Can an investigator proceed with a non-Federally funded research project without IRB review?

An investigator navigating the complexities of human research protections must recognize that the necessity for Institutional Review Board (IRB) review does not solely depend on the source of funding. Although federal regulations mandate IRB review for research involving human subjects when federally funded, non-federally funded research may also be subject to institutional policies, state laws, or other ethical considerations.

The correct choice acknowledges that the requirement for IRB review can depend on several factors beyond funding. For instance, an institution may have its own regulations that require IRB review for all research involving human subjects, regardless of funding status. Compliance with state laws and institutional policies is critical in determining whether IRB review is necessary. Hence, while federal funding is one piece of the puzzle, it is not the only consideration when evaluating whether an investigation can proceed without IRB oversight.

By considering these other regulatory requirements, one can better understand the broader landscape of human research protections and the responsibilities of investigators in ensuring ethical conduct in research.