When conducting research on human subjects, what aspect must researchers particularly ensure compliance with?

In research involving human subjects, compliance with federal regulations regarding human subjects is crucial for a number of reasons. Federal regulations are established to protect the rights and welfare of participants in research activities. These regulations, found in the Code of Federal Regulations (CFR), specifically Title 45 Part 46, outline the requirements for Institutional Review Boards (IRBs), informed consent, and the ethical considerations necessary when conducting research. By adhering to these regulations, researchers help to ensure that their studies are conducted ethically and that participants are treated with respect and care.

While institutional funding policies, state regulations, and international research guidelines are also important, they often build upon or may not provide the comprehensive protections guaranteed by federal regulations. Federal guidelines take precedence in many cases and are essential for maintaining the integrity of the research process in the United States, making them a primary focus for researchers working with human subjects.