The Comprehensive Cancer Center-University of Puerto Rico Institutional Review Board’s (IRB) primary responsibility is to ensure that the rights and welfare of human subjects in research are protected. The IRB must guarantee that the human subject research is conducted ethically, and in compliance with Federal regulations, the requirements of applicable local law, and institutional policies and procedures. The ethical conduct of research is a shared responsibility that requires cooperation, collaboration, and trust among the institution, the investigators and their research staff, the subjects who enroll in research, and the IRB.
An IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with the Common Rule and FDA regulations, the IRB has the responsibility of approving, requiring modification in to secure approval or disapproving research. The IRB also has the authority to suspend or terminate research for continued noncompliance with the Common Rule, FDA regulations, or its own findings, determinations, and initial and continuing review procedures.