http://nyti.ms/15nHkOR
The Bronx High School of Science spent more than a dozen years and $1 million on a Holocaust museum and studies center. “Great scientists have to be ethical people,” said the school’s principal.
11Apr13 Feds Fault Preemie Researchers For Ethical Lapses
http://m.npr.org/news/front/17681180913Mar13 NYTimes: African Trial of H.I.V. Drugs Fails
The failure was not due to the methods — two different pills and a vaginal gel — but to the fact that the women did not use them consistently.
http://nyti.ms/ZbxRSZ
Discussion questions (from case I scanned and emailed you on Sun 10 March):
1. What are Ellen's responsibilities to Sebena, to Tefera, to her adviser and to the research study?
2. How could the informed consent form or the process of obtaining informed consent be modified to address Ellen's concerns? Consider issues such as different cultural meanings of disease, the need for background knowledge about science, medicine and research study design, and the length and depth of the information provided?
3. Ellen notices that Sebena appears intimidated through the informed consent process. Moreover, the research study has provided the funds to build the new medical care facility in this resource-poo area. Does the evident inequality in power between the researchers and the participants have an ethical impact on the informed consent process?
4. What are the ethical implications of providing a U.S. standard of medical care through a research study in a society that cannot support the cost of such care outside a foreign-sponsored research protocol?
5. What ethical issues are raised in obtaining individual informed consent in a culture where family and/or community consent is also warranted, and, as in this situation, obtained in the form of an agreement between the researchers and the community elders?
Heres a piece from my third paper in response to questions 3 and 4 based off my take on any coercion present in this study that Sebena may have faced:
ReplyDeleteThe fact that Sebena appears intimidated is not very surprising. She most likely is used to living in squalor and shacks. Now she is placed in this immense, well-made building with equipment she has never seen before. Then people start using scientific language she doesn’t understand. It would be very easy to appear intimidated in such an unfamiliar setting. In some manner this power inequality seen between the researchers and the participants acts a form of slight coercion. The participants are obviously going to be intimidated and thrown out of their comfort zone. They are probably slightly scared and may feel like they should say yes to people with so much power and wealth. The coercion from giving free U.S. standard medical throughout the entire experiment is much greater than that of the power inequality. I do not think it is ethically concerning though. The researchers are doing medical research. They have the means to improve the health of the locals who have no real modern medical aid. It would be completely different if the entire village was starving and they offered food or water to convince the locals. The final point is that all research involves a certain amount of coercion. If there was no benefit from participation in a research study then there would be very few volunteers. There has to be incentive to make people want to participate. It is unavoidable to prevent the power inequality and I think the beneficence from giving the locals quality medical treatment outweighs the negatives from the slight coercion involved. The coercion is not of a form that would ruin the autonomy of the participant (you are starving and they will give you food, etc.).
You make an interesting point, Michael, stating that all research involves some type of coercion. However, I don't think incentive and coercion should be used interchangeably. I think research can be coercion free, but still have incentives. This just depends on what the incentives are, and if these incentives are not directly related to the research itself then they are more likely to be coercive. For example if you are providing food and water, to participants only, than that would be considered a coercive incentive. An incentive that would not be coercive would simply be the results of the research having a positive impact on the whole of the participating area. So I agree that incentives are how research gains participants, but it does not mean coercion is necessary in all research. Coercion simply should not be present in any research, otherwise the methods and results could be subject to ethical and scientific scrutiny.
DeleteGood point Gabrielle. I guess I did miss the distinction between coercion and incentive. Glad you caught it! I also think you defined what coercion and incentives were very well and I agree that if incentives are directly related to the research, it helps prevent them turning into coercive forces.
DeleteIn response to the first question: Ellen’s responsibility to Sebena is to ensure that Sabena’s rights as a research subject are being followed. In a utilitarian point of view, human experimentation is morally permissible and required, because its future benefits and prevention of harm to many will outweigh its harmful consequences to some research subjects. Sebena does not have a duty to participate in this research, but if she does she will be helping out the greater mankind. Ellen’s first responsibility to Tefera is to answer any questions she may have concerning the rules and regulations that govern medical research with human subjects. Ellen’s second responsibility to Tefera is her ethical responsibility to train Tefera to detect when a research subject does not seem comfortable filling out the informed consent form. Ellen’s third responsibility would be to train Tefera to conduct the informed consent process in a less intimidating environment, so that the research subjects do not feel obligated to sign the informed consent form. Ellen’s responsibility to her advisor would be to make sure that the study is ethically following all the rules and regulations. Ellen’s responsibility to the research study is to make sure that all the subjects sign up voluntarily, and that all the research is collected within her ethical and moral standards.
ReplyDeleteI feel that the points that you all make are valid points and when research is done in a third world country such as the one from the case, there is going to be some sense of coercion, it is almost inevitable. But I agree that Gabrielle definitely established a clear line that there can be incentive without coercion and in this case I feel that the result is as such, incentive without coercion. I feel that we see most cases of coercion when research is done and the native people home to the land where the study is being done, don't see any direct benefit. Just tests are ran and products made and they ship them back to the first world. But in this case, the mothers of the kids, and the kids themselves benefit from the study, which establishes the fact that there is incentive. If there were no direct benefit to the people involved in the study, and they were somehow "forced" to do it anyway, then I would say that coercion was in effect.
ReplyDeleteI agree with everyone that at the end of the day some element of coercion is there. because the fact a developed country is providing a treatment that can reduce the risk of transmitting viruses during pregnancy is something a third world country would feel to repay them for providing the treatment. So Sebena feels the obligation to respect the wishes of her tribe, but also to participate in the studying knowing that the treatment will allow for her unborn child to live a better life. I agree with Gabrielle that there is incentive without coercion because the community is directly benefiting from the study that is being conducted. I feel however there is some a coercion element in the community elders and Sebena obligation to respect the wishes of her elders and participate in the study.
ReplyDeleteIn response to the African Trial of HIV drug testing maybe they should have done a smaller study first and absolutely made sure that the girls took the medicine and gel. It was probably hard to keep tabs on 5,000 girls and make sure they were actually taking it so you could get accurate results. It is a shame for the researchers to waste their time trusting the girls that said they were taking their medicine but really were not.
ReplyDeleteIn regards to the African Trial of the HIV drug. I find it amazing that they have found a drug that is effective in preventing the contraction of HIV, but why when given the drug do the participants not take the drug on a daily basis. I agree with Craig if they start of with smaller sample size of girls then maybe they can observe and keep a stricter regimen of the treatment in play. The prophylaxis treatment with this drug is a good idea. I feel they should try maybe give an incentive to those who follow along with the planned treatment regimen and will be better result for future studies.
ReplyDeleteI do agree in that it is a good idea to start of with a smaller study to get more concrete data,but I think that even if trials were successful and it was pushed to become more widespread, once again there would be problems with persuading the locals to stay on the drug, or even take it at all. The huge rural population of Africa makes it extremely difficult to keep up with who is taking the medicine or not. I commented on a similar situation in Kenya, where female genital mutilation is technically against the law, yet still occurs a ton because of the difficulty enforcing the law(very spread out, rural population).
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