How long must IRB records be retained after the completion of research?

How long must IRB records be retained after the completion of research?

• A. At least one year
• B. At least three years
• C. At least five years
• D. At least ten years

Answer: (B)

The requirement for the retention of Institutional Review Board (IRB) records is at least three years after the completion of research. This timeframe is specified in federal regulations that govern human subjects research, ensuring that appropriate records related to the research, including consent forms, protocols, and records of IRB activities, are maintained for a sufficient period to uphold accountability and transparency. Retaining records for three years provides a reasonable duration for oversight, allowing regulatory bodies and institutions to review and audit the study's adherence to ethical standards and compliance with applicable regulations. This duration is also in line with the guidelines provided by the Office for Human Research Protections (OHRP) and ensures that important information is available should any issues arise concerning the conduct of the research after its completion. Other timeframes, such as one year, five years, or ten years, do not align precisely with these federal requirements, making the three-year standard the correct answer for ensuring compliance and ethical governance in research involving human subjects.

The requirement for the retention of Institutional Review Board (IRB) records is at least three years after the completion of research. This timeframe is specified in federal regulations that govern human subjects research, ensuring that appropriate records related to the research, including consent forms, protocols, and records of IRB activities, are maintained for a sufficient period to uphold accountability and transparency.

Retaining records for three years provides a reasonable duration for oversight, allowing regulatory bodies and institutions to review and audit the study's adherence to ethical standards and compliance with applicable regulations. This duration is also in line with the guidelines provided by the Office for Human Research Protections (OHRP) and ensures that important information is available should any issues arise concerning the conduct of the research after its completion.

Other timeframes, such as one year, five years, or ten years, do not align precisely with these federal requirements, making the three-year standard the correct answer for ensuring compliance and ethical governance in research involving human subjects.