Final answer:
Clinical research laws and guidelines are designed to protect participants through ethical principles, mandated oversight by IRBs and IACUCs, and regulations like the AWA and PHS Policy.
Step-by-step explanation:
The laws applied to clinical research are designed to protect the rights and well-being of human and animal participants. Historical abuses in studies such as the Tuskegee syphilis study led to the creation of ethical guidelines and the principle of informed consent, which is central today. Institutional Review Boards (IRBs) and Institutional Animal Care and Use Committees (IACUCs) are oversight bodies that ensure compliance with ethical standards and laws like the Animal Welfare Act (AWA) and the Public Health Service (PHS) Policy.
In clinical trials involving humans, the four primary ethical principles that must be adhered to are respect for persons (informed consent), beneficence (minimization of risks), nonmaleficence (avoidance of harm), and justice (equitable treatment of participants). Ethical and legal safeguards are established to ensure that clinical research is conducted in a manner that honors these principles, providing protection to participants and promoting ethical conduct in research.