Final answer:
Researchers are primarily responsible for the safety and well-being of trial subjects, abiding by ethical principles, and adhering to the oversight of Institutional Review Boards (IRBs).
Step-by-step explanation:
The individual or entity responsible for the safety and well-being of all trial subjects in clinical trials is the researcher or research team leading the study. They are tasked with ensuring that trials are ethical and that participants' rights are protected. When conducting research involving human subjects, ethical and legal obligations require that the researchers:
- Minimize and balance risks against the potential benefits.
- Obtain informed consent from participants, making sure they understand the risks and consent voluntarily.
- Protect participants' privacy and data confidentiality.
Moreover, Institutional Review Boards (IRBs), which are comprised of experts across various fields, play a critical role. IRBs review and approve research proposals to ensure compliance with ethical principles and federal regulations. Their approval is necessary for a study to commence.
Researchers lead clinical trial safety, ensuring ethical conduct. Duties include risk balancing, informed consent, privacy protection. IRBs review and approve proposals for ethical compliance.