IRB APPLICATION HELP:
Recordkeeping

The federal regulations require institutions to retain records of IRB activities and certain other records frequently held by principal investigators for at least three years after completion of the research (45 CFR 46.115(b)). Documentation of the informed consent of the subjects is a record related to human subject research that is typically held by investigators and must be retained for at least three years after completion of the research.

At John Carroll, principal investigators have been designated to retain informed consent and assent documents signed by subjects on behalf of the university. These signed forms must be maintained for at least three years after completion of the research. Such records may be preserved in hardcopy, electronic or other media form and must be accessible for inspection and copying by authorized representatives of the Department of Health and Human Services. If an investigator leaves the university, the investigator is responsible for maintaining those records for the three year period of time required under the regulations.

If a principal investigator is a student, the student investigator must provide the original or a copy of any signed informed consent and assent forms to their university faculty/staff sponsor. Sponsors are then responsible for maintaining these forms for at least three years after completion of the research. Sponsors may choose to give these forms to their departments to store on their behalf; however if a sponsor leaves the university, the IRB recommends that the sponsor give all signed consent and assent forms obtained from student projects to their department to be maintained for the specified three year time period.

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