Discussion Questions:
Answer each of the following and respond to 2 other posts by 27 May.
1) Regarding our readings on research with human subjects, do you think that these clinical trials on human subjects are ethical, or not? Explain. Just pick 1-2 examples from the readings.
2) How would you address each of the criticisms that Brody discusses? (Do you agree or disagree?)
3) Pick an ethical perspective analyzed in this course, and assess a case from that perspective. For this question, whomever gets to it first, gets to pick the example case (from a reading) to discuss :)
I choose to discuss the blood collecting mission in Cebu. I would be wrong to collect blood from these people because the cost of the drug makes it unobtainable whether it is inexpensive or not. This population is very vulnerable.The study should be performed in a developed country first. If treatment were found to be as simple as folic acid and vitamins, it would be a relatively simple treatment. Then a humanitarian mission could render aid.
ReplyDeleteI agree Cindy that it is not right to collecte data from a population
Deletethat can't afford treatment once it is found. It is better served if treatment is found by another population that is not so vulnerable. Then it can be shared with others by humanitarian mission.
How terrible to be given the hope of a potential new treatment for something , then not be able to obtain it when the treatment has been developed . In this instance the people were taken advantage of and given false hope . This is incredibly unethical both in medical practice and just as good human beings .
DeleteSometimes I think this occurs even in developed countries. We do research and monetarily compensate the subjects but the end results medication's cost is above and beyond what the population can afford. Look how the AIDS epidemic started. I don't think that population could afford treatment when it first became available.
DeleteFeeding off from what Cindy stated about the blood collection mission in Cebu I feel this is not ethical because I feel it is not a fair process. It should be done it a different population of people that has a better understanding and that could afford to give the trail drugs first before exposing it to such a vulnerable group of people. Exploitation of subjects is wrong because I feel we would just be using them to benefit people that can only use the new treatment. The population that was used for research has taken all of the risk and might not be rewarded with the results. It just does seem justifiable.
ReplyDeleteI think the population must benefit in some way after conducting the research. It is unjust to simply use them for study and not to reap the benefits.
DeleteI know the health officer felt the prevention may not be available to the people of Cebu. Was that his personal opinion based on historical facts? The study does not state that Munger will refuse to follow through with providing either education on how to increase B6 and folate in diet or supplements. There is clearly a level of mistrust and to say if this study is unethical, I would like to know if the mistrust is warranted.
DeleteIt is easy to see both unethical and ethical positions when it comes to research. I would say the use of undeveloped countries for research is ethical, if used in a way of utilitarianism to produce the greater good. Of course, the subjects should not be mistreated regardless of the state of the country, every person deserves the right to protection. Vulnerable populations definitely need greater protection, but in the end if it creates the greater good, then I feel like it is ethical. The people of Cebu did not seem well informed of what the purposes and outcomes of the study were, as well as being coerced through food, raffles, etc. This particular study did not seem ethical. Brody makes valid points of control groups, coercion, and exploitation. I agree that in some cases control groups may not have any better access to care, thus not creating a situation of neglect. I don't think the women were coerced just because it reduced the HIV transmission rate to their child, this was a benefit of the study. They had a choice not to participate and those who did not were not changed in any way. Exploiting developing countries is not unethical if they are well informed and benefit from the results of the research in which they have participated.
ReplyDeleteDid you really mean to say that "Exploiting...is not unethical?" Maybe a different word was meant, like "Utilizing subjects?" I agree with your thoughts on Brody's point about coercion of the subjects. I don't believe they were coerced. If that were the case when indigent subjects volunteer for research projects to make money that would be coercion also and yet this is practiced now in developed countries. And then again someone else might think that coercion.
DeleteThis comment has been removed by a blog administrator.
DeleteI think Robin is right to gently challenge you on your use of exploitation. By definition, exploitation can't ever be ethical, right? So, Kelli, either use a different word or elaborate some so we can understand your position.
DeleteI don’t believe that it is ethical to do research on human subjects when there is no potential benefit for them. Some of those very vulnerable include those in underdeveloped countries. Even if they are studied it is highly unlikely that they will not be able to access the treatment deemed beneficial. Using the example of the maternal-fetal HIV transmission studies, the desire was to determine if a lower dose of AZT would reduce the rate of transmission by 2/3 of the United States higher dose. While using a control group who does not receive a medication or treatment that is already known to be effective does not feel right, it may provide helpful information, as it did with the PETRA trial.
ReplyDeleteI don't understand the need to go to an underdeveloped country in this case. If the treatment is available here and being given, why would they not have attempted the clinical trial here. I think the answer lies in the likely fact that no one would be willing to put their child at risk - which makes it unethical to ask someone form another country to do so.
DeleteI am not sure if the control group would get not treatment. Is it possible the "control" group is the population already receiving the $800 worth of AZT?
DeleteI agree it is unethical as well and as Kristi said, unless we would be willing to do it to our own child, we should not be asking that of another. Research is a good thing when done correctly and I know it is necessary to further the medical field and treatment available. There has to be a more ethical way to obtain this information while at the same time benefiting the participants. This is taking advantage of them and exploiting them and their entire country!
DeleteIf there is no potential benefit for the person then I believe it is highly unethical to do research on human subjects. The example of using the HIV transmission studies from maternal to fetal, I do not feel that this was ethical because we already had a treatment that worked. I also feel that it can be unethical to do research in third world continues because a lot of the people that were asked to be in these studies may not have the education to understand all the risks involved with this study. Many of them may of just seen the medical treatment as a good thing since any kind of medical treatment is very poor in these counties.
ReplyDeleteI agree. If there is no benefit to the person, especially in a trial of this caliber that could potentially decrease maternal-fetal transmission of HIV, it would be unethical. That is true the participants may not understand risks involved and if the benefits out weigh the risks.
