Brittany Smith, Carly Ryan, Danielle Klein, Hannah Petterson, Molly Downing, Rachel Steffen, Alex Videka, Jordan Smason, Haley Hines, Cassidy Conlan, Taylor Oakley, Kevin Sparks, Rachel Bohnenkamp, Katie Klingbeil, Kirsten Videka, Morgan Buisker, Lyndsey Dresen, Ashley Brown, and Adam Scafuri
Read Their Op-Eds, Please Use Your Search Function)
Topic the Students Wrote On:
on the information presented in the five case studies, you
are to voice your view on how Institutional Review Boards (in the
U.S.) and/or Review Ethics Boards (in Canada) should enforce a
set of common rules regarding research. How much freedom should
researchers be allowed in conducting their research? What regulations
should be enforced to prevent the abuse of research subjects and
ensure, more generally,
I Pledge Allegiance to my Research
My very first day of kindergarten began with morning announcements, the days of the week song, and a pledge that rings loyalty into my thoughts even to this day. From a very young age, we engrave the Pledge of Allegiance into our hearts and begin our days promising our neighbors that we believe in liberty and justice for all. This holds true in every realm of life from the working world to the anthropological world and especially to the research world. In order to ensure the justice and safety of society, research must be regulated in a way that restricts funding prior to consent, requires approval by multiple entities, but also allows for researcher flexibility in topic and nature of studies to make way for innovation and creativity.
Research can be a wonderful thing when used properly. Without regulation, research studies will lead towards manipulation and harm of individuals in our society which cannot be tolerated in order to enhance our future as a species. In the past research has been used to analyze and understand immunizations and test the effects of vitamins on the human body. Knowledge of these medical issues has the capacity to enhance the quality of life for future members of the human race. However, it is imperative that researchers draw the line at prioritizing human life that exists now before future, hypothetical beings because if we do not take care of our own now, then there will be no future to consider. For example, a study that took advantage of malnourished aboriginal children stripped these under -nurtured individuals of their right to medical justice under the name of a vitamin effectiveness study. In this case, potential enhancement of a future population took precedence over an existing population and therefore is unethical and unjustified.
Research to promote the welfare of current and future members of society is undoubtedly possible via enforced regulation. At the root of any research study needs to be the safety and well-being of every individual involved. This can be made possible through a system of required consent documents for participants and a method of approval by two separate entities. By enforcing a government level of approval as well as a researcher level of approval, safety requirements will be met while still allowing researchers to have a meaningful say in the final decision. Incorporating a research party into the decision brings more knowledgeable and research-oriented persons to the surface and enables an opinion of why a given study should be done to be heard. This type of balance of power has proved very successful in the United States Government with the use of each branch checking each others' actions. A similar system can ensure safety in research while still allowing a researcher party to be heard and approve innovative studies that can potentially enhance the future.
With a systematic policy such as the one presented above, situations such as a research participant feeling untrustworthy of a study because their consent forms contradict anonymity can be avoided. For example, the consent phase of the study can be conducted by a governmental party while the research aspect can be conducted by the research party. That way, the two remain disconnected while still fulfilling participant consent and safety precautions. Researchers will be enabled to study any population regarding any issue that they can prove beneficial to greater society as long as the governmental party gains consent first. On the flip side, failure to gain consent will result in zero funding for the research party as a way to enforce this system.
All in all, in order for research to inflict a positive impact on larger society, it must be systematically regulated through a checks and balances system similar to the United States Government. This system should include one party to handle safety and permission and one party for further explaining the importance of a particular study and delegating research topics in order to keep researchers satisfied as well. With these policies set in place, a safe research world has the power to ensure justice and well-being for the present and the future.
Cutting off Curiosity
Curiosity is what motivates our society to uncover new information about ourselves, each other, and the world around us; research is one method of acting on our curiosity. From research comes a multitude of advantages for our society. Unfortunately, some research projects mentally or physically distress its subjects, taking away from the advantages the research would ultimately produce. In order to avoid such situations, regulation of experiments through boards such as Institutional Review Boards(IRBs) and Review Ethics Boards is essential. Though experimental regulation boards are necessary to avoid harm to subjects and ensure advantages for our society, such regulatory groups control experiments too strictly and should have less power over what researches can be performed because take away freedom and the motivation to act on curiosity.
While regulation boards should have a more limited control of research, it is essential that they have the power to reject any research that may harm its subjects in any way. "Harm" includes any demoralizing experience that takes away the subjects "dignity or fails to respect the subjects"". For example, sexually transmitted disease experiments were conducted on Guatemalans in 1946-1948. Doctors infected them with syphilis or other STDs, sometimes via prostitution, without consent of the subjects. Not all subjects received "adequate penicillin therapy" after infection. This experiment "resulted in at least 83 deaths", an obvious illustration of physical harm inflicted on subjects. This inhumane abuse could be avoided through IRB intervention and enforcement of consent laws. Such harmful cases are why regulation boards are necessary to control research to a certain extent.
With that being said, IRBs can be quick to declare research "unethical, unrealistic or illegal", often limiting researchers' freedom. As a citizen of the United States, I expect to be able to question what I want and relay new information that I discover. IRBs often make that difficult if not impossible. For instance, one sociologist was told that she "had to get cosmetic surgery patients to sign permission slips to speak with [her] even though the interviews would be anonymous and details would be changed in such a way as to protect everyone's identity". This seemingly unnecessary precaution could lessen the likelihood of honesty among the subject, something the researcher would not have freely chosen to do. Researchers should have the freedom to manipulate the experiment as they choose as long as they do not cause any harm.
Additionally, the selective nature of IRBs discourages researchers from acting on their curiosity. Researches are giving up on what they are truly passionate about understanding because IRBs make it so difficult to get research projects approved. For instance, one field researcher gave up interviewing prisoners because they are considered "vulnerable populations" and getting research approval seemed "more difficult than getting through the prison doors". Great discoveries could have been by this researcher and many others who have been turned down or discouraged to attempt seeking approval at all. Decreasing the researchers' motivation decreases the amount of benefits that could be harvested by bringing those observations to the public's attention.
