For how long must an investigator retain consent documents, IRB correspondence, and research records?

Retaining consent documents, IRB correspondence, and research records for three years after the completion of a study is essential for several reasons. This duration aligns with federal regulations and guidelines set forth by agencies such as the U.S. Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA), which emphasize the importance of maintaining research records to ensure participant rights are protected, to support any audits or reviews, and to provide adequate documentation in case of inquiries into the research’s integrity or safety.

Additionally, three years allows for a sufficient period to address any potential issues that may arise, including questions about the research methods, participant consent, or results. Researchers may need to defend the ethical and procedural adherence of their studies during this time frame. Retaining documents for this period not only contributes to scientific accountability but also fosters trust in the research process.

The other time frames listed do not meet the regulatory requirements set forth for record retention in the context of research oversight. It’s crucial to adhere to the three-year guideline to ensure compliance with ethical standards and administrative policies.