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Resources :: Guide :: Consent :: Keeping good records

Keeping Good Records

If a representative of the Office of Health and Human Services (OHRP, division of the DHHS that oversees IRB regulations) were to walk into your office today, would you be able to provide documentation showing that the participants in your study consented?  Do you have copies of your participants’ consent forms in an accessible system of organization?  The IRB-SBS does not routinely audit its researchers at this time; however, should our university be audited by OHRP, they will look to see that researchers are conducting studies according to their protocols. It is important that you keep your records in good order. Make sure that you have an organized system of storing your consent forms and you can demonstrate that everyone participating in the study has signed a consent form. For more information, please see Record Keeping, Data Storage, and Record Retention.

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