Final answer:
The distinction between minimal risk research and more than minimal risk is critical for IRBs to assess the necessary level of ethical review, ensuring that human participants are protected from undue harm and that their informed consent is obtained.
Step-by-step explanation:
The purpose of distinguishing between minimal risk research and research that is more than minimal risk is primarily to help institutional review boards (IRBs) determine the appropriate level of ethics review needed. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Research proposals that involve more than minimal risk often require a more rigorous level of scrutiny to ensure the protection of human participants. These regulations are in place as part of a long-standing tradition of ethical considerations in research to ensure human dignity and safety are maintained.
Research involving human participants must be guided by ethical standards that protect participants from undue harm. These standards are governed by federal regulations and are enforced by IRBs, which are committees with the responsibility to review and approve research proposals before any study begins. These bodies make certain that risks to participants are minimized and reasonable compared to the potential benefits, and that participants give informed consent. This framework of oversight serves to uphold the ethical integrity of research as well as the safety and rights of participants.