What is the minimum required time for an investigator to keep consent documents and research records?

The minimum required time for an investigator to keep consent documents and research records is three years after the completion of the study. This timeframe is consistent with federal regulations and institutional policies that mandate retaining research documentation for a specified period to ensure accountability and facilitate any necessary audits, monitoring, or inquiries related to the research.

This three-year duration helps ensure that researchers maintain essential ethical and legal documentation of the informed consent process and any associated data. These records may be critical if any questions arise regarding the research's conduct, the validity of the data, or the ethical treatment of the participants after the study has concluded.

While some may believe that records should be kept for a shorter duration, such as one year, this would not sufficiently cover the relevant legal and ethical obligations necessary for potential future clarifications. On the other hand, retaining records indefinitely may not be practical or required, as it could lead to issues related to storage and confidentiality. Thus, three years serves as a balanced and standardized requirement in the context of research with human subjects.