Dominic Chiarelli

by Dominic Chiarelli

Preparing for sIRB: Selection and Budget

Starting September 25, 2017, all sites participating in a multi-site research study funded by the National Institutes of Health (NIH) must use a single Institutional Review Board (sIRB) to conduct ethical reviews.1 The goal of this policy, which is a rather radical departure for the field, is to streamline and enhance IRB review so that research can proceed as expeditiously as possible without compromising ethical principles and protections for human subjects. In this series, we will explore the considerations and practical steps confronting researchers and institutions as they prepare for the sIRB mandate.

We begin with what’s likely most important to researchers and institutions: the grant proposal. Will your sIRB selection and budgeting improve your application’s scoring?

 

How To Select an sIRB for NIH-Funded Studies

In an application for research funding, the applicant must provide a plan for selecting a single IRB of record for all participating study sites.2 This plan at a minimum must:

1) Identify a proposed sIRB,

2) Describe how all regulatory requirements will be met, and

3) Confirm that all sites will rely on the chosen sIRB.

Important sIRB Selection Criteria

NIH recommends applicants consider the history and experience of the IRB and its capacity to serve as the IRB of record for the particular protocol. At a bare minimum, this IRB must:

  • Be registered with Office of Human Research Protections,
  • Have the necessary medical, scientific and legal experience and expertise to appropriately review the proposed research,
  • Possess sufficient diversity, cultural sensitivity, and understanding of the populations implicated to ensure respect for its advice and counsel,3 and
  • Have the infrastructure in place to coordinate and document all required review activities, such as accounting for local context issues; delivering all board-directed communications; soliciting reports of ongoing study activities; and issuing site-specific consent forms.4

 

Importantly, the applicant must also have confidence, usually in the form of a letter of support, that all expected participating institutions are willing to work with the selected sIRB and, as necessary, are able to negotiate a reliance agreement.

Despite, and perhaps because of, the many requirements for the sIRB, the applicant is free to choose the sIRB and is not required to give preference to the lead institution’s IRB or even the IRBs of participating sites.

Interestingly, the selection of the IRB is not evaluated during peer review and has no effect on the overall assigned score or the rating of the acceptability of the Protection of Human Subjects section.5

That said, compliance with the sIRB plan will be a term and condition of the award and will be subject to enforcement actions if it cannot be followed.

What This Means In Practice

In the early stages of the new sIRB mandate—as applicants learn to navigate the new system—an applicant’s plan for any protocol involving more than a few research sites will likely involve selection of a well-established, AAHRP-accredited independent IRB with a strong reputation and compliance record. This IRB will likely also need to have demonstrated flexibility in negotiating reliance agreements with research sites, and applicants may find that an IRB’s participation in agnostic IRB reliance platforms like the Streamlined, Multi-Site, Accelerated Resource for Trials (SMART) IRB Reliance Platform as a necessary requirement.

 

sIRB Budgeting for NIH Grant Applications

An applicant may seek direct-cost funding support for sIRB as a categorical expense within an application.6 The NIH has not to date presented a specific formula, or even a cap, for calculating sIRB costs. The only firm requirement is that all charges follow the cost principles found in the award regulations and outlined further in NIH grants policy, which essentially requires that all costs attributed to a NIH award be reasonable and necessary, allocable, consistently treated, and conformant with any limitations or exclusions contained in the terms and conditions of the award.7

The cost of ethical review—a primary sIRB activity—must be accounted for according to the reviewing institution’s/IRB’s F&A rate agreement (indirect costs), assuming this agreement includes IRB review.8

This cost can be accounted for as a direct cost, however, if the institution chooses to rely on an independent IRB that is neither affiliated with a research institution nor otherwise subject to a federally negotiated indirect cost agreement. The cost of site-specific reviews, a secondary sIRB activity that is not typically a part of an institution’s F&A rate, can be charged as a direct cost.

The NIH has stated that it will provide no additional funding support to develop the infrastructure needed to create a de novo local sIRB function. In fact, the policy goes even further as to explicitly disallow the use of NIH funds, direct or indirect, to support a site-specific ethical review in addition to the sIRB review.9 The NIH policy as such appears to heavily incentivize the use of commercial IRBs.

What This Means In Practice

In budgeting for the direct costs of sIRBs, institutions and the IRBs they work with should develop and provide applicants a fee schedule that includes the projected review cost based on actual usage. These review fees could be set by site, per year, or per event. The only meaningful limitation is that these fees, which are subject to the same standards as other highly specialized services, be consistent with current market rates for those services.

 

sIRB is Here—Start Preparing Today

Applicants may begin selecting and budgeting for sIRB even before the policy’s implementation date, and they would be wise to do so. In most cases, they should begin by working with independent commercial IRBs to develop a viable sIRB plan and budget to ensure their research moves forward unimpeded. Our next post will explore how the sIRB policy will change the role of local IRBs and institution based human subject protection programs and, perhaps paradoxically, the new opportunities this may present for improving human research protections.

 


James Riddle, VP of Client Services

Executive Insight

James Riddle, MCSE, CIP, CPIA, VP of Client Services

 

Institutional IRBs should thoughtfully consider whether serving as an sIRB is in the institution’s best interests. Doing so for a multi-site grant means the organization is taking on responsibility to oversee research at locations far away—this takes dedication and resources.

Mitchell Parrish, JD, RAC, CIP, VP of Legal and Regulatory Affairs

 

There are a number of decisions in selecting an sIRB. One decision not to be overlooked is whether the sIRB, typically a central IRB, requires exclusivity. Institutions should avoid such exclusivity and retain the freedom to work with all potential sIRBs. This ensures they are not limiting their research opportunities or their ability to receive the best service.

References

1 NIH Policy on the Use of Single Institutional Review Board for Multi-Site Research (last accessed on May 19, 2017).

2 Id.

3 45 CFR § 46.107.

4 45 CFR § 46.108; 45 CFR § 46.109; 45 CFR § 46.115.

5 NIH Single IRB Policy FAQs for External Community (last accessed May 19, 2017).

6 NIH Policy on the Use of Single IRB for Multi-Site Research, FAQs on Costs (last accessed May 19, 2017).

7 45 CFR § 75.403; see also NIH Grants Policy Statement, Section 7.2 The Cost Principles.

8 Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research (last accessed May 19, 2017).

9 See, NIH Policy on the Use of Single Institutional Review Board for Multi-Site Research, Participating Site.

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