How long must research records be kept after the completion of a study?

Research records must be kept for a minimum of three years after the completion of a study to ensure compliance with federal regulations and guidelines. This timeframe is in line with the requirements set forth by institutions that follow federal policies, such as those from the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), as well as the ethical standards involved in conducting research, which include maintaining accountability and transparency.

Retaining records for at least three years allows for necessary follow-up inquiries, audit checks, and potential evaluations regarding the research. It also facilitates the preservation of data integrity and participant protection, as researchers can refer back to original data if questions or disputes arise about the study's findings or methodology. This period strikes a balance between sufficient record preservation and the practical management of records when the study is concluded.