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Biology 103
2001 Second Web Report
On Serendip

The History and Importance of Informed Consent in Clinical Trials

Jessica Kiefer

The twentieth century was a time of many scientific advances, especially in the field of medicine. Doctors were able to use advancing technology to understand more about the human body and the many diseases that attack it. During the twentieth century, a great many medicines and vaccines were developed that were able to almost entirely eradicate diseases such as small pox and polio. These advances required years of research and testing. However, some of these wonder drugs have a dark past. Many of the early advances in medicine were made at the expense of many marginal groups such as asylum inmates and prisoners. These test subjects were involved in these clinical trials without being informed, or even asked. The horrors of World War II and unethical clinical trials done by the U.S. health service made the public and medical community aware the need for the field of bioethics. Bioethics is a field that strives to create fair and ethical medical procedures, covering a wide range of procedures from organ transplantation to clinical trials. Clinical trials were made more ethical by the creation of Institutional Review Boards, and the notion of informed consent. Before an individual can participate in a clinical trial, they must properly be informed of the risks and give their consent. Examining the history of informed consent demonstrates the importance it has had in protecting the rights and health of individuals participating in clinical trials.

Informed consent is designed to protect individuals participating in clinical research trials. An individual interested in participating in a medical research trial will receive a document that contains information about the benefits and risk of the trial, the research procedures and the reasons for the research. (1). The participant should be able to review the document with doctors and ask questions about things they do not understand. (1). Official consent to participate in the trial is given when this document is signed, with the researcher and the participant retaining a copy. (1). However, the process of informed consent should not end there. The researchers are obligated to keep the participant updated and answer any questions the participant has.(1). Informed consent does not obligate the participant to finish the trial. A participant has the right to leave the trial at any time during the study. (1).

During World War II, doctors in Nazi Germany were conducting horrifying research on prisoners in concentration camps. This research was done on involuntary participants who usually died as a result of the experiments. After the war, many of these doctors were tried at the Nuremberg trials for their crimes. The International community was shocked by the revelations of their research. As a result of the trial, the Nuremberg Code was created in 1948. (1). This international document was one of the earliest to address ethics in medical research. It stated that voluntary consent was mandatory for any clinical research. Voluntary consent meant that the participants were able to consent, were not being coerced to do the study and understood the risks and benefits involved. (1). The Code was adopted by the United Nations in 1948.(1).

However, there were many unethical clinical research trials being done during World War II in America and Britain. President Franklin Roosevelt created an Office of Scientific Research and Development to combat diseases such as dysentery, influenza and malaria, diseases that commonly affect soldiers. (2). One of the research teams created a potential vaccine for dysentery. To test it the researchers used orphans and mentally retarded individuals in institutions. The orphans developed dangerously high fevers, thus proving that the vaccine did not work. (2). Another research team purposefully gave psychotic patients at then Illinois State Hospital with malaria, in order to test a cure. (2). Penicillin, the wonder drug of the century, was tested on prisoners to find the most effective dosage. (2). At the time, many attitudes were that t was necessary for some sacrifices to be made to benefit the whole of society. (2). After the war and creation of the Nuremberg code, many American medical researches still felt the same and continued with unethical medical research. (2).

Many medical advancements came from World War II, the US government sought to continue this trend by creating the National Institutes of Health, which provided funds for experimentation. (2). These funds were given with no stipulations about the rights of the experiments participants. In the period of time between 1945-1966 the NIH funded 2,000 research projects, and none of them used informed consent. (2). During this same period of time a drug called thalidomide was being developed. This drug was supposed to prevent miscarriages. The head of the Food and Drug Administration did not want to approve the drug for use because she was unsatisfied with test results. (2). However, 200,000 American women were given the drug without knowing that it had no been approved. These women were essentially taking part in a drug trial without knowing it. They were not warned of the risks. (2). The result was that many babies of women taking this drug were born with extreme birth defects. (2). This caused a huge scandal. Congress passed an amendment to the Food, Drug and Cosmetic Act that required doctors to tell patients if they were taking a trial drug. (2).

