Budgeting for IRB Review: A Guide for HRPP Leadership

At institutional research programs around the U.S., there exists a pervasive myth: internal institutional review board (IRB) reviews are free. Years of relying on local IRB reviews have led many in research to mistakenly believe there is no cost associated with local IRB review.

This misconception can lead to significant budgeting oversights, impacting both the institution and its research strategy – especially in the current era of single IRB (sIRB) mandates.

In this blog, we hope to debunk this myth while also providing practical strategies for assessing and establishing IRB review costs.

Internal IRBs serving as single IRBs for multicenter trials can use this flexible approach, originally developed by Kelley O’Donoghue for an R1 research university. The model also supports other local human research protection program (HRPP) functions, ensuring these research-related resource expenditures are appropriately valued and funded.

Challenges Arising from IRB Cost Misconceptions

The misconception of free internal IRB reviews overlooks the various resources—personnel, processes, technology, and time—required for IRB reviews. This can lead to inadequate budgeting and unforeseen financial strains.

Many investigators, as well as grants and contracts offices, are not fully aware of the costs associated with IRB reviews. This can result in incomplete budget planning for federal grants, potentially resulting in resource shortfalls (and scrambling for additional funds) as the research proceeds.

Additionally, when IRB resourcing is not properly accounted for, institutions serving as single IRBs for multisite research studies may not be able to adequately provide sIRB services.

Investigators may also face uncertainty regarding whether their local institution will charge for sIRB reviews or if they will need to seek external IRB partnerships.

Implementing a Costing Model for IRB Reviews

A practical approach to managing IRB review costs is to implement a costing model. Let’s explore one possible framework for this purpose.

The approach we present here assigns weights to each HRPP activity based on workload and operating budget, calculates a dollar value per work unit, and assigns costs for each IRB activity. These activities may include initial reviews, continuing reviews, modifications, and consent forms.

This model offers flexibility and adaptability, allowing institutions to tailor it to their specific needs and circumstances. By assigning a value to each activity, institutions can better understand the financial implications of their IRB reviews and plan accordingly.

As a best practice, periodically review and adjust these templates to reflect changes to the actual work and costs. This helps the institution maintain a balance between accurate costing and supporting its investigators.

How to Build a Costing Model for IRB Reviews

If organizations have not yet determined the actual cost of their IRB’s work, HRPP experts suggest the following steps.

Note: In this model, the generic term “work unit” is used to mean “the value assigned to the IRB work based on the operating budget.”

1. 1. Examine IRB review data from the most recently completed fiscal year to identify the items approved and number of reviews performed in that year.
      • Weight each activity based on the work required as a percentage comparison to other HRPP activities.
        • For example, an HRPP may decide full board review should be weighted 100%. Comparatively, they may then weight expedited review at 85%, since it does not require as many resources as full board.
      • Using the activity totals from the most recent fiscal year, calculate how many work units were used in total.
   2. Next, determine the cost per work unit.
      • Multiply the number of activities by the weighted percentage, then divide the overall operating budget by the total of weighted activities for that fiscal year. This is your cost per work unit.
      • See Figure 1 for an example of these calculations.

      

   3. Assign a cost for each IRB activity: Start by rounding your work unit costs so they’re easier to work with. Then assign the “work” required for each IRB activity, and calculate the cost per activity.
      • The cost per activity will serve as the budget template’s building blocks.
      • Figure 2 provides an example of these calculations for an organization serving as single IRB, with costs broken down by protocol-level and site-level activities.

   

   Creating a Budget Template

   With the true costs of IRB review established, you can develop a budget template to help ensure grant budgets and other financial projections account for all potential costs.

   When building your template, be sure to identify the factors potentially impacting costs. These may include the number of participating sites, the study’s duration, expected number of amendments or modifications, and other variables.

   Figure 3 provides an example of a single IRB budget template based on this model.

   

   For realistic budget planning, be sure not to underestimate costs. Consider all potential expenses to prevent budget shortfalls during the project. This includes administrative and expert time, technology expenses, and any other relevant costs the organization incurs.

    

   Best Practices for Internal and Single IRB Communications

   Understanding and communicating the true costs of IRB reviews is essential for effective financial planning for an HRPP. Developing clear policies and procedures, maintaining ongoing communication, and utilizing flexible financial models are key for success.

   Effective communication within the institution about IRB processes and costs helps ensure all stakeholders, including researchers, grants and contracts offices, and other stakeholders (including vice presidents for research), understand the true cost of IRB reviews.

   By understanding the financial realities of IRB reviews and implementing effective communication and financial planning strategies, HRPP leadership can better support their research programs.

   Recognizing no IRB review is truly free is the first step towards creating a sustainable and transparent financial model benefitting both the institution and its researchers.

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