Read the "Crossing Cultural Barriers" case distributed in hard copy in class on Thursday 27 Feb and electronically via email.
Respond to the following questions from the case:
if you worked in a group, you can provide just one answer, but please note group members.
1. What are Ellen's responsibilities to Sebena, to Terfera, 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.
Answer on your own or in a group:
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? (please refer to at least 1 of the 3 readings on international research ethics that we've discussed in class).
Tyler Thompson, Daniel, Tyler Smith, and Caleb
ReplyDelete1. Her responsibility to Sebena is to make sure that she is capable of giving informed consent. This means making sure that she is capable of making a decision for herself. Her responsibility to Terfera is to make sure that she follows standard research procedures and doesn't coerce any research subject in to participating. Her responsibility to her adviser is to make sure that no research protocols are broken and to raise any concerns that she has to him. Her responsibility to the research study is to make sure that the study is done as well as it can be inside of research standards.
2. It could be written in a much simpler language that it currently is. It seems to presume a certain level of scientific knowledge that is lacking in the culture. To address this it could be written in layman's terms for the culture that it is aimed at. This would enable every individual that reads it to make an informed decision based on the presented information.
4. The ethical implication of providing a U.S. level of health care through a study to a group who could otherwise not afford it is that the group performing the research should continue that level of health care to those individuals. To not continue to provide the same level of health care that they received in the study would be to worsen the overall health of the population after increasing it temporarily. This would contrast with several sections of the Declaration of Helsinki with the most notable being the introduction. Inside of the introduction the Declaration of Helsinki makes it clear that the top priority in any research is the patients well-being. It would be potentially exploitative to give a higher level of health care to a research group only to remove it when the research is done. This could be seen on a similar level to not sharing the benefits of the study with the research group which is condemned by the Declaration of Helsinki. In both instances the researchers essentially give the research group what they need for the duration of the research and then leave them in the same condition as they were before the research.
ReplyDeleteWill Freibert and Cory Lynch
ReplyDelete1. Ellen has a responsibility to ensure that the informed consent form is explanatory enough to a person without basic education and to make sure Teferr is comfortable with the form.
2. Simplify the form and to have a neutral party present to explain that if the participant feels uncomfortable that they can opt out at any time.
4. Everything has to be imported, if the infrastructure is bad equipment could be potentially damaged during transportation when the researchers so does the equipment.
1. Ellen's responsibilities to Sebena are to make sure she understands the study and is giving her consent in light of her actually understanding her part in the research. Ellen may need to have a translator speak for her to Sebena to make sure she really understands. To Tefera, Ellen should also make sure she understands the research and the informed consent they are trying to obtain. To her adviser, Ellen should let her know of the discrepancy she is noticing. For the research study, Ellen should make sure that it is being done properly, especially as regards this issue of informed consent.
ReplyDelete2. Ellen may need to give Sebena (through a translator) a general lesson on disease, how it works, and the study in general to be sure she understands. She also may need to explain everything in a location that is more comfortable for Sebena.
4. In a developing country, there may not be a very high level of education in disease, science, and the like in comparison to the U.S. Therefore, it is difficult to apply the U.S. standards when doing a medical research in one of these countries. Glantz presents some of these difficulties in his article, like in saying the issue of proper funds being able to provide for the amount of research.
Kelcia Jackson and Maria Hehman were in this group.
DeleteSummer Smith, Exodus Edmerson, and Julie Mapes
ReplyDelete1. Ellen’s responsibilities to Sebena include making sure she fully understands the situation. She needs to ensure that Sebena is indeed giving informed consent, meaning that she must fully comprehend what is going to happen, and not feel pressured by any outside circumstances. Her responsibilities toward Tefera include making sure she’s explaining the situation to Sebena correctly in a more personable and less instructional manner. Ellen should make sure she’s keeping her adviser updated on the proceedings of the research study, and to ask for advice if she’s unsure of what to do. Her responsibilities to the research study are to make sure that it’s following through as planned, and that adjustments are made if problems were to arise.
2. The consent form could be modified so that it sounds not necessarily less complex, but more geared toward Sebena’s educational background and understanding of the material. Simplifying the language used in the consent form could help immensely in this regard. Ellen could also make the situation a lot better for Sebena by taking her out of the current setting used for the research study, which seems to be making her uncomfortable and conducting research in an area where she feels more at ease. Ellen should try and consult with Tefera so that the explanation of the research study sounds less instructional, and doesn't feel forceful or coerced. Changing so much as the tone of your voice or the way in which words are phrased can make a lasting impact.
4. 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 is that there needs to be some type of guarantee that this medical care won’t die out the moment the researchers have concluded their study. The Nuremberg Code informs us that experiments should not be performed in situations where physical and mental suffering would result; if these treatments were to abruptly end, noticeable suffering would likely increase.
Group: Tara LaMendola, Tori LaMendola, Rachael Moran
ReplyDelete1. Ellen's responsibility includes one to herself and to the patient. She has a responsibility to patient advocacy- speaking for the patient, especially since she is sensing there is a lack of complete understanding. Ellen contains the responsibility, because she is the research conductor, to be certain Sebena completely understands to make an accurately informed consent. She also has a responsibility to herself, and speaking that she feels uncomfortable about the situation. Finally, Ellen has a responsibility to conduct the research study fairly.
2. The process of the consent could be altered to adhere to Ellen's concerns. Because she is afraid of a lack of comprehending on Sebena's part, a second person could come in to help communicate for a full understanding. Another way to help would be reducing external stimuli in the environment (loud machines) to help Sebena concentrate. Another way to ensure the consent is to converse with her multiple times for a complete understanding. Lastly, a brief, general education about the disease, vaccine, and study could occur before the consent to have a more informed decision.
4. Providing a U.S. standard medical care in a location that can't afford it would be illogical. To provide a medical treatment or care to a society with the chance of it being removed, or the chance of the society not being able to maintain the care because of the cost would provoke them. If a country is receiving research from a specific society, they ought to provide the treatment if discovered.