Address 1-2 of the following, then comment on 1-2 of your classmates' responses.
1) What do we mean when we ask about the quality of informed consent? What could undermine informed consent (see the Glantz et al. essay in particular).
2) Who are vulnerable populations which might need special attention when asked to participate in research?
3) What is exploitation? How could medical research be exploitative?
4) Should there be different standards (of risk/benefit, or informed consent, etc.) for developed vs. developing countries?
Background
Institutional Review Boards (IRB)
UC's IRB http://researchcompliance.uc.edu/Home.aspx
More info from
Hastings Center Report (a bioethics periodical) http://www.thehastingscenter.org/Publications/IRB/
& Harvard http://www.hsph.harvard.edu/ohra/
Immortal Life of Henrietta Lacks
http://rebeccaskloot.com/the-immortal-life/
Tuskegee Syphilis "experiments"
• Transcript of President Clinton's 1997 formal apology to study members.
• Centers for Disease Control (CDC) Tuskegee study Web site .
http://www.cdc.gov/tuskegee/
• Background on the Tuskegee study, from the Tuskegee University National Center for Bioethics.
http://www.tuskegee.edu/about_us/centers_of_excellence/bioethics_center.aspx
• Tributes to Herman Shaw, who died Dec. 3, 1999, and Fred Simmons, who died Feb 5, 2000.
2. Vulnerable populations are ones which, as plainly as possible, are less able to protect themselves from injustice than non-vulnerable populations are. Developing countries which may not have a benevolent government, prisoners who are often at the mercy of their jailers, and the mentally incapable (whether through external factors like drug use or internal mental illness like schizophrenia) are all examples of populations that cannot protect themselves as well as ones without these detriments.
ReplyDelete4. There should indeed be different standards when comparing developed countries to developing countries. When conducting research in developing countries, there is greater possibility of committing an injustice (whether intentional or not) than in a developed one. This is because citizens of a developed country often have better legal structures to protect their citizens than developing countries, and also have multiple options for citizens to find services required - the need for research isn't as important to developed countries as it is for developing ones.
I agree about your answer to question 4. There is always a chance for committing injustices in different areas than what the researchers are accustomed to in their own area. Every place is different worldwide, and will, of course, have different legal and medical structures.
Delete2. Vulnerable populations are populations that are for whatever reason unable to protect themselves from potential exploitation. These reasons could be anything that could prevent a person from making an informed decision about participating in research such as lack of education or poverty. Populations that are at particular risk of exploitation in research are individuals in developing countries, prisoners, and the mentally handicapped. These groups in particular do not have much of a voice on their own and need protection from an outside organization to ensure that they are not exploited.
ReplyDelete3. Exploitation is the use of another human being as merely a means toward an end. It is to use a human being as a means to advance one's self with little or no regard towards the individual that they are using. Medical research could be exploitative in a couple of ways. First the researcher could use the research merely as a tool to advance their career rather than to help those that they were conducting the research on. Another way that medical research could be exploitative is in something as simple as not providing the fruits of the research with the people who were the subjects in the research. This would be using the research subjects merely to advance the research with little to no regard for their well-being.
2) The vulnerable populations which might need special attention when asked to participate in research are those who may not be able to fully protect themselves from being exploited. These populations can be those who are illiterate, individuals who cannot think for themselves or people who have to rely solely on others. These groups need special consideration to insure that they understand the experiment in as many aspects as possible and possible ramifications. These vulnerable populations who are seen as extremely vulnerable are basically at the mercy of others and should have special attention so exploitation does not occur.
ReplyDelete3) Exploitation is using others solely for personal/selfish gain without the intent of “helping”. Medical research most definitely can be exploitative. Taking advantage of vulnerable populations solely for gain and not taking special consideration of the test subjects is exploitative. Also not properly compensating the individuals who took a role in the research is another method of exploitative research.
I agree with you that medical research can indeed be exploitative. If research is to be done, it ought not deliberately harm an individual to excess. There needs to be real benefit attempting to be gathered from the research, benefit that would outweigh negative effects.
Delete1. In order to have the best quality of informed consent individuals have to be completely competent in making their own decisions and additionally have a full understanding of the procedure or experiment before participating. The individual additionally should receive any necessary background information that could help clarify any questions or concerns. They additionally have the right to be aware and warned of any side effects, and informed they can voluntarily remove themselves from the study at any time. Researches ought to ensure that their participants have these comprehensions, and should also understand any cultural, communication, religion, ect. barriers that may occur with an individual. Basically, in order to have a successful informed consent the participant must be competent, have a full comprehension of the procedure, disease, side effects or any other significant information about the experiment, overcome any communication barriers, and ensure the individual is comfortable with the experiment. There are some obstacles that could weaken the informed consent, few examples include the environment, communication barriers (including body language and cultural or religious influences), individual’s personality, education, the way the researcher delivers any information about the procedure, or their authority.
