Special Council Review

Special Council Review

The following FAQs refer to NOT-NS-18-060, which announces modifications to NINDS implementation of the Special Council Review (SCR) Policy.
 
The preliminary FY2022 NINDS payline is set at 14th percentile and the NINDS SCR payline is between the 1st to 7th percentile.

In September 2012, NIH implemented a general policy whereby Advisory Council members were instructed to provide additional consideration of new and renewal applications from investigators who receive $1 million or more in direct costs of NIH funding to support Research Project Grants (RPGs).  To provide flexibility, individual Institutes can modify the policy so that it aligns with their funding strategies.

With the endorsement of its Advisory Council, NINDS has refined the SCR policy and procedures (see NOT-NS-18-060). The modified approach will be part of the assessment of applications under funding consideration beginning with the January 2019 Council meeting. 

The policy: (1) sets the funding threshold that requires special review of a pending application by the NINDS Council to $1M direct costs inclusive of the pending application 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 $1M threshold for up to 90 days.

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.

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.

In addition, applications submitted in response to a Funding Opportunity Announcement (FOA) supported by Congressionally directed funds will generally be exempt from SCR. However, 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
  • Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
  • 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.

The FAQs below are intended to provide general guidance to applicants who may be affected by this policy. It is important to note that every situation is unique, and that the scenarios below are meant to represent common situations.  ALL funding decisions (including those involving applications with percentiles within the SCR payline) are subject to the approval of the NINDS Advisory Council and the NINDS Director. The scenarios below are intended to convey a likely outcome, but it is possible for this outcome to change based on Council discussion.

 

FAQs for general guidance to applicants who may be affected by the SCR policy and procedures (see NOT-NS-18-060).

If you have an application under funding consideration and you will have $1M DC of NINDS research as described above, you are subject to the new policy.  This means that 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 exemptions listed above and described in further detail below.  Your application will not be recommended to council for funding: (1) If it receives a percentile score outside the more stringent SCR payline unless the research is considered inherently expensive or (2) 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.

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

Subawards and related activities are not excluded when calculating the research support an investigator has on a grant on which he/she is 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 policy applies only to PIs or Multi-PIs (e.g. Co-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.

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 DC 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 Officer 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.

In general, applications submitted in response to an FOA supported by Congressionally directed funds will be exempt from SCR unless issues are identified by NINDS program staff and leadership (e.g. insufficient committed effort).  However, investigators should be advised that awards made through one of the programs listed above will, unless it involves inherently expensive research, be included when determining whether a future application submitted to NINDS will be subject to the SCR policy.

Non-percentiled applications from PIs with greater than $1M in direct costs (including the new application) 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 30 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 30 or better does not guarantee funding and a subset of applications with scores above 30 may be recommended for funding.

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.

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 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.

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.

No.  As mentioned above and in the Notice, to provide continuity of support a period of 90 days during which an applicant exceeds the $1M cap will be permitted.  Delaying the start of an award to come in under $1M in support will not be permitted.

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).

No.  NINDS will not approve budget reductions beyond the standard administrative cuts taken by the Institute (e.g. 17.5% non-modular, with exceptions for specific programs). A significant reduction of the budget of an application would likely affect the investigator’s ability to achieve the specific aims outlined in the application – NINDS cannot encourage this reduction without potentially undermining the result of the peer review process.

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.

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 the preliminary FY 2022 NINDS 14th percentile payline and an SCR payline at the 7th percentile.

Q.  I am currently the PI on 2 R01s and have a pending R01 that scored at the 14th percentile.  This pending application brings my total NIH research support to $1.25M.  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 1-7% in order to be funded.  We encourage you to apply again when you are approaching the end of one of your other two grants

Q.  I am a PI on a recently submitted MPI application that scored at the 15th percentile.  One of the other PIs on our grant application has 3 R01s totaling more than $1M.  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.

Q.  I am the PI of a modular R01 and an R21 that together total approximately $350K in direct 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 $750K DC.  Will I be subject to a more stringent SCR payline?  It is unlikelyNote 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.

Q.  I plan to submit a $1M P01 application with a total of 4 PIs / Project Leaders.  One of the project leaders has several NIH grants totaling $1.8M.  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.

Q.  I do not currently have NIH support; however, I am planning to submit a clinical trial application with a budget well over $1M DC/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.

Q. I have a single modular R01 that funds my discovery research and am interested in submitting a therapy development application in excess of $1M DC/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.

Q.  I am a PI on several MPI grants but the R01 that funds my lab is up for renewal, putting my research support over $1M.  Am I subject to the more stringent SCR payline?  In most cases, yes: your R01 would need to score at the 8th percentile or better to be funded.  However, there may be occasional exceptions.  For example, if your participation in the MPI awards involves providing a service rather than being directly involved in the research, an exception to the SCR payline may be considered.  Please consult your program director to discuss this situation.