For how long must an investigator maintain consent documents and study records after a study's completion?

The requirement for an investigator to maintain consent documents and study records for at least three years post-study completion is grounded in federal regulations and guidelines governing research involving human subjects. Specifically, the U.S. Department of Health and Human Services (HHS) regulations set this standard to ensure that adequate records are available for review and verification of the study's conduct, especially if questions arise regarding the rights and welfare of participants or data integrity.

Keeping the records for a minimum of three years allows for sufficient time to address any potential inquiries, audits, or challenges related to the research. This timeframe aligns with the expectation that important documentation should be retained, balancing the need for oversight without imposing excessive burden beyond what is necessary for compliance.

While other options may suggest varying durations or conditions under which records might be kept, the three-year minimum is a widely recognized requirement in the research community, ensuring that consent and study data are accessible and appropriately managed for a defined period following the study’s conclusion.