It is evident that researchers have the ability to demoralize subjects through the process of researching, and regulations must be enforced to avoid this. However, IRBs' over-selectivity sets limitations on researchers that suppress their freedom and motivation, which ultimately lessens the overall good that benefits the larger society. As you can see, harming subjects must be avoided, but IBRs must set regulations that allow us to reap the optimal benefits of research.
Does Regulation Matter?
There has been a substantial amount of debate concerning whether the Institutional Review Boards (IRB) in the Unites States have been overstepping their boundaries. Working in a research lab, the frustration that researchers undergo when trying to get funded or get approval for their study by the IRB is quite evident. It is understandable that the IRB plays an important role in protecting the rights of individuals, but researchers should not be limited in the topics that they want to study in order to help others.
The IRB should have a set of guidelines when approving a fieldwork study. It is important that the validity of a study is confirmed, and also that the conclusions from a study will benefit not only the researcher, but society as a whole. The board should be concerned with ethical principles and making sure that the people participating in the study will not be used because of their situation. The Guatemala Syphilis Study and the Aboriginal Experiments are great examples of this. While there are researchers out there that may want to take advantage of people's disadvantages, most are doing their research in order to help society learn of issues faced every day and address them properly. It is also important that the risks of the study are noted when a person is giving consent. These factors are of great importance when the IRB is reviewing a study.
Furthermore, while these issues are important, it is clear that IRB are also concerned with other issues that may limit a researcher's ability to conduct a study in the way he or she wishes. The fact surrounding spelling mistakes being taken as a note of trustworthiness should not be adequate reasoning for disapproval. The reviewers should not be as concerned with spelling mistakes as they are with benefits the study will produce once it is completed. Another issue that comes up when IRB committees are reviewing studies for approval is if the people participating are considered a vulnerable population. It is worth noting that some populations, such as children and people with mental illness, may fall under this category. On the other hand, there are populations, such as prisoners and transgendered people that, while they may be different from others, could be of great use to be studied. Conducting a study on these people may answer questions that people in the general population may have themselves. The IRB should not let their personal opinions get in the way of what could be a crucial study.
While IRBs are important for main ethical reasons and receiving consent from participants, researchers should not be concerned that they cannot do a particular study because they believe it will be rejected by the IRB. Going through the IRB process should be just another step the researcher must go through in order to move forward with their study, not something that may delay their research for months.
The Institutional Review Boards are in charge to cover federally funded research. "They have the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy." When reading the five cases provided in the reading, one can only see there was a serious miscommunication when it came to the unethical research being conducted, and the monitoring and approval that was required to be done by the Institutional Review Board is not to blame in these cases, but the researchers conducting the experiments. It is evident that research needs to be better monitored after examining previous case studies from our nation's history. It is the right of American researchers to experiment in a vast amount of fields and have the opportunity to get findings on anything that could be supplemental to society as long as those experiments are highly supervised.
In case one, we were given the information regarding The Guatemala Syphilis Experiment. "This experiment was conducted in Guatemala lead by the United States from 1946-1948. Doctors infected soldiers, prostitutes, prisoners and mental patients with syphilis and other sexually transmitted diseases, without the consent from the individuals." The Institutional Review Board is in charge of monitoring and approving such experiments like this one. Reasons this was not stopped or disapproved was not because of the turning of the heads of the individuals a part of the IRB, but the researcher not passing along the proper information needed to stop this unethical experiment. Due to the lack of passing along proper information between researchers and individuals of the IRB, there was severe harm being done to human subjects. It is clear there is no other way to end, or disapprove experiments without serious regulation from the government.
This being said, there needs to be a very strong sense of governmental regulation going on in research. It is highly appropriate that this is necessary due to the multiple unethical experiments that have occurred in the past. The Institutional Review Board should have every right to end, or to approve the continuing of an experiment that has been properly communicated. The IRB is clearly not solely to blame for the negative consequences behind the unethical experiments being conducted, but the lack of communication between the board and the researcher.
How Improvements in the Research Field Need to Be Made
Through the topics of creating common rule regarding research, the freedom researchers have, and how subjects should be treated during the process, there will be discussion about the practices that researchers follow and how some need to be improved in order to help the field grow and develop in a positive way.
To be able to prevent more incidents like the one in case study number 2, there should be paperwork that researchers have to fill out from the IRB or REB before they can continue further with whatever project they are doing. Yes, this paperwork would probably be somewhat time consuming and tedious but it would prevent unwanted incidents from happening and trouble down the road. This paperwork can be along the lines of having to state what the researchers are trying to accomplish and how they are going to go about preforming their tasks or the researchers can send their plan directly to the institutions for review. Another possibility for them would be to have someone from either IRB or REB on staff to be able to make sure that the researchers are following the guidelines set up by both institutions. Researchers could then check in with the staff member before doing anything major and check on things before they get out of hand. These two options will allow researchers to be able to have the freedoms they need for collecting data but to also preserve the surroundings and artifacts they find along the way.
To go along with what was mentioned within the last paragraph, researchers also need a guideline on what freedoms they do and do not have while they are collecting data. These guidelines should map out what they can and cannot remove from the excavation site without someone's approval. This could be an IRB or REB staff member or, like in case study 2, someone in the community that holds the authority. This way, problems can be avoided and the researchers will not run into anymore dilemmas with other nations or people. That being said, once they have asked all the right questions and gained the right approval they should be able to do anything that fits within ethical and moral guidelines. For example, the researchers should not be repeating incidents like the ones from case studies one and five. The people from Guatemala and the aboriginals should not have been subjugated to that just because they were an easy target for experiments. As long as the researchers do not breach this, then they should have the freedom to explore what they want to.
