Special Council Review (SCR)

      • Effective February 29, 2024: the NINDS SCR threshold is $1.5M in total costs in active NIH research project grant awards. The pending application is no longer included in the SCR calculation (see NOT-NS-24-060). This will be in effect for the May 2024 NINDS Council. 
        • There is a more stringent payline (the “SCR payline”) for pending applications with a PI  that is subject to the NINDS SCR policy. See the NINDS Paylines page for more information. 
        • Exceptions to the more stringent SCR payline may be granted when the applicant’s current funding includes projects that involve research that is inherently expensive. 
        • Research Project applications not subject to the SCR policy are those that are funded through Congressionally-directed programs (e.g. BRAIN, HEAL, AD/ADRD, COUNTERACT)
        • Applications that do not directly support a research project such as training, SBIR/STTR, conferences, research resources are also excluded from being subject to the SCR threshold.
        • The SCR threshold calculation includes active research project awards, including those funded through Congressionally-directed programs (e.g. BRAIN, HEAL, AD/ADRD, COUNTERACT)

       

      • Here is an example: a PI holds currently holds $1.8M in total costs including an HEAL award. 
        • If the PI submits an application to the parent R01, all eligible costs including the HEAL award would be included in the SCR cost calculation. The PI exceeds the threshold and the SCR policy would apply.
        • If the PI submits an application to a Congressionally-directed program (such as the HEAL Initiative or BRAIN Initiative), the SCR policy does not apply to the PI regardless of total costs held, but only for that specific application to the Congressionally-directed program (would still apply to the PI for the parent R01 application). 

      If you are unsure if the NINDS SCR policy does or will apply to you or your application, reach out to your NINDS Program Director. 

          The NINDS SCR Policy

          The Special Council Review (SCR) policy helps NIH effectively manage resources. The policy requires NIH Institute and Center (IC) Advisory Councils to perform additional review of grant and cooperative agreement applications from Principal Investigator(s) who exceed a specified threshold of costs from active NIH awards. This policy does not represent a cap on NIH funding. 

          With the implementation of this policy change, NINDS seeks to:

          • Support a larger, more diverse pool of investigators and
          • Foster a research environment in which investigators have sufficient effort available to oversee a program of rigorous research and mentor trainees effectively.

          The NINDS SCR policy: (1) sets the funding threshold that requires special review of a pending application by the NINDS Council to $1.5M total costs, in active NIH research funding  and; (2) sets a more stringent payline (referred to here as the “SCR payline”) for pending applications that cause an investigator to exceed this funding threshold. Council will continue to ensure that applications approved for support through the SCR process afford a unique opportunity to advance research which is both highly promising and distinct from the other funded projects from the PD/PI. To ensure continuity of research support, investigators with an existing grant nearing its end date will be permitted to exceed the $1.5M threshold for up to 90 days beyond the earliest start date of the Council round in question.

            All competing NINDS primary research applications within the NINDS payline (or non-percentiled applications under funding consideration) are potentially subject to this policy.  This includes P01s, Centers, and other multicomponent RPGs.  Multi-PI projects will be subject to the policy if one or more of the PIs meets or exceeds the funding threshold described above.  Exemptions to this policy are limited and fall into a small number of general categories.  Note that the descriptions of these exemptions are intended to serve as examples and are not exhaustive. 

            • Training – Applications soliciting support for Institutional Training programs, Research Education (R25) programs and individual Fellowship (F) and Career Development (K) awards are exempt from this policy.
            • Conferences – Applications soliciting support for scientific conferences (i.e. R13 or U13) are exempt from this policy.
            • Research Resources – Applications soliciting support for research resources (e.g. R24, P30, S10) are exempt from this policy.
            • SBIR/STTR activities.

