What federal regulation framework was established for human subjects research in 1981?

The correct answer is the Common Rule, which established the foundational framework for the ethical conduct of research involving human subjects in the United States. Enacted in 1981, the Common Rule provides guidelines for the protection of participants by outlining the requirements for informed consent, the process for institutional review board (IRB) approval, and the criteria under which research must be conducted. This regulation applies to multiple federal agencies and ensures a standardized approach to safeguard the dignity and rights of individuals participating in research.

The Common Rule is pivotal as it has influenced not only federal regulations but also institutional policies regarding human subjects research, making it a cornerstone of ethical standards in this field. In contrast, while HIPAA deals with the protection of health information privacy, it does not specifically address the broader ethical considerations of human subjects research. The Federal Insecticide, Fungicide, and Rodenticide Act pertains to the regulation of pesticides and is unrelated to human subjects research regulations. Similarly, the Food, Drug, and Cosmetic Act covers the security of food and drugs but does not provide the comprehensive ethical framework for human research that the Common Rule does.