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)
Due October 26, 2012
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13 comments:
I feel that informed consent play a huge factor when similar cases arise.
I do also feel that in today's time we are a massive growing society. And that yes, better undertanding's for cure's and such is needed to help better tomorrow society in conjunction to our healths.
So therefore, such measures can be taken. For instance, in light of a new birth and the child with such sympotms that need further studies informed detailed consent is not necessarrly required instantly.
I feel that a further understanding is needed to help impove our treatment options as well as prevention to some diseases.
With these types of measures being taked, many improved studies can be done and more cures can be discovered.
So again, I do feel informed consent is necessary, also that it is in layman's terms for which pertains to whom.
However,the informed consent if not intially necessary and is not to be required if found to delay any study that would better the human race.
It is imperative that informed consent when given it is thoroughly explained and understood by the people. It is not ethical for someone to conduct study without disclosing the full intent and scope of a particular experiment or research. It is not ok to assume that since a certain disease falls under the category of " Medical illness/diagnosis" that the person will agree to that his or her DNA will undergo research for all the diseases available. It is important that when a particular informed consent is written it is A.SPECIFIC B. give side effects if any C. that the privacy is ensured. That is the main purpose of informed consent is to protect both concerned parties if any law suit is made but by definition it is a legal condition whereby a person can be said to have given consent based upon a CLEAR appreciation and understanding of the facts, implications and future consequences of an action. So that means the individual giving consent must understand therefore the one asking for a consent should provide education and detailed information. This is one of the patient's right, Patient has the right of informed consent and to privacy and confidentiality. Not disclosing the full scope of a research violates those rights.
It seems, to me, that the informed consent that was provided for the Havasupai when they began collecting samples was not detailed enough for them. The tribe’s people that had chosen to give samples all signed consent for their samples to be donated to “study the causes of behavioral/medical disorders.” I would read this and think that my sample is being donated for unlimited testing regarding behavioral and/or medical disorders. The tribe’s members, on the other hand, felt that they had been betrayed because they were only told and- had only asked for help -in finding out why Type 2 diabetes is so high risk among their people.
Informed consent is important to provide all necessary information to people in regards to the study so that the person can make a well-informed decision on whether they chose to participate. With that being said, I feel that it is also essential for the researchers to be informed about the people that they are recruiting or collecting samples from; it is equally important that one’s moral, cultural, or sacred beliefs not be compromised. As a society it is imperative that we continue to make advances in science and in medicine, especially as science and research continues to advance. It is also vital that these procedures remain ethical in every aspect.
The comment that most stuck with me in these articles was from the New York Times article, Where’d You Go With My DNA? In this article it stated that “Courts have ruled that individuals do not have a property right to their cells once they are taken in the course of medical care, but they do, under federal guidelines, have a right to know how they will be used.” As I mentioned before, if I were to have read the “blanket” statement provided in the consent I would have read it with it meaning that I am donating for an unlimited cause, but I am only one person and I interpret things my own way. For this reason I believe it is important for the person(s) conducting the study to be well informed about the people they will be working with and from there they can draw up their informed consent.
They may also need to include that the possibilities and research are limitless with the medical advances that continue to be made. This way not only are they able to collect samples in an ethical and inoffensive manner from a well-informed person, but it makes the subject aware that their samples maybe used in future studies that may differ from what the sample was originally collected for.
The main idea of this assignment is to discuss the importance informed consent in human subject’s research. This is an important topic because like we have mentioned in previous assignments, it’s important to know why certain experiments are done on humans. People need to know why certain experiments are being conducted, especially if it involves people giving their own DNA. For instance, the Havasupai Indians, who live deep in the Grand Canyon, were giving ASU students permission to take DNA from there tribe. However, once the Havasupai Indians found out that there DNA was being used for something else they quickly changed the way they felt about letting ASU students conduct further studies. According to the article, Indian Tribe Wins Fight to Limit Research of Its DNA, the tribe succeeded in banning the students from their tribe. In any case, I believe the tribe has the full right to do this. ASU students had the privilege to conduct experiments, and they took advantage of it. They could have just been up front from the start instead of lying to the Tribe. The article also stated that the students were using the DNA for good, but if they were using it for good, why lie. Obviously if they had to lie to the tribe about what there DNA was being used for, then something wasn’t right. If they had just come up front about what they wanted the tribes DNA for, the Indians wouldn’t have felt offended. This situation could tie back to the assignment were women were being sterilized without being notified. The women that went through that experience felt like they had no rights, and they even felt worthless. Imagine how the Havasupai Indians felt when they heard their DNA was being conducted for other things. They probably felt abused, worthless, and inferior. “I’m not against scientific research, I just want it to be done right (Tilousi).’’
