What is the best course of action after receiving an OHRP letter regarding a specimen bank without IRB approval?

The best course of action after receiving an OHRP letter regarding a specimen bank that lacks IRB approval is to provide OHRP with a summary of the findings and a Corrective Action Plan. This approach demonstrates an acknowledgment of the concerns raised by OHRP and a commitment to rectify the situation.

By submitting a summary of what transpired and outlining a corrective action plan, the organization shows that it is taking the matter seriously and is willing to comply with regulatory standards for human subjects research. This response can help to mitigate potential compliance issues and demonstrate the organization’s dedication to ethical research practices and participant protection. Engaging proactively in this way is crucial to maintaining trust with oversight bodies and the public.

This option emphasizes the importance of accountability and transparency in research practices, especially when mistakes or oversights occur. Additionally, it can help establish a clear trajectory for correcting any deficiencies associated with the specimen bank's operations, which is vital for future compliance and ethical considerations.