Kaitlyn Peper, Lindsey Poquette, Rubin Goldberg, Caroline Alkire, Mary Butler, Aleksey Jordick, Lauren Barth, Ryan Dix, Leyla Dickason, Charlie Parker, Madeleine Trtan, Rachel Hurwitz, Erik Kernan, and Seamus Cuddy
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Topic the Students Wrote On:
Based 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, that the research strives to promote positive benefits for the larger society sponsoring it?
In 1945, the International Code of Ethics passed the Nurenberg Code, requiring informed consent of all participants in research. This law was the first attempt to deal with ethical issues in research. But how, during the same decade, did The Guatemala Syphilis Experiment and the Canadian Aboriginal Experiment cause the deaths of people that never consented? Over the past 60 years, Institutional review Boards have made it very difficult to study prisoners, children, pregnant women and the mentally ill. They have made so many restrictions that a simple spelling error may cause the denial of the research project. The IRB's regulations have become stricter, but do they remember their original goal of requiring informed consent? Institutional Review Boards need to strictly enforce informed consent of all participants and focus less on the details of the research project.
From 1946 to 1948 the United States ran human experiments in Guatemala where hundreds of prisoners, prostitutes and soldiers were given syphilis without their consent. Only 26% of the people infected were fully treated with antibiotics, and at least 83 people died due to the experiments. Somehow, this was going on after the Nurenberg Code was passed, and it took 62 years for the United Stated Government to apologize to the Guatemalans in 2010. The job of the Institutional Review Board is to make sure things like this aren't happening. Their top priority should be to make sure informed consent is given before research is done, and it shouldn't have taken 62 years to apologize for unlawful research.
Also during the 1940's, experiments on starving aboriginal people in Canada were being done. Some of the starving people would receive vitamins while others were not given them to see the effect of the vitamins. The serious problem with this research is that the people studied did not consent to the research. If the people consented, which maybe they would because at least some of their people receiving vitamins is better than none, than the project would be much more ethical.
During 2012, Insider Higher Education interviewed Laura Stark, a member of an IRB. Stark mentioned that a simple spelling error on a research application can cause the Board to reject the project because maybe the applicant isn't trustworthy. She also said that a research proposal where companies would be tested to see if they screened ex convicts based on race received very different responses from 18 IRBs. "This finding goes to show the many ways in which IRB administrators and members can interpret the rules," she said. These are examples of powers the IRB shouldn't hold. The Board should be much more concerned with if the people have informed consent of the project being done. Details such as spelling errors, or who the research actually applies to should not be something that passes or fails a project if everyone involved is okay with it. The regulations of the IRB should be straightforward so that results are consistent and predictable.
Some people would argue that the IRB has responsibilities other than ensuring informed consent. They say that IRB's need to make sure subjects are not being harmed and that the research must be beneficial to society. Some even say research can't be done on criminals, the mentally ill, pregnant woman and children. These regulations make research very difficult, restrict many people who would produce valuable research outcomes and often leads to researchers giving up. If researchers can find people willing to consent to their project, it should be passed by the IRB. Why can't someone research prisoners if they say it's okay? Why can't the treatments of a disease be studied if the participants agree? Why can't the bodies of deceased be used for research if the person consents before death? Even if the experiments are potentially harmful, they should be passed by the IRB if people agree to participate knowing the potential harm. The job of the IRB is to check for informed consent, not strictly dictate research in this "free" country.
The main goal of Institutional Review Boards should be to ensure that participants knowingly consent to be studied. IRBs should give consistent responses and should be passing a majority of the proposals. Researchers should be allowed to conduct any research that they can find people to consent to. The current Institutional Review Boards are hindering research that could be very valuable to society because of rules that dictate who and what can be researched. Basically, Institutional Review Boards should allow the people to decide what research can be done by which projects volunteers consent to.
The Balance of Freedom
It took over sixty
years for the United States of America to issue a formal apology for
the injustices they caused during the Guatemala Syphilis Experiment.
The conduction of this fieldwork is one example where there was a clear
violation of the American Anthropological Association's statement on Ethics.
Researchers failed to obtain informed consent from the participants and
create a respectful and ethical experiment. But above all else, this research
violated the policy of doing no harm. While research regulations have improved
since then, and such clear policy breaches have become less common, there
is still a vital need for Institutional Review Boards to enforce a clear
set of common rules regarding research. I think this could best be done
by establishing a system of "checks," put in place to maintain
no one has too much control and no violations are occurring.
Being that Anthropology
is the study of humans, it is illogical to think that proper research
could be performed without involving actual people.
