Renewing or Closing A Study

EXISTING protocols (paper-based) are transitioning to IRBIS as of January 2017.  All Renewals must be submitted using IRBIS.  Please contact ORC for details and/or refer to your protocol renewal notification email for details.

EXISTING protocols Closure:  Investigators needing to close EXISTING protocols (those protocols not submitted through IRBIS) may use the current Annual Renewal or Closure Form.  This is only applicable for closures of existing protocols.

 

Renewing or Closing Your Study: Continuing Review and Annual Renewal

The purpose of continuing review is to analyze a study and to determine if the anticipated risks and benefits are reflected in the actual experience of the subjects. It is also designed to make certain that the safeguards that were in place at the original approval phase are indeed adequate to insure the safety of the subjects.

The initial IRB approval is based on the researcher’s best estimate of the anticipated risks and benefits to the subjects. It is only after research has begun that the real risk is established and the actual risk/benefit ratio can be calculated. Therefore, responsible researchers need to stay involved in continuous reevaluation of a project.

The continuing review process for the IRB is done by completing progress reports on a project. The investigator submits regularly scheduled reports at least annually and sometimes more frequently. The IRB dictates the frequency of review based on the level of risk. The higher the risk of the research, the more frequent the review. The minimum terms of review are outlined when the original IRB approval is granted.

IRBIS Manual Existing Studies Renewal

Ongoing monitoring

There must also be "ongoing monitoring" that the researcher performs. This is intended to alert investigators to changes in the project that may affect the participant’s decision to continue involvement in the research. The responsibility of ongoing monitoring is just as important as continuing review by the IRB. Both types of review are an ongoing process and not a one-time step. Investigators need to make sure that procedures are in place for the continuous monitoring of the research activity before they begin data collection.

Maintaining compliance

Research that is on-going in any phase (i.e., data collection, data analysis or dissemination) must be renewed annually. It is very important that the renewed prior to the expiration date. Federal regulations require that research be discontinued if the IRB protocol approval has expired.

Closing your study

In order for a study to be complete, data analysis and dissemination (e.g., student dissertaiton defense is complete) must be completed. 

Faculty responsibilities on student research projects

Faculty listed as Responsible Faculty on any student research project need to know that they are responsible for notifying the Compliance Office of the completion of a research project or upon the graduation of the student.

How will I know when it’s time to renew my project?

The Compliance Office begins sending Investigators and/or Responsible Faculty renewal reminder notices at 90, 60, and 30 days in advance of protocol approval expiration. Renewal notices for student researchers are sent to the Responsible Faculty listed on the approved protocol.

Plan to submit for renewal at least two (2) weeks in advance of the renewal deadline to allow adequate time for IRB renewal review.

What happens if I miss my renewal deadline?

All research activities must cease until IRB renewal approval is obtained unless discontinuing research activities will put the participants at increased risk.

If a protocol is not renewed within 30 days of the expiration of approval, the protocol will be permanently closed and an investigator must submit a new protocol application if the research will continue.

What do I do when my study is complete?

Consider the following: Research protocols should remain active until all research related intervention or interactions with human subjects are complete and all data collection and data analysis are finished.

  • The protocol should remain active if you are collecting data about participants even when no participant contact is necessary.
  • The protocol should remain active if you are still “cleaning” data.
  • The protocol should remain active if you are conducting data analysis for research purposes in preparation for publication.
  • The protocol should remain active until the thesis or dissertation defense is complete.

Once a protocol is terminated, no more data may be collected and no more contact with participants for research purposes is allowed. Also, protocols may not be re-opened once they are closed.