NHLBI R35 Outstanding Investigator Award (OIA) and Emerging Investigator Award (EIA) Program

August 31, 2017

RFA-HL-16-024 NHLBI Outstanding Investigator Award (OIA)
RFA-HL-16-025 NHLBI Emerging Investigator Award (EIA)

The goal of the NHLBI R35 Program is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced and emerging Program Directors (PDs)/Principal Investigators (PDs/PIs) conducting heart, lung, blood and sleep (HLBS) research. The NHLBI R35 Program is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding on individual grant awards. The NHLBI R35 Program will support the research program of NHLBI-funded investigators for up to seven years. The NHLBI R35 Program will provide investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer timeframe. This NHLBI R35 will support the overall research programs of NHLBI-funded investigators for up to 7 years, at a maximum level of $600,000 direct costs per year.

Below are answers to commonly asked questions regarding the NHLBI R35 OIA and the EIA Programs. Further questions about the NHLBI R35 Program should be sent to the NHLBI R35 mailbox.

NHLBI R35 Program Frequently Asked Questions

I. Funding Opportunity Description

  1. Q. Can I continue to work with my current collaborators, including foreign collaborators?
    1. NHLBI strongly encourages collaborative research, including foreign collaborators. NHLBI will accept R35 applications with a foreign collaboration. However, NHLBI will not provide funding for foreign consortium arrangements through this funding opportunity.
  2. Q. Can the R35 application be submitted as a multiple-PI application?
    1. No. OIA/EIA applications are not eligible to be multi-PI applications.
       
  3. Q. Can you clarify how much flexibility is meant by "flexibility to pursue new research directions"?
    1. In research, potential new directions often arise that may, for example, require changes in the model system used or involve the pursuit of new biological problems related to the overall goals of the research program. To accommodate the dynamic nature of research, the R35 program provides flexibility to pursue new directions that are reasonable extensions of the overall themes of the peer-reviewed application, provided the science remains within the mission of the NHLBI. PD/PIs are expected to work with program staff to ensure that the program remains within the mission of the NHLBI. Any changes in scope to what was originally proposed in the application will require prior approval from NHLBI Office of Grants Management. See next question for additional details.
       
  4. Q. What might be considered out of the scope of an OIA/EIA?
    1. Work that migrates fully into the mission of another NIH institute or center would be considered out of scope and not appropriate for pursuit through the OIA/EIA. Changes in scope could include, for example, the addition of or a change in the approved use of human subjects, vertebrate animals, select agents or human embryonic stem cells (hESCs). Such changes require prior approval by NHLBI before the work is initiated. However, such changes in scope can be approved with appropriate documentation. Please refer to the NIH change in scope policy (NIH GPS 8.1.2.5) for additional guidance.
       
  5. Q. In the absence of specific aims, how do I conceptualize and prepare a non-modular budget?
    1. The requested budget should include information for costs related to accomplishing the Research Strategy proposed in the application. Given that the NHLBI R35 Program will generally fold in investigators’ current research projects, the requested budget should reflect the budgetary needs for the current research. If the proposed R35 research program is intended to continue the R01 line of research, it may be appropriate to consider existing R01 budgets as a baseline.

 

II. Eligibility Information

  1. Q. One or both of my grants is/are in a No Cost Extension. Am I eligible to apply?
    1. Grants in a no cost extension (NCE) remain active and expire at the end of the no cost extension period; however eligibility will be limited to grants in their first NCE.
       
  2. Q. At some point in the previous four years, my grant was either on a NCE or I had an NHLBI R56 award. Do I still qualify as having had NHLBI support for the last four consecutive years?
    1. Yes. Continuous support from NHLBI on an active grant (including those on a NCE or R56) qualifies as four years of consecutive NHLBI support.
       
  3. Q. One of my current grants is equivalent in budget and scope to an R01 grant (e.g., U10, P50, P01, a sub-project of a Program Project Grant, etc.) but is not the specified R01-equivalent type identified in the OIA FOA (i.e., R01, R37, DP1, or DP2). Am I eligible to apply?
    1. As specified in the OIA FOA, grant types for R01-equivalent awards are limited to only the R01, R37, DP1, and DP2 mechanisms.
       
  4. Q. For the EIA, does “two current R01s” include the R37, DP1, and DP2 mechanisms, as stated in the companion OIA FOA?
    1. Yes. For the purposes of NHLBI R35 pilot program, two “current R01s” and “R01-equivalent” refer to the R01, R37, DP1 and DP2 mechanisms.
       
