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Record Retention

November 2008

On January 2, 2008, John Hopkins University (JHU) issued the “Policy on Access and Retention of Research Data and Materials” http://jhuresearch.jhu.edu/Data_Management_Policy.pdf . In June 2008, JHU School of Medicine issued a revision to the Faculty Policy on Responsible Conduct of Research, and the revision outlines specific Data Management Requirements http://www.hopkinsmedicine.org/som/faculty/policies/facultypolicies/responsible_conduct.html#III

The principal investigator of an application approved by a JHM IRB is required to retain records associated with a human subjects research project. The recordkeeping requirements vary depending on whether federal funding was provided for the project, whether there is funding from industry with contractual provisions governing data retention, or whether the protocol was conducted under FDA regulations.

Federal Requirements

  • DHHS regulations require that, “…records relating to research which is conducted shall be retained for at least 3 years after completion of the research.” 45 CFR 46.1115(b)
  • For Investigational New Drug (IND) research, the FDA requires that sponsors and investigators retain “records and reports required by this part for 2 years after a marketing application is approved for the drug; or if an application is not approved for drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA so notified.”
  • For Investigational Device Exemption (IDE) research, the FDA requires the investigator or sponsor to maintain the records “for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated of completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.”

Corporate Sponsors

For research sponsored by corporations or private foundations, the investigator should maintain the records for either the length of time required by the corporate sponsor, or the time required by DHHS rules, or institutional policy, whichever is longer.

JHM Organization Requirements

For research involving children, the School of Medicine requires that records be retained (at a minimum) until the pediatric subject reaches the age of 23.

For all other studies:

For all other studies, the School will require that original data be retained for at least five years from the date of publication. Beyond that, where questions have been raised regarding the validity of the published data, investigators must preserve original data until such questions have been resolved to the satisfaction of the School and any involved government agencies. The chief  of each research unit must decide whether to preserve original data for a given number of additional years or for the life of the unit.

HIPAA:

Under the HIPAA Privacy Rule, subjects have the right to ask Hopkins for an accounting of certain disclosures of their identifiable health information for a period dating six years from the date of the last covered disclosure.  To ensure that Hopkins can meet this accounting requirement, the School of Medicine requires investigators to retain study records, along with records of all disclosures of study information, for the following time periods:

1) At least 7 years after the last subject has completed his or her participation in the study, or

2) The date of the last disclosure of identifiable health information from study records, if disclosures continue after all subjects have completed the study.  45 CFR 164.528.  

This requirement to retain study records and to account for disclosures also applies to research that involves the secondary use of medical records or other identifiable health information.


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