Finally, in order to make sure that subjects related to studies have a beneficial experience, regulations should be put in place. First of all, a survey should be conducted (anonymously) about what would make these types of experiences. These surveys can either be sent to the populace or just handed out to people that are already doing studies. That way, researchers can get a general idea of what subjects are expecting while they are participating. Also, subjects should be guaranteed anonymity while participating so they do not have to worry about their personal information getting out. This is also beneficial to the researchers so that the likelihood of their questions being answered truthfully is greater than it would be without it. And once the researchers gain the trust of the subjects, they could see more and more people coming in to participate which would greatly help the researchers so that they are able to have more accurate data.
With these practices in place, the researchers will find it much easier to be able to do their work and not have to worry about the potential consequences that might happen. More work will get done and new things will be discovered helping the world advance in more way than one.
Freedom to be Fair
When I was growing up in my small hometown in Iowa, I was taught in school that soldiers went to war to fight for our freedom. Freedom is a strong word and sometimes very hard to define. What I believe freedom means is someone's ability to fight for what they believe in. It is a way of life in America. It allows a person to work to their full potential until they are satisfied with what they have accomplished, without being restrained. But when is there thought to be too much freedom? Looking over these five cases, freedom does need some restraint and regulations. There has to be a limit on what is thought to be right and what is down-right wrong. That is why we as Americans believe in a democratic government, where we are able to have a say in what is proposed in the government system.
There are a lot of good regulations and requirements that are listed in the Code of Federal Regulations. The most important regulation that is mentioned is getting the consent of research subjects. Doing so will help prevent future abuse and ensure positive benefits of research. "Doctors infected soldiers, prostitutes, prisoners and mental patients with syphilis and other sexually transmitted disease, without the informed consent of the subjects." Not having a person's consent is thought to be a "crime against humanity." The syphilis experiment put people's lives in danger. The subjects didn't know exactly what they were getting in to. They didn't know whether they were going to live or die. Having consent is mainly a way for the research subjects to be able to have their say in what is going on. It is their sense of freedom that is taken away when they are not informed about what their lives are about to go through.
Another way that could help improve the idea of research and the regulations of the IRB or the REB is allowing research propositions to go through a series of steps before being able to carry on with their project. With this idea we can fulfill the idea of fairness and trustworthiness that was discussed in case four. "As I argue in the book, that seemingly disproportionate concern over typos and written mistakes in applications is not a matter of fairness, but trustworthiness." With this new idea of a trial basis in each step the researcher and their team would have to work with the IRB to gain approval of their research. Each step would express the need for the project and show how determined they are to complete the created goal. This way the IRB could see their improvement through the steps in the process other than just getting the straight verdict of if you're in or out. This would establish their trustworthiness and would also be fair. Also through the process, the IRB should come to the conclusion if the experiment will truly help those who are involved. "I think they really did think they were helping people. Whether they thought they were helping the people that were actually involved in the studies, that's a different question." In the end we need to make sure that people's lives are not in danger.
A regulation that needs to be added is to allow the work of research to be available for public eyes and ears. A big problem about the cases that we read was that all the information about a "wrong" act of research was hidden from the public, as if they were trying to erase it from history. Researchers need to know that there were mistakes in the past, which allows future researchers to learn and make the whole process of experimentation safer and more positive for society. A benefit of research is learning new things and possibly saving lives, but every experiment needs to make sure that is legal and safe for their test subjects. Allow freedom for all.
Researcher's and their experiments
There has been a lot of controversy surrounding anthropologists and how
they conduct their research. After reading the five cases, I think there
should be a set of rules by the Institutional Review Boards (IRB) and Review
Ethic Boards (REB) concerning research. There is no reason a researcher
should conduct an experiment similar to the experiments conducted in the
five cases. Without regulations anything could happen in experiments.
A researcher should have freedom in conducting research, but that freedom should be limited. If researchers had all the freedom they wanted, we would see more research like the Guatemala syphilis experiment in case one. The researchers should have freedom, but it needs to follow the rules and regulations established by the IRB and REB. With no limit on freedom the research that some researchers would conduct would be inhumane and wrong, very similar to some of the case studies. There could be serious harm to a subject's health and even death. As we saw from the five cases, researchers will do a lot of things to get results. It doesn't matter to the researchers if their experiments are right or wrong and cause harm to the participants. All that matters to a researcher is getting the results they want.
Regulations Needed to Modernize and Regularize Experiments
Throughout history, the way research is conducted and published has improved drastically due to many necessary provisions and changes in the guidelines researchers have to follow. In the past, there weren't specific rules and regulations that researchers needed to comply with, and that is why the identities, well-being, and effects on the people experimented weren't normally beneficial or positive. However, in today's day and age, we have what's known as the "common rule", or a set of requirements researchers need to follow in order to be approved by the Institutional Review Board (IRB). That being said, I believe that Institutional Review Boards and Review Ethics Boards should have a mandatory set of requirements that every researcher needs to meet before being authorized to conduct their experiment. Also, at the end of the experiment, it would be beneficial if the experimenters gave proof to the IRB that they have kept the names of the participants private, and that the experimenters have given them a detailed guide of what they will be participating in so there is no debate or litigation if something is to go wrong.
It is crucial for regulations to be implemented by the IRB to ensure that experiments are being done to better society as a whole and provide us with knowledge of new findings. With that idea in mind, I think researchers should have clear rules they have to abide by in order to keep all experimenters on the same page. In "The Guatemala Syphilis Experiment", it is stated that, "...without the informed consent of the subjects", referring to the people in the experiment not being told that they would be injected with a potentially fatal virus. IRB's should have rules for all experimenters that identities and names need to be kept anonymous and the people being experimented on need to know what they are participating in because in the case of Guatemala, there was a result of at least 83 deaths since people weren't told what they were getting injected with. Therefore, having a set of clear and concise regulations that are the same for all experimenters will help alleviate abuse of participants and will also better the results so they will be more effective for the society at large, especially since they are the ones sponsoring the experiments.