  5. Q. What is meant by “four years of continuous support”?
    1. Continuous support means having an active NHLBI R01-equivalent grant (i.e., R01, R37, DP1, or DP2) in each of the last four fiscal years, including the current fiscal year. For example, for the March 15, 2016 receipt date, the PD/PI must have had an active NHLBI R01-equivalent grant in each fiscal year from 2013 (which began on October 1, 2012) to 2016.
  6. Q. What is meant by "minimum of 50% research effort"?
    1. ​ Per the FOA, “minimum of 50% research effort” means the PI must be able to commit 50% effort or six calendar months per year for the duration of the R35 award.
       
  7. Q. Why are U01s being excluded from eligibility consideration?
    1. The overall goal of the R35 Program is to promote scientific productivity and innovation by providing stable and flexible funding. Since U01s are cooperative agreements and involve substantial NIH staff involvement, the NHLBI has decided not to incorporate them into a research program designed to provide investigators increased freedom to pursue research directions, such as the OIA/EIA research program.
       
  8. Q. What is meant by “currently” funded applications? Does it mean funded at time of receipt or at time of award?
    1. Eligibility is conferred after the receipt of applications on the intended receipt date. That is, if a potential applicant intends to submit an application for the March 15, 2016 receipt date, he or she must have two active awards that render them eligible for this program on that date.
       
  9. Q. Are individuals who have support from sources of funding other than NHLBI (e.g., other NIH components, Howard Hughes Medical Institute, or other types of substantial, unrestricted laboratory grant support) eligible to apply?
    1. Yes. Individuals may have support from other NIH components or from other sources, provided they meet all other eligibility requirements and are able to commit at least 50 percent (i.e., six calendar months) of their research effort to the OIA/EIA. The level of outside support may be considered when determining the OIA/EIA budget. The relationship between the work supported by non-NHLBI sources and the work supported by NHLBI must be carefully explained, but need not be separated into different projects and different specific aims. Study sections, the National Heart, Lung, and Blood Advisory Council, and NHLBI staff will consider all support, including PD/PI salary support from all funding sources when considering the appropriate budget level for the OIA/EIA.
       
  10. Q. Can I submit an application for continuation of my current NHLBI grant support and apply for OIA/EIA at the same time?
    1. Yes. As indicated in the FOA, investigators are encouraged to apply for the NHLBI R35 award and an R01 award in parallel to maintain funding continuity. Should both the R35 and R01 applications be selected for funding, the PD/PI will be permitted to accept only one of the awards.
       
  11. Q. I have two active NHLBI R01 awards. One was originally awarded when I was an Early Stage Investigator (ESI), and it has since been successfully renewed. Does my renewed NHLBI ESI R01 award qualify as “an NHLBI-funded NIH Early Stage Investigator award” and therefore meet that eligibility criterion for the Emerging Investigator Award (EIA)?
    1. No. Once an R01 has been renewed, it is no longer considered an Early Stage Investigator award. However, with two currently active R01 awards and four years of consecutive R01-equivalent NHLBI funding, it is possible that the investigator is a candidate for the companion Outstanding Investigator Award.
       
  12. Q. If I have an appointment at more than one institution, can I apply for a separate OIA/EIA through each institution?
    1. No. An investigator can only receive one OIA/EIA award. The application should be submitted by the institution where he or she primarily conducts his or her research program. Under rare circumstances, a subcontract may be permitted to support a part of the research program that is based at a different domestic institution.
       
  13. Q. Can I get a definitive determination of my eligibility prior to submitting an application to this Request for Application (RFA)?
    1. No. NHLBI staff can provide advice about eligibility; however, applications are evaluated for eligibility by the Receipt and Referral Office at the NIH Center for Scientific Review based on the criteria stated in the FOA after receipt of the application.
       
  14. Q. If one (or both) of the grants that I am PD/PI on are multi-PD/PI R01s, am I eligible to apply for the R35 Program?
    1. As indicated in the eligibility section of the FOAs, investigators that are currently PD/PI or multiple PD/PI on at least two NHLBI R01-equivalent awards are eligible to apply.
       