The mindset that these sorts of unethical trials were permissible because they helped the whole society was slowly changing. One major event that caused this was an article written by Henry Beecher that appeared in the June 16, 1966 issue of the New England Journal of Medicine.(2). This article exposed many clinical research trials that had been funded by the government that very highly unethical. He gave 22 examples of unethical research. One of the examples was that mentally retarded children at a state school were infected with hepatitis virus. The researcher who carried out this experiment eventual became head of the pediatrics department at New York University. (2). He felt that he was justified because a cure for hepatitis would help many more people. In each of BeecherŐs examples, clinical trials were done on marginal members of society such as the poor, developmentally disabled and senile. (2). These marginalized members of society were unable to decide to participate in these trials. The NIH had already been working to make clinical research more ethical. In July 1966 a set of standards was issued that called for an independent Institutional Review Board to review all research done by an institution. These Review Boards examined risks and benefits of research and how the researcher intended to obtain informed consent. (2). Shortly after the FDA also created rules for obtaining informed consent in itŐs investigations of new medicines. (2).

One of the major events that brought the issue of obtaining informed consent to the public was the revelation of the Tuskegee Syphilis Study. The study was conducted by the United States Public Health Service.(2). The Tuskegee study began in 1932 and continued till 1972, when it was revealed to the public.(3). The purpose of the study was to examine the long term affects of syphilis. The subjects of the study were 400 African American males, who were primarily poor sharecroppers. These men all had syphilis, but were unaware of it. They were also unaware of the true nature of the experiment. (3). The most horrifying aspect of the experiment was in the 1950Ős penicillin was proved to be effective at curing syphilis. The researchers did not treat the menŐs syphilis and even prevented other doctors who saw the participants from treating the syphilis.(3). As many as one hundred men may have died from complications from their untreated syphilis.(3). The study was revealed in 1972 by a researcher who had worked on the project. His newspaper article shocked the country and caused the project to be shut down.(2). In 1997 President Clinton formally apologized for the study.(2).

The many revelations of unethical medical research in the 1960Ős and 1970Ős led Congress to pass the National Research act which created the National Commission for the Protection of Human Subjects in Biomedical and Behavioral research. (4). The commissions final report and recommendations is known as the Belmont report. (4). The intent was to create a cohesive set of guidelines for conducting ethical research. The commission felt that medical advancement should not require a loss of human rights.(4). The commission reaffirmed the role of the Institutional Review Boards that had been created in the 1960Ős. (4). The Belmont Report also expanded the definition of informed consent, making sure that participants were kept informed throughout the experiment and more fully understand risks and benefits.(4). It also stated that individuals with a lower capacity for making decisions, such as children, the elderly and the developmentally disabled needed to be protected. (1). The US departments of Health and Human Services and the FDA revised their research rules based on this report. (1).

However participants in research trials may still be at risk. On September 17, 1999 an 18 year old research participant died. He was involved in a study being done at the University of Pennsylvania. In investigations of his death, it was discovered that the participant and his father had not been told enough about the risks of the procedure.(2). Because he did not understand all of the possible risks, the participant put himself in a dangerous situation and died as a result. As a result of this incident, the Department of Health and Human Services worked to make sure that people were properly informed. One of the measures they enacted was legislation that would allow the FDA to fine research projects up to one million dollars for informed consent violations. (2).

Informed consent is one of the most important facets of bioethics. It has applications outside of just clinical trials. Doctors are obligated to make sure that a patient understands the risks and benefits of any medical procedure. Requiring informed consent protects many marginal groups from being forced to participate in medical studies without understanding the risks involved. The Belmont Report quotes philosopher Hans Jonas Ňprogress is an optional goal, not and unconditional commitment, and .. its tempo ... compulsive as it may become, has nothing sacred about it.Ó (4). Medical advances should not require some people to sacrifice their health and rights for the good of all. Informed consent is a key instrument in protecting these rights.

WWW Sources

1)Cancer Trials,

2)Nurse Week Ethics Education Program,

3)Tuskegee Study Information,

3)The Belmont Report ,

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