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NIH Costing Scenarios for Multi-Site sIRB Review

Copied from NIH Notice NOT-OD-16-109 (June 21, 2016) to illustrate the use of direct and indirect costs on single IRB review for multi-site research.

Guidance is provided 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.

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 a Federally 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: SingleIRBPolicy@mail.nih.gov