Who has the authority to approve changes to a consent form during a study?

The authority to approve changes to a consent form during a study typically resides with the IRB committee as a whole. This is because the IRB is responsible for ensuring that any changes made to consent forms align with ethical standards and regulatory requirements meant to protect research participants. The involvement of the entire committee is crucial as it promotes thorough discussion and evaluation of the implications of such changes on participant rights and welfare.

While the chair of the IRB plays a significant role in the review process and may have some authority to expedite certain approvals or decisions, it is generally not within their purview to approve substantive changes independently without the input and consensus of the full IRB committee. Instead, all members contribute to a collaborative oversight that safeguards participant interests. Thus, the collective authority of the IRB ensures that all aspects of consent changes are critically examined and appropriately addressed.