  15. Q. How will my multi-PI application impact the EIA/OIA award amount?
    1. To preserve the collaborative nature of the multi-PI awards, the NHLBI will not fold the multi-PI awards into the OIA/EIA during the Pilot Program. PDs/PIs with multi-PI applications should continue and complete the project. Meritorious OIA/EIA applications from PD/PIs with multi-PI grants may initially be awarded at an amount commensurate with single investigator research awards that will be folded into the OIA/EIA (i.e., the OIA/EIA will be funded at a reduced level). At the end of the multiple-PI project period, the OIA/EIA investigator’s proportionate share from the multi-PI project will be added to the future year OIA/EIA commitments such that funding stability is maintained for seven years. For example, a meritorious OIA/EIA application from an investigator with a single PI R01 at $250K direct costs and a two investigator multiple-PI award at $250K direct costs may initially be awarded the OIA/EIA at $250K direct costs until the end of the project period of the multi-PI award. Then, the future year OIA/EIA commitments will be adjusted to $375K direct costs so that the investigator’s funding is stable for seven years. This approach also facilitates the goal of the OIA/EIA to reduce the time researchers spend writing grant applications. In most cases, the expectation is that the OIA/EIA will be the sole source of funding for a lab, therefore potential applicants with multi-PI award(s) should consider whether applying for this program is optimal for their situation. Furthermore, the R35 award must retain a 50% effort (i.e., six calendar months) throughout the duration of the award (including the initial period of time when the multi-PI portion is not incorporated into the R35 award).
       
  16. Q. I know that once I am awarded an R35, I cannot be awarded a multiple-PI application while my R35 award remains active. However, what happens to my multiple-PI application that is under review in the same Council round as my R35 application? Will both the R35 and multiple-PI applications be considered for funding?
    1. Yes, both the R35 and multi-PI applications under review in the same review and award cycle will be considered for funding. Please see FAQ above.

 

III. Application and Submission Information

  1. Q. What became of the specific aims section of the grant application?
    1. Specific aims are not required because the goal of OIA/EIA is to move the scientific enterprise away from a focus on narrowly defined projects with highly tailored specific aims and to refocus attention on the big picture and overall impact of the research.
       
  2. Q. What format should the application follow?
    1. Follow the instructions in the SF424 R&R application guide as modified by theinstructions in the FOA. In brief, this means that the scientific content of the application will rely mainly on the abstract, facilities and other resources page, biographical sketch and the six page research strategy, plus details on the involvement of human subjects and vertebrate animals, as necessary. Avoid duplicating material covered in other sections. Do not include lists of publications, except as part of the biographical sketch, or references as necessary in the Bibliography & References Cited section of the Other Project Information Form. Provide current and pending research support information at the time of application using the format typically used for Just-in-Time information. Be sure to distinguish the direct costs per year that support research in the investigator's laboratory from support that goes to other investigators.
       
  3. Q. Can I request money for equipment in the budget?
    1. Yes. You may request money for equipment with appropriate justification. Remember that such requests should be accommodated within a budget that is commensurate with the overall NHLBI grant support of the laboratory in recent years. This is not intended as a mechanism to acquire "big-ticket" items that may be covered under instrument-specific funding opportunities or to furbish a lab with equipment. Standard NIH Prior approval requirements (NIH GPS 8.1.2) apply to post award equipment requests.
       
  4. Q. Who, if anyone, in addition to the PD/PI should be listed as "key personnel"?
    1. Key personnel include any other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically, these individuals have doctoral or other professional degrees, although individuals at the master's or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" are not acceptable levels of involvement for those designated as senior/key personnel.
       
  5. Q. How will support of other senior/key personnel (co-PD/PIs) be considered?
    1. Senior/key personnel who are independent investigators can contribute effort toward OIA/EIA. They may receive support from the award, but only if they do not also receive support from their own OIA/EIA award.
       
  6. Q. Can I include a consortium for a collaborator?
    1. Yes, but such requests must be well justified and describe why collaborative research with the OIA/EIA PD/PI is not feasible without funding support from the OIA/EIA. The NHLBI encourages collaborative and interdisciplinary research when it is appropriate, and individual OIA/EIA grantees are free to collaborate with one another or with other investigators using funds from their respective individual grants to support their parts of the team's research. Consultants may be an additional option to support collaborative research.

 

IV. Review Information

  1. Q. How will the review process for OIA/EIA differ from that for regular R01 research grant applications?
    1. Reviewers will consider each of the review criteria in the determination of scientific merit, and give a separate score for each. For this FOA, reviewers will be asked to shift emphasis away from details of the application and the approach, and to emphasize the potential impact of the investigator's research program on the field. Reviewers will be asked to recommend a budget for work within the investigator's laboratory that is within the mission of NHLBI and is of high scientific merit. They will be asked for guidance on whether the budget should be increased, decreased or stay essentially the same as the level of NHLBI support over the previous several years.
       
