Renewing or Closing A Study

The purpose of continuing review is to enhance protections to research subjects. Continuing review may be used 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. In addition, some sponsors require documentation of continuing review as a requirement of the award.

The initial IRB review and approval is based on the researcher’s best estimate of the anticipated risks and benefits to the subjects. The IRB, at the time of initial Expedited review, may determine that continuing review will enhance protection of research subjects. This must be explicitly justified by the Expedited reviewer. Therefore, except in these cases and/or in cases where continuing review is required per the regulations (e.g., Full Board review protocols), per University policy and/or sponsor requirements, continuing review is not required for all studies. The IRB approval letter will state any continuing review requirements.

Regardless of whether continuing review is required, responsible researchers need to stay involved in continuous reevaluation of a project. Therefore, after research has begun, researchers are expected to carefully consider the risks and benefits associated with the study and if new risks are identified, researchers are expected to notify the IRB and submit a Modification to establish further procedures to mitigate the risk.

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 and/or post-approval monitoring 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., recruitment, data collection, or data analysis) and requires continuing review must be renewed prior to the expiration date. Federal regulations require that research be discontinued if the IRB protocol approval has expired. In addition, expiration of IRB approval for funded research may result in restrictions on accessing award funds and reporting of compliance expiration to the sponsor.

Closing your study

In order for a study to be complete, data analysis (e.g., student dissertation defense is complete) must be completed and identifiers removed from the data such that the data are non-identifiable.

Do not allow the study to simply expire even if the research is complete. The protocol should be formally closed. Allowing a protocol to expire may be perceived as an indicator for non-compliance. In addition, formally closing the protocol allows the audit and records retention timelines to begin.

Faculty responsibilities on student research projects

Faculty listed as Faculty Advisors on any student research project need to know that they are responsible for notifying the Office of Research Protections and Integrity 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?

If your study requires continuing review, Investigators and/or Faculty Advisors receive renewal reminder notices at 60 and 30 days in advance of protocol approval expiration. Renewal notices for student researchers are sent to the Faculty Advisor 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.

Allowing a protocol to expire and IRB approval to lapse may be an perceived as an indicator of non-compliance and may result in post-approval monitoring or an audit. In addition, expiration of IRB approval for funded research may result in restrictions on accessing award funds and reporting of compliance expiration to the sponsor.

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.

The protocol should be formally closed by submitting a Closure request. Formally closing the protocol allows the audit and records retention timelines to begin