Which document is typically the foundation for an IRB's review process?

The research protocol submitted by the researcher serves as the foundation for an Institutional Review Board (IRB) review process. This document outlines the study's objectives, design, methodology, and procedures, including how researchers plan to protect the rights and welfare of participants involved in the study. The protocol provides detailed information about the research, including recruitment strategies, potential risks to participants, and the measures in place to mitigate those risks.

The IRB reviews the protocol to ensure that the research complies with ethical standards and regulatory requirements. This assessment is crucial for safeguarding participants and ensuring that their rights and well-being are prioritized throughout the research process. While informed consent forms, previous publications, and participant feedback are important aspects of research involving human subjects, they do not serve as the primary basis for the IRB's review. The protocol lays the groundwork for understanding how the research will be conducted and the ethical considerations involved.