Does the Common Rule prohibit communications between IRBs and investigators to maintain independence?

The correct answer is that the Common Rule does not prohibit communications between Institutional Review Boards (IRBs) and investigators. In fact, open communication is encouraged within the framework of human subjects research protections.

The intention behind allowing communication is to facilitate a better understanding of the research protocols and ensure that all ethical considerations are adequately addressed. While it is crucial for IRBs to maintain their independence in making review determinations, this independence does not preclude dialogues that can enhance the review process.

Through appropriate communication, IRBs can clarify issues, seek additional information, and ensure that investigators are fully informed about the requirements and expectations surrounding human subjects protection. This collaborative approach helps to ensure that research is conducted ethically and in compliance with federal regulations, thereby protecting the rights and welfare of participants.

Overall, the Common Rule emphasizes the importance of IRB independence in decision-making; however, this does not mean that communication between IRBs and investigators is restricted.