NOT-OD-16-109: 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

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

Notice Number: NOT-OD-16-109

Key Dates
Release Date: June 21, 2016

Related Announcements
NOT-OD-20-058
NOT-OD-18-004
NOT-OD-18-003
NOT-OD-16-094
NOT-OD-21-006
NOT-OD-23-097
NOT-DA-23-033

Issued by
National Institutes of Health (NIH)

Purpose

This document was prepared by the NIH Office of Science Policy in consultation with the Office of Policy for Extramural Research Administration in the NIH Office of Extramural Research and the Division of Financial Advisory Services, OM, to provide guidance about the activities associated with serving as an single IRB (sIRB) under the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research and which of those activities should generally be charged as Facilities and Administrative (F&A) costs (also called indirect costs) and which may be charged as direct costs.

Activities of the sIRB will generally fall into two categories which, for the purposes of this guidance, are referred to as primary activities and secondary activities.

Primary activities refer to the activities associated with conducting the ethical review of the proposed research protocol that will be carried out at all of the participating sites and the review of the template informed consent document describing the study.
Secondary activities refer to the activities associated with the review of site-specific considerations for all of the participating sites, including investigator qualifications, institutional capabilities, state/local regulatory requirements, and community ethos. Following initial approval, there are additional activities associated with fulfilling IRB oversight responsibilities, including the reviewing reportable events from all participating sites, e.g., unanticipated problems, protocol deviations, and, as necessary, reporting them to the Office for Human Research Protections (OHRP) and the funding Institute or Center as appropriate; receiving and reviewing any complaints that arise with regard to the conduct of the study; notifying all participating sites of serious or continuing non-compliance and all other determinations; and communicating with participating sites on matters related to sIRB determinations.

In general, primary activities should be charged as indirect costs if those activities are included in an organization’s Federally-approved indirect cost rate agreement. Secondary activities may be charged as direct costs, with appropriate budget justification.

Further guidance is provided below through the scenarios below illustrating how costs are handled in different sIRB arrangements. Although the scenarios do not address every possible situation, they provide principles for planning and decision-making

For sIRB cost allocation questions related to grant applications and awards, please contact the Office of Policy for Extramural Research Administration, OER at [email protected].

For sIRB cost allocation questions related to contract proposals and awards, please contact the Division of Financial Advisory Services, OM at [email protected].

