Vulnerable subjects in clinical research

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According to the dictionary definition, the word vulnerable means someone who is “exposed to the possibility of being attacked or harmed, either physically or emotionally”. So who constitutes the vulnerable population in Clinical Research and why do we need to protect them? To answer this question first, let’s take a brief look at the history of research abuse.

Regrettably, the history of research abuse is quite a long one. Perhaps the first ever thought which comes to our mind when we talk about this topic is the abuse of war prisoners during the Nazi regime in Germany. They conducted a series of inhumane experiments on the large number of people, mainly the Jews (including children) from across Europe. The population also included disabled non Jewish Germans, Soviet Prisoners of Wars, etc. The experiments were conducted without taking any form of consent from the prisoners and the prisoners were always forced to participate in such kind of medical experiments. The experiments were often performed on the subjects without any form of anesthesia and the subjects would be rendered to extreme form of pain, humiliation and often death. Even if the lucky ones managed to survive these horrors, they were often executed in order to study post mortem results. As an aftermath of these experiments, the doctors who were captured after the debacle of the Nazi regime were put into trials wherein several of them argued in their defense that there is no known law which can be regarded internationally to prevent them from conducting such experiments. The modern cases of abuse are quite similar to the ones described previously. Every researcher is aware of Tuskegee Trials which took places in the United States wherein poor Afro-Americans were never told that they had syphilis nor were they being treated for it. For participating in the study, the men were given undue advantages of free meals, insurance and medical care. Even when there was a cure available for syphilis, the subjects were not given the cure. Recently in 2007, major pharmaceutical giants like Sun and Novartis were involved in unethical trials with the medicine Letrozole which is approved only for breast cancer but was used for inducing ovulation.

Coming back to our subject of discussion on vulnerable population, a population is called to be as vulnerable when a person’s ability to protect himself/herself is greatly diminished or is absent. Vulnerable population includes people who are institutionalized such as prisoners, pregnant  women and women of child bearing potential because of the risks involved to their fetuses, children as they have underdeveloped skills when it comes to decision making, people with psychiatric disorders as may not conceive the information provided to them to make informed choices. We need to get familiar with another term called as “Coercion” while discussing this topic. Coercion involves forcing an individual while presenting a threat of harm to him/her. Sometimes, potential investigators may use their influence on the subjects to make them participate in the trial. Often in countries like India, there is almost a blind faith the patient puts in his doctor. The kind of patients will bother to read details in the consent form and blindly sign it without making an informed choice. The economically deprived can be also induced to participate in trials by offering them monetary benefits and other forms of influences. Another form of vulnerable population can be be students and employees of a particular organization. Recently there was an incident in India wherein parents were sent a note from the school authorities that their children needs compulsorily to participate in this trial which is being conducted. Employees are also considered vulnerable when a decision to participate relies upon factors like job promotions, opportunities, prevent the loss of benefits and privileges.

Recently the Drug Controller General in India has suggested that video recording should be made compulsory while obtaining informed consent from the subject. This step is definitely a way to protect vulnerable population from getting undue influenced to participate. Besides, the investigators have to be responsible towards their duty of protecting the rights of the subjects at any cost. Investigators should be aware of the federal regulations imposed on clinical studies which are meant to protect vulnerable population.

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