At the same time, experimenters should be allowed to question a rule if it could be beneficial to the experiment, giving a bit of freedom to researchers, but not enough to drastically harm or damage the experiment or morale of a participant. When looking at "Studying Old Bones--Preservation or Perversion?," it is possible that since regulations can't be absolute for every different kind of experiment, the experimenters believed that they had the ability and acceptance to take the bones for academic study. This action wasn't drastic enough to harm the people involved physically, but since it did emotionally, it could be beneficial if a stricter set of regulations were set by the IRB to try to avoid the kind of reactions that this experiment received. Hypothetically, as long as the experimenters asked the IRB if they could take the bones, in regards to a rule that should've been given at the time, I think that that is enough freedom to be given to researchers in order to make their experiments beneficial.
Overall, I think that IRB's and REB's should have specific rules that all researchers need to comply with, but at the same time, experimenters should have the ability to question a rule if it could better their experiment, while not posing harm on society and the participants.
Hurting to Help
What is respect? What is consideration? What is being sensitive? According to Google these three ideas mean "a feeling of deep admiration for someone or something elicited by their abilities, qualities, or achievements," "careful thought, typically over a period of time," and "having or displaying a quick and delicate appreciation of others' feelings," respectively. How is it that we, speaking as a world society, with our boundless cultures, define these terms in such a way that they hold the same standard to all people? Maybe this question encompasses the conflict around experimentation.
While reading the RED's, I encountered the sentence, "Respect for human dignity requires that research involving humans be conducted in a manner that is sensitive to the inherent worth of all human beings and the respect and consideration that they are due." To me, this is saying that because of our deep admiration for the humans involved, the experiment will be conducted with deep thought and much time because the subjects deserve our delicate appreciation. Thinking deeply into this meaning reveals a much different approach to experiments than what is being performed.
Louisiana State University gathered bones for an educational purpose. They believed the gathering of the specimen was done in a respectful manner by first contacting the Alderville First Nation. However, after excavation and the revelation that these remains were not of First Nation descent but of another cultural group, problems arose. Huron-Wendat, the correct descendants of the bones, were disrespected and hurt by the actions of LSU, because of a cultural difference. So I ask again, how is it that we define such critical terms in a way that encompasses the world's cultures as a whole? This idea seems almost impossible. However, if we stuck to the script and took careful consideration into subjects and therefore cultures at hand, problems such as this one, would never have arisen.
Now not all people are trained to think like a culture based anthropologist who knows how to negotiate the obstacles of culture borders. In the same sense, not all experimenters have the same interests involved when feeding an experimental food to an already malnourished child like a certified dietitian would. So I say, bring them in! By doing do, every experiment can first be looked over and approved and then observed and halted if any work is not respectful, sensitive, or considerable. This allows researchers to have freedom. They have the ability to perform which ever experiment however they want, but the terms and protocols must then be analyzed by a specialist and the study itself observed.
In order for our world to grow, it is essential that we experiment to expand our knowledge. But hurting our world's people only sets us back. Instead of helping the society by hurting its people, those people that are already hurt (or sick, or infected, etc.) should be tested on given they have provided full consent and are fully aware of what the study entails and the consequences that could occur. Healthy individuals should not have to undergo treatment, ect. for a condition they do not even have.
Furthermore, I ask that research begin to look deeper into the ideas of respect, sensitivity, and consideration. In order to protect our people, we must understand what these terms mean to them. Once we start doing so, our experiments will uncover answers without harmful effects on their subjects.
Government Regulated Research
Over the years, much debate has arisen over government-regulated research. It is the duty of the International Review Boards (IRBs) in The United States and the Review Ethics Boards (REBs) in Canada to protect the unalienable rights of human subjects in research and experiments.
But how much regulation is too much regulation? On one hand, if the government is not involved enough, human lives could be endangered and the faculties promoting the research could face potential lawsuits. On the other hand, too much government involvement could restrain the potential of the researcher and prevent positive findings that could help humanity in the long run.
I believe that the main focus of the IRBs and REBs should be to make sure the subject is fully informed of potential risks and desired benefits of the research/experiments. Each subject is an individual, and as an individual it is his or her right to be aware of all outcomes the research may result in.
It is also important, in addition, to be sure that the chance for benefits is greater than the chance for risks. This may require the involvement of an additional board. It is unethical to put human subjects at an unnecessary risk for the sake of scientific advances.
Contradictory to previous statements, researchers should also be allowed enough freedom to promote their findings without being overly protected by government regulations. If the individual being interviewed for research consents to being a subject, it should not be the responsibility of the government to deny their involvement.
In conclusion, the primary concerns of faculty-promoted research should be as follows: Is the individual aware of the risks/benefits associated with the research or experiment? Has the individual fully consented to being a subject? Do the potential benefits outweigh the risks of the research? It should be the responsibility of the IRBs and the REBs to make sure these concerns have been addressed and dealt with in an appropriate manner. Once this has been done, then and only then is it the responsibility of the federal government to approve or disapprove of the research. With this approach, the chance for a more positive outcome is increased along with protecting the rights of individuals.
How Far is too Far?
How far is too far? Are scientific findings that will aid others in the future significant enough to harm subjects in the present to obtain these findings? Also, who's more important: the people being experimented on or the persons receiving the benefits of the study? But, who is qualified to make these executive decisions impacting others' lives? This problem will be resolved with the cooperation from all aspects of the study; including the subject, experimenter, and IRB administrators. If all three work together, studies will have more accurate outcomes for the experimenter and the subjects will not be ethically violated.