With this being said, taking into consideration how certain experiments
may alter the lives of participants should be the top priority. Researchers
should be given the freedom needed to conduct ethical research. However,
in these situations, this often means that researchers have a great deal
of power, which must be handled responsibly. This again, is something that
can be monitored by the "checks" panel.
Living in the Past: The Problems of
It seems that every year, new examples of the brutality of human research
come to light. Just last year, researchers in Canada unearthed a shocking
experiment from the 1940s, wherein agents of the Canadian government allowed
and even encouraged malnutrition in aboriginal communities, attempting
to test the
While perhaps unnecessary, the codification of ethical guidelines could hardly be considered harmful. Instead, the harm to science is largely the product of IRBs, who ostensibly act as the first line of defense for ethical research. The goals of IRBs are admirable: they attempt to minimize risk to subjects, and require that informed consent be given. But unfortunately, their approach has been fundamentally flawed. Take, for example, their concept of "vulnerable populations," including "prisoners, terminally ill persons, children, people with mental illness [their definition includes transgender individuals], and pregnant women." These people are among those who merit the most study in the social sciences, but restrictions placed on them by IRBs complicate research to an unreasonable degree. To make matters worse, IRBs often mandate informed consent in the form of a written and signed document: a crippling blow to fields which value anonymous studies. More and more, IRBs seem designed simply to protect universities from any possible litigation or controversy.
After the horrors of the first part of the 20th century, the creation of official protections hardly seemed unreasonable. But the current form these protections take is ineffective and wrong. By attempting to legally standardize practices related to human subjects across all disciplines, IRBs and other legal safeguards force sociologists and anthropologists seeking to interview teens to jump through the same hoops as a sadistic biologist hoping to unleash a deadly pathogen in Latin America. Before the government stepped in to regulate professional behavior, the social sciences were capable of policing their own ethical standards remarkably well. Perhaps a return to that state of affairs is in order, with the standards and oversight of professional associations being backed by the legal muscle of the government.
Research Regulations: Still Necessary
From 1946 to 1948, 83 Guatemalan prostitutes, prisoners, infected soldiers, and mental patients were killed from being infected with syphilis by United States researchers in order to test the effects of certain antibiotics on test subjects, leaving those in the control category to die without any treatment.
Though almost 70 years have passed since this tragic incident, the fact that it occurred is proof why research needs to be regulated by Institutional Review Boards and Review Ethics Boards with strict and careful control so that those involved will stay out of harms way no matter how valuable the conceivable information, and to make sure that research is always conducted in an organized and faultless manner.
Anthropological research began to see restrictions and rules in 1974 when the National Research Act was passed, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission's job was to see that all research fit the three ethical principles: respect for persons, beneficence, and justice. From then on, several other regulations were put in place such as the Federal Policy for the Protection of Human Subjects in 1991, known as the "common rule". Leading into the 21st century, Canada updated their regulations in the Research Ethics Board in 2010, basing their judgment on a slightly amended version of the National Commission's ethical principles.
Arguments against the addition of regulations on research in the anthropological field have always existed, but with the many new inclusions that have been created to counteract continuous episodes of mistreatment of research subjects, many people feel that now more than ever these regulations have gone too far. In the Chronicle of Higher Education, Laurie Esseg argues that the field research of anthropology is much different than that of psychology, where having regulations makes sense because of the infamous researchers "who would recreate prison situations to see how nasty humans could be to total strangers or would tell their subjects that they had to administer electric shocks to a stranger with heart disease just to see if they'd do it". In Esseg's mind, anthropological field researchers are simply "speaking to people" as their research. To her, they are not harming or mistreating anyone in any way. This, obviously, is not the case when looking at the several examples of field research deliberately dishonoring entire cultures such as the Huron-Wendat Nation incident involving ancient ancestor's bones being dug up and hoarded, despite this group of people's cultural attachment to the bones, as well as the Guatemalan STD experiments previously mentioned that led to the deaths of many people, disrespecting the nation of Guatemala as a whole. Dealing with other cultures often brings out the inherent ethnocentrism found in most humans, and dealing with them in a flippant manner often occurs, making regulation a necessary enforcement from Review Ethics Boards and Institutional Review Boards.
Along with watching out for any signs of human or cultural abuse in research, common rules regulated by review boards should also ensure the research will be done in a manner that will prove results to be helpful and advantageous to unanswered questions. Mitch Smith of Inside Higher Education mentions the rigid system in which institutional review boards judge whether proposed research should get approval. Anything from spelling mistakes to incorrect word usage could potentially bring the rejection of a proposal. Although seen as strict and unnecessary to some, this tactic helps weed out any potentially hazardous research proposals created by those who don't have the fundamental skills to run an organized program. If one is not going back and checking on simple things like spelling in something as important as a proposal, it would be worrisome to put them in charge of an anthropologic field research team that could put many people at risk.
