How does NIH describe a New Investigator?

A New Investigator is an NIH research grant applicant who has not yet been awarded a substantial, competing 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. For a complete list of NIH grants that do not disqualify a PD/PI from being considered a New Investigator, visit http://grants.nih.gov/grants/new_investigators/resources.htm.

How does NIH describe an Early Stage Investigator (ESI)?

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/). 

How does NIH recognize New Investigators?

A New Investigator is identified in the NIH eRA Commons by searching for evidence of previous substantial research grant awards.  See number 1, above.

How does NIH recognize ESIs?

ESIs are identified in the eRA Commons (https://commons.era.nih.gov/commons/) based on information entered about degree conferral date and the end of residency dates.  

If I am an ESI, how do I ensure that NIH recognizes me as such?

Software within the eRA Commons will check first for New Investigator status based on the individuals 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.

How do I get an eRA Commons account?

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 as 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 commons@od.nih.gov.

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 career and may be affiliated with more than one institution at a given time. 

Which grant opportunities are available to ESIs?

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.    

How can institutions assist NIH in its commitment to ESIs?

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.

I self-identified on my grant application as a New Investigator/Early Stage Investigator (ESI), but this designation does not appear when I view the grant folder in the NIH Commons. How can I correct the information?

For applications submitted for or after February 5, 2009, individuals are identified as new investigators based on a search of prior award history.  The parameters for identifying New Investigators are described in the definition of New Investigator that appears on the New Investigator Webpage.  New Investigator status is not dependent on the Check Box on the face page of the application.  In the relatively near future, the New Investigator Check Box will be removed from the face page of the grant application form.  For those individual identified as New or Early Stage Investigators (ESI), that classification will be assigned to R01 and DP2 applications that are submitted during the period of eligibility.  ESI status is  based on the time since the terminal research degree or the end of clinical residency as described on the New Investigator Webpage.   Note that New Investigator/ESI status will not appear on Exploratory/Developmental Grants (R21), Smalls Grants (R03), AREA (R15) applications; NIH Challenge Grants (RC1), Grand Opportunities (RC2), etc.  Special review and funding considerations associated with New Investigator and ESI status only apply to R01s and DP2s.   

Yes. Only those who have previously competed successfully as PI for a significant independent NIH research grant are excluded from consideration as a New Investigator. The definition of New Investigator is available on the New Investigator website.

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 commons@od.nih.gov.  

Yes it is correct.  Receiving a substantial, competing NIH grant will end your status as a New Investigator.  Receipt of an NSF grant or a grant from any other funding agency has no effect on that status. 

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.

Can medical specialty or subspecialty training be considered a part of medical residency?

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.

I performed two medical residencies. Which one will be considered the start of my 10 year ESI period?

The ending date of the second residency is considered the start date of your 10 year ESI period.

I earned a Masters of Business Administration after my Ph.D. Can my M.B.A. be considered my terminal research degree? What about an M.P.H?

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.

Do I have to be a U.S. citizen to be considered a New or Early Stage Investigator?

No. There are no citizenship or residency requirements for ESI (or New Investigator) status.

5. If I am a New or Early Stage Investigator, will all my research grant applications receive special consideration?

No. Only applications for R01 research grants will receive special consideration.

I have ESI status but I plan to submit a Multiple PI application.  Will my application be flagged as ESI? 

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.

I had an R01 several years ago but have no R01 now. Can I be considered an ESI?

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.

May I apply from a foreign institution?

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://www.fic.nih.gov/funding/grants_info/faq.htm useful.

Can investigators at small businesses be considered ESIs?

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.

Can investigators at government agencies, non-academic, and/ or for-profit organizations be considered ESIs?

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 commons@od.nih.gov.

I am a scientist in the NIH Intramural Program.  Can I be considered for ESI status?  

I’ve entered the date of my terminal research degree and/or the end of residency date. Where do I look to find my ESI status?  

How do I request an extension of my ESI status?

A form for requesting an extension of ESI status is provided at http://grants.nih.gov/grants/new_investigators/index.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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html. 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.   

When should I apply for an ESI extension?

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.  It will be difficult to reclassify an application after it has been received and processed.

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.

Must the application for an extension come from or be endorsed by an institution?

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.

Is documentation required?

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.

Will NIH ask for more information to support my request for an extension?

In some cases, NIH may ask for additional information or clarification regarding a request.

Who will make the decision about my request for an extension?

An ESI Extensions Committee composed of senior NIH extramural review and program staff will evaluate the requests for extensions and will make decisions.  The Division of Receipt and Referral in the Center for Scientific Review will be responsible for coordinating the committee.

How long will it take to get a response?

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.