In the past, many vulnerable groups of people, such as prisoners, mentally ill, and hungry children are used as subjects on experiments. Experimental gains in knowledge can be very powerful in our world and provoke many positive changes in our society and medicine, but what happens to the subjects? The Belmont Report's main goals are respect for all persons, beneficence, and justice. These three goals incorporate all participants' rights and enable protection and awareness to all involved with the study. Although these experiments are important for future generations, we still need to keep in mind the subjects are real people and should not suffer for our scientific benefits.
The Guatemala Syphilis experiment is a great example of what is deemed more important, the subject or the future consumer? During this particular experiment, people are infected with the syphilis disease, which can be fatal without proper treatment. The subjects were injected with this disease to test the effects of penicillin. Is killing others for medical gain ethical? No. We should not treat human beings as guinea pigs. We cannot operate on individuals without their knowledge and consent of all the logistics of the specific study. Especially, if the side effects of the experiment are fatal and/or life altering. Experiments are important and needed to be done in order to find cures for diseases. We should find alternative ways in finding the cures that do not harm others or blindly give them a disease in the process.
Who should be allowed to make these executive decisions affecting many people's lives? Instead of having one person in control of what happens to hundreds of innocent individuals, we should find another solution. Not only have a committee of persons examining the ethics of the experiment, but also verifying it meets The Belmont Report guidelines. The experimenter needs to show a specified outline of all the aspects and procedure the experiment. Also, the relevance of the experiment needs to be valid. Another key component in this new approach is trust. Trust between subject, experimenter, and IRB administrators. The subject should be informed of all the possible side effects of the experiment. The experimenter needs to be respectful of the willing subject and be honest of what all the experiment entails. Also, the IRB administrators should examine the experiment thoroughly and validate the reason for it. Using this approach, the experimenters will gain accurate insight and the participants will be treated ethically.
New findings to help future generations are important and vital for our society's survival. However, we cannot treat the subjects of these studies unethically. We can use an alternate route in order to benefit all three parties involved and still find valid information to use in the future.
Maintaining Good Ethics, or Inhibiting Freedoms?
When performing research, one of the most important things to consider is the ethics behind it. This is, without a doubt, an indisputable fact among professionals and students alike. However, the issue that consistently arises is where to draw the line between what is unethical and what is simply controversial but still overall beneficial to society. Thus, we have just defined the purpose of the IRB's/REB's. These boards should enforce a set of rules that determine ethics not by a preset guideline of rules and regulations, although there are still base ones to consider, but rather on an individual case-by-case basis, looking at each research plan as its own entity, rather than a part of a master formula that deems it ethical or unethical.
To best express this thought, Case Two will be examined, particularly the discussion of grave-robbing/disturbing preservations versus utilizing the remains for educational use. This case is mentioned specifically because of the matter it discusses and the ways in which the situation discussed was handled by the Ethics Boards. The problem with using these remains, it seems, doesn't deal with whether or not its ethical, per se, but whether or not a certain group, the Huron-Wendats, was offended by it. Is the offense of someone based on their Religious/Spiritual beliefs something we should be concerned with? Should spiritual matters at all, for any belief, be the main priority over the possible education and further societal advancement that researchers can use these remains for? If these remains don't necessarily "belong" to anyone, then are they not free for beneficial public use? The Ethics Boards, in this case, should set rules about whether or not there is any public claim to the remains, not whether or not a certain subgroup would be offended from using them for research. From this then, wouldn't researchers be prohibited from using any human remains, as anyone who is human can say they are offended from "violating" another human's remains? The ethics that should be considered by these boards should focus more on human rights in this case rather than spiritual beliefs.
Furthermore, in Case Three, it is brought up by the Chronicle the concern of the Ethics Boards decision making and possibly unintentional prevention of researchers from being able to perform work that may ultimately provide various benefits to society. I believe that the Ethics Boards should reevaluate their idea and concept of "vulnerable populations" as these populations are often the subject of research and interest. There is much research that needs to be done, for example, on transgender populations, as their rights are becoming an increasingly more prominent issue. If the Ethics Boards continues to prevent researchers and groups from questioning these and other certain groups of people then our knowledge on them and further advancements in science and technology will be severely limited. In the transgender case, especially, much of society is highly unlearned about the transgender life, so it is important for published research to be done about this. As far as the prison interviews are concerned, the information and lives of the prisoners needs to be obtained to ensure fairness and justice for them. If researchers are denied this then who is to say we won't have another case of negligence like the famous one of Nellie Bly?
With all of this in mind, then, not only must we question the Ethics Boards regulations and case decisions, but we must question the methods of the researchers themselves and ensure that they aren't abusing their freedoms. I've primarily focused on the Ethics Boards and what they are, rather, aren't doing right or should change. However, it should be noted of the irrefutable good that these boards do and the supreme purpose they serve. They keep the researchers in check, and while sometimes it may seem they limit their freedoms, other times they grant freedom in a morally sound way. I believe the Ethics Boards do, and should continue to do this or start if they don't, by performing extensive background checks on the research projects in themselves. Though this may seem obvious, I believe it is important and essential to reinforce that nothing in this matter should be allowed, whether it be research or other matters, without sufficient knowledge on the subject at hand and the groups or people preparing to perform the work to be done. Researchers should be granted the natural rights and freedoms that they are legally allowed, if, and only if what they are doing will be beneficial to the larger society or, at least, beneficial to a smaller group as long as it does not cause harm to others. The cost-benefit ratio is definitely a significant factor, cost covering both monetary concerns as well as health and other concerns.
Though there exists ways in which the IRB's/REB's have much room to improve, it would be foolish to say that their purpose if futile or unnecessary at all. While these Cases showcase more of how these Ethics Boards need improvement and are flawed, there exists undoubtedly evidence of abuse performed by the researchers in their research, as is evident from the Syphilis Case as well as the Children's school Vitamins case. What should be taken from this, then, is to understand that the relationship between the Ethics Boards and the researchers is tenuous and sometimes hard to navigate but that the struggles researchers face and the rules that the Boards set in place are ultimately and ideally for the benefit of society. Though this may not always be clear, it truly is the case, and ultimate success on either end will not come without the undoubted cooperation and perseverance of either group.