With countless examples of professional anthropologists abusing and mistreating people and cultures for the sake of information, it is obvious that the review boards of the United States and Canada need to be regulating research in order to keep subjects safe from harm, and to make sure no proposed research opportunities are potential disasters from the beginning. The Guatemalan STD experiments brought shame onto the name of American anthropology; with the help of regulation and control, we can assure this never happens again.
The Search For The Rules Of Research
As a psychology major, I am very interested in fieldwork and how researchers carry out their experiments. I have read a wide range of research articles that have left me wondering how the researchers acquire their data, especially when it's a touchy topic. In present-day U.S. and Canada there is a disparity in opinions regarding the need for common rules when conducting research, and how review boards can enforce them in a way that satisfies society's ethical standards.
It is inevitable that people have different morals, but for many issues there is a consensus to what's right versus what's wrong. However, there seems to be a very thin line for many matters. This thin line becomes a problem when humans are involved, especially when potential harm is a concern. In order to protect the people, Institutional Review Boards in the U.S. and Review Ethics Boards in Canada should establish clear guidelines and strictly enforce them.
I believe it is very important for the review boards to prioritize people's health. There should be extremely firm regulations regarding what medicines and treatments researchers are able to administer. If stricter laws had been enforced in the 1940's, the Guatemala Syphilis Experiment could have been avoided. It is completely unethical and actually disturbing that scientists, aware of the harm they were causing, would intentionally infect innocent people with deadly diseases.
Nutrition experts in Canada conducted an experiment using malnourished aboriginals as the subjects. In doing so, they risked the lives of many of these aboriginals, even though their actions "would probably have been considered ethically dubious even at the time."
No experiment that threatens a human life or puts any person in danger can ever be justified, and no research findings are worth that risk. It is necessary to have rules that prevent the possibility of harming a human being.
It is also very important to implement regulations that are in favor of people's values. Louisiana State University offended the Huron-Wendat Nation in an attempt to study human remains. Although they believed they had permission to take the 500-year-old bones, they apparently did not execute the process appropriately. This troubled the Huron-Wendat Nation because it involved matters of extreme importance to their culture. They need to set clear rules that limit researchers' procedures in order to ensure that people's principles are respected.
It is very necessary that researchers receive consent from their subjects. In the Guatemala Syphilis Experiment, the subjects didn't give informed consent for an issue that would eventually consume their entire life, which just simply isn't fair. The review boards should emphasize how important people's worth is and establish rules that protect the way of life they are entitled to live.
Before approving an experiment, it is necessary to ensure that research is being conducted for the greater good of the people. In the nutrition experiment, the researchers viewed real persons as if they were objects, "a possible means of testing these theories." They devalued an entire race in order to test a theory, which is selfish and groundless.
Although the nutritionists had plausible reason to conduct their research, it wasn't in favor of the people. In the Huron-Wendat Nation and LSU case, the students were indeed researching for the greater good of the people because they were just trying to expand our knowledge. It proved to be opposite of the greater good when the Huron-Wendat Nation expressed their reaction. If there were stricter rules, the entire situation could have been avoided.
It is very necessary that the review boards in the U.S. and Canada enforce clearer rules for conducting research to make sure the researchers' intentions are pure, with the least amount of room possible for error.
It's not as simple as it seems. There are also reasons why the rules should be more lenient in many cases. Some of the rules that already exist severely cripple researchers' abilities to collect the data they truly desire. In the case regarding fieldwork, the author mentions how limited field researchers are in their practice. "The IRBs have treated speaking with someone as equivalent to experimenting on them." I think in this sense, the rules are too serious. The "vulnerable populations" should still be accessible and rules about subject matter should be broader. If stricter rules are implemented, it could possibly kill fieldwork completely.
Research is a huge field of work and is the source of almost everything we know. Rules regarding people's health, values and intentions need to be strict in order to prevent any potential upset. The rules should be strict enough to protect the people, but tolerant enough to allow researchers to gain the knowledge they desire.
Regulating Research Laws to Protect those being Affected
Article Number five in the United States Declaration of Human Rights, states that no person shall be subjected to inhumane treatment or faced with cruel and unusual punishment. The Institutional Review Board (IRB), In the United states, and the Research Ethics Board (REB), in Canada, need to strictly regulate research that is conducted so that it does not violate Human Rights, and also respects the privacy of people as well as places.
