Study documents and/or records acquired by the IRB or principal investigators shall be retained according to the terms of federal regulations and Florida statues. Pursuant to federal regulations [c.f. 45 CFR 46.115(b) and 21 CFR 56.115(b)], the HSRO shall be responsible for maintaining its documentation, files and IRB meeting minutes relevant for each study for a minimum of three (3) years following IRB approval of the closure of the study.
With certain exceptions, Principal Investigators must retain complete records and documents (including the consent documents) from their study for the duration of that study and for a minimum period of three (3) years following closure of a study. Exceptions to this 3-year minimum retention period are:
- HIPPA REQUIREMENTS: - if a study involves the collection of identifiable health information, principal investigators must retain study records and documents for six (6) years following study closure. This retention period is consistent with the HIPAA Privacy Rule under which subjects may ask investigators for an accounting of all uses and disclosures of their study information for a period of 6 years after their participation is completed (c.f. 45 CFR 164.528).
- FDA REQUIREMENTS FOR A STUDY INVOLVING AN INVESTIGATIONAL DRUG UNDER AN IND (c.f. 21 CFR 312.62): if a study involves the use of an investigational drug under an IND, principal investigators must retain study records and documents until at least the later of the following dates:
- 2-years following the date a marketing application is approved for the drug for the indication for which it was being investigated; or,
- 2-years after the investigation is discontinued and the FDA is notified if no marketing application is to be filed or, if the application is not approved for such indication; or
- 3-years after IRB approval of the closure of the study
- FDA REQUIREMENTS FOR A STUDY INVOLVING AN INVESTIGATIONAL DEVICE UNDER AN IDE (c.f. 21 CFR 812.140): if a study involves an investigational device under an IDE, principal investigators must retain study records and documents until at least the later of the following dates:
- 2-years following the date on which the investigation is terminated or completed; or
- 2-years following 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; or
- 3—years after IRB approval of the closure of the study
NOTE – The FDA two-year requirements may occur during the applicable retention period required by the University and other regulations or it may occur afterward and be additional to that period.
- VA REQUIREMENTS: if a study engages the VA, principal investigators must retain research records and documents for a minimum of five (5) years after IRB approval of study closure. This retention period is consistent with the VA’s Records Control Schedule (RCS 10-1).
Records must be retained longer than the times specified in the above policies other requirements apply such as may be forthcoming from sponsors in executed contracts, institutional entities or extramural funding agencies.