Part 2, Ch. 22 - Project Closure

Projects should NOT be closed unless all of the following are completed:

  1. Protocol indicated research activities including interaction with subjects and collection of data or specimens
  2. Collection of data about subjects even when no subject contact is necessary
  3. “Cleaning” of data
  4. Analysis of identified or linked data for research purposes or during the publication process
  5. Any other research use of the data which involves access to identified or linked (coded) data or specimens collected during the conduct of research

When a study ends, is closed, canceled for any reason, or is prematurely completed, the investigator or his/her delegate must complete a Project Closure Form.  A Project Closure Form serves as notification to the Human Subjects Office that IRB continuing review of the study is no longer needed.

If no subjects have been enrolled in a study for a period of three or more years, the IRB may require that the project be closed, unless there are extenuating circumstances for keeping the project open (e.g., the study is about a rarely seen condition).  If a project is closed and no subjects have been enrolled, study records must be maintained for at least three years after the closure was submitted.

Take care not to close the project too soon.  Once a Project Closure Form is submitted, no more data may be collected about any of the subjects in the study and no more contact with subjects for research purposes is allowed.  There is no mechanism to re-open a closed study.  Therefore, if an investigator is still collecting follow-up data about subjects (either directly from subjects or indirectly from existing records), the project should remain open until all data have been collected, even if new subjects are no longer being enrolled.

If the project was started in the HawkIRB system or has been transferred to the HawkIRB system, the investigator or his/her delegate should use HawkIRB to close the project.  Log-on to HawkIRB and select the project that should be closed.  Choose the “Project Close Form” and follow the directions to submit the project closure.  Take care not to close the project too soon.  Once a Project Closure Form is submitted, no more data may be collected about any of the subjects in the study and no more contact with subjects for research purposes is allowed.  There is no mechanism to re-open a closed study.

In adherence with federal regulation once a research project is formally closed with the IRB via the HawkIRB electronic system, all research related activity must halt.  Research activity includes contact with subjects, review of identifiable subject data, analysis of identifiable subject data, etc.  If new information that may affect the safety or medical care of enrolled subjects is discovered or provided to the research team after a project has been closed, notification to the IRB must occur within ten working days of the event or notification to the investigator of the event.  In order to inform subjects of the new information, IRB approval is required prior to subject notification of such information.  In order to provide the appropriate IRB approval to notify subjects of the new information, a HawkIRB new project application submission will be required for a previously closed project.

 The project application will require an explanation including the new information that was discovered or provided to the research team and a plan for how the information will be disseminated to the enrolled subjects.  If the new information requires action to be taken, or information to be provided to subjects, prior to IRB review in order to avoid immediate harm to the subjects, an IRB chair should be consulted to determine if the action or notification can be undertaken prior to IRB review.  In such cases IRB review should be still be carried out eventually as described.  All relevant materials in connection with the method of dissemination will need to be included in the HawkIRB application for IRB approval.  In most cases, a waiver of informed consent can be obtained in order to provide the new information to the enrolled subjects.