Informational Session on the Renewed ELSI Funding Opportunities FAQ
On December 11, 2023, the National Human Genome Research Institute hosted a pre-application webinar on the Renewed ELSI Funding Opportunities: R01 (PAR-23-293), R21 (PAR-23-294), and R03 (PAR-23-295).
The following questions were answered during the webinar.
Eligibility
Are international applicants eligible for New Investigator/Early Stage Investigator (NI/ESI) status?
Yes. NI/ESI status, designed to accelerate investigators’ transition to independence, applies to eligible investigators in foreign settings as well as domestic settings. All applicants should determine their eligibility for NI/ESI status by creating and updating your own personal NIH profile in Commons. First, your organization must be registered in eRA Commons. Then your institution’s grant official can create individual account for you.
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. An NI is a PD/PI who has not previously competed successfully as a PD/PI for a substantial independent research award.
Learn more about Determining Early Stage Investigator (ESI) Status and see Frequently Asked Questions - Early Stage Investigators.
Can those who have a terminal master’s degree in their field (rather than a PhD) be eligible for ESI status?
Yes. ESI eligibility is based on the date you received the highest research degree you’ve earned, which could be a master’s or a bachelor’s degree. If your highest degree is a master’s degree, this will be your terminal degree. However, if you received a master's degree in a different field after earning a Ph.D. or M.D., your Ph.D. or M.D. is the terminal degree.
See the Eligiblity for Consideration as an Early Stage Investigator.
Are the ELSI NOFOs open to researchers outside the United States?
Yes. For all three NOFOs, institutions outside the United States and its territories are eligible to submit applications or may be proposed as partners on applications. Complete eligibility information is provided in Section III. Eligibility Information in each of the three NOFOs.
Budget
How can I budget for involvement of community members or members of other relevant groups?
Community involvement can take many forms. You should be clear in your application what roles community members will serve and how the involvement of community members will further the proposed research goals. You should include in your budget all costs that are necessary and reasonable to support the successful involvement of community members. The budget justification should describe how the funds will be used in support of the project.
During peer review of your application, reviewers will look for reasonable costs and just whether your request is justified by you aims and methods. Budgets are not considered in the scoring of applications.
Can I request an additional project year from NHGRI if needed during an awarded grant period?
If a grant is coming to a close, and additional work remains to be completed, most NIH grants can extend a project one time for up to 12 months using a No Cost Extension. Requests for a No Cost Extension (NCE) are considered within 90 days of the end of the final grant year. The fact that funds remain toward the end of the grant period is not sufficient justification for an additional year. Investigators requesting a No Cost Extension should be sure to request the amount of additional time needed to complete the proposed project.
For additional information on NCEs, see the NIH Grants Policy Statement on Changes in Project and Budget.
Submitting an Application
If I want to revise and resubmit my ELSI application, do the new requirements and the new NOFOs apply?
Yes. All requirements of the funding opportunity announcement used for the resubmitted application apply and must be followed, including all new requirements.
See additional Frequently Asked Questions regarding resubmission of applications.
Any advice for people who have not received funding from NIH previously?
The NIH Grants Conference is a wonderful opportunity to learn more about the NIH grants process and policies. You can view slides, videos, transcripts and other information from the 2023 conference.
You might start with the following sessions:
NHGRI funds the Center for ELSI Resources and Analysis (CERA) which developed an electronic platform called ELSIhub to enhance the production, sharing, and use of ELSI research. As part of ELSIhub, TraineeHub provides a central location for networking and resources for trainees and early career scholars in ELSI research.​​​​​​ View the recorded sessions about applying for NIH funding held by ELSIHub and TraineeHub.
Review sample ELSI grant applications and corresponding summary statements.
Please be sure to reach out to a program officer early in your thought process to discuss your interests and goals.
Funding Priorities
Are there special funding considerations for the Office of Research on Women’s Health (ORWH)?
Yes. The ORWH does not fund applications independently but does provide co-funding for meritorious applications in collaboration with other Institutes and Centers. ORWH will consider co-funding applications that meet the research interests of both ORWH and one of the other participating Institutes or Centers. The same is also true of the Office of Behavioral and Social Science Research (OBSSR).
What percentage of projects are funded for the R01, R21, and R03, respectively?
The number and types of grants awarded vary year to year. Applicants should consider which mechanism is most appropriate for the size and scope of their projects. If you have questions about which mechanism is best for your project, please contact a program officer.
Foreign Applicants
As a domestic institution, am I able to propose a foreign or international organization as a partner?
Yes. Applicants may propose foreign organizations as partners or collaborators in their applications, including co-investigators from foreign or international institutions.
NIH held a comprehensive webinar titled, International Collaborations: Policies, Processes, & Partnerships. The webinar site contains the recording, transcript and slides. Applicants proposing foreign components are encouraged to start early to complete the registration process.
