For how long are investigators typically required to keep consent documents and research records?

Investigators are generally required to keep consent documents and research records for a minimum of three years after the study's completion. This requirement aligns with regulations and guidelines established by various oversight bodies, including the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in the United States. Retaining these documents for at least three years allows for adequate oversight, accountability, and the opportunity for audits or reviews of the research.

Keeping consent documents and records for this duration ensures that all participant information and consent processes remain accessible for evaluation if any issues arise after the study has been concluded. It underscores the importance of maintaining participant rights and safety even after the research has been completed.

In contrast, various other options do not align as precisely with established regulations. For example, retaining documents only for the duration of an investigator's tenure at an institution does not adequately consider the need for post-study accountability. While completing data analysis is essential, it does not constitute sufficient reason to retain documents indefinitely. Furthermore, closing a study does not eliminate the necessity to keep records for the mandated retention period. The three-year requirement serves as a standard for diligent data management in research practices.