August 23, 2007
My Doctor Has Asked Me To Participate In An Arthritis Clinical Research Trial… What Should I Know?
Once… as recently as 20 years ago, it was not uncommon for patients with arthritis to rapidly become crippled or to die from the devastating effects of arthritis.
Today, many patients are able to experience remission from their arthritis. To get to this point has taken the work of many hard-working researchers as well as the dedication of thousands of patient volunteers.
The goal of arthritis clinical research is to safely translate promising basic laboratory discoveries into safe and effective medical practice.
All clinical research conducted in the United States is guided by the Nuremberg code. These guiding principles were established to protect human subjects from unethical conduct, such as what took place under the Nazis during World War II.
The eight fundamental standards that guide clinical research are:
0 The risks of a study must be minimized through sound research design and methodology
0 Risks must be reasonable relative to the anticipated benefits of the study
0 The selection of research volunteers must be equitable and without bias
0 Informed consent must be obtained from the person participating in the study
0 The consent language agreed to and the process for obtaining consent must be documented carefully
0 Research patient privacy and confidentiality must be protected
0 Ongoing safety of […]
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