April 2016

The Principal Investigator (PI) of a study approved by a JHM IRB is required to retain records associated with a human subjects research project pursuant to Organization Policy 115.2. 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 study was conducted under FDA regulations.

JHM Organization Requirements

Original data must be retained for at least 5 years from the date of publication. Beyond that, where questions have been raised regarding the validity of the published data, investigators must preserve the original data until such questions have been resolved to the satisfaction of the Organization and any involved government agencies. The director or chair of each department or research unit must decide whether to preserve original data for a given number of additional years or for the life of the unit.

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

For additional information on Organization requirements, see JHU Policy on Access and Retention of Research Data and Materials and the JHU School of Medicine Faculty Policy: Rules and Guidelines for Responsible Conduct of Research, Section III “Data Gathering”.

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 6 years from the date of the last covered disclosure.  To ensure that Hopkins can meet this accounting requirement, investigators must retain study records, along with records of all disclosures of study information, for at least 7 years after either of the following (whichever is later):

• The last subject has completed his or her participation in the study; or,
• 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.

Federally-Funded Research and FDA-Regulated Research

• 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 46.115(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.”

Private Sponsors

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