Researchers should generally be able to conduct their research in such a way that will be beneficial to their studies, but will not infringe on the well being of persons involved.
In a 1942 study conducted by the Canadian government, officials subjected Manitoban aboriginals for a test focusing on the consumption of specific vitamins and supplements. These aboriginal people were malnourished, and did not maintain healthy lifestyles, making them less than ideal candidates for such a study. The officials selecting subjects for this study chose this group despite apparent health concerns already present in the subjects.
The aboriginals used for this particular study were unaware of the basic facts regarding the test, leaving them to question why they were being used. The disclosure of information concerning risk and approval of participation should be considered a basic human right, and should be adopted by the Canadian Research Ethics Board. The results from their tests did not yield evidence that could be used in any way, and thus they were not published.
In 1946, the United States government began research in Guatemala with consent from Guatemalan health professionals. The subjects included prostitutes, prisoners, soldiers, and mental patients. They were all unknowingly inoculated with sexually transmitted diseases. Eighty-three of the test subjects died. This clearly goes against the code of ethics established by the Institutional Review Board, which states, "Informed consent will be sought from each prospective subject." None of these subjects gave approval to the US government to be a part of this research, thus violating the IRB.
The results were not published, and the subjects were left with crippling diseases or perished, all for a study that was inconclusive. The United States government sent an apology to Guatemala, apologizing for violating The Declaration of Human Rights. The US felt the need to apologize years after this research was done, "President Barack Obama apologized to President Arévalo, who had called these experiments 'a crime against humanity'." This demonstrates how unethical it was to condone research that has negative health benefits on those involved, without their permission.
Regulations for the IRB and REB should be more specific in their wording in order to guarantee that researchers cannot violate human rights, and to ensure that the subjects provided consent, and will not be negatively affected from the results of the tests administered. A more rigid set of rules and regulations should be created to govern the ethics of government research in order to further protect the safety and privacy of the subjects.
On the other hand, some may say that research is subjective and in order to provide substantial qualitative findings, it is crucial to use whatever means necessary to gather the information. It would be unfair to have a set of regulations limiting researchers from practicing their work because of what may seem to be unethical, but what will actually progress society forward in discovering new breakthroughs.
Conducting research is important as it leads us to make discoveries that would otherwise be left unknown without extensive research, although it can be done in such a way that does not interfere with the basic human rights of people. The IRB and REB should update and strengthen their rules and regulations regarding the ethics of research in order to protect the subjects of their studies, whom they depend upon for the progression of their scientific fields.
Freedom vs. Regulation in Research
History has shown itself that research must be regulated in order to ensure the safety and rights of research participants. Not only have research studies caused physical harm to populations, but have also violated their ethical rights. The Institutional Review Boards (IRBs) and Research Ethics Boards (REB), in my opinion, must regulate research studies to ensure participants are protected, told all pertinent information and informed consent is signed.
Between 1932 and 1972, the US Public Heath Service conducted a study to try and further scientific and medical knowledge on the progression of syphilis. The study, known as the "Tuskegee Syphilis Experiment, was done on African American men in Alabama". This study occurred prior to the existence of IRBs in the United States and REBs in Canada and was unethical in many ways. By 1940, "doctors conducting the study knew that penicillin was the drug of choice to treat syphilis" (Villarosa), yet opted out of providing it to those in the study. They coerced the participants with syphilis go untreated as to allow the venereal disease to run its natural course by making them think they were getting free health care by participating. Allowing these individuals to go untreated, falsifying information and withholding data/results, to me as well as many others seems extremely unethical, just to see the progression of the disease. This says that in the name of science, these African American men's lives were less important than research and could be put through pain, suffering and ultimately sacrificed.
Not only was immediate harm done to the participants being untreated, but the harmful effects branched out. "Wives contracted syphilis from their husbands, and children were born with congenital syphilis" (Villarosa). Not only do we now have IRBs that regulate the research done on humans (especially medical research), doctors participating in studies also have the Hippocratic Oath to live by, that they swore to upon graduation of medical school. One statement in the Hippocratic oath specifically states: "I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone".
An extension to this Tuskegee study, between 1946 and 1948, American doctors took to Guatemala. This study dives deeper into the ethical debate than the one going on in Alabama. "696 men and women prisoners, soldiers and patients in mental hospitals" (Villarosa) were infected/exposed, most of which being known now as vulnerable populations. These individuals were exposed or infected without any form of informed consent.
