How long is an investigator required to keep consent documents, IRB correspondence, and research records?

How long is an investigator required to keep consent documents, IRB correspondence, and research records?

Introduction

Investigators conducting human subjects research are required to maintain study records, including consent forms and IRB correspondence, for a specified period after the investigation is complete. This is an essential requirement, as supporting proper documentation allows for examining research activities if any concerns arise later. In this article, we’ll look at the regulations around record retention and the types of documents that must be kept.

Regulations on Record Retention

HHS Regulations

According to regulations from the U.S. Department of Health and Human Services (HHS), records from human subjects research must be kept for a minimum of 3 years after completion of the investigation. This applies to all documents related to the study, including signed consent forms.

FDA Regulations

For research involving FDA-regulated products such as drugs, biologics, or medical devices, there may be additional record-keeping requirements beyond the HHS minimum of 3 years. Investigators should consult FDA regulations to determine if a longer record retention period is specified.

Other Federal Agency Requirements

If research is funded by a federal agency such as the National Institutes of Health (NIH) or National Science Foundation (NSF), the agency’s regulations must also be followed. The funding agency may require keeping records longer than the 3-year HHS minimum.

Types of Records to Retain

Informed Consent Documents

Each study participant’s original signed informed consent documents must be retained for the specified period. These forms document that consent was appropriately obtained.

IRB Correspondence

All correspondence between the investigator and the IRB must also be kept. This includes study protocols, submissions, approvals, and reports of adverse events or unanticipated problems.

Research Records

Research records that must be retained include source documents, data collection forms, study logs, and any other files created during the research. Documents related to the interpretation and reporting of results should also be kept.

Length of Time Records Must Be Kept

Minimum 3 Years After Study Completion

At a minimum, federal regulations require research records to be kept for three years after completion of the study. Study completion is when all research-related interventions and interactions with human subjects have ended.

Longer Retention May Be Required

While three years is the minimum, the IRB, funding agency, or FDA regulations may require retaining records for a longer time. Papers should be kept for the most prolonged specified retention period if multiple requirements apply to a study.

Storage and Security of Records

Protecting Confidentiality

Research records must be stored securely to protect confidentiality. Papers should only be accessible to authorized individuals, and identifiers should be removed whenever possible.

Secure Location

Records must be protected from fire, water damage, or loss. Many institutions have policies on appropriate storage methods. Off-site storage may be utilized if needed.

Accessibility for Inspection

Despite being securely stored, records must be readily accessible for review and inspection by authorized representatives of regulatory agencies. Papers may need to be produced within 1-2 days if requested.

Destroying Records

Once the required retention period has ended, research records may be destroyed. Any identifiers should be removed before disposal, and confidential shredding is recommended. Some institutions may have specific procedures for record destruction that investigators must follow. The IRB should review and approve the process of destroying study records.

Conclusion

Proper maintenance of research records is crucial for documenting regulatory compliance, protecting research participants, and enabling review of study activities if needed. Investigators must securely store consent forms, IRB correspondence, and other records for at least three years after study completion. However, requirements vary, so investigators must know all applicable regulations and institutional policies when establishing record retention and destruction plans. Keeping meticulous records ultimately supports ethical and responsible research.

FAQs

How long should I keep signed informed consent documents?

Each participant’s signed informed consent documents should be kept for at least three years after completing the study.

Do I need to keep a copy of all IRB submission forms and correspondence?

Yes, all IRB correspondence including initial submissions, modifications, renewals, and adverse event reports should be retained for the required time period.

My research is funded by the NIH – how long do I need to keep study records?

NIH requires records to be kept for at least three years after submitting the final financial report. Always follow the most prolonged retention period that applies.

What if my institution has a longer record retention policy than the federal requirements?

You should follow whichever policy requires retaining records for the longest period of time, whether that is your institution or the federal regulations.

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