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Informed Consent Procedure in Clinical Trials

Clinical Research

Informed Consent Procedure in Clinical Trials

Informed Consent in clinical trial is often the most important part of clinical trial and sometimes neglected too, resulting in serious consequences, for the patient, the doctor involved in the trial and the pharmaceutical company sponsoring the trial. Which brings us to the question of what exactly is an Informed Consent Procedure? It is process wherein the patient is made known details about the clinical trial and is asked whether he / she is willing to participate in the trial voluntarily. Doctors have a duty to fully explain the risk and the consequences of the participating in the clinical trial to the potential subject. Informed consent in a term used both in medical and legal terms.

Let us examine a few of the scenarios wherein the informed consent procedure importance is highlighted. Suppose a patient suffers from an injury during the trial which may or may not related to the study drug .But he / she can still sue the doctor and has legal grounds to accuse to doctor of malpractice is informed consent is not obtained before hand. There are many who believe that getting a signature on the  informed consent procedure from the patient suffices. But in reality, the doctor must be patient with the subject, thoroughly explain all consequences of the treatment in simple terms to the patient and the person accompanying him/her. So informed consent procedure does not merely mean taking the potential subject’s signature on a informed consent form.

The history of making informed consent procedure mandatory goes back since a long time during the World War. During this period, NAZI scientists conducted horrific experiments on prisoners and just left them to die a horrible death. Even though several doctors were tied in courts later after the war, the world was shocked when these doctors revealed the nature of their experiments. As of result of this, the Nuremberg Code was created in the year 1948 which was one the earliest document to represent ethics in medical treatment. This was first documented which stated and emphasized the need to  voluntarily participate in clinical trials.

Even after the creation of the Nuremberg Code, many unethical practices where still going on around the world. Vaccines and drugs were continued to be used on “vulnerable” subjects such as prisoners, soldiers and mentally challenged individuals. The worst of one such practice was the use of a drug called thalidomide, which was suppose to cure morning sickness in pregnant women. During the time period of 1945-1966, thousands of American women where given this drug, which informed consent process and not being told them about the consequences of the drug. This resulted in the birth of babies with extreme birth defects. In another just horrific incident, school children were subjected to the Hepatitis Virus in order to find a cure for Hepatitis. The children were not mentally stable. The Tuskegee Trials, which began in the year 1932 and continued till the year 1972 started with a purpose of examining the long term effects of the Syphilis. The subjects of this study were African-American men who were patients suffering from Syphilis but were unaware of this fact. The most horrifying part of the study was even though the cure of this dreaded disease was discovered, the patients were not allowed to take the cure and was allowed to die just like that.

History will reveal many biases to the informed consent process even the present day. The need for the hour is to make sure that the participants of the trial make sure that the Informed Consent Process is not just a form but a Procedure which needs to be followed through and through for patient safety and protection of his/her fundamental rights.

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