  2. Q. How do the review criteria differ from those for a regular R01 research grant application?
    1. The review criteria are the same, but the wording has been modified to emphasize the review of the investigator's overall NHLBI-relevant research program rather than a specific, narrowly-focused project with highly tailored specific aims. Reviewers should emphasize OIA/EIA-specific aspects of significance, investigator qualifications, innovation, approach and environment.
       
  3. Q. Given the absence of specific aims, how will the study section determine the appropriateness of the requested budget and arrive at a budget recommendation?
    1. Reviewers will be asked to consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed work. In answering this question, it is anticipated that reviewers will consider the past productivity of the investigator's laboratory in areas relevant to the NHLBI mission, given the resources at the laboratory's disposal, evidence of efficient use of funds in the past and likelihood of efficient use of funds in the future. Reviewers will not be asked to recommend specific, detailed budget cuts. Rather, they will be asked to recommend an overall budget amount or a budget within one of a few specified ranges still to be determined.
       
  4. Q. Does the expertise of reviewers on the R35 study section encompass the heart, lung, blood, and sleep fields? Or will the applications be reviewed in panels with organ-specific (i.e., heart, lung, blood) scientific expertise?
    1. The panel reviewing the R35 applications will collectively have expertise from each of NHLBI’s organ-specific mission areas. Given the absence of specific aims in this application, the expectation is that the review will be general in nature and focused on the challenge or gap in the field (as articulated in the OIA/EIA application), the applicant’s prior research contribution and impact on the research gap or challenge, and the expectation for the investigator’s research program to continue on its outstanding and productive trajectory.

 

V. Award Administration Information (Including Funding Restrictions in Section IV.2 of the FOA)

  1. Q. What is the timeline for transitioning from current NHLBI grant support to OIA/EIA?
    1. This is determined on a case-by-case basis depending on the expiration dates of existing NHLBI grant awards, their unobligated balances, and the best way to provide a smooth transition.
       
  2. Q.What, if anything, is different about the annual reporting required for OIA/EIA?
    1. Annual reports are required using the Research Performance Progress Report (RPPR). The FOA includes some additional instructions consistent with the broader goals of the research program supported by OIA/EIA and the absence of detailed specific aims. Additional information is requested that relates any new program directions to the NHLBI research mission, discussion of how the work continues to be innovative and of high impact, and the relationship of any new other support to the activities supported by OIA/EIA.
       
  3. Q. Is carryover of an unobligated balance from one budget period to another permitted?
    1. As stated in the FOA in the Funding Restrictions Section, carryover of an unobligated balance from one budget period to another budget period requires prior approval from the NHLBI Office of Grants Management.
       
  4. Q. Are OIA/EIAs eligible for administrative supplements? Competitive supplements (Revisions)?
    1. OIA/EIAs are eligible for Research Supplements to Promote Diversity in Health-Related Research and other types of administrative supplements, including equipment supplements that may be offered by NHLBI through notices in the NIH Guide for Grants and Contracts. Competitive supplemental applications (revisions) in response to the NHLBI R35 FOAs are not permitted. Generally, R35 awardees will be expected to reallocate existing resources to accommodate new research directions.
       
  5. Q. Can I transfer my R01 grant to another PI instead of relinquishing it?
    1. No. The NHLBI R35 FOAs specify that a change of PD/PI will not be allowed.
       
  6. Q. On what basis will award decisions for the OIA/EIA be made? How will the budget for my OIA/EIA be decided?
    1. As for all other awards, the award decisions will be based on the scientific and technical merit of the proposed program as determined by scientific peer review, availability of funds, and relevance of the proposed program to program priorities. As with other research awards, the budget is generally based on the requested amount; modifications suggested by initial peer review or Council review, the availability of funds, and precise timing and approach for folding in of the existing research awards (which ideally would be at the same time the R35 is funded). Since the OIA/EIA program is intended to be budget neutral, the OIA/EIA budget will also be influenced by the funding level of the PD’s/PI’s current NHLBI research projects.
       
  7. Q. Do I need to relinquish my K24 award in addition to my R01-equivalent awards when I receive the R35?
    1. Yes, the NHLBI K24 awards must be relinquished.
  1. Q. Are no cost extensions to the R35 award permitted?
    1. All extensions, including the first no cost extension, will require NHLBI prior approval. Extensions beyond the first NCE will be granted only in rare circumstances and will require extensive justification.
       
