Final answer:
The Common Rule mandates that IRBs review research involving human participants according to specific criteria, such as minimizing risks to subjects, managing conflicts of interest, ensuring equitable subject selection, and providing additional protections for vulnerable populations.
Step-by-step explanation:
The Common Rule requires the Institutional Review Boards (IRB) to review research with human participants using specific criteria to ensure their safety and ethical treatment. Among the criteria that an IRB uses to review such research are:
- Risks to subjects are minimized: The IRB checks that the research plan includes steps to minimize risks to participants, ensuring that any potential harm is outweighed by the benefits of the research.
- Investigators’ conflict of interest: The IRB must consider whether the investigators have any conflict of interest that could unduly influence the study or harm participants.
- Selection of subjects is equitable: The selection process for participants should be fair and impartial, making sure that the benefits and burdens of the research are distributed fairly.
- Additional protections for vulnerable populations: When the research involves groups who are considered vulnerable, such as children or people with impairments, the IRB ensures that extra precautions are in place to protect their rights and welfare.
Importantly, the IRB's role is to protect the rights and welfare of human subjects involved in research.