I also agree with Hank Greely, a law professor and director of the Center for Law and the Biosciences at Stanford University. He stated that the ASU students showed distrust. In this case, researchers shouldn’t lie about what experiments are being conducted because then people will not trust the research experiments. Therefore, if people can’t rust experiments, then experiments won’t be conducted. If this were ever to occur, then we wouldn’t be able to discover new things in the future. Everyone will always think that they are being lied to. In any case if, CORRECT informed consent would be ensured, then people will be more than happy to participate. That’s why CORRECT informed consent is important, in order to conduct further experiments and to keep people happy.
Stephanie Galaviz
Informed consent is something that is very important especially coming from a human body. People now a days take everything so seriously about themselves and very personal. I think that the indians did over react a little, but at the sametime I understand them. They just felt like they were betrayed because they were nit told everything about why there DNA was used for. The researchers in my opinion did take advantage of the situation and that is not fair. The researchers might think it is dumb to explain to them everything they want to do, but it is very important. All they ask for from the scientist is a little of information on what they are doing with THEIR DNA. I mean people can just deny them and not give them anything to work with. I doubt that they would want that to happen but if they keep doing things like this and misleading people. Then I feel like people will stop helping out all together and then they really won't have anything to work with. I feel like it doesn't take much to inform people but then again I am not in their shoes so i really wouldn't know what to do. People just put so much trust in the researchers with something so personal as that. For people to mislead them like that makes them feel I think used. Every person has the right to clearly have an understanding of what they are getting themselves into. Now a days you have to explain everything on labels and products to inform people of all cautions and I think it should be the same for experiments like this.
Informed consent is extremely important when collecting any sample or prior to doing any procedure/experiment. It helps to avoid lawsuits such as the Havasupai/ASU case.
I have worked on a med-surg floor in a major hospital and the harp on us about INFORMED consent. Technically, the doctor has to be the one to explain the consent fully and get the patient to sign it once they feel that they fully understand it. However, the nurses on the floor go over the consent with the patient first and then the doctor goes over it again prior to the procedure and gets the signature.These patients are given an interpreter, if necessary, so that they are very clear as to what is going to happen.
I feel like the people getting the consent signed by the Havasupai tribe didn't fully explain what the consent said. They sold them on the Diabetes research and briefly breezed through the rest of the consent. My belief is that they may have taken advantage of the tribe so that they could use their samples for more research.
I realize that the consent was signed and it included the "behavioral and/or medical disorders" but that consent should be null and void if it wasn't gone over in their native language and explained in great detail. It's not fair to take advantage of a language barrier and/or lack of understanding just for ASU's own benefit.
There are plenty of people who understand the importance of giving samples and participating in research and they are the ones who should be giving the samples. People should not be tricked into being included in certain research that they didn't know that they would be a part of.
Chelsea Holgate
Informed consent is a very important factor in human subjects research. People need to know what research will be conducted and how scientists will be using their medical samples, such as DNA. In the case of the Havasupai Tribe in AZ, the scientist in charge failed to communicate the full extent of how the blood samples and DNA of the subjects was going to be used. I believe that the subject should have the right to choose which studies their samples may or may not be a part of. Biological studies are so important to medical advances and I think that the more studies that can be done with one blood sample, the better--however, informed consent must be given in order to move forward with these studies. The Havasupai blood samples were taken so that they may find out why there were so many of their tribe diagnosed with diabetes. Instead of just using their samples to study diabetes, they also used them to study mental illness, including schizophrenia, and many other studies that offended the tribe members. The lawsuit that followed could have been avoided had the researched properly explained how the blood samples were going to be used, or had they asked permission to use the samples for more studies. Informed consent is extremely important for both parties involved and for the research being done.
