Surveys show that people participate in clinical trials for a number of reasons. Some simply want to assist in the advancement of science, while others are looking for some income. Still others are looking for unique treatments to their specific medical treatment. Regardless of the reason for participating, these people deserve, and receive protection during their involvement in clinical research trials.
Firmly entrenched ethical guidelines and Codes of Regulations protect a participants Safety and Welfare during participation in clinical trials. These guidelines and codes have been in place for decades, and provide an excellent safety and welfare shield for patients participating in clinical research. There were abuses in the past, such as patients being prevented from receiving care so doctors could study the progress of a disease. These abuses provided motivation for the development of ethical guidelines.
The National Institutes of Health says that seven main principles have been described as guidelines for those conducting clinical research. The first is that the trial must have social and clinical value.
“Only if society will gain useful knowledge — which requires sharing results, both negative and positive — can exposing human subjects to the risk and burden of research be justified,” nih.gov reads.
Other guidelines are that studies should be designed in a way that a valuable answer will be found. Furthermore, participants should be selected with the goal of improving the research, and not because of factors unrelated to the research. Bias should be kept out of the process.
An important guideline is that studies should have a good risk to benefit ratio. This means that researchers must do everything they can to minimize risks and maximize benefits.
Possibly the most important ethical guideline of all is that participants give Informed Consent. This means that participants know the purpose of research, the risks and how the study relates to their own clinical condition, if applicable. Everything should be done in a volunteer process.
Safety of participants in clinical research trials is a well thought out topic, as it should be. After all, true advancement in medicine cannot be achieved without clinical research volunteers.
But who is to say that researchers follow these ethical guidelines? Each clinical trial in America is approved and monitored by what is called the Institutional Review Board (IRB), which works to make sure that risks are minimal and worth any potential benefits. The IRB committee is made up of physicians, statisticians, and members of the community, and is federally regulated. Furthermore, all study data is audited and monitored during the trial process. The trial process is well maintained.
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