Informed Consent & Biomedical Research Ethics

Instructor: Betsy Chesnutt

Betsy teaches college physics, biology, and engineering and has a Ph.D. in Biomedical Engineering

In biomedical research, it's important that all research subjects are informed of what is going to happen and have the opportunity to provide informed consent. In this lesson, learn exactly what this means and how these guidelines were developed.

What is Informed Consent?

Julie goes to the doctor and has some blood drawn for some medical tests. Julie doesn't know it, but her doctor is conducting a research study. He is measuring the quantity of a specific protein in the blood of volunteers from the local community in which Julie lives. Can he test Julie's blood for the presence of this protein without telling her? How would you feel about this if it happened to you? Would you be okay with participating in this research or not?

Perhaps you would want to participate in the research. After all, it won't harm you, and many people would likely be happy to donate a small amount of blood if it might be used in research to improve human health. However, some people might not want to participate. Do they have the right to be informed and to say no?

These questions are ones that researchers have had to answer for many years. In the past, medical research such as this was performed on patients without their consent. However, now we believe that all researchers have an ethical responsibility to make sure that all participants in the research have provided informed consent.

In order to provide informed consent, the research subject must first be informed of exactly what procedures will be performed, what the possible risks are, and how the data will be used. He or she must then agree, usually in writing, to participate. Just getting a form signed is not sufficient, however. It is the responsibility of the researcher to fully explain the process and make sure that the subject understands it BEFORE conducting any experiments.

The Nuremberg Code

How was it decided that research subjects must provide informed consent? All of the modern laws about research ethics can be traced back to Nuremberg, Germany in 1947. During World War II, German doctors engaged in medical experimentation on prisoners in concentration camps. Of course, these prisoners did not provide consent. Many of these experiments were painful, and they often resulted in death. Twenty three doctors and scientists were brought to trial for these crimes against humanity in 1947 in Nuremberg. During the trial, some of the defendents asserted that they did not know that the experiments were illegal because there was no law determining which kinds of experiments were allowed and which were not.

In 1947,the Nuremberg Code established guidelines for medical research following the trial of German doctors who were convicted of war crimes for experimentation on human subjects without their consent during World War II
nuremberg trial

As a result, the judges presiding over this trial added a series of ten guidelines for performing medical research ethically to the trial verdict. These were collectively known as the Nuremberg Code, and the first guideline in the code was that the voluntary, well-informed consent of the subject was always required.

Although the Nuremberg Code established ethical guidelines for medical research, including the obligation to insure informed consent, it was not legally binding, and there were no official laws regulating medical research, so problems still persisted. In one famous case, cancer cells were taken from a patient named Henrietta Lacks in 1951 without her knowledge or consent. These cells were used to start an immortalized cell line that has been used by researchers all over the world. A lot of good things have come from using these cells, including a vaccine for polio, and perhaps Henrietta Lacks would have agreed to donate the cells if she was given the opportunity to provide informed consent, but she wasn't given that option. While this was clearly not as unethical as what the German doctors did during World War II, it still did not follow the guidelines of the Nuremberg Code because she did not have the opportunity to give informed consent.

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