Clinical trials are a very important aspect of the pharmaceutical world. Prior to any new drug or medical apparatus being put into use for consumers, it must first go through rigorous testing to ensure safety. This is done in the form of clinical trials, usually involving humans. In order to ensure human test subjects are protected, the federal government has put certain regulations and guidelines into effect. While these regulations and guidelines are meant to protect people, there are times when they are not followed, and with the rush to get products to market and increase profits, clinical trial injuries are becoming more and more common.
There are three ethical principles that have been put into place to protect human participants in clinical trials. They are as follows:
Respect for the Person: The premise for this guideline is further divided into two individual moral requirements - the requirement to recognize independence and the requirement to protect subjects with reduced independence.
Beneficence: Subjects are to be treated in a manner that is ethical by ensuring their security and well being is protected. Two main rules are applied - do no harm, and maximize the potential benefit while minimizing risk.
Justice: This asserts to answer the questions of who will receive the benefits of the research and who should accept its responsibility. Injustice is classified as an entitled person not receiving the benefit without proper reason or if someone is forced to bear greater responsibility than others.
In addition to these three principles being put into place, there are also guidelines for applying these principles. They are as follows:
Informed Consent: The subject wishing to participate in the clinical research should be able to understand what is involved with the process, the associated risks, and how involved he or she will be with the research. Having informed consent is the cornerstone of the federal regulations and guidelines.
Risk Assessment: The researcher and sponsors of the study, as well as others associated with the trial should be able to properly assess the risk to the subjects taking part. If a human subject is harmed during the trial, the risk assessment process and the way that risk is conveyed to the subjects should be looked into.
Subject Selection: Those in charge of the trial are responsible for assessing the benefits to human subjects while weighing the risks that will be faced. Those who are vulnerable should not be exploited and should be carefully considered when approached for participation.
If you or someone you know has suffered injuries because of taking part in a clinical trial, the issue of informed consent plays a major role when bringing forth a lawsuit. Even if a signed form has been provided, it could still be argued that true informed consent, as classified by the federal regulations, was not given. This is a very complex issue that must be handled by a skilled attorney.
It was the Nuremberg Code that first recognized the importance of ethical treatment of human test subjects and informed consent. This set a standard for scientists and physicians who were conducting experiments on prisoners during World War II. It was this code that brought to light how far people will go for science and has been referred to specifically in the federal guidelines and regulations that were drafted for human test subjects in clinical trials. Regulators also took into account the Belmont Report, which was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Using these pieces of information three main components of informed consent were laid out:
Information: Human participants must be provided with adequate information regarding the research being conducted. This includes detailed data on the type of study being conducted, how long it will last, the associated risks, if it is experimental, and various other types of important information.
Comprehension: How effectively and clearly information is communicated is just as important as the actual information. Those handling the clinical trial must convey the information in a way that is clear, effective, and organized. The subjects should be allowed to ask questions and receive detailed answers, and they should be of sound mind to comprehend what they are being told.
Voluntary Consent: Consent has to be at the test subject free will without undue pressure. There can be no coercion to get the person to sign the informed consent form.
When injuries result from a clinical trial, there are usually two factors that are looked into: was there informed consent, and was there something wrong with the process of the clinical trial.
Even with protections in place, there are times when those who are conducting the trials are negligent in their approach, or carry out medical procedures incorrectly. Other times it is just not possible to conduct the research without injuring someone who participates.
The vast majority of clinical trial injuries that occur are due to a lack of informed consent to take part in the trial, or a lack of consent for one portion of the trial. The results of these issues include battery and assault, scientific fraud, clinical negligence, breach of the right to dignity, and in some cases wrongful death.
If you or someone you know has been harmed because of taking part in a clinical trial, you should not delay in contacting a personal injury attorney who is skilled in negligence and medical malpractice. These professionals know the ins and outs of this area of the law extremely well, and will handle every aspect of your case from start to finish. He or she will deal with everyone involved in your case, will collect medical records, will compile all types of evidence, will determine all responsible parties, will interview witnesses, and will arrange for expert testimony when needed. Since most personal injury attorneys work on a contingency basis, you do not have to worry about funding your claim in advance. This means that you have very little to lose, and a great deal to gain!
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