Being a very science and medically based individual, I understand where people come from when they say if it weren't for studies like the Tuskegee and Guatemala Syphilis studies, we would know much less about diseases and therefor in the long run, more people would die or be infected. The fact that the natural disease process was seen in these specific studies in many men, gave medicine new information on the stages of syphilis. With tight regulation on research, it is hard to go into detail without crossing boundaries. Without tight regulation, we may be able to advance our knowledge about other diseases and find cures and other treatments, which otherwise would be denied by IRBs.
Although these are ample arguments to have more freedom in research rather than tight regulation, without regulation, the lives of innocent people are toyed with. Humans are treated as animals as if their lives do not matter on this earth. Human research participants deserve full explanation of experiments, a list of risks, adverse effects as well as benefits, information and data regarding the results of the trial and it is imperative to have informed consent. Only when the participants fully know what they are getting into, can they then sign the informed consent.
There must be tight regulation on research in order to prevent abuse. Without it, as seen prior to the development of IRB in the Tuskegee study and Guatemala Syphilis Study, boundaries need to be set. Without them, lines are crossed and unethical decisions are made. Those running trials may not always act in the best interest of the research participants in order to advance science and medicine. I strongly believe that there should be less freedom and more regulation by the IRB when it comes to research studies, specifically those having to do with medicine. As researchers, they owe the participants justice; after all it is their lives they are experimenting on. In my eyes, research must be tightly regulated in order to preserve dignity, and provide protection and safety to those willing enough to participate.
Villarosa, L. (2010, October 2). The Guatemala Syphilis Experiment's Tuskegee. The Root. Retrieved April 5, 2014, from http://www.theroot.com.
A Balanced Scale
The year is 1946 and you are a Guatemalan prisoner serving time in jail when some American doctor in a white coat walks up to you and injects you in the arm with some unknown substance. Time goes by and you start feeling ill, a few weeks later you are dead. This is what happened to 83 soldiers, prisoners, prostitutes, and mental patients in the well-known Guatemala Syphilis Experiments. This is the reason we have rules and regulations protecting human subjects in research and an example of why these regulations should stay as they are today.
Based on past history, it only makes sense that researchers be controlled on a short leash. Luckily, regulations such as the Belmont Report and the Common Rule were enacted to do this, which led to the formation of Institutional Review Boards (IRB). One of the most crucial of these regulations is protection for vulnerable subjects. Most examples of past abuse of subjects in research have been on vulnerable subjects. These people are susceptible to factors such as coercion that may put them at risk. In order for a researcher to use vulnerable subjects in his or her research, it must be absolutely necessary, and additional safeguards should be included to protect the rights and welfare of the subjects. Laurie Essig is referring to vulnerable subjects when she states that, "IRBs have effectively shut down our ability to actually find out about peoples lived experiences." In reality, these IRBs are put in place to protect these people and it makes more sense to strictly regulate than to put vulnerable populations at risk.
Another important regulation that is essential to enforce is informed consent. This keeps the subjects safe because it allows them to know everything involved in a study before they choose to either join or not. This is contrary to what happened with the aboriginal or syphilis experiments because the subjects had no chance to make an informed decision. With full disclosure of the experiment occurring, researchers can no longer include harmful aspects in their studies without the subjects knowing.
The regulations mentioned above both contribute to preventing the abuse of research subjects and promoting benefits for the society as a whole. In addition to these, criterion such as the FINER acronym should be a regulation regarding research studies, thus limiting the researchers freedom further. FINER stands for a study being Feasible, Interesting, Novel, Ethical, and Relevant. In other words, the study/experiment; is possible to be done, has not been pursued before, will not have the researcher give up on it, is safe, and will provide important information. If a researcher is required to hold his or her study to these standards, it will then be beneficial for the subjects involved and society as a whole.
Some say researchers should be allowed more freedom in conducting their studies. I say the regulations, as "annoying" as they may be, are vital to maintaining a safe research environment for all subjects. Looking back at the Guatemalan prisoner from 1946, it is evident he is only one example of thousands who could have been saved by the regulations we have today. The current leash on researchers definitely is short, however, I believe the length of it is long enough so that the scale between freedom and regulations is in balance.
The IRB: Avoiding Unethical Research or
In the 1940s, researchers gave vitamin supplements to already malnourished,
aboriginal children. One of the supplements was not even legal where
they were distributing it in Canada. Their testing seemed to be driven
by the fact that there was a population of people already there for them
in the conditions that they wanted to test. The Institutional Review
Board (IRB) had not yet been established when this aboriginal experiment
happened. It was clearly a malpractice situation that could have been
prevented, and it is a perfect example of why the IRB needs to enforce
a specific, even strict, set of rules.
