A New Investigator is an NIH research grant applicant who has not yet competed successfully for a substantial, NIH research grant. For example, a Program Director/ Principal Investigator (PD/PI) who has previously received a competing NIH R01 research grant is no longer considered a New Investigator. However, a PD/PI who has received a small grant (R03) or an Exploratory, Developmental Research Grant Award (R21) retains his or her status as a New Investigator.
An ESI, or Early Stage Investigator, is a New Investigator who has completed his or her terminal research degree or medical residency—whichever date is later—within the past 10 years and has not yet been awarded a substantial, competing NIH research grant. The dates that start the period of classification as an Early Stage investigator are entered in the investigators eRA Commons Profile (https://commons.era.nih.gov/commons/). Under certain circumstances an extension to the ESI period may be granted.
A New Investigator (NI) is an NIH research grant applicant who has not yet competed successfully for a substantial, competing NIH research grant. An Early Stage Investigator (ESI) is a new investigator who has completed his or her terminal research degree or medical residency—whichever date is later—within the past 10 years and has not yet competed successfully for a substantial, competing NIH research grant. The ESI designation helps to differentiate between established and early-career investigators, and helps NIH meet the goal of accelerating the transition to an independent scientific career. It is expected that ESIs will constitute the majority of funded NIs.
Software within the eRA Commons will check first for New Investigator status based on the individual’s previous award history. For individuals identified as New Investigators, the software will calculate the ten year window of ESI status based on the date of the terminal research degree or the residency end date entered in the investigator’s Profile. To ensure that NIH recognizes your ESI status, you must update your eRA Commons profile to reflect the date of completion of your terminal research degree or the end of your residency.
NI and ESI status is determined automatically by the functionality built into eRA Commons, based on the investigator’s record of receiving NIH grants and the date of their terminal degree and/or completion of medical residency. If an extension to the ESI 10-year period is granted by the ESI Extensions Committee, the eRA Commons account is updated by NIH staff.
Degree and medical residency completion dates are provided by the applicant. Applicants are expected to provide true, accurate, and complete information and to produce documentation when requested. (Making false statements to the federal government can result in severe penalties).
Institutions must be registered with the NIH eRA Commons before faculty and staff can take advantage of electronic submission and retrieval of grant information. Only an individual with signing authority for the institution in grant related matters can register an institution. This individual is designated the “Signing Official.”
For most institutions, the Signing Official is located in the institution’s Office of Sponsored Research or its equivalent. Researchers should work through their institution’s Office of Sponsored Research or its equivalent to establish their own eRA Commons account. If you are unable to identify your institution’s Signing Official, please contact the NIH eRA Commons Help Desk at firstname.lastname@example.org.
Please note that an investigator will have a single Commons account and unique Commons ID for their entire career. Investigators will be affiliated with different institutions during their careers and may be affiliated with more than one institution at a given time.
In general, all grant opportunities are open to New and Early Stage investigators. You can find all NIH Funding Opportunity Announcements (FOAs) at http://grants.nih.gov. New investigators and ESIs may respond to specific Requests for Applications (RFAs) or Program Announcements (PAs) Including “Parent” FOAs such as R01 Parent: PA-07-070. Other parent announcements can be found at http://grants.nih.gov/grants/guide/parent_announcements.htm. Please note, however, that ESI status will be considered only on applications for traditional research grants (R01s) and the NIH Directors New Innovator Awards (DP2s). Only ESIs may apply for DP2s.
Institutions function as partners to the NIH in their ability to identify and attract biomedical researchers of the highest caliber. We urge institutions to continue to look for ways to reduce the duration of graduate and postdoctoral training; to enable new investigators to move quickly to research independence; and to compete successfully for extramural funding.
A number of opportunities are highlighted on the New and Early Stage Investigator Website at http://grants.nih.gov/grants/new_investigators/index.htm. Two NIH-wide awards of particular note include the Pathway to Independence Award (K99-R00) and the NIH Director’s New Innovator Award (DP2). The Pathway to Independence Award provides support as a postdoctoral scholar transitions from a training position to a faculty position. The NIH Director’s New Innovator Award (DP2) is designed to stimulate applications for grants to support highly innovative research approaches. Applicants for DP2s must follow the eligibility guidelines in the announcement.
