This chapter covers several ethical, legal, safety, and scientific aspects of medical research. The ethical aspect of medical science requires that every possible step should be made to prevent harm from occurring, which includes careful consideration of all available data. Ethical committees are made up of clinicians (who are not involved in the trial), other professionals (such as spiritual counselors, lawyers, psychologists, and statisticians), and laypeople. Thus, all protocols are subjected to profound social control and sound judgment by the committee members representing different aspects of society. Treatment of human beings and human samples also depends on the legal environment. Research objectives may also be subject to legal issues, as in cloning or stem cell research. Handling biological material always raises the issue of safety for the personnel involved. Chemical hazards and safety procedures relating to these are well known for chemists. Regarding biological hazards, first, the staff participating in the research should be aware of them, and second, adequate precautions should be taken and the personnel should be trained on how to handle human samples safely. Owing to the complexities and interrelation of the different aspects, establishing a well-defined protocol for a clinical trial is probably even more important than in other fields of science. Clinical trials comprise research that is designed and evaluated to provide reliable information for preventing, detecting, or treating certain diseases or for improving the quality of life of patients.
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