            In addition, applications submitted in response to a Notice of Funding Opportunity (NOFO) supported by Congressionally directed funds will generally be exempt from SCR. However, dollars awarded through Congressionally directed funds are included in the SCR calculation and will affect SCR designation. Each of these applications will be reviewed individually to ensure that the applicant(s) have sufficient time available to devote to the pending application.  At present, the programs that have been designated as exempt in this category include:

            • The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative,
            • The HEAL (Helping to End Addiction Long-term) Initiative,
            • Programs using Alzheimer’s disease / AD- Related Dementias (AD/ADRD) set-aside funds
            • Countermeasures Against Chemical Threats (CounterACT)

            Applications flagged for SCR will be reviewed on an individual basis, and exceptions to the more stringent SCR payline may be granted when the applicant’s current funding includes projects that involve research that is inherently expensive (e.g. primate research, human neuroimaging, clinical trials, later stage therapy development projects, etc.). 

            In accordance with NIH policy, new applications that exceed $500K DC in any budget year must be approved by NINDS before submission.  (If NINDS accepts such an application for review, we will communicate to the applicant whether or not it will be recommended to our Council as an exception to the more stringent payline.  In addition, NINDS will provide guidance to the PI(s) about whether future renewals of his/her current grant support are likely to be recommended as exceptions.) DELETE THIS

             

            General FAQs

            FAQs for general guidance to applicants who may be affected by the NINDS SCR policy and procedures (see NOT-NS-24-060).

            What does it mean for me if my application is “subject to the NINDS SCR policy”?

            If you have an application under funding consideration and you will have $1.5M total costs from active NIH research project awards as described above, you are subject to the NINDS SCR policy.

            Your pending application will be considered for funding:

            1. If it receives a percentile score within the more stringent SCR payline or
            2. If it is excluded from the SCR payline based on the provided exemptions.

            Your application will not be recommended to council for funding:

            • If it receives a percentile score outside the more stringent SCR payline unless the research is considered inherently expensive or
            • If it is determined that you do not have sufficient time to devote to the pending application. Note that, regardless of score, ALL applications will be reviewed to ensure that the Investigator has adequate time available to commit to the proposed project - no score is a guarantee of funding approval. Applications subject to the SCR policy will be reviewed by NINDS staff, Council, and the Director.

            Note that, regardless of score, ALL applications will be reviewed to ensure that the Investigator has adequate time available to commit to the proposed project - no score is a guarantee of funding approval.  Applications subject to the SCR policy will be reviewed by NINDS staff, Council, and the Director.

            Are standard administrative cuts factored in when calculating an investigator’s level of research support?

            Yes.  Research support is calculated based on the awarded total costs of funded grants (inclusive of administrative cuts) and the requested total costs (minus IRG recommended cuts and standard administrative cuts) of the pending application.

            How are subawards/consortium costs considered when determining how much research support a PI has?

            Subawards and related activities are not excluded when calculating the research support an investigator has on a grant on which they are the PI.  That is, the PI is “charged” with the entire cost of the grant (assuming a single PI award) unless the research has been identified as “inherently expensive”.  Subcontracts allocated from collaborating PI’s grant are NOT factored into the research support of the SCR PI.

            The Notice states that only research support for which the investigator is the PI or Co-PI will be considered.  Are investigators with co-investigator and collaborator status impacted?

            The policy applies only to PIs or Multi-PIs.  It does not apply to Co-Investigators or collaborators.  Moreover, funds received from investigators in their role as Co-Investigator or collaborator will not be considered when determining whether they will be subject to this policy.

            How is funding attributed for Multi-PI awards or Multi-Component awards when determining the amount of an Investigator’s Research Support?

            Only the portion of a Multi-PI (MPI) or Multi-Component award that is attributable to the PI with a pending application will be used. For the purposes of identifying PIs that may have a pending application subject to this policy, estimated levels of support will be determined by equally dividing dollars among all the research PIs on a project. For example, if there are two PIs on an MPI award, the award total cost dollars will be divided in half. If you believe this attribution of funds is incorrect and may erroneously cause you to be subject to the policy, you should contact your Program Director to clarify the situation. At this time, you may be asked to supply Just In Time information documenting your effort on the award(s) in question. Support received by a PI to lead a core facility on a multi-component grant or cooperative agreement will not be considered in these calculations.