Well Being of All
Institutional review boards should enforce a set of common rules in an effort to aid in the accuracy of the results, the well-being of all involved, as well as the earned respect amongst all communities and anthropological studies. This includes anyone involved in the study, anyone the study affects, and the researcher themselves. Anthropologists are important assets to our world and must be given enough lee-way to execute studies as long as they follow rules set forth. These rules must explicit in the effort to avoid the miscommunication or abuse some anthropological studies have exhibited in the past.
In an effort to promote the well-being of persons being researched, researchers must evaluate for the possible consequences or affects this study could have on the mental health, physical health, or history of the studies subjects. The subject's culture, religion, and any other beliefs must also be taken into consideration in the effort to respect their particular ways of life. For example, in case two discussing the studying of old bones, the anthologist seemed more concerned about her own research and findings through the bones, than the actual person they used to belong to. More care needed to be given to the idea that the bones still belonged to that individual's ancestors. Their beliefs involving the caretaking of the bones needed to be of the utmost concern.
Another important factor in monitoring the mental and physical health of the subjects lies in the anthropological researcher's hands. Before any study containing the possibility to impact the patient in these ways, the researchers must attain any previous knowledge about their study and provide any other possible conclusions to the subjects. In this way, they are as informed as possible and know there could be conceivable short or long term effects on them mentally or physically, before they agree to participate in a study. This brings up a major issue of subjects being forced into anthropological research.
The article that discussed Subject to Aboriginal Experiments discusses anthropologists not only giving children dietary supplements without explaining or researching possible effects, but also not allowing them to have a choice in the matter of whether or not they wanted or did not want to participate. The age of the children also calls into question their ability to understand what is taking place and what the consequences might be. When a child goes to the doctor in the United States they must have their parent's consent for any procedures or even shots until the age of 18. There is good reason for this. Children are unaware of and do not understand the severity of possible consequences. There was no mention that the children or adult caretakers were involved in any consent during this study, which is also highly unethical.
Anthropological studies also must be respectful of emotions surrounding issues being studied. Studies having to do with anything people identify with including religion, ethnic group, culture, and the way they do things like raise their children would be included. People around the world vary in many different ways amongst these categories and it is imperative anthropologists be sensitive to the way in which they are addressed when conducting research. People are more willing to open up and share about issues when they feel comfortable, and in order to attain the best and most accurate information anthropologists must go out of their way to do just that. Time should be spent researching information on different cultures surrounding issues to be studied in preparation. This will not only pay off for the relationships of the communities with the anthropologists, but also the quantity and accuracy of the information received in the studies.
As anthropology continues to be an imperative part of our society, cultures and people constantly grow and change, and there are more questions are being asked. The rules set for studies need to be much clearer. It is vital that the results can be trusted and must be attained with respect of those involved. An attention to the well-being of these subjects and anyone the study affects is also imperative.
Ethics Must Prevail
Humans have an inborn urge to ask questions and seek answers. We want to know why people do what they do, why they act the way they act, how cultures influence them, how they live, and the list goes on and on. The only way to get the answers to these imminent questions is through research. Research is a valuable tool that can teach us, provide us with answers, and even impact the way we think and live our lives. Research is very beneficial, but only if conducted in the proper manner. As evidenced by three of the case studies presented, there must be regulation to protect and "not harm" research subjects. Ethical abuses must be avoided and all participants should be treated with consideration, privacy, respect and dignity. In addition, the other two case studies address the need for not over-regulating research and not deterring the discovery of results that could truly help others. All things considered, when having to choose, I feel strongly that we must err on the side of ethical treatment and the physical and emotional well being of those being researched, over the potential over-regulation of research.
The Guatemala Syphilis Experiment, the Canadian Aboriginal Experiments, the Huron-Wendat Nation Bone Study, and research like them reveal a real need for regulation and enforcement of rules governing research activities. The infection of soldiers, prostitutes, prisoners, and mental patients without their informed consent in the Guatemala Syphilis Experiment "...involved unconscionable basic violations of ethics..." and was "a dark chapter in the history of medicine", as at least 83 people died as a result. The Canadian Aboriginal Experiments were conducted on small children who were starved, malnourished, and then denied dental care for nutritional experimentation purposes. In the end, not much was learned or written about the Aboriginal experiments and there isn't evidence that this research program of the early 1940's was actually completed. And the third case study described as academic grave robbing of the bones of Ontario's Huron-Wendat Nation, raises ethical concerns particularly for their descendants. So, how far is too far? Clearly, as revealed in these research experiments, without regulation people can take experiments too far.
The National Research Act of 1974 and the Common Rule in 1991 did much to address the atrocities of the aforementioned experiments and others like them. Personal respect, ethical treatment, and protection from harm were addressed. A uniform set of regulations for protecting human subjects were developed. Institutional Review Boards (IRBs) and Canadian Research Ethics Boards (REBs) were also introduced to regulate and monitor research activities, along with addressing the risk to the subjects and receiving their informed consent. The rules specified by these organizations set a standard to adhere to, and laid the groundwork for all research to be done in a proper and ethical way.
Now, not everyone agrees that there should be rigid regulations, as they believe they limit their research capabilities. This is shown in the remaining two case studies: IRB and the Future of Fieldwork and Behind Closed Doors, which address the varying and not always consistent way in which the IRBs interpret the rules regulating research. These boards were established to not only protect subjects, but to assure safe and ethical research is performed. Governing bodies, though not without imperfections, are absolutely necessary to protect against not only blatant ethical disregard, but also against errant oversight that could occur as a result of overly detailed or overly zealous research. As evidence of the turmoil present in America's two party political system, not all will agree on specific written rules that will absolutely address and govern research to the satisfaction of all those involved. There are issues that may have to be addressed, discussed, and even fought for before the boards on an individual basis, but at the end of the day, reliable, accurate research is important, and the confidentiality, safety, and welfare of the research subjects is paramount.