The New and Early Stage Investigator Website includes links to New Investigator pages at each of the NIH Institutes and Centers (ICs). IC websites frequently include a description of IC specific policies and initiatives for scientists at the beginning of their independent careers.
The parameters for identifying New Investigators are described in the definition of New Investigator that appears on the New Investigator Webpage. The first step in making sure that you are correctly designated as a New or Early Stage Investigator is to go into your NIH Commons Profile and make sure the degree completion and/or the end of residency date has been correctly entered. If the Profile screens indicate that you are a New Investigator or an ESI, that information should be correctly assigned to any R01 or DP2 application that you submit in the future (until you are no longer eligible). If you believe that your ESI eligibility window needs to be extended because of a lapse in your research or research training, you can request an extension using the instructions on the New Investigator Webpage. If you have already submitted an application that doesn't reflect your current New Investigator or ESI status, you can send a note to the helpdesk to request a correction of the new PI/ESI status for the submitted application.
New Investigator status is only applicable if you have not yet competed successfully for a substantial NIH independent research award. For a list of awards that are excluded from consideration as “independent research,” see the Definition of New Investigator.
If the new investigator is assigned a PD/PI role for the overall multi-project application, the individual will lose their NI status when the award is made. If the new investigator is the lead of a project or core, but not the PD/PI for the overall application, the individual will retain NI status when the award is made.
Yes. Only those who have previously competed successfully as PI on a significant independent NIH research grant are excluded from consideration as a New Investigator. If you are in this situation but a subsequent R01 you have submitted does not have New Investigator status you will need to contact the NIH eRA Commons Help Desk at email@example.com.
Yes, under certain circumstances. Investigators who are PD/PIs on subject accrual sites that are part of U01 or U10 multisite patient-oriented investigation remain eligible for new investigator status if the following qualifications are met: (1) the participation of the investigator on the subject accrual site in the overall U01 or U10 award must be limited to recruiting subjects and following pre-established protocols; (2) the funding of the subject accrual site must not exceed $150,000 in direct costs; and (3) investigators requesting this consideration must provide a letter from the Coordinating Site U01 or U10 Principal Investigator that affirms the level of participation of the subject accrual site investigators is limited. Although this is not technically a request for an ESI extension, investigators are asked to use the ESI extension request for this purpose.
If the application is awarded, you will no longer be considered a New Investigator, no matter how big or small your role is compared to the other PIs. Investigators should carefully consider and discuss their options with their mentors before they agree to be part of a multi-PI application that would lead to a loss in NI status. New Investigator status will not be restored simply because PIs didn’t realize that they would lose New Investigator status.
The 10-year ESI period was designed to allow for a consistent time period of research activities among applicants. While postdoctoral periods generally are devoted to research and research training activities, medical residency periods generally are not.
Individuals that are within 10 years of completing a mentored career development award are only considered ESIs if they are also NIs who are within 10 years of completing their terminal research degree or medical residency.
The formal date of receipt of your Ph.D. is the date the degree was conferred, as indicated on your diploma and/or transcript. That date determines the beginning of your 10 year window as an Early Stage Investigator.
No. The clinical fellowship training in a medical specialty or subspecialty in the years that follow the internship/residency period is not considered a part of residency for the purpose of this policy. Often the clinical fellowship period will consist of a mixture of clinical and research training. The time spent in research training will be considered as applicable toward the 10 years of research and research training that characterizes the period of ESI status. The time spent in clinical fellowship training and the associated clinical care that is unrelated to research will be considered favorably in a request for extension of the ESI period.
Generally, an M.B.A. or an M.F.A. and similar degrees are not considered research degrees. If you have such a degree after your Ph.D. or M.D., please indicate that this is not your terminal research degree. However, some types of research Master’s degrees (like M.S. or M.P.H) can be considered terminal if they mark the beginning of a period of research or research training or the new degree substantially expands or advances an individual’s skills within a field related to the NIH mission. For example, an M.P.H. or a comparable research degree earned after the medical degree may initiate a period of research and should be listed as the terminal research degree even when it follows a degree like the Ph.D.. The conferral date for the terminal research degree will mark the beginning of the ESI status period.
As with applications from New Investigators (see the Definition of New Investigator at http://grants.nih.gov/grants/new_investigators/index.htm), a multiple PD/PI R01 application will be flagged as an ESI application only if all the listed PD/PIs have ESI status at the time of submission.
