When might an IRB require modification of a research project?

An Institutional Review Board (IRB) may require modifications to a research project when ethical concerns arise during their review process. The primary role of an IRB is to ensure the protection of human subjects involved in research. If any aspect of the proposal raises ethical issues—such as inadequate informed consent, potential harm to participants, or questionable methodologies—the IRB will require that the researcher address these matters before approval can be granted. This process ensures that the research aligns with ethical standards and regulations, safeguarding participants' rights and well-being.

In contrast to ethical concerns, disapproving of the research topic might signal an inherent disagreement but does not directly lead to required modifications; instead, it may result in outright disapproval. High risks can certainly lead to closer scrutiny and possibly even the need for modifications, but it is the ethical implications that predominantly drive the IRB to mandate changes. Finally, while a researcher may request modifications, the IRB's authority ultimately decides whether those changes are necessary based on ethical standards. Thus, the requirement for modifcation is rooted in the IRB's commitment to upholding ethical research practices.