Rules must be established and implemented in order to make sure research is done properly without putting subjects in harm's way. These rules should not take away from or influence research findings, but rather enhance them and make the research more appropriate, and the results more reliable and respected. Without question informed consent from all participant, along with detailed documentation of all research and results are essential. The subject's physical and mental well being along with their personal privacy should be considered above everything else, and they should always be treated with the utmost dignity and respect. "Respect for persons recognizes the intrinsic value of human beings and the respect and consideration that they are due."
Who's to Blame?
In the past, people have been forced to participate in research experiments based on gender, ethnicity, race, and/or age. Some test subjects weren't given a choice to participate in the research projects, they were chosen, because they had a health problem, or they were prisoners so they did not have a choice. Some of these experiments resulted in deformities, serious health problems, and in many cases death of the subjects. The IRB monitors all research projects being conducted and also funds them. Therefore, the IRB should enforce a set of common rules regarding research projects. Without a common set of regulations, anything can be done during a research project. These regulations should state that: researchers need to fully educate their participants on the requirements of the project, the subjects should be able to drop out at any point and time during said project, and researchers need to fully inform the IRB of what their funds and support are going towards in the projects.
Researchers should be allowed freedom in conducting their research. Freedom should be limited, because if its not, then researchers would be able to do what they want with no exceptions. Researchers should have to supply test subjects with the information that is going to be conducted during the project, not just a brief over view, but all the information that is necessary in order for the experiment to be done. If the participant does not want to take part in the project anymore, they should be able to drop out at any point in time. The IRB should also be informed of everything that is being performed in the project, because they fund it. If they are funding a project, they should know exactly what is going to be done and the possible outcomes of the project, whether they be positive or negative.
Test subjects have a right as humans to give their formal consent before taking part in research projects. The IRB needs to enforce regulations so that test subjects can be protected from the abuse of research projects. One regulation would be formal written consent from the test subject. Test subjects have the right to know exactly what they are going to partake in and why the project is being carried out. This should be enforced, because in past experiments, like the Guatemala syphilis experiment, informal consent has led to deaths. "Doctors infected soldiers, prostitutes, prisoners and mental patients with syphilis and other sexually transmitted diseases, without the informed consent of the subjects, and treated most subjects with antibiotics. This resulted in at least 83 deaths." If researchers had to get formal consent from their test subjects, this project may not have been carried out. The IRB was not given all the information on what was happening in the Guatemala syphilis experiment, years later in 2010, "the United States formally apologized to Guatemala and announced that there was no statute of limitations for the violation of human rights in that medical research... President Barack Obama apologized to President Alvaro Colom, who had called these experiments "a crime against humanity"." This could have been prevented if the test subjects gave their consent to participate in the project and if the IRB knew what really was happening during the time the research project was being conducted.
Enforcing Research Regulations
"Doctors infected soldiers, prostitutes, prisoners and mental patients with syphilis and other sexually transmitted diseases, without the informed consent of the subjects" (Case One). This sentence alone was enough to convince me that a set of common rules regarding research should be enforced by Institutional Review Boards in the U.S.
The IRB does have criteria that they use in order to approve research. The IRB must determine that all of the following requirements are satisfied: risks to subjects are minimized, risks to subjects are reasonable in relation to anticipated benefits, selection of subjects is equitable, informed consent will be appropriately documented, when appropriate the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects, and when appropriate there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (Background Information).
If the above criteria of the IRB are true and enforced, then the question is how did something like the Guatemala syphilis experiment even exist?
Fortunately, the U.S. government did formally apologize in October of 2010 for these "crimes against humanity." The Presidential Commission also organized a panel of experts to review medical research on humans happening around the world to prevent such a case from occurring again. However, to actually ensure that an incident like the Guatemala syphilis experiment is not repeated, more than just a review of the past experiments needs to be implemented.
To prevent the abuse of research subjects, it is dire that the enforcement of regulations be put into practice. The National Research Act has already been established, which emphasizes respect for persons, beneficence, and justice. The Department of Health and Human Services and other Federal departments joined to create the "Common Rule," for the protection of human subjects. To assure these regulations are followed, the Office for Human Research Protections was established.
Between all of these departments, acts, and regulations, there really should be no reason that we have the Guatemala syphilis experiment or the Louisiana State University stolen bone case as past examples of the need for research regulation to prevent abuse. Case study three and four focus on the questionable practices of how the regulations are now enforced. To guarantee that the research strives to promote positive benefits for the larger society sponsoring it, along with the current departments, acts, and regulations working for this issue, one solution would be to have an anthropological perspective working on this issue as well. An anthropologist would be able to see beyond the legal technicalities and focus on seeking to avoid ethical abuses in medical research on humans.
Takes Just One to Ruin it for All
As I first read the case studies presented, I took an in between approach on the topic at hand. I felt that researchers should have some freedom regarding their studies, but I also felt regulations should be in place to protect the participant. As I re-read the first case study, my viewpoint changed. I believe that researchers should have less freedom and regulations such as, risks to subjects are minimized and informed consent will be sought from each perspective subject as well as documented, should keep being enforced by the Institutional Review Boards.
In the Guatemala Syphilis Experiment, "Doctors infected soldiers, prostitutes, prisoners and mental patients with syphilis and other sexually transmitted diseases, without the informed consent of the subjects, and treated most subjects with antibiotics. This resulted in at least 83 deaths, (case one, paragraph one)." I found this sickening. Not informing an individual that they are being infected with a disease and in return some dying from that infection is very cruel. You have to ask yourself if it is worth risking one"s life in order to achieve your goal. Without the rules of consent and respect for the individual, how can we trust that researchers will keep the best interest of the individual in mind and not put them in harms way? We need these regulations in place so studies like the Guatemala Syphilis Experiment are not repeated.
