DNA should be used other than what the initial purpose was for. Still in the end some of the tribe’s members passed away and the tribe still didn’t get the help that they sought out in the beginning. I’m personally am happy that the tribe won their case .
Human subjects’ research
Discuss the importance of informed consent in human subjects research
There is a lot of great progress being made with DNA testing. I myself have had genetic testing done. However, I never even thought about what they would use that sample for testing other than the specific condition I was being seen for. Now I wonder if any other testing was done and I do feel concerned there could have been more testing without my knowledge. If doctors and scientists are going to use our DNA for anything, I believe the American citizen has the right to know. There should be a federal informed consent document that states that samples can be used for any purpose that is chosen by the doctor’s. That way in the beginning before retrieval of the DNA the person completely understands what his options are and be able to make the decision on his own. I believe people will still donate DNA for research, now they will just have a little more faith in the government and scientists doing the research knowing they are being more truthful and open. We need the researchers to be able to do the testing that they do, just not behind closed doors. The Havasupai tribe was right in their desire to have their blood returned and sue for wrongful use. The researcher who drew their blood said it was only for diabetes research which they never even received help with.
What happen to the Havasupai tribe was wrong but also legal. The members of the tribe did sign consent but the problem was a lot of them did not understand English. Nor was it explained exactly what it was going to be used for exactly. The researchers should have explained better how their blood was going to be used. They also should have kept in touch with the tribe if new tests were going to be done in the future with their samples. The researcher did right by accepting to help out and to try to figure why Diabetes was so high in the Havasupai tribe when they were asked.
Cases like this are never good for doctors and researchers because it shows that there is not enough communication. Patients now will start to ask what is my blood being used for exactly and is it being disposed correctly. Screening DNA is matter of privacy for all humans. So researchers should have limits when testing DNA. The Havasupai were right in taking their case to court because researchers should not have the right to do whatever they want with someone’s DNA without full consent. I don’t think any settlement would have been sufficient because the damage it caused to their reputation was permanent.
The article never said if the Havasupai tribe ever received any information that would benefit them for their diabetes epidemic. This tells me A.S.U had their own agenda and already knew what they were going to do with the blood samples. I don’t think any of the tribe members would’ve agreed to give samples if they knew what it was going to be used for. This just seemed to have damage the tribes reputation and background by trying to get help for their people. This ordeal also caused irreversible damage to the tribe and their ancestors because they consider their blood to be sacred, what they did was an insult to the whole Havasupai tribe.
If situations like this keep happening it’s going to put DNA research on hold and new findings because of lack of trust. People that proceed in doing research with DNA should start considering more careful about how they explain things to people when getting consent from a person. There could be things a person doesn’t want to know or knowing could cause them harm.
Yvette Ferguson
The purpose of informed consent is so that the signee can know specifically, and even if possible, make specifications as to what will be done with his DNA. Informed consent should be in place because science braches into so many directions and various diseases are related and it would be easy to just assume one sample can be used across the board. Consent forms put barriers, or should put barriers on what extent researchers can go to with subjects' entrusted DNA or other fluids.
Without informed consent there is the possibility of limitless abuses of the rights of the subjects that have given their DNA or otherwise to be tested. If these
types of abuses go unaddressed then other contractual agreements are subject to be violated or blanketed as well. Human subjects research is supposed to be a good thing, creating opportunities for scientific break throughs and bringing understanding. There will always be something to research when it comes to humankind. As long as people are living longer and new diseases are being explored there will be a continous need for volunteers. This case can make people skeptical about participating in clinical studies, or even supporting them.
In their understanding, the Tribe thought they were being helped and everyone wants that. So not only did the ASU researchers prey on the Havasupai's ignorance, they also preyed on their emotions, and betrayed their trust. Their DNA was collected for the sole purpose of genetic research concering the inherent plague of type 2 Diabetes going throughout The Havasupai Tribe. This contract was violated by the ASU researchers that were involved in the case when they started to test outside of that specific allocation. These people wanted to help the future and longevity of their tribe, not be used as guinea pigs and tools so that the researchers could receive grants and complete the college degrees.
In the case of the Havasupai Indian tribe, I think in the beginning the researchers genuinely wanted to help in finding a cause to the increase of type II diabetes. I don’t think they intentionally mislead the donors in order to obtain DNA samples for other experimentation. There were two main problems that occurred when the scientists conducted this study. One being that the researchers did not fully communicate the possibilities of what their research may entail or reveal. I can understand why the Havasupai would feel betrayed. They had donated a very spiritually valued substance (blood) with the understanding that it would be used for experimentation relating to the increase in diabetes occurrences in their tribe, only to find out years later that their blood had been analyzed for other reasons not pertaining to the diabetes study. People deserve to be adequately informed about what their donations will be used for and where the donations may or may not end up.