            How are applications submitted in response to BRAIN, AD/ADRD, and/or HEAL Initiatives be affected by the NINDS SCR Policy?

            • In general, eligible awards and applications for Congressionally-directed programs (e.g. BRAIN, HEAL, ADRD, COUNTERACT) ARE INCLUDED in SCR PI cost calculations when applying for non-Congressionally-directed funding opportunities (e.g. parent R01).
            • However, the SCR policy does not apply for applications submitted to these Congressionally-directed programs, unless issues are identified by NINDS program staff and leadership (e.g. insufficient committed effort).
            • For example, a PI holds currently holds $1.8M in total costs including a HEAL award. 
              • If the PI submits an application to the parent R01, all eligible costs including the HEAL award would be included in the SCR cost calculation. The PI exceeds the threshold and the SCR policy would apply.
              • If the PI submits an application to a Congressionally-directed program (such as the HEAL Initiative or BRAIN Initiative), the SCR policy does not apply to the PI only for that specific application to the Congressionally-directed program (but would still apply to the PI for the parent R01 application). 

            How will the NINDS SCR Policy be applied to non-percentiled applications?

            Non-percentiled applications from PIs with greater than $1.5M in total costs from active NIH research project awards are also subject to SCR, unless deemed exceptions for the reasons above.  These applications, like percentiled applications, will require a more meritorious score to be considered for funding.  As a general guide, an application will be expected to have a priority score of 28 or better to be funded.  However, there are additional programmatic factors that enter into the consideration of non-percentiled applications for funding.  Therefore, a score of 28 or better does not guarantee funding and a subset of applications with scores above 28 may be recommended for funding.

            How will multi-center clinical research projects exceeding $1.5M/Yr be handled with respect to the NINDS SCR Policy?

            In accordance with NIH policy, PIs must obtain agreement from NINDS to submit any application with yearly direct costs over $500K.  At that time, NINDS staff will communicate to the applicant whether or not the project under consideration will be considered inherently expensive, and therefore recommended to the NINDS Council as an exception to the more stringent SCR payline. In most cases, such projects will be considered as exceptions if the PI dedicates effort to the project that is commensurate with the work proposed.

            How will therapy development projects that require greater than $1.5M/Yr to complete research necessary for an FDA IND or IDE be handled with respect to the SCR policy?

            In accordance with NIH policy, PIs must obtain pre-submission approval from NINDS to submit any application with yearly direct costs over $500K.  At that time, NINDS staff will communicate to the applicant whether the project under consideration will be considered inherently expensive, and therefore recommended to the NINDS Council as an exception to the more stringent SCR payline. In most cases, such projects will be considered as exceptions if the PI dedicates effort to the project that is commensurate with the work proposed.

            Can I transfer a grant to another PI to stay under the $1.5M cap?

            For a grant to be exempt from the SCR policy, the transfer must be completed before the application is reviewed. Note as per NIH policy, PI transfers require prior NIH approval.  In addition, changes from a single PI to a multiple PI grant, or changing the number of the PIs on an MPI award will require a new or revised leadership plan.

            Can I terminate an existing grant to stay under the $1.5M cap?

            Yes. However, in order to avoid a delay of funding, the terms of this arrangement must be agreed to by both NINDS and the Institution’s business office at least two (2) weeks prior to the meeting of the NINDS Advisory Council.  If arrangements are not made prior to the Council meeting, the application in question will be put forward with a recommendation of NOT FUND.   For a termination plan to be considered, the grant(s) proposed for early termination must have at least one year of remaining funds (e.g. the final year of the award has not yet been dispersed).

            How do I determine if I have sufficient effort on my pending application?

            NINDS generally expects a minimum effort of 2.4 calendar months or 20% effort on an R01 or R01-equivalent SCR application. For MPI applications, effort is typically divided equitably among the PIs or in a manner that is appropriate for each PI’s contribution to the project. Please reach out to your Program Director if you cannot meet this minimum requirement.

            Can I reduce my effort on existing awards to allow “sufficient effort” on my pending application?

            Effort reductions to existing awards must be completed prior to the submission of the application in question and are subject to the approval of your Program Director.