"People with the power to apply rules that affect science and scholarship are, in effect, shaping what we can know and say for both good and ill." Laura Stark, a significant authority on IRBs (Institutional Review Boards), has recently declared. This brings to light a frightening truth that questions everything we think we know, and even more so, what we don't. Many field researches voice the concern that "IRBs have effectively shut down our ability to actually find out about people's lived experiences."
Why then, one must wonder, do IRBs continue to exist? The root of the issue is apparent in just a glance back into the history of Research experiments in the US. The phrase, "you are only as strong as your weakest link" comes to mind when regarding this history. North American researches have intentionally spread syphilis, stolen the spiritual remains of other's ancestors, and deprived starving Aboriginals of a healthy diet all for the purpose of learning a thing or two about the world. Even among all of the incredible advancements we have made as a nation via creative and fresh ideas, these unfortunate cases still leave a prominent and tainted perspective on the research methods US.
Although the data gathered from these experiments left no lasting effect, the inhumanness of the researcher's methods and lack of care for the local people's culture or well-being has produced our current predicament, the IRB crisis. We have gone from one extreme to the next, from under to over regulation, blindly skipping past the middle ground.
Where might this middle ground exist, if it does at all?
Their original mission statement reads, "The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction." In the beginning, this jurisdiction was limited to federally financed projects, a fair and well founded response to combat unjust research methods. Yet, overtime this jurisdiction grew to apply to all faculty research. This change disrupted the capability of researchers who were working with controversial, and thus, most likely, significant populations of our nation.
Those people marked as "vulnerable populations", whose definition includes a wide spectrum of people, from pregnant women, to transgender people, to prisoners, are flagged and researches have difficulty even speaking with them. One such person, with a history of interviewing prisoners before the IRB era, gave up on such endeavors because "getting IRB approval is far more difficult than getting through the prison doors."
The IRB should not be discouraging innovative thinkers from designing new experiments and targeting diverse demographics of people. The review board's purpose is to protect, as well as ensure the benefit of, such research subjects. This is no simple task, especially when considering dissimilar cultures, whose beliefs and values are foreign and could be entirely opposite of what the scholars are invested in.
A solid argument to defend the thoroughness in which the IRB comes down upon research proposals lies in their attempt to test the scientist themselves. If one does not put the care in to at least review a research proposal for typos or clarity, why allow them the funding or ability to conduct such significant experiments?
In response, Laura Stark asks the question, "should researchers be evaluated at all, or simply the studies being proposed?" While the IRB is correct in seeking to ensure a flawless system that does not offend or neglect anyone, the leash needs to be given some slack. The core morals remain strong and good, but the method of applying rigid, categorizing nomenclature to populations as "vulnerable" or not, is clearly suffocating a good portion of the field's workers.
We must work towards a more self-sustainable system, one that takes into consideration history and context, as well as the point of view of all parties affected and involved in the research.
Humanity for Humane and Ethical Practice
Human rights are points that should not easily be contested; rights
are rights, not privileges. The principles of humaneness conducted on
people are treated as privileges; however, should be stated as laws.
Regarding anthropological research, Institutional Review Boards and Research
Ethics Boards must ensure that risks to subjects are minimal and that
informed consent will be sought from each prospective subject.
In 1942 in Manitoba, Canada, a series of unethical experiments were
conducted on aboriginal peoples in addition to aboriginal children. Researchers
believed that hungry, dependent, and isolated subjects would be ideal
for nutritional studies. The experiments, repugnant today, would probably
have been considered ethically dubious even at the time, said Mosby.
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 (Subject to Aboriginal Experiments).
There was no empathy or humaneness involved in the attempt to conduct
nutritional experiments. They took away dental practice on the children
in order to study the effects of the experiments on the gums. They fed
the adults a caloric intake less than the means of functioning and healthy.
These disturbing studies are unethical today, and were unethical at the
time. If IRBs and REBs would have implemented the points of keeping subjects
at minimal risk and seeking out informed consent, this practice never
would have been explored. The unethical treatment of human beings on
fellow human beings could have easily been prevented due to the implementation
of these key aspects to ensuring honest and proper practice.
The New Review: Field Autonomy
Recently, there has been great controversy surrounding the freedoms granted to academic researchers, and the regulations imposed on them. Such a controversy has led to hostility between scholars whose careers are reliant on the results of the research they conduct, and the bureaucratically selected members of Institutional Review Boards (IRBs) whose job it is to restrict research that is unethical. From an academic perspective, IRBs serve no purpose other than to reject valuable research proposals, with a "play it safe" attitude that protects university administrations from the threat of lawsuits. From the opposite perspective, unconstrained academics abuse research privileges, and naturally overlook the wellbeing of their subjects.