ReplyDelete4. Ideally, the standards should be adjusted to accompany each location. This is very similar to situations where a nurse might have to adjust his methods to fit a patient’s expectations or social needs. For example, if there is a patient that is getting a new medication that does not obtain a high education, the nurse would not use medical terms to explain the purpose or administration of the medication, they would explain it in a way that a patient would benefit the most information from. How you describe an informed consent should be altered individually in order for the participant to receive the full benefits, information, and effects of any procedure or experiment. There should not be a single way of delivering an informed consent because every person’s culture, personality, and social contributions differ that can effect the way a person receives information.
I agree. The standards do need to accompany each location. Every place is different, just as every person is different. It is the responsibility of the doctors and nurses to fully explain everything so that people can understand it no matter what type of education they have. That way, everyone will benefit from it.
DeleteI love the example that you used about nursing. It provides a clear and detailed example of how informed consent should be used in developing vs. developed countries. The standards change depending on which location or community you're in, no matter the situation.
Delete1. Informed consent requires that the subject be competent (i.e. rational and free of pressure), informed, and voluntary. The subject involved must have a certain level of education that would provide ample understanding of the research taking place. They also have to be able to retain a basic understanding of the information given to them. They need to be aware of exactly what to expect from what they are agreeing to; nothing can be left out. Also, according to the Glantz article, there must be a real benefit that could result from the research. This benefit needs to be for the whole population, and not just the subjects involved. Also, there needs to be a logical plan for the research.
ReplyDelete4. Developing and developed countries are very different from one another in matters of education, health of populations, economic status, etc. Therefore, when doing research in a developing country, one might need to go about it much differently than in the case of a developed country. A brief education may need to be given before obtaining informed consent, for example. The risk and benefits might be very different in a developing country with low health than in that of a developed country. These should be taken into account when doing research. Perhaps the standards should not be so much different, but rather the way in which those elements in doing research are considered and obtained.
I agree, the standards for informed consent shouldn't have leeway when obtained in developing countries. We should continue to hold the same standards that we normally would in developed countries, considering informed consent is not an issue to be exercised lightly.
Delete2. Those vulnerable who would need special attention are the less developed areas with less education than the well-developed areas. For example, in America, we are constantly learning. Through education, we have learned of our own personal autonomy, and how to make educated choices for ourselves to benefit ourselves the best. Less developed areas do not have these opportunities, and therefore can be exploited more easily when it comes to decisions affecting themselves. Essentially, while they do maintain knowledge, they may not have the adequate knowledge to make a completely informed decision about participating, and whether it would truly benefit them.
ReplyDelete4. Just as anything must adapt to the vast difference of individuals and culture, I definitely think there should be different standards. For example, in the case described in Crossing Cultural Barriers, the consent would have been more suitable to informed if there was a form of education prior to the consent. While developed countries, such as America, have more opportunities for education, we are educated in some aspects, such as science and medicine, than other developing countries. Therefore, the standards that currently have wouldn't be fair to place for developing countries that do not have the same opportunities for knowledge. While the consent would be considered informed in developed countries, it wouldn't be fully informed in a less developed area, such as Africa. An effort to create a more informed consent for areas with less education is to provide a brief teaching of the medical procedure or other health topics in order to have a more informed consent.
Your response seems to imply that there are little to no vulnerable groups in America due to education empowering individuals to make informed decisions that benefit themselves. Doesn't this idea assume that education across America is of a sufficient level to enable individuals to have adequate knowledge to make an informed decision? Are there not groups in America that may not have access to the education levels required to truly make an informed decision in regards to research?
DeleteIn America, there are definitely vulnerable groups that are unable to make as great of informed decisions in comparison to those with more opportunities. However, even with our vulnerable groups, I was simply writing about the areas with greater association to poorer opportunities, especially in medicine and education. Also, I was making a connection to the case we were discussing in class. Overall, I think wherever there is a lack of education whether it be America or a less developed country, it is a lack of quality information, and therefore, not an informed decision.
Delete1. When we ask about the quality of informed consent, we must be sure that a person is fully informed, meaning that he/she has a clear understanding of the facts and possible outcomes of an action. This person, in order to be fully informed, needs to have a minimal education, and it must be acknowledged that he/she fully retains and comprehends the information provided to him/her. Along with this, he/she must also be competent in their decision making; they should be rational and free from pain and emotional strain. Lastly, this person must be able to provide the informed consent voluntarily. Such things that could undermine informed consent may include coercion or undue influence from either a person’s family/friends or their surrounding community, language barriers between that of the researcher and that of the potential participant, and other miscommunications due to education and the manner in which the information is being presented.