  2. Q. How does receipt of support from OIA/EIA affect the eligibility of co-PD/PIs to receive other grants?
    1. Senior/key personnel other than the PD/PI may receive support from other awards, including other OIA/EIA awards on which they are also not the PD/PI. Investigators who are PD/PI on more than one NHLBI R01 award are encouraged to consider consolidating their support by applying for an OIA/EIA application.
       
  3. Q. What happens if the PD/PI becomes unable to carry out the duties as a PD/PI or will be absent for more than three months at a time for any reason?
    1. If the PI is no longer able to serve, the NHLBI will negotiate phasing out the award with the Recipient Organization. Extenuating circumstances may be handled on a case by case basis in compliance with NHLBI and NIH policies.
       
  4. Q. I have a NHLBI Diversity Supplement or a Re-Entry into Biomedical and Behavioral Research Careers Supplement on an award that will be folded into an R35 award. What is the process for continuing this Supplement and transitioning it from the current award to the R35 award?
    1. Since the R35 is a new award, the recipient must re-apply through the eRA commons to NIH FOA PA-16-288 or PA-16-289, as appropriate. Given that the Diversity Supplement or Re-entry Supplement to the existing award was already reviewed and approved, NHLBI staff will employ an expedited process for the review of these supplements, in an effort to minimize gaps in funding. In the meantime, R35 awards that required relinquishment of a grant comprised of a Diversity or Re-entry Supplement, may support that Candidate on the R35 award, under standard NIH pre-award cost authority (NIH GPS 7.9.1) until the new supplement is issued.

      Specifically, potential R35 awardees with currently active Diversity or Re-entry Supplement funding will be instructed during the Just in Time Process, by their Grants Management Specialist, to submit a new application with the following items:
      These materials must be submitted through the NIH Program Announcement for “Research Supplements to Promote Diversity in Health-Related Research (Administrative Supplement)” or “Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Administrative Supplement),” as appropriate, and in accordance with the guidance provided in the NHLBI Research Supplement Application Guidelines.

      All other multi-year supplements (e.g., ORWH, OAR, OBSSR) will end and will require a new supplement request application that will be processed on the typical (non-expedited) schedule.
      1. New face page for new supplement
      2. Remaining award balance and budget justification (for requests of an extension beyond the previously approved supplement duration, see next FAQ)
      3. Research project progress report to date
      4. Statement about how research conducted through the diversity supplement contributes to the R35 Program

VI. Post-Award Information

  1. Q. Can I apply for R01s from other ICs while I am on an NHLBI R35 award?
    1. Yes; as long as the scope of the R01s is outside the mission of NHLBI and there is not overlap with the R35 program.
  2. Q. Once I am awarded an R35, can I also receive a multiple-PI NHLBI R01 award?
    1. No, multiple-PI NHLBI R01 applications will not be awarded to investigators with active R35 awards. R01s proposing clinical trials and targeted RFAs, where the research cannot be accomplished using R35 funds will be considered.
       
  3. Q. How do I transition from R35s back to R01s (when can I apply for R01s again, etc.)?
    1. An R35 awardee can apply for an R01 any time. However, single PD/PI R01 (or equivalent) awards will not be made by NHLBI during an active R35. If an R01 becomes fundable during this time, the PD/PI has to choose between continuing the R35 and R01. As the end of the R35 award project period approaches, R35 awardees are encouraged to apply for R01 funding to maintain continuity of research support.
       
  4. Q. If I get an R35 award, can I then apply for an NHLBI P01?
    1. Yes. However, the PI must document any overlap in the Just-In-Time submitted for that application (per standard NIH rules) and explain how potential overlap due to the nature of the R35 will be mitigated. Before applying, investigators should consider whether the proposed research could be accomplished under the R35 award.
       
  5. Q. I want to apply for or extend an NHLBI Diversity Supplement or a Re-Entry Supplement to my R35 award. What is the Diversity Supplement or Re-entry Supplement application or extension process for the R35?
    1. The process for applying for or extending a Diversity Supplement or Re-entry Supplement to an R35 is the same as any other mechanism.Please apply through the eRA commons to NIH Program Announcement for “Research Supplements to Promote Diversity in Health-Related Research (Administrative Supplement)” or “Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Administrative Supplement)”, as appropriate, and in accordance with the guidance provided in the NHLBI Research Supplement Application Guidelines.