No. If you have competed successfully for a substantial NIH grant at any time in your career, you will no longer be considered a New Investigator and therefore you will not be considered an Early Stage Investigator.
Yes. ESI status is associated with individual investigators and the advantages offered are designed to accelerate the transition to independence. They can apply to investigators in foreign settings as well as domestic settings. Applicants from foreign institutions may find the FAQs available at http://fic.nih.gov/Grants/Pages/Frequently-Asked-Questions.aspx useful.
Yes, but the advantages of ESI status apply only to applicants for traditional NIH research grants (R01s) and NIH Director’s New Innovator Grants (DP2s). The advantages of New and Early Stage Investigator status do not apply to SBIR and STTR grants reserved for small businesses. Information on SBIR and STTR can be found at http://grants.nih.gov/grants/funding/sbir.htm.
Yes. Applicants from any organization with an eRA institutional registration can complete the degree date and residency date fields in their eRA Commons Profile for classification as an ESI. PD/PIs should work through their institution’s Office of Sponsored Research or its equivalent to establish an eRA Commons account. If you are unable to identify your institution’s Signing Official, please contact the NIH eRA Commons Help Desk at firstname.lastname@example.org.
With the exception of certain Roadmap programs and the NIH Pathway to Independence Award (K99/R00), NIH Intramural scientists are not permitted to apply for extramural grants while associated with the NIH Intramural Program. Those considering transitioning to an extramural position should consult NIH policies for information about changing affiliation and preparing grant applications. (see http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/fund-irp-erp-3-00.htm).
Once you have entered the date of your terminal research degree and/or your end of residency date on the Degree/Residency Page of your eRA Commons Profile, your ESI status and the End of Eligibility Date will be displayed. See screenshot.
A form for requesting an extension of ESI status is provided at http://grants.nih.gov/grants/new_investigators/esi_extension_add.htm. Submitting the completed form will generate an email to the NIH ESI Extensions Committee requesting an extension of the ESI status period. This form must be used to apply for an ESI extension. The policies and procedures for requesting an extension of the period of ESI status are detailed at NOT-OD-09-034. If an extension is granted a new ESI end date will appear in eRA Commons and you will be sent email notification of the change.
You may apply for an extension of the ESI period at any time after the eRA Commons has calculated and displayed your ESI status. PD/PIs are encouraged to update their degree and residency information and when necessary to request extensions well in advance of the due date for any planned R01 application. Early establishment of ESI status will avoid ambiguity about the ESI classification of submitted applications. Extra steps are required and must be initiated by the PD/PI to reclassify an application after it has been received and assigned. This page includes specific information on the required steps. What time units will be considered in a request?
Terminal scientific degrees and residency completion dates will be reported as month and year. Similarly, requests for extension should be made in whole months. Rounding up to the next whole month is permissible. For example, if the time away from research is 6 months and 3 weeks, a request of 7 months is appropriate.
Prepare a table as shown below, but do not submit it with the initial request. You will be able to submit the table on an email subsequent to the initial request. The key issues which should be included are the time period (for example January 2012 through March 2012), the % time working, the % time away from research, and the reason for the hiatus as described in NOT-OD-09-043.
No, ESI status applies to an individual and requests for extensions are submitted by individuals. It is not necessary to send the request to an institutional official. The individual submitting the request for ESI extension is responsible for providing true, accurate, and complete information.
No. NIH will not request any specific documentation at the time of submitting a request for extension. It will be useful, however, to explicitly describe your time away from research in months and years along with the reason for and the nature of the hiatus. It is possible, that the NIH will request documentation to support your request to better establish a reasonable extension period.
120 months. Although most extension requests are for periods less than 24 months, one can request an extension to account for lapses at any time during the ten year research or research training period (120 months) that occurred after the terminal research degree or the completion of medical residency. Those lapses, as indicated in NOT-OD-09-034, must be related to family care responsibilities, extended periods of clinical training, extended periods of additional didactic instruction, disability, illness, active duty military service, loan repayment, natural disasters or comparable disruptive factors. All extension requests will be considered on a case-by-case basis and the Extension Committee may ask for additional supporting information.