Scenario	Awardee	sIRB	Participating Sites	How sIRB Costs Should Be Able to Be Charged
1	Institution A ¹ prime awardee conducting the study	IRB at Institution A	Institution A + 14 subawardees	Primary activities are charged as Institution A’s indirect costs because Institution A has aFederally approved F&A rate and is a participating site. Secondary activities related to the other 14 participating sites may be charged as Institution A’s direct costs.
2	Institution A prime awardee not conducting the study but engaged	IRB at Institution A	14 subawardees	Primary activities are charged as Institution A’s indirect costs. Institution A is not a participating site,² but because OHRP policy generally considers prime awardees to be engaged even when all of the research is carried out by the subawardees, IRB review is required. Secondary activities for the other 14 participating sites may be charged as Institution A’s direct costs.
3	Institution A prime awardee conducting the study	Independent IRB ³	Institution A + 14 subawardees	Primary activities are charged as direct costs. Institution A will commission an Independent IRB to serve as the sIRB and reviews by the Independent IRB are charged as Institution A’s direct costs. Secondary activities for Institution A and the 14 participating sites may be charged as Institution A’s direct costs.
4	Institution A prime awardee conducting the study	IRB at Institution B⁴ B is a participating site	Institution A + Institution B + 13 other subawardees	Institution A will designate Institution B⁵ to serve as the sIRB. Primary activities are charged as Institution B’s indirect costs because Institution B has a Federally approved F&A rate and is a participating site. Secondary activities for Institution A and the other 13 participating sites may be charged as Institution B’s direct costs.
5	Institution A prime awardee conducting the study	IRB at Institution C⁶ C is not a subawardee	Institution A + 14 subawardees	Institution A will commission Institution C to serve as the sIRB. Primary and secondary activities may be charged as Institution A’s direct costs because Institution C is not a subawardee.
6	Entity B ⁷ prime awardee not conducting the study but engaged	IRB at Institution A Institution A is a participating site	Institution A + 13 other subawardees	Entity B will designate Institution A’s IRB to serve as the sIRB. Primary activities are charged as Institution A’s indirect costs because Institution A has a Federally approved F&A rate and is a participating site. The sIRB will also perform IRB review for Entity B, which is considered engaged as the prime awardee. Secondary activities for the other 13 participating sites may be charged as Institution A’s direct costs.
7	Entity B prime awardee not conducting the study but engaged	Independent IRB	14 subawardees	Entity B will commission an Independent IRB to serve as the sIRB. Primary and secondary activities may be charged as Entity B’s direct costs. The sIRB will also perform IRB review for Entity B, which is considered engaged as the prime awardee.
8	15 individual awardees ⁸	Institution A	Institution A and 14 other awardees	Primary activities are charged under Institution A’s indirect costs because Institution A is a participating site. Secondary activities for the other 14 participating sites may be charged as each of the 14 sites direct costs. Those 14 awardees will include the cost in their individual budgets for the study and each will pay Institution A for services rendered.
9	15 individual awardees	Independent IRB	15 awardees	Primary and secondary activities may be charged as each of the 15 sites direct costs. The lead PI’s institution will commission an Independent IRB to serve as the sIRB. The 15 sites may include the cost of IRB review in their individual budgets and each will pay the Independent IRB for services rendered.
10	Institution A prime awardee conducting the study	Institution A	Institution A 13 subawardees, and an intramural investigator at the NIH Clinical Center	Primary activities are charged as Institution A’s indirect costs because Institution A has a Federally approved F&A rate and is a participating site. Secondary activities related to the other 14 participating sites may be charged to the award as direct costs.
11	Institution A prime awardee conducting the study	NIH Intramural IRB	Institution A 13 subawardees, and an intramural investigator at the NIH Clinical Center	An awardee may enter into an agreement with an NIH Intramural IRB to serve as the sIRB No funds from NIH awards may be used to support the activities of an NIH Intramural IRB.
12	Institution A prime awardee conducting the study	NIH Intramural IRB	Institution A and 13 extramural subawardees	An awardee may enter into an agreement with an NIH Intramural IRB to serve as the sIRB No funds from NIH awards may be used to support the activities of an NIH Intramural IRB.

¹ Institution A is a university with a number of NIH human subject research awards; it has a human subjects protection program and an IRB registered with OHRP.

² Although Institution A is not a participating site from the standpoint of the NIH sIRB policy, OHRP policy generally would consider Institution A, as the prime awardee, to be engaged.

³ An independent IRB is not affiliated with an academic institution.

⁴ Institution B is a university with a number of NIH human subject research awards; it has a human subjects protections program and an IRB registered with OHRP.

⁵ Under the NIH sIRB policy, the awardee selects the sIRB.

⁶ Institution C is a university with a number of NIH human subject research awards; it has a human subjects protections program and an IRB registered with OHRP.

⁷ Entity B is an independent data coordinating center; when needed, it always relies on other IRBs. It does not have its own IRB and, therefore, does not receive indirect costs for a human subjects research protection program.

⁸ There are different ways in which these individual awardees may be linked as they carry out the same protocol. For example, an NIH IC may issue an RFA for the conduct of a specific trial. The NIH IC may designate one of the 15 awardees as a lead investigator. The NIH IC could also make separate awards to sites that are already linked through a network.

Inquiries

Please direct all inquiries to:

NIH Office of Extramural Research
Telephone: 301-435-0949
Email: [email protected]