What can potentially happen if an IRB disapproves a research proposal?

When an IRB disapproves a research proposal, the researchers are typically required to revise and resubmit the proposal. This is important because the IRB's role is to ensure that research involving human subjects is ethical and that participants' rights and welfare are protected.

A disapproval is often based on concerns related to ethical considerations, such as inadequate informed consent processes, potential risks to participants that are not sufficiently mitigated, or insufficient scientific justification for the research. In response to this feedback, researchers have the opportunity to address the concerns raised by the IRB. They can revise the proposal to improve the ethical safeguards or clarify the research methodology, ensuring compliance with regulatory standards. After making the necessary changes, the researchers may then resubmit the proposal for further review.

Other options do not accurately reflect the process following an IRB disapproval. Immediate publication would not occur if the proposal has not been approved, and appealing to a higher authority is not a standard protocol in most cases. The study would not be automatically terminated; instead, researchers are given a chance to modify their plans to meet the IRB's standards.