DeleteWhat was the benefit to redo a study that has already been proven effective or why have participants do a study that they can not afford and will never be available to them. That is exploitation and it is unethical.
DeleteI chose clinical trials in developing countries with the short course AZT regimen. The participants in this study were coerced and did not give consent which is unethical. They should be able to choose if they want to be in the study. The participants were also exploited because the drug would be unavailable after the study was over. As a participant they should also benefit from the study and receive the medication if the medication outcomes were proven to be positive in treating the disease.
ReplyDeleteI agree, it is unethical to coerce subjects into participating when the drug would not be available to them after the study is over.
DeleteI feel that all of these cases could have been unethical in some ways. I don't think it is ethical to do any type of research on human subjects that would not be available to them regardless of the cost it they participated and the treatment works. It is also unethical to try to coerce a subject into participating telling them the treatment may benefit them and/or their unborn child only to find out that they did not receive the actual drug but a placebo. Using a placebo drug to do an experiment that can be a life saving treatment is wrong. These experiments were done in underdeveloped countries to people whom were not very well educated or did not fully understand what was being done is also wrong. I feel that maybe there would not have been as many willing people had they been completely informed that they drug may not be available to them after the study was done because of cost.
ReplyDeleteDonna,
DeleteI feel like the same way about them choosing an area where people are mostly uneducated and do not understand modern medicine. I also feel that coercion shouldn't be allowed in any testing. How can you ethically do something to someone knowing that they do not fully understand what is going on.
Clinical trials on human subjects CAN be ethical , if it is a well designed study that could possibly provide benefit to the target population. However , going to impoverished countries to perform the clinical trials seems very unethical to me . It is exploitation. In the case of the blood collection in Cebu - I feel like they were attempting to coerce them into participation , but could not assure them that the alleged treatments or solutions could be applied to them for benefit. This is morally wrong.
ReplyDeleteI am not sure that the very act of doing the studies in underdeveloped countries makes the study unethical. I do think it can be a slippery slope. Are the participants really able to give informed consent? Impoverished does not necessarily mean ignorant, so possibly yes as long as there is a someone designated to give the women all the information on possible risks and benefits and the women are able to voice understanding.
DeleteI think it can be done too if well designed. Some of the impoverished countries could benefit greatly from these trials if only they were promised treatment in return. That seems the only fair thing to do, as compensation for their participation.
DeleteI will discuss the lower dosing of AZT research being done in Africa. If it is clear that this population on pregnant HIV positive women cannot afford the current, well established dosing of AZT this testing may be ethical. The question I would have to have answered is "how was it that the current dosing was established?" I would have to assume there were studies done to establish the efficacy as well as risks to the fetus when speaking of the current dose at the cost of $800. Were there any trials using lower doses? If not, then would the population in Africa be offered a "financial" benefit in the form of affordable medicine? With studies already having been conducted in Thailand showing that the lower dose of AZT can be effective and the African government not giving any assurance that even the lower dose would be made accessible to the women, I don't believe this study would be following the guidelines set by CIOMS. If the lower dosed drug had a predetermined price that was disclosed to participants prior to entering the study, I feel that would be ethical.
ReplyDeleteI think that the clinical trails, with regards to low doses of AZT, were unethical as the community would not have access to the spoils of the trails unless the medication were free. The subjects were from an impoverished nation/community and thereby unable to afford any type of medical costs for the drug. To me this exploits the subjects as members of their community. Also the results from the testing seem to be from a business standpoint for personal gain for the company that makes AZT, indirectly.
ReplyDeleteI agree with Brody's criticism concerning the just treatment of the subjects not being denied treatment, even in the control group for this country. I agree with Brody's criticism concerning coercion and there being no threat that put the subjects below their baseline giving to the idea that they were not coerced. I disagree with Brody's third criticism about if the subject is not exploited then the broader community is not exploited. I believe that since this population was chosen for this specific reason the population itself it is being exploited if it does not gain access to the spoils. I know that this idea is not acceptable as it is not practiced in developed countries. Indigents volunteer for research trails and get paid but the community they come from does not benefit from the spoils of the trail.
I do not believe these clinical trials on human subjects are ethical. They do not line up with the codes of ethics. If the patients are receiving no current or future benefit from AZT dosing for HIV, but only being used as test subjects, then it is wrong. For that matter, they could conduct this experiment on rats or apes. These poor poverty stricken women are hoping against hope for a chance at longevity and health for their babies, only to have it stripped away and given to those who can afford it. This is wrong on a lot of levels. If it would be wrong to do it on the poor and homeless in the USA, why would they consider it ok to do this research in other countries? This makes no sense. Even though there is no harm being done, they are offering hope when really there may not be hope.
ReplyDeleteI agree with Brody's criticism, it seems so unethical to deny proven treatment to women, even if the alternative would mean no treatment at all. They are hoping they didn't receive the placebo, and will be let down severely. This could cause a lot of anxiety and depression, not how research is intended to be. I don't believe they were forcibly coerced, but backed into a corner with no other options for protecting the health of their unborn child. Again, this is like playing the lottery, and they didn't know who would get the real treatment vs. the placebo. I would feel awful if I were in that group, a huge let down after getting your hopes up. Lastly, I agree with him in that exploitation of developing countries is wrong. It's so prideful of us as Americans to assume we can use the other countries for our own benefit. Only if we could have an agreement with them and perhaps work together on research would it be acceptable. Then they could also reap the same benefits and ultimately develop their own countries even more.
An ethical principle to view this is from a consequentialist theory. To do this experiment, knowing it benefits others more so than the trial participants is a form of "ethical egoism". The consequences are maximized only for those benefiting from the results of the trials once concluded.
Carla: very nice point about ethical egoism!
ReplyDelete