Yes. You may request a second extension if a second period away from research or research training occurred within ten years of your terminal research degree or within ten years of completing your medical residency.
You will receive an email response at the email address designated in your eRA Commons account. In addition, the ESI indicator in your eRA Commons Account will change and the end date of your ESI status period will be modified to reflect the extension granted.
a. I was enrolled for twelve months in the clinical portion of my Cardiology Fellowship from July 2000 to July 2001. In addition, I had a child and spent 6 months away from research between the period of May 2002 and October 2002. In total, I’m requesting that my ESI status be extended 1 year and six months. According to the eRA Commons the ten year period of my ESI status will end on July 2010. I’m requesting that it be extended until January 2012.
b. My Ph.D. was granted in November 1999. In August of 2002, my postdoctoral appointment was interrupted and delayed by injuries sustained in a car accident. I was in the hospital and away from the lab for two months until the end of September and then worked only half time for 6 months between October 2002 and March 2003. I’m requesting a 5 month extension of my ESI period. That would extend my ESI period from November 2009 until April 2010.
In the form for requesting an extension in the ESI period, we limit the reason for the request because time and experience with past requests has demonstrated that the rationale for a request can be explained clearly in 300 words. Please be brief but clear, and remember that the most important information is the time away from research for each reason in your extension request.
An ESI Extensions Committee composed of senior NIH extramural review and program staff evaluates the requests for extensions and makes decisions. The Division of Receipt and Referral in the Center for Scientific Review is responsible for coordinating the committee.
In most cases it is expected that a decision will be made within two weeks. If there are large numbers of requests for extensions or if there are unanswered questions after the first request, the process and the decision may take longer.
Yes. Please direct any concerns you may have to the mailbox for ESI inquiries (ESINIH@od.nih.gov). If you feel it is necessary to discuss a special situation, please indicate that in your email, and someone will call you.
A chronic illness (mental or physical) could be a valid reason to request an ESI extension. You should prorate the request. For example if the chronic illness led to working only 80% time over a 5 year period within the ESI eligible time frame, you should request a one year extension.
Yes. Once the date of the terminal research degree and/or the date of residency completion have been entered in the eRA commons, the data system will calculate the end date of ESI status. If there has been a lapse in your research or research training during the ten year period after your terminal research degree or the end of medical residency you can request an extension. In general, the NIH will consider requests to extend the ESI period for reasons that can include medical concerns, disability, family care responsibilities, extended periods of clinical training, natural disasters, and active duty military service. Any such request will be considered on a case-by-case basis.
Yes. A request for an extension of the ESI period can be based on natural disasters and other catastrophic events that led to a lab shutdown, relocation, or the need to rebuild resources required for your research. This can include a hurricane, fire, flood, earthquake or occurrences like an infection in an animal colony. In your extension request, please indicate the nature of the disaster and the actual time lost until you restarted your research or research training. As with other requested extensions, such requests will be considered on a case-by-case basis and the Extension Committee may ask for additional supporting information. The policies and procedures for requesting an extension of the period of ESI status are detailed at NOT-OD-09-034.
No. If the time away from research is a career choice and is not related to medical concerns, disability, family care responsibilities, natural disasters, active duty military service or comparable factors it will not be considered as the basis for an extension request.
Generally, no. Requests for an extension of ESI eligibility related to a period of unemployment will not be granted unless the unemployment period is a direct result of medical concerns, disability, family care responsibilities, natural disasters, or comparable factors.
Probably. Individuals who have engaged in clinical training after the doctorate or after the completion of an internship/residency can request an extension of the ESI period equivalent to the time away from research. For example, an MD degree holder who undertook a clinical fellowship after the residency period may ask for an extension of ESI status equivalent to the duration of clinical training leading to qualification in a medical specialty or subspecialty. Periods of the fellowship, however, that were devoted to research will count against the 10 year ESI period and should not be included in the request for extension. All such extension requests will be considered on a case-by-case basis. The policies and procedures for requesting an extension of the period of ESI status are detailed at NOT-OD-09-034.
While NIH generally receives requests for extensions due to parental leave of 3 to 6 months, we recognize that experiences differ. The ESI Extension Committee will consider longer and has approved extensions on a case by case basis that correspond to the time away from research.
