What might cause an IRB to disapprove a research study?

An Institutional Review Board (IRB) plays a crucial role in ensuring that research involving human subjects is conducted ethically and that participants' rights and welfare are safeguarded. One of the primary reasons an IRB may disapprove a research study is if there are inadequate participant protection measures in place.

This can include insufficient plans for securing informed consent, lack of confidentiality safeguards, or failing to provide adequate oversight of participant safety. If the IRB assesses that the proposed measures do not adequately protect participants from potential risks or harm, it is likely to reject the study. The emphasis on protecting individual subjects is a fundamental aspect of ethical research, aligning with regulatory requirements and ethical guidelines set forth by organizations overseeing human subjects research.

In contrast, while factors such as innovative research designs, excessive funding requests, or high participant incentives can raise concerns or require further scrutiny, they do not inherently indicate a lack of participant protection. Therefore, these factors alone would not typically lead an IRB to disapprove a study in the same direct manner that inadequate protection measures would.