NIH has published this next generation initiative policy to carry out the provision of Cures on encouraging new and early stage investigators. Below is the NIH notice which is also available here. Inquiries may be directed to the NIH office of Extramural Research at NIHTrain@mail.nih.gov. Additionally, Teratology Society Vice President-Elect Christine P. Curran has been invited to serve on the Working Group to the Directors’s Advisory Council for this initiative. She welcomes comments from Teratology Society members on policies and mechanisms to meet the program goals. She may be reached at Curranc1@nku.edu.
Policy Supporting the Next Generation Researchers Initiative
Notice Number: NOT-OD-17-101
Release Date: August 31, 2017
Implementation Date: August 31, 2017
National Institutes of Health (NIH)
This notice announces a new policy designed to invest in the next generation of researchers; this policy implements, in part, Section 2021 of the 21st Century Cures Act 1. This policy supersedes previous notices on new and early stage investigators (NOT-OD-08-121, NOT-OD-09-013 and NOT-OD-09-134).
NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. NIH recognizes that to meet its mission it must take steps to promote the growth, stability and diversity of the biomedical research workforce.
NIH and its stakeholder community have been concerned for many years about the long-term growth and stability of the biomedical research work force. The current hypercompetitive environment is challenging for early stage investigators and early established investigators. Many highly meritorious applications go unfunded. While scientific workforce diversity supports the NIH mission, expanding the pool of investigators from nationally underrepresented backgrounds in the biomedical research workforce remains an elusive goal.
Even with long-standing congressional support for early research independence2, NIH funding, and government-wide efforts to promote STEM workforce diversity3, early career scientists find it increasingly difficult to obtain support for a first research award, and retain that support in subsequent years.
Funding Impacts on Next Generation Investigators
Section 404M of the Public Health Service Act, entitled, “Investing in the Next Generation of Researchers” is intended to provide opportunities for earlier research independence while enhancing workforce diversity. To ensure the long-term stability of the biomedical research enterprise, NIH must encourage successful independent careers for early stage investigators, and retain them as they become early established investigators in a way that enhances workforce diversity.
Next Generation Researchers Policy
Consistent with the directives of the 21st Century Cures Act, the Next Generation Researchers policy requires institutes and centers (ICs) to prioritize awards that will fund Early Stage Investigators (ESIs) and Early Established Investigators (EEIs).
Early Stage Investigator (ESI): An ESI is a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award. A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found at https://grants.nih.gov/policy/early-investigators/list-smaller-grants.htm. ESIs are encouraged to enter the date of their terminal research degree or the end date of their post-graduate clinical training in their eRA Commons profile to ensure their correct identification.
Under the Next Generation Researchers policy, meritorious R01-equivalent applications with ESI PD/PIs will be prioritized for funding. ICs will put this prioritization into effect starting in fiscal year (FY) 2017. The goal for FY 2017 will be to fund approximately 200 more ESI awards than in FY 2016.
By providing funding priority for ESIs, NIH intends to encourage funding applications that involve researchers earlier in their career. An NIH R01-equivalent research grant application with more than one PD/PI (MPI) will be prioritized for funding only if all MPIs have ESI status.
Early Established Investigator (EEI): An EEI is a PD/PI who is within 10 years of receiving their first substantial, independent competing NIH R01-equivalent research award as an ESI. A meritorious application with a designated PD/PI EEI may be prioritized for funding if:
- The EEI lost or is at risk for losing all NIH research support if not funded by competing awards this year, OR
- The EEI is supported by only one active award.
NIH will identify EEIs in their eRA Commons profile by January 2018. An NIH grant application with more than one PD/PI (MPI) will be prioritized for funding only if all MPIs have EEI status and meet prioritization criteria.
By providing funding priority for applications with EEIs, the NIH intends to stabilize the career trajectory of research investigators, consistent with the legal directives described herein. The goal for FY 2017 is to achieve an overall opportunity for funding 200 more EEIs across the NIH than in FY 2016.
Requests for Extension of Next Generation Researchers Status
NIH anticipates that some PD/PIs may have experienced a lapse in their research or research training or have experienced periods of less than full-time effort during their ESI or EEI status. In order to accommodate such lapses, the NIH will consider requests to extend ESI or EEI period for reasons that can include medical concerns, disability, family care responsibilities, extended periods of clinical training, natural disasters, and active duty military service, determined on a case by case basis at the sole discretion of NIH.
ESIs and EEIs may request an extension of their eligibility under existing ESI procedures.
To facilitate the development of evidence-based strategies consistent with the mandates of the 21st Century Cures Act, the Office of the NIH Director (OD) will centrally track and maintain an updated census of the status of ESIs and EEIs.
Enhancing Scientific Workforce Diversity
Promoting diversity in the extramural scientific workforce is critical to the success of the NIH mission, and is consistent with the mandates of the 21st Century Cures Act. The OD will monitor the implementation of the Next Generation Researchers policy to determine the impact on individuals from nationally underrepresented backgrounds in the NIH portfolio. General information about NIH’s diversity initiatives can be found on the extramural diversity website. IC-specific strategies and trans-NIH plans responsive to the Next Generation Researchers policy will be reflected on this website.
IC Implementation Strategies
ICs will develop evidence-based strategies to identify, grow and retain ESIs and EEIs across these critical career stages. Effective strategies will consider factors such as emerging areas of scientific inquiry, the needs of the IC portfolio and the projected needs of the scientific workforce. In addition, these strategies will consider and implement steps to enhance the pool of applicants from nationally underrepresented backgrounds in the biomedical research workforce.
1 Section 404M of the Public Health Service Act (added by Section 2021 in Title II, Subtitle C, of the 21st Century Cures Act, P.L. 114-255, enacted December 13, 2016), entitled, “Investing in the Next Generation of Researchers,” established the Next Generation of Researchers Initiative within the Office of the NIH Director. This initiative is intended to promote and provide opportunities for new researchers and earlier research independence. In particular, subsection (b) requires the Director to “Develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity; and subsection (c) requires the Director to “Carry out other activities…as appropriate, to promote the development of the next generation of researchers and earlier research independence.”
2 Section 402 of the Public Health Service Act requires the NIH Director to "ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health."
3 Public Law 114-329, American Innovation and Competitiveness Act of 2017, promotes a national goal of diversifying STEM fields, and creates a working group to study how to improve inclusion of historically underrepresented populations in STEM fields.
Please direct all inquiries to:
Office of Extramural Research