ABSTRACT
In this century, research subjects have been cruelly, unfairly, and unethically abused in clinical trials both in the United States and abroad. To protect research subjects, the Food and Drug Administration (FDA) has developed specific regulations: 21 CFR 50 summarizes these regulations as they pertain to Ihvestigational New Drug (IND) studies. Additionally, the Department of Health and Human Services (DHHS) has issued regulations (in 45 CFR 46 Subparts B, C, D) to protect research subjects participating in studies supported by federal grants. To fully understand the intent of the regulations protecting research rights, the following readings are highly recommended for anyone associated with enrolling human subjects in research trials:
PROPER INFORMED CONSENT The basic premise of the FDA regulations is that respect for human subjects' rights and dignity requires that informed consent be obtained before a human subject participates in any clinical investigation. Institutional Review Boards (IRBs), clinical investigators, and sponsors all share responsibility for ensuring that the informed consent process is adequate. The investigator is responsible for ensuring that the research subject freely gives fully informed consent to participate in the clinical trial.
