Version
1.2
Date Updated
Tuesday, January 5, 2016
Descripton

POLICY


  1. Principal Investigators (PIs), or other responsible parties as applicable, must file a UIC OPRS Final Report form to request study closure with OPRS for IRB approved and exempt studies upon the completion of the study but prior to the expiration date of IRB approval.    
  2. A Final Report form must be submitted even if the research was never initiated, no subjects were enrolled, or the PI is terminating the research earlier than originally planned.
  3. Once a study has been closed via a Final Report form, it cannot be re-opened.
    1. If a later use for the research data is identified, then the PI must submit a new research application for the use of the previously collected data.
    2. The later use of the data may qualify for an exemption or meet the definition of research not involving human subjects, if the existing data is recorded without identifiers (de-identified).
  4. The Final Report form must include a security plan for storing data with the level of security proportionate with the form of data to be retained (i.e., de-identified vs identified, sensitive vs non-sensitive, PHI, etc.).
  5. Department Heads, Unit Heads, and Faculty Sponsors are responsible for ensuring that PIs leaving UIC submit a Final Report form for each of their active protocols or transfer the responsibility to another qualified investigator to serve as PI by submitting an amendment form.  Refer to the UIC HSPP policy Managing Research Prior to Departure, Sabbatical, Medical Leave, or Other Absence for additional information.
  6. PIs who do not file a Final Report form may be subject to sanctions, including but not limited to, the classification of the applicable protocol as “lapse in IRB approval,” determination of research non-compliance, additional education and training, research termination and reporting to appropriate agencies, and/or a restriction of research privileges.
  7. Lapse in IRB approval represents a failure to obtain approval of a continuing review or final report by the expiration date assigned by the IRB.  After expiration of IRB approval, all research activities must stop, including any recruitment, research related interventions or interactions, data collection, data sharing/reporting, analysis of data, and no new subjects may be enrolled.  Refer to the UIC HSPP policy and procedure Lapse in IRB Approval for additional information.