What might researchers need to do when a study is ongoing and changes are made?

When researchers make changes to an ongoing study, it is essential to submit modifications to the Institutional Review Board (IRB) for approval. This process is crucial because the IRB is responsible for ensuring that the study continues to meet ethical standards and that the rights and welfare of participants are protected. Any changes, whether they involve the study's design, methodology, participant recruitment, or consent processes, could potentially impact the risk level or the benefits of the study for participants.

By submitting modifications to the IRB, researchers ensure that any alterations are reviewed in the context of ethical considerations and compliance with regulatory requirements. This helps maintain the integrity of the research and protects the participants involved, as they should be informed of any changes that may affect their participation or the study itself. This process aligns with the core principles of ethical research, including respect for persons, beneficence, and justice.