NIH/NHLBI – NHLBI Outstanding Investigator Award (OIA) (R35 Clinical Trial Optional)

February 7, 2019 by kjt5j@virginia.edu

The purpose of the NHLBI Outstanding Investigator Award (OIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Director/Principal Investigators (PD/PIs) who are currently PD/PIs on at least two NHLBI R01-equivalent awards and whose outstanding record of research demonstrates their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The OIA is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding.

The OIA will support the research program of NHLBI-funded investigators for up to seven years. The OIA will provide investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PD/PIs to take greater risks and to pursue research that requires a longer time frame. Research supported by the OIA must be within the scope of the NHLBI mission (http://www.nhlbi.nih.gov/about/org/mission).

Applicants are strongly encouraged to review the NHLBI R35 Program Frequently Asked Questions (FAQs) and consult with the appropriate scientific research contacts.

Overview

This FOA is intended for established investigators who have the potential to conduct outstanding, innovative research. For this reason, eligibility is limited. Please refer to Section III. Eligibility Information for specific details.

It is anticipated that the NHLBI OIA will:

  • Provide a stable funding environment, thereby improving productivity and facilitating nimble, ambitious, creative research;
  • Accelerate scientific innovation by enabling flexibility in pursuing new research directions as they arise, since PD/PIs will not be bound to specific aims proposed in advance of the studies;
  • Reduce the time researchers spend writing grant applications and managing multiple grant awards, thereby allowing more time to be devoted to conducting research;
  • Facilitate PD/PIs’ commitment to research through increased stability of funding; and
  • Enable PD/PIs to devote more time and energy to mentoring junior scientists and providing scientific service.

An OIA is intended to be the primary, and in most cases, sole support for all of the NHLBI-related research conducted by an investigator. Research supported through the OIA must be related to HLBS research as described within the scope of the NHLBI mission (https://www.nhlbi.nih.gov/about/mission-statement).Within these bounds, investigators will have the freedom to explore new avenues of inquiry that arise during the course of their research. Work involving the addition of human subjects, vertebrate animals, stem cells, select agents, or a new foreign component requires prior approval of NHLBI according to existing policies and procedures.

It is expected that the OIA will replace current NHLBI funding on other NHLBI individual research grants as described below. NHLBI investigators with additional NIH support from other NIH Institutes or Centers (ICs) are welcome to apply, however funds cannot be requested through the OIA for activities supported by another IC, federal or state agency, or private foundation. PD/PIs will be expected to renegotiate their time and effort on other (non-NHLBI) NIH grants in order to accommodate the required OIA level of effort.

Research involving human subjects is permitted under this FOA. Specifically, mechanistic trials and/or fundamental or basic experimental studies with humans (BESH) are permitted. Phase I, II, III, and T4 clinical trials are not permitted under this FOA. NIH defines a mechanistic study as a study “designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.” NIH defines basic research consistent with the definition of basic research in federal code, “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena or of observable facts without specific applications towards processes or products in mind.”

The amount of an OIA will be determined by NHLBI, based on the recommendations of the study section, the National Heart, Lung, and Blood Advisory Council (NHLBAC), and evaluation of the needs, expected productivity, and impact of the proposed research program. NHLBI will continue to implement the NIH $1,000,000 total direct cost Special Council Review policy in considering all sources of investigator support (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-140.html).

Investigators should consider the pros and cons of the OIA award when deciding to apply. Benefits include:

  • OIAs will be for seven years instead of the current NHLBI average of four years;
  • Support for other currently-funded NHLBI research grants of the individual PD/PI will be folded into the OIA and will thereby be renewed;
  • Increased flexibility to pursue new ideas and opportunities as they arise during the course of research, since the OIA is not tied to specific aims or predicated on completing specific, pre-defined projects;
  • A reduction in administrative burden associated with writing multiple grant applications and managing multiple grant awards;

It is anticipated that the OIA will be highly competitive. To prevent a lapse in funding, a PD/PI can submit an R01 application and an OIA application in parallel. Should both applications be selected for funding, the PD/PI will be permitted to accept only one of the awards . The NHLBI will not consider funding future individual PD/PI research grants from an OIA awardee during the OIA project period, except for applications included under the list of exempted awards below. To clarify which awards are exempted from this policy, applicants are strongly encouraged to contact NHLBI staff.

The OIA is intended to provide the primary, and most likely sole, source of NHLBI funding on individual grant awards. The OIA does not eliminate the eligibility of the PD/PI for the following separate sources of NHLBI funding:

  • Grants supporting research resources (e.g., P30, R24, or U24 awards);
  • Contracts;
  • Cooperative agreements;
  • Grants supporting training (K01, K08, K12, K22, K23, K25, K99, R25, T32, T35)
  • Grants supporting workforce development or diversity building
  • Clinical trials that are not permitted under this FOA (see above and in Section VI. for allowable Clinical Trials.)
  • SBIR/STTR grants;
  • Conference grants;
  • NHLBI program project or center grants
  • R35 Eligible Supplements (R35 awardees should check R35 eligibility on supplemental FOA announcements.)

Research Not Supported by the NHLBI OIA

The following types of projects are not responsive to this FOA and will not proceed to review:

  • Research outside the scope of the NHLBI mission; and
  • Research that meets the NIH clinical trial definition (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).
  • Please see https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts for a list of all available FOAs in which NHLBI participates, including those that support clinical trials.

Deadlines:  March 14, 2019; February 14, 2020; February 15, 2021 (letters of intent due 30 days prior to the deadline)

URL:  https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-20-011.html

Filed Under: Funding Opportunities