Institutional Review Boards (IRBs) are assigned with the critical job of reviewing, approving, and monitoring research involving humans. One of the main responsibilities of an IRB is to protect the rights and welfare of human subjects from harm – be it physical or psychological.
With such responsibility resting on their shoulders, it is imperative that IRBs perform at optimum levels of efficiency. What can be done so that the performance of IRB can be improved considerably?
The main challenges faced by IRBs revolve around getting faster results, motivating and retaining employees, and having sufficient manpower and other resources. Potential solutions of these problems are presented below:
- Streamline workflow: The first step towards improving performance is to simplify the workflow and streamline the process of protocol review. For this, you have to classify reviews into different categories based on the type of review (Full Board, Expedited, and Exempt) and the type of submission (Initial Review, Amendment, Continuing Review and Unforeseen Events). You can create workflows for each type of review and submission, and assign relevant staff to handle specific segments and workflows. For example, one analyst works only on expedited amendments, while another analyst works on initial and continuing reviews.
- Reorganize staff: In every IRB, there is a group of workers who are knowledgeable about many facets of the review process. These analysts/coordinators have a 360° view of the entire process of review and approval. These “generalists” should be assigned all the committee reviews from all types of submissions. It is important not to mix administration work with IRB-related work. So, staff for both categories of work should be trained separately.
- Reduce needless effort: By creating and maintaining effective Standard Operating Procedures (SOPs), one can reduce hours of unnecessary work. It is vital to separate SOPs from other worksheets and checklists. SOPs should be accurate, brief, and easy to follow. Also, these SOPs should comply with all regulations and follow business processes. In other words, an SOP needs a purpose, a starting point and an ending point. Remove all unnecessary and unclear language while developing SOPs so that they are not ambiguous.
- Understand the requirements: One of the requirements for efficient functioning of IRB is to understand the objectives of regulations for different kinds of review; for instance, if a submission is assessed as minimal risk, try to waive the document of consent, thereby reducing paperwork. IRB members should also fully comprehend the extent of the role of the Board; knowing what falls within the purview of IRB (research requesting approval etc.) and what does not.
- Finally, for ease of performing its functions, it is highly recommended that the IRB use an efficient software application for management of IRB-related issues. Effective and efficient software can help simplify as well as expedite the process of obtaining/granting approvals for human research. A desirable program would be one that is independent of the kind of platform used, does not require extensive training to use, and is flexible enough for revision, renewal, and reporting of adverse events.
Compliance software application for IRB can help streamline the review process and allow IRBs to be more efficient and work with maximum efficiency. The IRB can utilize such software in a way that allows it to grant approvals in a timely and efficient manner, thus maximizing the potential and the performance of the IRB.