ReplyDelete3. Exploitation can be referred to as the action of treating someone unfairly, and making use of a particular situation in order to gain advantages for oneself. Medical research could be exploitative, for example, when research is exercised with human subjects that will, in the end, not directly benefit from the research performed on them if this research is a success. Also, if the research being conducted becomes solely a tool for the researcher to have his/her name more prominently known, the subjects no longer become the prime concern in this scenario.
You say that exploitation can be referred to as the action of treating someone unfairly. I have to ask though is it always possible to find a fair way to compensate someone?
DeleteI wouldn't necessarily say that it's possible to find a fair way to compensate everyone that is treated unfairly or exploited. Yes, there are going to be situations where people feel as though they have not been properly compensated for. However, I think that even the slightest form of compensation helps. We see in "The Immortal Life of Henrietta Lacks" how poorly Henrietta and her family have been treated. They felt as though they had been "cheated" as a result of their belief that Johns Hopkins stole Henrietta's cells without her informed consent. While some family members considered suing the hospital, at the very least they wanted Henrietta to be recognized and honored for her incredible contribution to science. While we may not always be fairly compensated for via material goods or wealth, it's nice to feel as though we are being properly recognized for what we give up/what is taken from us.
DeleteWho are vulnerable populations which might need special attention when asked to participate in research?
ReplyDeleteVulnerable populations that might need special attention when asked to participate in research could be defined as everyone. Yes it is possible to say that the economically poorer and those incapable due to their age (old or young) are probably most at risk to need special attention when asked to participate in research. However the truth is that it is not possible even for those trained in a medical profession to always be aware of the results research might inflict upon them. Therefore I think that all populations must be given special attention to when asked to participate in research rather than populations that are seen as easier to exploit.
I think you make really good points. Because everyone is different, it is fair to say that everyone requires a certain type of attention that suites well to who they are- economically, culturally, age-wise, etc., for a variety of reasons. I also believe that it is a just thought that it is extremely difficult, and probably close to impossible, for researchers to provide all possible results of a study.
Delete1. What we mean by informed consent is that the patient’s involvement must be voluntary and that they actually know what they are getting themselves into. There must be an education level behind the person the is volunteering so they actually know the side effects and what could happen to their body, or somebody must be there to explain it to them in their language. Things that could undermine informed consent are people who do not know what is truly going on they are just volunteering for the reward or because someone told them to go volunteer themselves for the study.
ReplyDelete2. Vulnerable civilizations that need special attention when it comes to informed consent are populations that have very low level of education or no education at all, so people do not have any clue whatsoever to what is going on in the experiment they are just there to receive the reward at the end. Also, an area that is really poor because people would do almost anything to receive medical attention to get better.
2. Vulnerable populations could include anyone who is uneducated, children, the elderly, natives of other countries/cultures. With these people or anyone who may not seem to fully understand, necessary steps should be taken to help them understand. If a doctor does not think a patient understands, and a patient doesn't speak up saying so a doctor should not proceed. The patient may be afraid or embarrassed to ask a question or further explanation, the doctor should make sure that the patient is fully aware of what their situation entails.
ReplyDelete3.Exploitation is using a person or persons for something other than what the agreed to or taking advantage of them. Exploitation could occur when a doctor puts his own "needs" over those of a patient. A doctor could value their career and strive for greater success and in the pursuit of these goals they could use a patient as a pawn in achieving these dreams. They could overlook the patient as a person and just use them to help further their research.
2. Vulnerable populations that might need special attention could be people with a disability and children. Certain things may be extremely difficult to understand so in order for them to give consent, they have to be fully aware of the situation. Also, people who are not well educated may need some attention too. The main goal is for the participant to understand the entirety of the situation along with possible risks so that they can properly give consent.
ReplyDelete2. Vulnerable populations might include populations that aren't able to protect themselves, or perhaps those who are uneducated and aren't sure what exactly they're participating in.
ReplyDelete4. There should absolutely be different standards for developed vs. developing countries. Developed countries are typically more educated, whereas developing countries are not, meaning that they might not be entirely sure what they're doing in experiments, informed consent, etc.
I agree that the developed countries should be held to a higher standard than countries still developing.
Delete1. informed consent is when the patient has the mental awareness to make decisions about their health care. the mental stability of the patient and the overall state of the patient could undermine their ability to consent.
ReplyDelete3. Exploitation is when you use someone or something for your own personal gain and then after you get what you need you stop communicating with them. Medical research is very exploitative. When companies go to underdeveloped countries and conduct their research on people who will most likely never get to actually benefit from the findings of the research.