What does 21 CFR 50 aim to protect?

21 CFR 50 is a crucial regulation that focuses specifically on the protection of human subjects involved in research. This regulation outlines the requirements for informed consent and additional protections for vulnerable populations when participating in clinical trials or studies. The core objective of 21 CFR 50 is to ensure that individuals are treated ethically and their rights are safeguarded throughout the research process.

The regulation sets forth detailed requirements that researchers must follow to ensure participants are fully informed about the nature of the research, potential risks, and benefits before consenting to take part. This commitment to ethical standards is fundamental in maintaining trust in the research community and ensuring that the rights and welfare of participants are prioritized.

In contrast, the other options relate to different aspects of regulatory oversight but do not address the primary focus of 21 CFR 50. Financial interests of sponsors pertain more to the business side of clinical trials, while data integrity in clinical trials is governed by other regulations that concentrate on the accuracy and reliability of data collected. Biological sample collection is relevant to biobanking and specimen handling regulations, which also fall outside the scope of 21 CFR 50. Thus, the regulation's primary emphasis is unequivocally on the protection of human subjects in research settings.