Continuing Review and Compliance
The Southern California Brainspotting Institute is committed to ensuring excellence and integrity in every aspect of its research. Therefore, after approval, studies will be assigned a continuing review protocol that they will need to submit at a decided frequency (usually once per year) during the project until its completion. This allows SoCal BSP to audit and keep track of the projects and ensure they remain in compliance to research protocol and best practices as they are conducted.
All studies are provided with their own specific continuing review form and assigned a required frequency to submit them as outlined in their Terms and Conditions of Approval letter. Failure to complete continuing review forms may result in notice of corrective action up to and including retracting study approval. While all approved proposals are assigned their own continuing review form, a general sample may be found here.
All continuing review forms are to be emailed to IRB@SoCalBrainspotting.org no later than 5 p.m. on the assigned date. Please allow ten business days for a confirmation of receipt.
Basic requirements
General questions that will be asked during continuing review are if the study is still active, how many participants have been enrolled and how many are required till completion, updates on budget concerns (if relevant), a summary of findings and if there have been any adverse circumstances or complaints. This is in addition to a general write up of the study progress.
Modifications to study protocols
In most circumstances study modifications do not require a new proposal, but will require IRB approval. Please download and fill out the CR3 Modification Request form and send it to IRB@SoCalBrainspotting.org if any modifications are needed. Minor changes do not require a modification request. Criteria that require a modification request include but are not limited to:
- Adding or removing staff from the project
- Amending the approved project budget and/or its provisions
- Adding new study modalities (such as new surveys, interviews or experiments) not in the original proposal
- Adding a vulnerable population to the study (children, prisoners, cognitively impaired adults, etc)
- Changing the venue of the study
- There have been adverse events or complaints related to the study
As a rule of thumb, always inform the IRB of any modifications no matter how minor, and you will be informed if a modification request is necessary. Please allow ten days for a confirmation of receipt, which may include additional information required. After receipt, the modification will be placed on the agenda of the next IRB meeting to be approved. You will be notified five days in advance if you are requested to attend (meetings are held by teleconference). Notification of the board’s decision will be released within three days of the meeting.
Corrective action
In the event that a study is not in compliance with SBCI’s policies and procedures or best practices, the IRB may issue a Notice of Corrective Action to protect the integrity of the institution. These are included but not limited to:
- Requiring an in-depth audit to the project, potentially including site visits
- Requiring the study to change staff roles or remove certain individuals from the study, including the PI
- Requiring the study to change sites
- Alteration or removal of certain study protocols or modalities
- Alteration or suspension of the project budget
- Retracting study approval (immediate termination of project)
Circumstances that can spur corrective action include but are not limited to:
- Failing to abide by the approved parameters of the study as established in the proposal and the Terms and Conditions of Approval
- Failing to report adverse events or complaints
- Failing to submit continuing review forms by the assigned deadlines
- Failing to handle funds as prescribed in the approved budget
- Adverse events or complaints that endanger the reputation or integrity of SBCI
- Making major deviations from the intended aim of the study
- Making major modification to the study without IRB approval or notification
- Unprofessional behavior to participants or the IRB
It is the responsibility of the Principal Investigator to report to the IRB any and all adverse events and complaints related to the study in a timeline manner.
Upon receipt of a Notice of Corrective Action, you will be provided with a clear outline of any required actions, mandated changes and their deadlines and how to report them. Failure to comply to corrective action may result in further sanctions or retraction of study approval (immediate project termination).