Experiments conducted on animals are essential to the development of new chemicals for the management of disease. The safety and efficacy of new drugs, however, can be established only by adequate and well-controlled studies on human subjects. Since findings in animals do not always accurately predict the human response to drugs, subjects who participate in clinical trials are put at some degree of risk. The risk comes not only from the potential toxicity of the new drug but also from possible lack of efficacy, with the result that the condition under treatment becomes worse. Since risk is involved, the primary consideration in any clinical trial should be the welfare of the subject. As a consequence of unethical or questionably ethical practices committed in the past, most countries have established safeguards to protect the rights and welfare of persons who participate in clinical trials. Two of the safeguards that have been established are the institutional review board (IRB) and the requirement for informed consent.
The IRB, also known as the ethics committee or human subjects committee, originally was established to protect people confined to hospitals, mental institutions, nursing homes, and prisons who may be used as subjects in clinical research. In the United States any institution conducting clinical studies supported by federal funds is required to have proposed studies reviewed and approved by an IRB.
People who volunteer to be subjects in a drug study have a right to know what can and will happen to them if they participate (informed consent). The investigator is responsible for ensuring that each subject receives a full explanation, in easily understood terms, of the purpose of the study, the procedures to be employed, the nature of the substances being tested, and the potential risks, benefits, and discomforts.
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