In case three, they mentioned how these regulations make it hard for researchers who interview individuals rather than experimenting on them to do their studies. One example mentioned anonymous interviews; these are very hard to conduct because the regulations in place require one"s signature in order to participate. "People love it when you offer them anonymity and then ask for a signature. Really makes them want to open up to you," said the researcher. I see where she is coming from in that these regulations make it difficult for one to collect research. You have to be able to observe individuals to collect any sort of data and it may be hard to find someone willing to do that. But, without consent forms how do we really know that the individual understands the study and is willing to participate?
Researchers need to deal with the rules in place and learn ways to conduct studies that follow these regulations. Because, in the end the individuals you are studying are the most important and should be treated as humans and not just test subjects.
No Harm Please
Ever since I first started going to the doctor to receive flu shots, I have felt comfortable and empowered by my choice to receive or not receive a vaccine. My doctor would always lay out the risks and benefits of getting vaccinated in order to ensure that I could make an informed decision. I was made aware of the risks involved, but I always opted for the flu shot because it has proved to keep me healthy. It is comforting to know all the information, risks, and benefits of something new and "risky". I know that if all the information about this drug was not given to me, then my family and I would probably not have trusted it. We would have felt like the doctors and government were just trying to experiment or get money out of us.
I would have been furious if we were not given the information necessary to make a proper and informed decision in terms of getting vaccinated. Without this freedom of information, I'm sure the Guatemalans were extremely mad when they were harmed from the injections of the syphilis disease for testing purposes. Doctors injected the disease into perfectly normal and healthy people. These subjects did not know what they were getting themselves into. They were not properly informed. They were manipulated into taking part in a study through money incentives. People are vulnerable and easy targets when they need money and it is unethical to take advantage of them in this state.
When it comes to research in this day and age, people have become way more pushy. Whenever you walk down the street on campus, you will always encounter someone holding a clipboard asking you if they can ask you a couple questions. They want to collect research for a project or just simply to study people. This intense pushiness can cause mental harm to the person being tested.
Elaborating on that, it is unjust to medically experiment on subjects who are given only part of or none of the information regarding the study. You could argue against this and think that it is helping more people in the long run to cure a certain disease. Yet, these people are hurting the subjects along the way. It is not fair to them because they didn't exactly understand what they signed up for. This implies that future lives that can potentially be helped are more important than the lives of human participants in these studies.
The IRB explains that before research can be approved, researchers have to minimize the risks to subjects. There should not be any risks in the first place. Why would you purposely try to harm someone? The IRB says they need consent documented from the subjects before research can begin. How is it proper consent to something that they don't realize can really harm them? The risks of any research project should be entirely eliminated. The government and IRB make it seem like they want safety and peoples rights protected. However, they contradict that by harming innocent people along the way. I think the IRB should be stricter and have zero tolerance towards harmful and unjust situations to people being experimented on. Furthermore, if these civilians agree to be tested on and are informed of all of the risks and benefits, and there are no surprises about what will happen, then the study is acceptable. Being informed is absolutely necessary and researchers need to understand where to draw the line. Research is important, but not when it harms human life.
Let the Good Finds Roll
Informational Review Boards are crucial when conducting research, but they have been dealing with experiments and fieldwork studies as the same entity. IRBs need to establish different ways to regulate each type of research.
When administering experimental research, IRBs should enforce strict regulations. Before the experiments are conducted, researchers should be required to educate test subjects on exactly what is happening to them throughout the experiment, ask for absolute consent of subjects to be used in the experiment, and disclaim all possible harm or stress that could result from performing the experiment. Once consent from all of the subjects is given, the researchers should be allowed the freedom to conduct experiments of their own discretion. Even if the experiment can cause harm or stress, if full consent is given, the study should be able to be conducted. Unlike the, some studies that require the subject to be harmed or stressed are needed for society to acquire cures and treatments. The IRBs should only interfere if the pain and stress will cause irreparable damage such as the Guatemalan case study. Or when experimentations like the excavation case study are conducted, the researchers can carry out any studies and testing as long as they are given the green light by officials or the owners of the site being excavated. Because researchers are being given this freedom to conduct experiments, IRBs should, in turn, have the power to show up to the experimentation sites unannounced and observe or require documentation on the consent forms or progress reports. After the experiments, IRBs should also confirm the consent of all subjects and evaluate damages inflicted on subjects if any have been incurred.
When administering field workers who simply gather research by asking questions and conducting interviews, IRBs should regulate much more loosely. As case study 3 depicts, IRBs have been extremely petty about whether the questions asked by anthropologists are "offensive" and have banned many studies. Since the research conducted by fieldworkers does not invoke any harm or stress, the researchers doing fieldwork should have free reign to conduct any study and ask any personal question that will benefit the study as long as the researcher respects the subject's anonymity and does not exploit certain groups of people. Researchers should be able to ask about sexuality, race, or any other personal questions or interview about explicit personal accounts if the questions are not discriminatory toward a certain group and as long as the subject remains anonymous (unless the subject gives consent to be associated with the study). The only power IRBs should have regarding fieldwork is making sure each subject that asks for anonymity receives it, and making sure the questions being asked are not attacking a specific group of people. IRBs should also have the power, like in experiments, to show up to the subject's houses or observe interviews or questioning unannounced and request documentation.
IRBs should also review whether the research, fieldwork or experiments, would benefit society. If the research being done is only being done for personal gain or is intentionally attacking groups of people and will cause societal distress or physical harm to the subjects, IRBs have full authority to shut down the study completely. Each study should be ethically conducted to better the society in some way, or the study is a waste of time and resources.
IRBs are the main entities that protect human rights and personal safety, but they have been to overbearing and scientists and anthropologists must be given the freedom to discover the benefits their studies can provide for the future.