Final answer:
The student's question pertains to the requirement of following an IRB-approved protocol during research involving human subjects, with an exception to alter procedures in the face of an immediate hazard. IRBs oversee research to safeguard participant safety, enforce ethical standards, ensure informed consent, and review risks and benefits of studies. Deviations from the protocol are significant and strictly regulated, only acceptable to protect participants from immediate harm.
Step-by-step explanation:
The question relates to the ethical considerations in research studies that involve human subjects, and specifically addresses the role of Institutional Review Boards (IRB). These boards are responsible for reviewing research protocols and ensuring they align with ethical standards protecting participant safety. IRBs have the authority to approve research studies and they mandate that risks to participants be minimized and reasonable in relation to the benefits. Informed consent is a critical aspect, with participants being fully aware of potential risks prior to agreeing to be a part of the study. In case of an immediate hazard to human subjects, the predefined protocol may be deviated from to ensure participant safety.
IRBs are comprised of individuals with expertise in various fields who review research proposals to protect the dignity and safety of all participants. Additionally, strict guidelines exist to govern experiments involving human subjects, and an IRB's approval is generally required for the research to proceed. Though the overarching goal is the advancement of knowledge, there must be a compelling respect for the well-being of the human subjects involved in any research activity.
Historical abuses in clinical trials have led to the development and implementation of oversight measures like IRBs to prevent unethical practices, ensuring that all trials with human subjects adhere to ethical principles such as minimizing risks, ensuring informed consent, and protecting participant privacy and confidentiality.