Without IRB approval, a clinical trial is, of course, unable to go ahead and so understanding what the review board is looking for and ensuring compliance should be considered of paramount importance to investigators, sites and sponsors.
The role of the IRB is simply to protect the safety and rights of clinical trials participants and so it is understandable that approval is a thorough process. Nevertheless, it needn’t be a source of worry. Here are some key considerations when seeking IRB approval:
Prepare and Organize information
In order to review the study and determine approval, the IRB requires access to all relevant documentation and information regarding the study.
In order to guarantee swift approval, and study activation, the principle investigator must ensure that all the necessary information is provided and that every necessary step has been taken to ensure compliance. In order to ease this process and prevent the submission being returned without review by the IRB, the principle investigator should ensure that the submission is thorough, includes all the required information and that it is well organised and presented.
Maintain Open Communication
Following on from initial approval, the IRB initiates a continuous review process to ensure compliance throughout the duration of the study.
Sponsors, sites and principle investigators can insure that this process is as smooth as possible by meticulously maintaining communication with the IRB throughout the study. By keeping the IRB informed, and enabling any changes to be tracked and reviewed as they occur, an efficient and uninterrupted trial can be completed.
Ensure Staff Are Properly Trained
Whilst initial IRB approval is successfully granted to most studies, many fail to receive the necessary approve a year later when the IRB initiates continuing review. More often than not, this is simply down for to a lack of staff training. Investigators, nurses and research co-ordinators need to be aware of the importance of continuing review and effectively prepared for it in order to secure approval. Good training is a collaborative effort that encourages staff to buy-in to the process.
Take Responsibility for Compliance
Finally, sites should always take responsibility for encouraging their own compliance with the requirements of the IRB. Whilst it is the responsibility of sponsors to oversee site activity and correct any faults or spot gaps in compliance, a site should also be proactive in ensuring it’s own practices meet the regulatory standards. This helps to position patient safety as the central priority, and increases the likelihood IRB requirements are met.
To get more information how CitrusLabs can help you with IRB approval and Patient Recruitment, contact us here.