If the remote location was a place where employment options were extremely limited, the ESI extension committee will consider your request. All requests are evaluated on a case-by-case basis and the extension committee may request additional supporting information.
Extension requests are evaluated on a case-by-case basis and detailed information is extremely helpful to appropriately evaluate the request. While you are not obligated to provide medical or personal details, the committee appreciates specific information whenever possible, such as the amount of time that your illness or family issue caused you to remain away from research.
The ESI Extension Committee regards this situation as a personal life choice and generally does not approve an extension beyond a reasonable parental leave period. If there are special circumstances (a child with disabilities or an illness for example) this should be described in an ESI extension request and will be evaluated.
In a fellowship, only the time spent performing clinical duties is eligible for an extension. Time spent performing research is not eligible. Please be specific in your request, and provide the time periods when you performed clinical duties.
No. It is not appropriate to ask for an extension of a certain period of time so that you can submit your application by a certain date. As with all requests for extensions, you must explicitly describe your time away from research along with the reason for and the nature of the hiatus.
Generally, non-research, service payback time is eligible for an extension. All requests are evaluated on a case-by-case basis and the extension committee may request additional supporting information.
Time spent fulfilling a payback obligation to an employer is generally acceptable. Note that time spent in research while fulfilling the payback obligation should not be included in the time requested.
Generally, no. Investigators generally use such time to advance their research, such as performing experiments in colleagues’ labs to keep their research going, and/or writing publications or grant applications that are directly relevant to their research. If you feel there are extraordinary circumstances involved, please explain in your request.
No. The tenure clock is not related to ESI status. ESI status may be extended for reasons that can include medical concerns, disability, family care responsibilities, extended periods of clinical training, natural disasters, and active duty military service. It is possible that these same circumstances may have prompted the tenure clock extension, but changes in the tenure clock will not be considered as a reason for extension of ESI status.
NIH generally considers extension requests only for periods of time away from research. If your certificate program involved a defined period of non-research activities that limited research time, then you may submit a request. Please include the details of the certificate program, including the course work, requirements including non-research activities, and duration. Also be sure to include details on the time away from research that occurred as a result of your participation in the certificate program.
Postdoctoral training is not time away from research, and therefore is not considered a valid reason for an extension. In addition, didactic training that is expected in a standard postdoctoral position (such as attending lab meetings, presenting or attending conferences, or participating in the occasional university course) should not be considered grounds for an extension.
A multiple PD/PI grant application will be flagged for ESI status if all Principal Investigators listed are ESIs. The policy for ESIs on multiple PD/PI applications is parallel to the situation for New Investigators (see the Definition of New Investigator at http://grants.nih.gov/grants/new_investigators/index.htm.
The ESI status of the PD/PI(s), on any R01 or DP2 application will be determined at the time of submission. If the PD/PI(s) on the application is/are classified as ESI on the date the application is successfully submitted to Grants.gov, the application will be flagged as ESI and will receive special consideration during the review and funding process.If the application status does not correctly reflect the ESI status on the day of submission, contact ESINIH@od.nih.gov.
Go into your NIH eRA Commons Profile and make sure that your end of ESI status has been changed; this normally occurs a few days after you receive an email regarding the granting of your request. Then contact the NIH Commons Help Desk at http://ithelpdesk.nih.gov/eRA/ and ask them to ensure that your corrected ESI status is correctly associated with your application.
The NI status for an application is calculated based on investigator status on the date the application is successfully submitted to NIH. The application will reflect the NI status regardless of whether the investigator loses NI status because of a substantial award after the submission date. Any NI application will be grouped with other NI applications during peer review. NI status will be reassessed for any pending application after peer review and prior to consideration for award.
For individuals who are still New Investigators at the time of resubmission of the A1 application, there is a 13 month period during which the New Investigator can submit the A1 resubmission application to retain ESI status. That is, if an original application is flagged as an ESI application and it is resubmitted as an amended application (A1) within 13 months after the submission date of the original application, it will retain its ESI status even if your eligibility period has expired. However, if the resubmission application (A1) is submitted more than 13 months after the submission date of the original application, the ESI status and New Investigator status will be recalculated based on the submission date of the resubmission application. In addition, if you are no longer a New Investigator at the time of submitting the A1 resubmission (because you successfully competed for a significant NIH research award as described in the New Investigator definition), then you cannot have ESI status.