What most don't realize is that the solution to the problem is not a matter of who is right and who is wrong, but a matter of WHAT is right and WHAT is wrong.
That which is wrong is inherent in the current research review structure. Therefore, it is first necessary for the current structure to be altered. I suggest that IRBs grant autonomy to specific fields in conducting their own research.
Let's face it: not all fields of study have the same goals. So why should an anthropologist face the same research limitations that a psychologist does? Why can't anthropological research be reviewed by anthropologists, and subjected to regulations pertinent to the field of anthropology?
IRBs should oversee the formation of smaller field-specific review boards. This would both increase a field's research freedom and create guidelines with institutionalized restrictions better suited to the field. Each field should be given the right to interpret the Code of Federal Regulations individually.
IRB interpretation of requirements like that of "informed consent" has needlessly impeded countless research efforts. With field-specific review boards, it would be easier for an anthropologist to conduct research among "vulnerable populations. They'd be allowed to interview prisoners, who HAVE the freedom to choose whom they want to speak with; mentally ill individuals, who HAVE the capability of communicating their many troubles; and children, who HAVE a basic understanding of their own bodies. More would be done for the common good.
But members of IRBs would not be left jobless. They would assume more administrative roles. For example, to verify the ethics of a health-related research proposal, an IRB could demand that an ad hoc board (perhaps from another field) reviews the proposal after its initial approval. If the proposal were then deemed unethical by the ad hoc review board, it would be brought in front of the IRB itself for a final review. In other words, the IRB would maintain supremacy, but would be required to delegate power to the fields below it.
To ensure the maintenance of ethical research, these field-specific review boards would both incentivize research with positive outcomes and sanction research conducted poorly. In this system, a researcher with a good track record would be more likely to have his or her proposal approved than a researcher with a history of conduct violations. In effect, a researcher would be both obligated to "do no harm" and encouraged to do good.
A critic of my suggestion may say that I'm placing too much faith in both the field and the researcher, as they are both self-interested actors. But the field-specific review board would still have to answer to an IRB, and the researcher would be motivated by incentives and sanctions to conduct good research that yields positive results. One may also criticize this system of sanctions, arguing that poor research should be not punished, but prevented. Well, I believe that to allow good to be done, we must take risks. Research has been paralyzed by the preoccupying fear of doing harm; research must now strive simply to do good.
It is imperative that the current structure of research review is changed. Field-specific review boards would promote good research that is valuable for humanity.
Research Regulation: An Essential Practice
One would assume that studies involving fatally dangerous diseases would be done with the utmost concern for the well being of the subject, but this is not always the case. In the period of 1946 to 1948, syphilis was tested on Guatemalan soldiers, prostitutes, prisoners, and mental patients were infected with syphilis to test the effects of penicillin. The caution that should be researcherÃ¢ï¿½ï¿½s highest priority was not existent. At least 83 human beings died as a result of this study. When studying the effects of disease on human beings can be very beneficial, it is a practice that needs to be carried out with caution.
Preforming studies on human beings can serve as an exceptional tool to gain knowledge about our species. That being said, not all studies are ethical. Bodies such as the Institutional Review Board (IRB) should have the ability to enforce rules and regulations regarding research. Researchers should have freedom to conduct their experiments as long as they do not pose harm to their subjects, are based on informed consent, and are not deceptive in nature. Studies should require approval from institutions such as the IRB before they are conducted. If this was the case, unethical studies like the syphilis experiments in Guatemala would not take place, and 83 people would not have been killed.
Research should not take place if it poses any harm to its subjects. For this reason, the IRB should have the ability to deny a study if it could potentially harm the participants, either mentally or physically. The experiments in Guatemala, led by United States Public Health Service physician John Charles Cutler, clearly did not consider the negative physical effects that their experiments would have. They intentionally infected people with venereal diseases, and even forced infected prostitutes to have sex with healthy prisoners. Also, the researchers only completed treatment for 26% of the participants. If a research review board had been in place to regulate the nature of research, they could have identified the blatant possibility for harm to subjects, and denied the study.
Another aspect of research studies that would maintain the ethical nature of research if regulated by an organization such as the IRB is the required acquisition of informed consent. If the participants in Guatemala knew what effects the syphilis study would have on them, they would likely have not participated. It is important that researchers use only subjects that are willing to participate, so review boards need the ability to regulate this aspect of any study.
