I noticed a peculiarity in AAHRPP’s 2012 Metrics on Human Research Protection Program Performance updated in July. IRB budgets were… wait for it… UP! Budgets are returning to levels not seen since 2009 before the national and state economies took a nose dive. The dramatic course correction after two years of decline makes me wonder, what could account for this reversal?
As an IRB builds out a budget, they have many factors to consider including: IRB Administrator and Staff Salaries, IRB Chair/Vice Chair Support, Electronic IRB Systems (eIRB), Accreditation Costs, in addition to expenses such as building space, training, meetings, computers, supplies, copiers etc. According to the AAHRPP report, the Average Annual Budget for Institutional Review Boards (IRB’s) at institutions in 2011 was $721,923. In 2012, the number was up 30% to $932,267. Of these different factors mentioned above – the line items of salaries, eIRB Systems and Accreditation Costs are probably the most revealing.
The theme of transformation of the Human Research Protection Programs (HRPPs) into Quality Assurance and Quality Improvement mega houses is driving IRB’s budgetary compositions. The makeover is being promoted by organizations such as AAHRPP, required by many Human Subjects research sponsors, and supported as institutions compete for dwindling research dollars. Results, data, continuous process improvement, safety and ethics are the new names in the game. IRB’s are aiming to market themselves as shining examples of quality research compliance programs with the capacity, knowledge and merit to attract sponsored research dollars and satisfactorily oversee them.
IRB’s are investing and adapting to the increased competition. They have no choice but to react to increased research complexity, the marketability of their research dossiers, the mandate to improve turnaround times, the dire need for in-house accreditation experts, and the call for more eIRB system administrators. IRB’s must be strategic in how they make their case for increased budget requests through a demonstration of all of these factors. It might go a little like this…
An institution decides it would like to be accredited in order to be recognized as a program certified at the “Gold Standard.” by AAHRPP. Embarking on the first steps to understand the requirements and ramp up preparations can be a potential 1-2 year project employing a full-time individual. A Quality Assurance Analyst is hired with salary and benefits to fulfill this obligation. Next, an application is submitted to the accreditation body with costs ranging from $7,300 – $82,800 depending on the number of active protocols. Annual renewal costs after approval may be $3,100 – $26,000; again based on the number of active protocols. Despite these costs, AAHRPP continues to show growth in its accredited institutions with approximately 180 active clients and 10 approved in 2012 alone.
The accreditation push drives internal metrics and a new evaluation at IRB business processes. Institutions react with organizational changes and the investment in eIRB systems. Request for Proposals (RFP’s) are up for research compliance systems. IRB forums and listservs buzz with the search for advice with good reason. Expenditures like these can be significant, with subscription, implementation, maintenance fees and the hiring of an eIRB administrator to support the new system. The power that these types of systems provide however, with regard to business process and management cannot be underestimated.
Department size has increased as well. The average number of Full Time Employees (FTE’s) in IRB’s was 11.6 in 2011 and in 2012 it was 16.2; this reflects almost a 40% increase. This may be in response to expanded IRB portfolios and the need to have appropriate coverage but the demand for qualifications has also increased. Applicants must possess significant experience to be considered for positions. In some cases legal or nursing degrees are required. This is a direct reflection of the growing complexity of research reviews and supervision. Additionally, existing staff are being further trained and expected to continually advance themselves with regard to human subject research protections.
I communicated recently with Maeve Luthin JD, Professional Development Manager at PRIMR. She shared that the number of Certified IRB Professionals in 2011 was 1,461 and in 2012 it was 1,544. Many institutions provide for training by sending not only IRB Directors to conferences such as PRIMR and AAHRPP but also Coordinators; quite naturally at a cost to the IRB. This line item can be filed under “Conferences, Training and Continued Education.” Furthermore, institutions are building career ladders in their organizations to attract and retain quality people. The roles in these career ladders tend to have increased responsibility and salary with promotion. Gone are the days of one role IRB Specialists. IRB’s are recognizing the need for quality, human resources in their efforts to keep institutional research in compliance with federal regulations and reactive to the accreditation “gold standards. The interwoven budget argument begins to take shape with these 3 major elements.
The resourcefulness doesn’t stop there. Years of belt tightening have IRB’s evaluating “undervalued” revenue streams (i.e., IRB Fees). I’ve seen numerous postings online where institutions are raising their IRB Fees for Initial and Continuing Reviews on sponsored research to match “National Averages.” Departmentally, sponsored research fees that formerly slipped through the cracks, are being collected due in great part by the investment in the eIRB . Lastly, simply brand new IRB budget models are taking hold. For example, an “Agenda Scoring Method” used by an Illinois University IRB. According to the Director of Human Research Oversight, each item that appeared on their IRB’s agenda in the previous year was counted as an individual action. Points were assigned to each item based on the staffing and resources required to provide substantive and meaningful review based on a predetermined scale. They then use the results of these tallies to show effort, as well as project expenses and demonstrate shortfalls for service. More information can be found here.
IRB’s are emerging from the silent ranks of Research Administration while leaning forward into the future. Departments are becoming savvy at positioning themselves with increased compliance, marketability and viability as a happy coincidence. At least that’s what the 2012 metrics whispered to your humble industry watcher’s ear. As the old adage goes, “It takes money to make money!”
- Association for the Accreditation of Human Research Protections Programs (AAHRPP) (2013). 2012 Metrics for Human Research Protection Program Performance. AAHRPP. Retrieved from https://admin.share.aahrpp.org/Website%20Documents/2012%20Metrics%20(2).pdf
- Association for the Accreditation of Human Research Protections Programs (AAHRPP) (2013). 2013 Application and Annual Fees. AAHRPP. Retrieved from http://www.aahrpp.org/apply/fees/2013-application-and-annual-fees
- Smith, L., Perdomo, J., Klein, M. (2012). Outsourcing to an AAHRPP-Accredited IRB vs. Creating a Local, Regulatory-Compliant IRB. Huron Consulting Group. Retrieved from http://www.huronconsultinggroup.com/Insights/Webinar/Life_Sciences/~/media/Insights-Media-content/Outsourcing%20to%20AAHRPPAccredited%20IRBs%20vs%20Creating%20a%20Local%20Regulatory%20Compliant%20IRB.pdf
- Reeter, M. (2012). Solutions in IRB Budgeting. PRIM&R’s Ampersand. Retrieved from http://primr.blogspot.com/2012/02/solutions-in-budgeting-irb-process.html