I think that informed consent is important because as we read in the assigned articles it will protect both parties from this kind of confusion. In this case, the Havasupai Tribe felt betrayed when they found out their DNA was used for additional research and at the end they didn’t even get an answer on the diabetes issue. They felt angry and sad to find out that the stories they heard growing up were not anywhere near the truth. They felt disrespected when all the new information was given to them. Informed consent would have helped them understand what the DNA was going to be used for and any risks that they need to be aware of.
Having a signed informed consent will give the patient full understanding of what the experiment or test will include or exclude. With that on-hand, the researcher will know that the patient has a clear and full understanding of the experiment foundation. Second, the informed consent gives the researcher an opportunity to inform their patients of the possible risks and benefits. Third, having a written consent will give the patient additional information about the experiment that they may have not otherwise understood in the beginning.
I think everyone will benefit from this action and it’s why it has become an ethical issue.
When I first began reading the articles, I felt that people were taking a blood samples too seriously. I then realized, with further reading, that the samples were only to be used for testing the high rate of diabetes, not the other spectrum that they had been tested on. I believe that informed consent should be given, no matter who a person is. I know I wouldn't want my blood or tissue being used for something that I didn't give a person rights to. Though the Havasupai were given some sort of consent form, which they signed, it was not clear to them. Miscommunication and misunderstanding does not equal consent. Nobody's body should be used in ways that they haven't given consent for.
Informed consent is highly important in human research subjects because they are the only decision makers in anything regarding their bodies. They have the right to fully understand the procedures, benefits, and risks involved in an experiment.
Also because people have different beliefs and cultures, and they might become involved in a procedure that they do not approve of. Finding themselves in this kind of situation can result in negative psychological and physical effects.
I can’t help but to feel that ethical morals have taken a nasty unethical turn; and a sense of deja vu of the similar Tuskegee Syphilis Experiment has once rear its ugly head again. It is makes me sad to know that guidelines and ethics were breeched in this experiment. Also that they will have certain tribe members believing in ones work all alone by conjuring up others to do the blood test as well; for findings that were not all the way explained. Other agendas were for sure used in this experiment that was not related to what the grant was given for. Inform consent to me can only happen when all parties are fully aware of their rights, the guidelines and the procedures and so forth. The consequences of this informed consent has left a tribe not only breaking their ethical moral “spiritually” by allowing others to come in and take their blood for different reasons other than spiritual reasons; but they also compromise the integrity of their tribes by allowing for such studies to reveal undisclosed things about their tribes other than what the grant study was intended for. Since Inform consent has been breached, in these instances when only a few spoke English and that only a hand full had graduated from High School; I feel justice was served when a settlement had to be reached for one tribe for 700,000 dollars to be given to the 41 members who gave their up their blood under consent not really knowing what they gave their blood for. I will close with this to me it’s kind of hard to pinpoint inform consent dealing with human factors; for example the asbestos incidents, still to this day is an ongoing continuing lawsuits brewing because of the many ways people have got around the whole ideal of the guidelines for “Inform Consent” dealing with humans. How it to be measured to me, there is no way you can fully measure it.
Informed consent is very important in human research. These people use there bodies so that we can test on them or on things that came from there bodies. If we don’t inform them of what there consenting to completely and they find out we loose there trust. When this happens people no longer want to participate because they don’t trust us and then we have no way of knowing if certain things are going to have a bad effect on us or harm us. Theses people are putting themselves on the line for them so we need to give them the respect of informing them of what they are consenting to.
Informed consent is essential because we recognize that patients/test subjects have a right to know what procedures or treatments will be administered and what possible side-effects they might have. Or at least to be aware that they are part of an experimental treatment option and that there could be unknown side effects and unknown outcomes. Without this kind of permission the studies become unethical. In addition to being the right thing to do, informed consent is also the legal thing to do--not having it could result in costly law suits or in the treatment not being approved by the FDA.
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