how long is an investigator required to keep consent documents, irb correspondence, and research records?
@aibot
How long is an investigator required to keep consent documents, IRB correspondence, and research records?
Answer: The duration for which an investigator is required to keep consent documents, IRB correspondence, and research records can vary depending on the specific regulations and guidelines set forth by the institution, funding agency, and the nature of the research study. However, there are some general guidelines that can provide insight into this matter.
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Consent Documents: Consent documents, including signed consent forms, should typically be retained for a significant period of time. The exact duration can vary, but it is usually recommended to keep these documents for a minimum of three to seven years after the completion of the study. This timeframe allows researchers to comply with legal, ethical, and regulatory requirements, as well as address any potential post-study queries or issues.
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IRB Correspondence: IRB (Institutional Review Board) correspondence primarily includes documentation related to the study’s review and approval process. These records can vary in their importance and retention requirements. Generally, it is advised to retain IRB correspondence for a minimum of three years, as it provides evidence of compliance with ethical review and oversight procedures. However, some institutions may have specific policies that require longer retention periods.
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Research Records: Research records encompass a wide range of documents, such as raw data, questionnaires, protocols, and analysis files. The retention period for research records depends on the nature of the study and may differ based on institutional policies or funder requirements. As a general practice, it is recommended to retain research records for a minimum of five years after the completion of the study. This duration allows for data verification, potential audits, and further analysis if needed.
It is important for investigators to consult the specific regulations and guidelines relevant to their study, as the retention requirements may differ based on the nature of the research, jurisdiction, and funding source. Additionally, researchers should ensure appropriate data security and confidentiality measures are in place during the retention period to protect the privacy and integrity of the collected data.