Applied Clinical Trials
A recent paper published in PLOS ONE addresses research institutions? willingness ?or lack thereof?to defer to central institutional review boards for multicenter clinical trials.
A recent paper published in PLOS ONE(1) addresses research institutions’ willingness —or lack thereof—to defer to central institutional review boards for multicenter clinical trials. Among other concerns, the respondents to the authors’ survey reported the loss of revenue to the institution when IRB review was centralized. The respondents also expressed general “discomfort” with the perceived loss of control they saw in outsourcing IRB. Additionally, after a review of local IRB responsibilities, it seemed their activities had extended beyond the original purpose of the IRB.
BRANY has been working since 1998 with academic institutions that pioneered the use of the BRANY central IRB. This white paper addresses some of the key benefits for institutions that use central IRBs, as well as tips on how to ensure a smooth transition to the use of central IRBs.
Running a local IRB can be a complex and expensive endeavor for any research institution. Between research office staff salary and benefits, as well as the infrastructure — office space, furniture, supplies, etc. — annual operations can cost up to hundreds of thousands of dollars. Even with sponsors paying for studies, many IRBs may be operating at a loss.
Some IRBs may feel that by outsourcing to a central IRB they lose control of the institution’s human subject protection requirements and relevance within the organization. IRB staff members may also think that this is an all or nothing proposition—either all activities are managed internally or all of them are contracted to a central IRB.
Even with a central IRB in place, there are other key responsibilities and activities that could fall to the IRB research office staff. In fact, the use of a central IRB can increase productivity in areas of critical importance to institutions because resources can be redeployed to focus on establishing institutional clinical research priorities and operationalizing systems to improve clinical trial performance.
Re-focus resources. A 2009 report by AAHRP demonstrated that nearly 90 percent of organizations reported increased workloads, with the average IRB reviewing 400 protocols. As both study sites and sponsors are seeking ways to improve efficiencies and reduce redundancies, the role of a central IRB requires another look. There are various ways to ensure a streamlined approach so that local and central IRBs can co-exist, each with a clear understanding of the others’ responsibilities.
Some institutions have expressed concerns regarding the reimbursement from sponsors for IRB activities. These fees may contribute to the research budget and outsourcing the IRB may have a negative impact on the bottom line.
There are other activities that can yield as much, if not more, funding than an IRB review fee. By utilizing a CIRB for selected protocols, an institution can re-deploy staff to other related clinical research departments. This requires a new way of looking at the role of the research staff and a process by which to operationalize the functions of the team. A research nurse, for example, can spend more time screening for subjects and enrolling rather than data entry. Other staff can focus on research compliance. Generally speaking, the reimbursement per patient enrolled in a study will be higher than the reimbursement to the IRB for protocol review.
Get comfortable. The first step for an institution considering the use of a central IRB is to be familiar with the CIRB organization/review board conducting the protocol review. AAHHRP accreditation can provide and extra level of comfort for institutions. Additionally, by increasing access of a representative from the local IRB, a central IRB may seem less mysterious. Here are some tips to increase familiarity:
Understand responsibilities. Changing regulatory guidelines, along with highly publicized litigation about patient safety and non-compliance, have made many institutions anxious about their liability. Over time some IRBs have evolved to include a variety of responsibilities that are best suited for other committees. This “mission creep” can lead to inefficiencies and a lack of focus.
Rather than spending precious time collecting documentation for industry sponsored multi-center trials, internal resources can be used to focus on real, on-the-ground patient and employee safety issues.
Be relevant. The frustration of investigators with the IRB process is well-documented. Too often this creates a tension between the researcher and the IRB and the risk of misconduct can increase (2).
Unfortunately, too often the delays in IRB review are administrative and not substantive or relevant to patient protection. The February 2010 issue of Annals of Neurology (3) reported that 67 percent of changes to a clinical trial participant consent form, submitted by local IRBs at research sites, was primarily reflecting institutional language and did not offer any substantive changes to the protocol. The price tag for these changes was $100,000.
To those unfamiliar with the IRB administrative process, it can sometimes seem that a local IRB’s main activities are in the collection of documents and checking requirements off a list. By shifting these administrative responsibilities to a central IRB, the local IRB and research staff can identify meaningful ways to ensure patient safety and increase research opportunities, as well as facilitating investigator-initiated research.
Bring it home. Often local IRB review is most important for investigator-initiated studies. When a local IRB can focus its time and attention in facilitating review of studies generated within the institution, the institution benefits in multiple ways.
By allowing a central IRB to take care of the human subject protection and administrative compliance tasks for multi-center protocol review, a local IRB and the institution’s research office open opportunities to encourage innovative research and ensure patient safety. An institution can use its resources to create an environment of collaboration and encouragement for researchers to explore ideas and develop research projects that are innovative and help the organization achieve its other mission—improving patient care.
(1) Flynn KE, Hahn CL, Kramer JM, Check DK, Dombeck CB, et al. (2013) Using Central IRBs for Multicenter Clinical Trials in the United States. PLoS ONE 8(1): e54999. doi: 10.1371/journal.pone.0054999
(2) Keith-Spiegel, P., Koocher, G. (2005) The IRB Paradox: Could the Protectors Also Encourage Deceit? Ethics & Behavior. 15(4), 339-349.
(3) Ravina, B., Deuel, L., Siderowf, A. and Dorsey, E. R. (2010), Local institutional review board (IRB) review of a multicenter trial: Local costs without local context. Ann Neurol., 67: 258–260. doi: 10.1002/ana.21831