Frequency

Federal regulations require that protocols be renewed no less frequently than annually.

The IRB is required to decide when a protocol needs continuing review at the time of the original approval and of each subsequent renewal. Factors for making the decision about the frequency of review include the level of risk, location of the study, and any other factors that might affect the welfare of the subjects.

When an original protocol or renewal application is approved, investigators will be notified of the date upon which the protocol must be renewed again.

The IRB's database is designed to generate reminder notices as renewal dates approach.

There is no limit on the number of renewals that may be approved for a project. However, the IRB reserves the right to request that a new protocol be prepared if changes are extensive.

Type of Review: Expedited or Full

Renewals of protocols that were reviewed through expedited procedures, may be expedited under the following circumstances.

1. There are no proposed changes.
   
2. Proposed changes are minor.

1. The research is permanently closed to the enrollment of new subjects; all subjects have completed all research related interventions; and the research remains active only for long-term follow-up of subjects.
   
2. No subjects have been enrolled and no additional risks have been identified.
   
3. The remaining research activities are limited to data analysis.
   
4. The IRB determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. (This scenario could occur if a protocol required full review due to the risk of coercion. If the possibility of coercion was removed and if additional risks were minimal, the IRB could document in its minutes that there are no greater than minimal risks to subjects, thus paving the way for expedited review of renewals.)

Under all other circumstances, if the original protocol required full review, the continuing review must
be conducted by the full committee, even if there are no changes or if proposed changes are minor.

The rationale for this requirement is that if a full review was required the protocol either used a vulnerable subject population or involved more than minimal risk to the subjects. These protocols should be revisited even if the investigator does not propose to change the protocol. The progress report, together with the results of other new research, may indicate that the risk/benefit balance has shifted. Or, new research about how subjects understand consent forms, may require that the forms currently in use be modified.

Content of a Continuing Review

1. The number of subjects accrued.
   
2. The number of subjects anticipated for the renewal period.
   
3. A copy of the current consent document.
   
4. A summary of progress to date.
   
5. For research with more than minimal risk, or research that provides and evaluates behavioral or psychological interventions, a summary of recent literature related to the research topic. Federal policy requires that investigators inform subjects of important new information that might affect their willingness to participate in the research. This information may be findings of this research or of that carried out by others.
   
6. A description of any adverse events or unanticipated problems involving risks to subjects and proposed solutions, any withdrawal of subjects from the research, or complaints about the research. Adverse events include reporting of suspected child abuse to NC authorities.

Timing of Renewals

The federal Office of Human Research Protections recognizes the logistical advantages of keeping the IRB approval period constant from year to year throughout the life of each project. Therefore, when a continuing review (expedited or full) takes place within 30 days before an approval period expires, the protocol may retain its anniversary date.

Failure to Renew a Protocol

Continuing reviews must be reviewed and approved on before the expiration date of the current approval period of a protocol.

The regulations make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. If continuing review is not secured by the expiration date, the research must stop, unless the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions.


The Application Form

Instructions for completing and submitting the request to renew a protocol are provided on the form. Please note that if you do propose to change a protocol, there are two documents needed, in addition to the form.

1. A memo describing the changes.
   
2. A modified version of the currently approved protocol highlighting the changes in bold type.