Even if a researcher has the best of intentions, they do not always carry out their fieldwork in an ethical manner. One prominent example of this phenomenon is when research studies are deceptive in their nature. The syphilis experiments in Guatemala certainly fall into this category; they did not adequately explain to the subjects the possible outcomes of being infected. They forced prostitutes to have sex with uninformed prisoners, which is profoundly unethical. Regulation of this aspect of research studies is essential.
Some believe that the regulation of research limits the extent of what we can learn from studying human beings. They might argue that if the syphilis experiments had been regulated, we may not have the knowledge of sexually transmitted diseases that we do today. However, they are ignorant to the possible outcomes of regulated research, and do not consider that we can learn just as much while conducting ethical, regulated research. The subjects in the Guatemala syphilis studies could have been treated effectively, informed of the nature of research, and respected as human beings without hindering the quality of findings.
When studying human beings, whether it is for medical, biological, social, or anthropological research, researchers need to take the well being of their subjects seriously. Some researchers put potential findings before the health of their participants, which is an undeniably unethical practice. The ability for bodies such as the IRB to regulate studies with the intention of protecting participants is a crucial component of scholarly research today.
Reasonable Regulations: A Necessary Evil for Ethical Conduct
From 1946 to 1948, human-based research conducted by the United States in Guatemala led to at least 83 deaths, all of which could have been avoided. Little was concluded from the research. While the death count of this incident was both preventable and disturbing, perhaps the most unsettling aspect of the experiment is the lack of informed consent. The fact that the subjects had no option of participation was one factor that encouraged the emergence of regulations on research, especially research involving human subjects.
Institutional Review Boards were put into place as social concern rose over events such as the one described above. With a list of requirements that must be met, the IRB is charged with concluding that all research will protect research subjects from unethical researchers. Unfortunately, regulations and IRBs are still no guarantee of ethical behavior in research. In order to better protect human subjects, Institutional Review Boards should enforce a set of common rules regarding research which, when enforced, will prevent the abuse of research subjects and ensure that the research strives to promote positive benefits not only for the larger society sponsoring the research but for the research subjects as well.
The horrifying statistics referenced at the beginning of this piece refer to the Guatemala Syphilis Experiment conducted by a United States Public Health Service physician. The research was conducted overseas in Guatemala because it would not have been approved domestically. To do this 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." The results were at least 83 deaths of previously healthy research subjects.
There are many problems with this experiment. The first issue is the lack of consent given by the human-subjects. A major tenant of the IRB requirements is that informed consent will be sought from each prospective subject and appropriately documented. This clearly shows the need for regulations on research regarding human-subjects, as the subjects in this study most likely would not have agreed to the conditions of this research. Another problem with the study is that "most" subjects were treated with antibiotics. The subjects not treated with antibiotics had no chance against these fatal diseases with which they were injected, and "although adequate penicillin therapy was prescribed for 76% of subjects, completion of therapy was documented for only 26%. Not only were the subjects not given an option to participate in this experiment, but also the research was not conducted according to today's IRB regulations.
Today, the IRB is charged with ensuring that risks to subjects are reasonable in relation to anticipated benefits. I would argue that by not treating patients appropriately, as they claimed they would in the original plan for the study, the risks to subjects were nowhere near reasonable in relation to the anticipated benefits of the study. The findings were never published, suggesting that there were close to no benefits of the study.
The idea of more serious regulations on research raises the valid concern for some that the type and amount of research than can be done will be limited, and we will no longer be acquiring the knowledge we need to continue forward as a society. While it is important to note that much of what we know today would not be available were unethical experiments never conducted, this situation comes down to a decision of what our society should value more- its citizens or the knowledge that these citizens can provide.
I would argue that human lives should be valued more than they were in experiments such as that conducted in Guatemala. Regulations on research in cases such as Guatemala would not necessarily render the experiments impossible to conduct; rather, the issue would be more on the lack of consent. Were the IRB to have existed at the time of this case, they would have been more concerned about the transparency of the study than its existence.
While the formal regulatory rituals of IRB committees are incredibly valuable when research involves human subjects, ethical socialization of the researchers conducting these experiments may be a more viable solution. IRBs can continue to review studies and research, but until the professionals doing the research understand the ethical issues surrounding their research, major change is not possible. With regulations in place, and ethnical awareness of professionals, researchers can then be allowed freedom in their work to a reasonable extent. Research should be done for the good of the society as well as for the good of the study participants. When experiments are finally looked at with the goal of doing good, rather than doing no harm, appropriate and ethical research will finally exist.