That was the other mistake the scientists made. By not taking into account for where the specimens could end up in the long run and allowing the donated specimens to make it into inappropriate hands (for testing that did not correlate with finding a cause to the diabetes), they inadvertently mislead the Havasupai. Some of these findings may have devalued the stories that have been passed down over many generations. In retrospect, I can see how the scientists did not see this coming, but in turn, this definitely should be a learning experience for the entire medical research community. It is one thing to not like the findings of a consensual study of one’s DNA. It is an entirely different issue when research, that was not consented to or done under false pretenses, takes place. It is not only unethical, but deceitful to the donor(s) as well.
DNA is the one piece of and individual’s makeup that distinguishes him or her from any other person on the face of this earth. It is what makes us who we are. DNA is the most personal information person possesses and should therefore be handled with the utmost respect.
Everyone human being has the right to refuse anything they want to refuse. I dont agree with what the A.S.U researchers have done to the Havasupi tribe, they gave them DNA test without of them knowing and everyone deserves to know what is being done to them and they have ther right to refuse if they dont want it. In this case the Havasupi tribes DNA was collected and were told that the purpose of them doing that is to test for any genes that is involved in type II diabetes but it wasnt the truth their blood was going to be used for other researchers and they did not know they. This tells you how well the US follows their Decleration of Independence rights as the fourth amendment states about the freedoms but no one seems to be going by that nowadays. The Havasupi tribe had all the rights to take their case to court. DNA is what makes us who we are and it is not entitled for it to be used for anything we are not aware of. People should always question why their blood is being taking and where is going and what is it being used for because your blood can not be used for anything against your will.
PP9
Human Subject Research
I think the Havasupai Indian tribe has the right to sue for unauthorized use of their DNA for anything other than they requested. The tribe signed permission for ASU to use their DNA to research on the consistently high rates of Type II diabetes. I don’t think it was okay for the researchers at ASU to do further testing with the DNA without the people of the tribe being notified. ASU should have explained to them that they may later on use the left over DNA samples for further testing or they should have contacted the people whose DNA was used again for authorization. Because blood is something very sacred and valued to the Havasupai tribe the researchers should have honored and valued their beliefs. The thing that was the most unethical to me was that they used the DNA to prove and find that the origins or backgrounds of the Havasupai tribe was wrong, they had no right to go and investigate about their past and to question their history without the tribes permission. If it was given to ASU for research to search the problem of Type II diabetes it should have only been used for that. I feel like ASU violated the privacy and confidence of the tribe by using the DNA years later. It is true that we may never find out if our DNA is used for anything other than we think but legally the labs need to have the patients sign an informed consent form and understand what is being asked. In this case I think both the scientist and the tribes are at fault for not getting or providing full understanding of the research. But the tribe was right because they should have gotten informed since it was done years after they signed the consent.
Informed consent is very important to have in terms of research or private matters. If there is no informed consent, then information could end up in the wrong hands or possibly used against someone’s interests. In the case of minors, parents may not want people to know their child’s private information. When it comes to research, some individuals may not want to know specific information about their self or may not want others to use their data. For example, the Havasupai Indians only consented to have their blood drawn and tested for research and studies of diabetes, but later and without consent researchers decided to use it for studies on many other things such as mental illness and theories of geographical origins, against the Havasupai’s traditions and beliefs. If the Havasupai’s had consented to this further research, then it could have been accepted ethically and valued much more.
I believe that having human subjects in research is important because it helps to advance the medical field much more. Human subjects provide a better match than other animals with respect to research findings. Without research done on humans we would not have been able to make treatments for some diseases. If someone has a disease already we could learn from them without harming them, since they already have the disease, as long as they consent to the proposed research. Lab rats may not be able to help in finding a cure for cancer, but perhaps they could help grow new ears for burn victims. However, human research has its downfalls. Consider the Tuskegee case. Doctors led the syphilis patients to believe that they no longer had the disease. This caused long and short term health risks for these patients, as well as those who they may have affected. In addition, some diseases being researched could be passed on to the subjects’ children, causing a burden on them and their families, if controls and consent are not put into place. Having a disease or being subjected to certain research may also have detrimental mental effects. With respect to the protection of individuals’ rights, we should never conduct research on people unless they are informed of the nature of the research and consent to it.
I think all of us as people have the right to refuse anything we want to refuse to a limit but what those researchers did was very wrong I don’t understand why the ASU people did that to the Havasupai tribe, they gave them blood thinking it was going to be used for research on type 2 diabetes which would be something very helpful for the health of their tribe and without them knowing they turned around and used the left over DNA to do other testing that the tribe didn’t consent to so what happened to their right to refuse if they didn’t want it. In this case the Havasupai tribes DNA was collected and were told that they were going to research their DNA to try to find out where the diabetes genes came from at that time the tribe believed them and gave their samples to the researchers but it turns out that after the researchers were done doing their research they used the left over DNA to try to track where the tribe came from and for other things The Havasupai tribe was in their right to want to take matters in to court that’s like if they would have held them down and did research on them against their will .
Human Subject Research is wrong if it is done with out a persons consent these days you never know what people are doing with your blood or your information or any thing else you should always ask why things are being done or what they want specimens for
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