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Informed Consent to Participate in Clinical Trial

Informed Consent as Defined by Federal Regulations
If you have been harmed as a result of participating in a clinical trial, a critical issue is whether you gave informed consent. Even though you may have signed a form, you still may not have given true informed consent as defined by federal regulations. Informed consent is a complex issue that should be discussed with an experienced lawyer. Attorney Fred Pritzker has 29 years of experience handling scientifically and legally complex lawsuits. His peers have recognized his outstanding achievements, and he has, once again, been named a Super Lawyer. He has also been selected for inclusion in the 2005-2006 edition of The Best Lawyers in America.  Call Pritzker | Ruohonen & Associates, P.A., toll-free at 1-888-377-8900, email us at info@pritzkerlaw.com, or fill out our online free consultation form.

Below is some information about informed consent to participation in a clinical trial. It is not intended as legal advice, but only to communicate some of the issues surrounding informed consent.

Informed Consent of Human Subjects of Research
Informed consent was recognized as critical to the ethical treatment of human subjects of research by the Nuremberg Code, a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners during World War II. The Nuremberg Code is a poignant reminder of what people are capable of doing in the name of science and has been referred to in drafting federal regulations and guidelines for clinical trials using human subjects. Federal regulators also looked to the Belmont Report, a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, to draft regulations regarding informed consent.

There are three basic elements to informed consent:

1. Information. –The human subject must be given adequate information about the research. This includes information as to the nature of the experiment, the duration of the research, the risks involved in the research, if the research is experimental, and other pertinent information.
   
2. Comprehension. –The manner and context in which information is conveyed is as important as the information itself. Those in charge of the clinical trial must present the information in an organized fashion without undue speed. The human subject must also have the capacity to comprehend the material. Read about special protections for vulnerable people. 
   
3. Voluntary Consent. –Consent must be free of coercion and undue influence. An individual must not be pressured into signing an informed consent form.

Federal regulations outline specific requirements for informed consent. Those in charge of a clinical trial have to follow, to the letter, federal and state laws and regulations regarding informed consent. If not, they are liable for any damage caused by the failure to get informed consent.

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