             

            Note: The scenarios posed below are based on FY 2024 NINDS 11th percentile payline and an SCR payline at the 5th percentile.

            I am currently the PI on 2 R01s totaling $2.5M in NIH research support and I have a pending R01 that scored at the 10th percentile.  Will my grant application get funded? 

            No, unless one of the exemptions applies.  Your third R01 would need to have scored in the range of 1-5% in order to be funded.  We encourage you to apply again when you are approaching the end of one of your other two grants.

            I am a PI on a recently submitted MPI application that scored at the 10th percentile.  One of the other PIs on our grant application has 3 R01s totaling more than $1.8M.  Will our application get funded? 

            No.  The application will be subject to the SCR policy and will not be recommended for funding unless one of the exemptions applies.

            I am the PI of a modular R01 and an R21 that together total approximately $950K in total costs.  I am interested in moving my research into a non-human primate model that will significantly increase the budget of my next R01 application.  I anticipate the budget of this application will be in excess of $1.3M TC.  Will I be subject to a more stringent SCR payline?  

            No.  Note that all applications greater than $500k DC/yr require that you obtain permission from NINDS at least six (6) weeks prior to submission (see NOT-OD-02-004).  At that time, NINDS will evaluate your pre-submission proposal and will likely advise you that your non-human primate research is considered ‘inherently expensive’ and therefore an exception from the more stringent SCR payline. Note that this determination will be based on your ability to commit sufficient effort to the application in question and on your level of research support at the time of your pre-submission proposal.   Any changes to your level of research support (e.g. award of an additional grant) may impact this decision.

            I plan to submit a $1M RM1 application with a total of 4 PIs / Project Leaders.  One of the project leaders has several NIH grants totaling $2.4M.  All three of the other PIs on the application have only 1 modular R01 each.  Will our application be subject to a more stringent payline? 

            Most likely.  Note that all applications greater than $500k DC/yr  require that you obtain permission from NINDS at least six (6) weeks prior to submission (see NOT-OD-02-004).  At this time, NINDS will evaluate your pre-submission proposal and will likely advise you that your application will be subject to the more stringent SCR payline.  Note that this determination will be based on your ability to commit sufficient effort to the application in question and on your level of research support at the time of your pre-submission proposal.  Any changes to your level of research support (e.g. award of an additional grant) may impact this decision.

            I do not currently have NIH support; however, I am planning to submit a clinical trial application with a budget well over $1.5M TC/year.  Will I be subject to a more stringent SCR payline?   

            No.  Note that all applications greater than $500k DC/yr  require that you obtain permission from NINDS at least six (6) weeks prior to submission (see NOT-OD-02-004).  At this time, NINDS will evaluate your pre-submission proposal and likely advise you that your research is considered ‘inherently expensive’ and therefore an exception from the more stringent SCR payline. Note that this determination will be based on your ability to commit sufficient effort to the application in question and on your level of research support at the time of your pre-submission proposal.  Any changes to your level of research support (e.g. award of an additional grant) may impact this decision.

            I have a single modular R01 that funds my discovery research and I am interested in submitting a therapy development application in excess of $1.5M TC/year to gather the necessary evidence to submit an Investigational New Drug (IND) application to the FDA.   If this new application is funded, will the renewal of my modular R01 be subject to the more stringent SCR payline?

            No.  Note that all applications greater than 500k DC/yr require that you obtain permission from NINDS at least six (6) weeks prior to submission (see NOT-OD-02-004).  At that time, NINDS will evaluate your pre-submission proposal and will likely advise you that your proposed project is considered ‘inherently expensive’ and therefore an exception from the more stringent SCR payline.  When you attempt to renew your R01, your research portfolio will likely be viewed as ‘inherently expensive’. Provided the level of effort committed to both grants remains unchanged, the renewal application will be considered an exception from the more stringent SCR payline.

            I am a PI on several MPI grants totaling $1.3M TC. I am submitting an R01 for $450K.  Am I subject to the more stringent SCR payline? 

            No, as your active NIH research grant support does not exceed $1.5M TC