Can I appeal the decision of the ESI Extension Committee?

Decisions of the ESI Extension Committee are not appealable.

I have a chronic illness that generally impairs my ability to work full time.  Am I eligible for an extension? If so, how long can this extension last?

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.

If I request and receive an extension and another issue comes up, can I ask for a second extension?

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.

How will I know if my extension has been granted?  

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.

Can I talk to someone about my situation?

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.

I had a hiatus in my research career to take care of family members. Can I request an extension in my ESI status?

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.

I had a delay in my research due to a flood in our animal facility that resulted in the loss of a valuable mutant mouse colony. May I request an extension of the time equivalent to the time required to replace my experimental mouse colony and restart my research career?

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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html.

I spent 4 years conducting research in industry before taking my first academic position. Can I request an extension of my ESI to account for time out of academia?

No. There is no distinction between research or research training time spent in industry and comparable time spent in academia.

I spent 2 years working in the telecommunication industry after my degree. Can I request an extension of my ESI period to cover this time away from research?

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. 

I was unemployed for 2 years after my terminal research degree. Can I request an extension of my ESI period to cover this time away from research?

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.

I spent time in a research staff associate position and was not permitted to apply for NIH grant support. Can I request an extension of my ESI period to cover this time away from research?

No. Institutional restrictions on the ability to apply for external research support the basis for an extension request.

I spent several years as a clinical fellow after my MD and my residency before I started my research training.  Can I extend my ESI status?

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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html.

Can you provide a few clear samples of requests for extension of the ESI period?

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. 

What is the maximum ESI extension that I can request?

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 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html, 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. 

Is there an expected amount of time for requests for extensions due to parental leave?

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.

Can I request an extension for changing research fields?

Changing research fields is generally not a valid reason for an extension to the ESI period.

Can I request an extension if my clinical responsibilities are associated with my faculty appointment?

No, clinical responsibilities associated with faculty appointment or other position are generally not eligible for an extension of the ESI period.

Because I am part of a dual-career couple, I took a less than ideal research position so that I could remain in the same city as my spouse. Can I request an extension for this time period?

Time spent in a research position, even if the position is less than ideal, is not a valid reason for extension of the ESI period.

My military spouse and I lived in a remote location where my spouse was stationed. Because this location was so remote, I was not able to obtain employment. Can I request an extension for this 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.

How much information should I submit to justify an extension request for a chronic illness or family issue that resulted in low productivity?

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.

I worked part time for six months: 75 % for two months; 80% for two months; 90% for 2 months. How should I calculate my request for an extension.

NIH generally considers 50% or more time not working as a reasonable request for an extension.

I decided to stay home for six years until my child reached school age. During that time I had sporadic part time work related to my scientific interests. May I request an extension of 72 months?

The ESI Exception 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.

I have an M.D. and I performed a fellowship following my degree that included research and clinical periods. Can I request an extension for the full fellowship period?

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. 

I am preparing an R01 application for a receipt date next summer.  Should I let the committee know my plans to submit so that they will feel an urgency to approve my extension?

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. 

I had a visa which allowed me to perform research in the United States, but when I completed my degree I was required to go back to my home country for clinical service payback.  Is the time away from research in service payback eligible for an extension?

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.

I secured a research position in the United States but I was unable to begin research because visa processing was delayed for six months.  I spent part of that time in the US and part of it in my home country.  Is this period eligible for an extension?

No.  Time spent waiting to process a visa or time spent in the home country before applying for a visa is not eligible for an extension.

I am an ESI and I am planning to submit a research grant application jointly with two other investigators. Will my ESI status ensure special consideration for our application?

A multiple PI grant application will be flagged for ESI status if all Principal Investigators listed are ESIs. The policy for ESIs on multiple 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.

How are applications from ESIs identified in the review process?

The ESI status of the PI(s), on any R01 or DP2 application will be determined at the time of submission. If the PI(s) on the application is/are classified as ESI on the submission date, the application will be flagged as ESI and will receive special consideration during the review and funding process.

I submitted an application within my ESI eligibility window, which ends this month. I plan to submit a resubmission version of this application at the next receipt date, which will be after my eligibility expires. Will my resubmission application be ESI-eligible?

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. 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.
 

I entered my degree/residency end dates after submitting my R01 or DP2 application and my New Investigator and ESI status is not correct.  How can I change it?

Go into your NIH eRA Commons Profile and make sure the dates have been correctly entered and your New Investigator and ESI status are correct.  Then contact the NIH Commons Help Desk at http://ithelpdesk.nih.gov/eRA/ and ask them to ensure that your corrected New Investigator and ESI status is correctly associated with your R01 or DP2 application.