Ethical Issues in Pharmacy Research
Ethical Issues in Pharmacy Research Reflection There is abundant evidence showing how easy it is to exploit individuals in the history of medical research in the twentieth century. It was not until the early 1960s when the public began to take notice of the ethical neglect that researchers had for their subjects.
The exposure of gross abuses in medical research generated a public furor that was finally noticed by those who administered research funding which enabled changes to policy to begin to take place such as the Declaration of Helsinki which addressed the issue of independent review of research protocols by a committee not associated with the project. It is enough to make one sick when you look at the unethical medical research that has taken place in the United States alone. In the name of “research” there has taken place many clinical experiments that have been done unethically.
In the 1940s several “research” studies where done using either patients from state insane asylums or from prisons. These studies ranged from injecting patients with experimental flu vaccines to malaria and hepatitis. All of these studies were federally funded. The “Nuremberg Code” was established as a set of international rules to protect human test subjects after the prosecution of Nazi doctors in 1947. However, many American doctors ignored them, arguing that they applied to Nazi atrocities, not to research they were doing.
By the 1960s, more than half of the states allowed for prisoners to be used as human guinea pigs for medical research. However, two studies would come to light in the 1960s which would turn public attitude about the use of humans in research. The first study was done at Brooklyn’s Jewish Chronic Disease Hospital in New York. 1 The researchers injected cancer cells into 19 old, debilitated patients to see if their bodies would reject them. The patients were not told what they were being injected with because the researchers believed the cells harmless.
However, a lawyer who was on the hospital board was upset over the research which led to the state investigating. The second study was done over three years at Willowbrook State School where mentally retarded children were given hepatitis to see if they could then be cured. 2 Then in 1972, the Tuskegee experiment sparked extensive critical media coverage and public outrage. 3 The Tuskegee experiment took place from 1942 to 1972 in Macon County, Alabama. About 400 poor, black men were used under false pretentions by the U.
S. Public Health Service. These men were illiterate sharecroppers that were never told what disease they were suffering from or where they give treatment for syphilis. They were deliberately left to degenerate under the ravages of syphilis in the name of research. The public was very sensitive to this type of research due to the publicity that the crimes committed by the Nazi doctors had received. When awareness arose that our own government was capable of carrying out unethical experimentation, fear arose.
This led to Federal regulations to express the social values and concerns of the people. The first regulation was the National Research Act in 1974 which established the research proposal with informed consent. The Institutional Review Board (IRB) was also established with this act. The purpose of the IRB is to protect the rights and welfare of research subjects. This is an institution –specific board that is made up of at least 5 individuals of which one must be a nonscientist and one being a member from the public community.
To be able to establish the safety and efficacy of a therapy it is necessary to do clinical research. So what is the correct pathway to obtain a patient’s consent in a clinical research project? The National Institute of Health (NIH) requires that clinical testing be done before a product license for that treatment can be given. However, the patient is being put at risk of any unknown side-effects by taking part in a clinical trial. So how can we protect patients? The strongest protection for patients is his or her consent.
According to the NIH website, “informed consent explains risks and potential benefits about a clinical trial before someone decides whether to participate. ” 4 When the researcher obtains consent they are respecting the patient and enabling them to self-governing plus upholding the principle of respect for persons. IRBs have been a good standard for ethical research; however with the advancing fields of research in genetics, reproduction, and neurology, it may be time to develop more regulations.
There are four basic principles of medical bioethics. These are autonomy, justice, beneficence, and non-maleficence. Autonomy comes from the Ancient Greek which means self-law. It is the ability of an individual to make an informed, un-coerced decision. Justice means to give all persons what is due to them that can refer to treatment and education. Beneficence refers taking actions that sever the best interests of the patient. And finally, but not least the principle of non-maleficence means to avoid causing harm to the patient.
These four principles must be firmly ingrained into the medical research process for the safety and well-being of the patients. As Christians in the medical profession and involved in research we must ensure that we are upholding not only the NIH requirements but also what the Bible teaches us about the sanctity of life. Research is an important part of furthering the well-being of human life but we cannot let it be done at the expense of other humans.
As upcoming professionals in the field we need to develop a firm Christian worldview and be not ashamed to stand up for what we know to be moral and ethical. We also need to educate our peers as such as when tainted unethical research is allowed to take place it reflects poorly on the entire medical profession. 1. http://www. columbia. edu/itc/history/rothman/COL476I5027. pdf 2. http://willowbrookstateschool. blogspot. com/p/history. html 3. “The Deadly Deception” http://www. youtube. com/watch? v=ofiOzzfKK84 4. http://www. nih. gov/health/clinicaltrials/glossary. htm