What is IRB Continuing Review and when should it occur?

What is IRB Continuing Review and when should it occur?

This is called “continuing review.” The continuing review for these studies is required to occur as long as the research remains active for long-term follow-up of the research subject, even when the research is permanently closed to the enrollment of new subjects and all subjects have completed all research-related …

What is a continuing review?

What is Continuing Review? If you want to continue working on a study beyond its expiration date, you must submit the study to the IRB for continuing review approval. The IRB re-reviews the study to determine if it is appropriate for the study to continue, as is or with modifications.

When must IRB review occur?

An IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109(e)).

When should I close my IRB study?

A study should be closed when all access to and use of identifiable data is complete. Study closures are submitted to the IRB via Kuali Protocols….Study closure should occur when:

• the study was not and will not be initiated;
• the study was discontinued prior to its completion;
• or the study has been completed.

When must IRB review occur quizlet?

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Must occur within 12 months of the approval date.

When must a protocol be submitted on Irbnet for review?

Protocols submitted for Expedited Review will generally be processed within two to three weeks. Protocols submitted for Full Review must be submitted by the first working day of the month to be reviewed at the convened IRB meeting for that month. That meeting is typically held on the second Thursday of the month.

How often should an IRB meet?

The IRB receives approximately 12 new studies each month that require full board review. The full board meets weekly; the interval between submission and review depends on the timing of the submission relative to the next scheduled meeting.

Do IRB approvals expire?

The initial expiration date for a study can be no more than one year from the date of initial review. The IRB sets the date for expiration of IRB approval, usually based on the risk level of a study. Current regulations specify that the period of time until expiration of IRB approval may be no more than one year.

When can a study be closed?

Studies may be closed when the involvement of human subjects ceases (interventions, interactions, observations, and the gathering, use, study, and analysis of identifiable private information, including specimens, are all complete).

How do you close a research study?

To close a study, submit a Final Review submission in eRA, including the Continuing Review e-form. Note that the information requested is the same for a Continuing Review as for a Final Review.

Which of the following best describes when expedited review of a new proposed study may be used by the IRB?

According to federal regulations, the expedited review process may be used when the study procedures pose: No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

When can expedited review process be used?

5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects.

How long does it take for a continuing disability review?

In general, the SSA will be reviewing the period of 12 months prior to the notice, although the agency can look at evidence from any time after you were initially granted benefits. For more information on the process, see our article on how long a continuing disability review takes.

When does a research project need continuing review?

At the time of initial approval of a research project, the IRB should specify the duration of the approval period and the interval by which continuing review must occur (e.g., 4 months, 6 months, or 1 year) in order for the research to continue.

When does an IRB review not constitute a continuing review?

In general, IRB review of a proposed change to a research project or a report of unanticipated problems during the period for which approval is authorized does not constitute continuing review of the project as a whole.

What is the purpose of the continuing review guidance?

This guidance is intended to assist IRBs in carrying out their continuing review responsibilities under 45 CFR part 46 by providing recommendations regarding, among other things, the approval criteria, process, and frequency for continuing review to assure the protection of the rights and welfare of human subjects participating in research.