IRB Manual
      4.7 Retention of Signed Consent Documents
   

 


Research investigators must store signed consent documents in a repository which has been approved by the IRB. The signed consent documents should be retained for the duration of the study and must be made available to the IRB upon request.

As a general rule, retention of signed consent documents for a minimum of three years following completion of the research is required for social science research and three to fifteen years for medical research unless the IRB has waived the requirement for  informed consent or waived the requirement for documentation of consent . When minors are involved, retention for a period of three to fifteen years after the subjects reach 18 years of age is recommended.

A copy or the original of the signed consent document should be filed in the patient's medical record, if the subject is a patient under treatment at the institution.

When the research has been completed, the investigator should seek the advice of the IRB and, if necessary, legal staff about the retention period for consent documents. When research is conducted under  a contract with an external sponsor the minimum retention period specified in the contract must be also be complied with.

4.7.1  
FDA Requirements
 
   

For studies involving investigational drugs, consent forms must be kept for at least two years following the date of approval of a marketing application for the drug for the indication for which it was being investigated. If no application is filed, or if the application is not approved for the indication, the consent forms must be retained for at least two years after the IND is discontinued and the FDA is notified of that fact.

For studies involving investigational devices, consent forms must be retained for at least two years after the latter of the following dates: the date on which the investigation is terminated or completed or the date that the records are no longer required to support a pre-market approval application or a notice of completion of a product development protocol.

     
   


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