If a study is determined to be exempt, will it always remain exempt if changes are made to the study?

When a study is designated as exempt, this status is based on a specific set of criteria defined by regulations. However, if any changes are made to the study, it may no longer meet the criteria for exemption. Each modification could potentially alter the risk profile, the population involved, the methodologies used, or the nature of the data being collected.

Therefore, it's crucial that any alterations to an exempt study undergo a reevaluation to determine whether it still qualifies for exemption. This process ensures that participant protections are upheld and that the study complies with the ethical and regulatory standards required for human research. As such, the notion that an exempt study will always remain exempt regardless of changes cannot be considered accurate; reevaluation is necessary to maintain compliance.