What can foreign and international organizations do to be successful in obtaining an ELSI grant?
All applicants, including applicants from domestic, foreign and international organizations, must submit a competitive application to receive NIH funding. When applying for a research grant, applicants need demonstrable expertise in the disciplines, fields and methods tied to the proposed project. Foreign applications are reviewed alongside all other applications in the appropriate study section, as determined by the Center for Scientific Review (CSR)
Learn more about CSR and study sections.
In addition to all the review criteria listed in the NOFO, NIH will consider whether foreign applications:
- are relevant to the mission of the Institute you are seeking funding from;
- offer an opportunity not readily available in the U.S., such as unusual talent, resources, populations or environments, or if the application augments existing resources;
- have the potential to advance health science in the U.S.; and
- follow human subject, animal welfare, and inclusion requirements.
The following archived webinar materials offering additional guidance in this area are available:
- International Collaborations: Policies, Processes & Partnerships
- Grant Writing for Success: Preparing a NIH Grant Application: Webinar by the Consortium of Universities for Global Health (CUGH)
Is partnership with researchers and institutes from specific countries a mandatory requirement?
No. Applicants are not required to involve or collaborate with investigators or organizations from any country.
What are the requirements for applying as a foreign applicant from a middle-income country?
The ELSI Program Announcements do not have specific requirements related to the submission of applications from low- or middle-income countries (LMIC). You should follow requirements for foreign and international organizations as appear in NIH grants policy.
For more information, see NIH Grants Policy Statement Chapter 16 Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components.
Also be sure to review NIH Application Submission Tips for International Applicants, which provide helpful information regarding registration with Grants.gov and NIH’s eRA Commons systems.
Registration alone can take six weeks or more, so be sure to plan ahead.
Application Requirements
If you do not plan to analyze sex or gender in your proposed project, do you still need to complete a "Planned Enrollment Table?"
Yes. To adhere to NIH Inclusion Policies for Research Involving Human Subjects, planned enrollment tables are required for all grant applications involving human subjects. Collecting the data required to report actual study enrollment in the NIH enrollment tables does not mean you have to use those data in your analyses. Applicants are not required to include in their scientific analyses any variable that is required for NIH inclusion enrollment reporting, unless proposing a clinical trial.
Lear more about human subjects reporting in Clinical Trials, particularly Questions 1-4.
Learn more on NIH Inclusion Policies for Research Involving Human Subjects.
Is there a link to information on population descriptors? This is very highly politicized, and sometimes reviewers and participant populations differ in their preferred language (e.g., LatinX). Guidance would be very welcome.
NHGRI has released an explainer with more details on the Use of Population Descriptors in Genomics. The explainer provides a thorough overview of population descriptors, their relationship to genomics, their use in society over the last few decades, and the importance of using these population descriptors thoughtfully in genomics research and health. The explainer also includes numerous references and links to further reading. The explainer does not offer specific language or terms to be used in research.
When submitting an R01 or an R21 application, the NOFOs require that applicants name and define population descriptors used in proposed analyses (if any), provide a rationale for their use, and note any associated limitations. Please note, applicants are not required to include in their scientific analyses any variable that is required for NIH inclusion enrollment reporting.
Are there any requirements for team science?
No. There are no specific requirements pertaining to team science in the ELSI funding opportunities. The research application should include the subject matter and methodological expertise needed to carry out the proposed study Aims.
Is preliminary data required for an R01?
While preliminary data is not explicitly required for an ELSI R01 application it is generally expected. The lack of preliminary data may negatively impact your overall score in peer review.
Before the grant review, how can we ensure that the Data Management and Sharing Plan (DMSP) we've drafted is accurate and acceptable? It appears that this is crucial to prevent any issues during the grant review and acceptance process. Will there be chance to revise it?
DMSPs submitted with your application are not considered in peer review and are not considered final. DMSPs will be reviewed administratively by program staff. If a DMSP is considered inadequate or unacceptable, the assigned program officer will contact the investigator to discuss concerns. Investigators will be asked to submit a revised plan responsive to program officer feedback. An acceptable DMSP must be submitted before a Notice of Award is released. Over the course of a funded project, investigators may need to submit an updated plan to address new or additional information received that may impact informed consent, study design or implementation, or data collection.
Learn more about the assessment of DMS Plans.
Selecting the Right Funding Opportunity
Do I need a professor to work with me for this funding?
There is no specific requirement for who is proposed as an investigator on a grant; however, during peer review, reviewers will assess whether the principal investigator, collaborators, and other researchers are well suited for the proposed project. If the applicant is in an early career stage, then the reviewers will consider whether they have the appropriate experience and training.
Learn more about peer review.
Can an individual researcher apply for two different funding opportunities (say R01 and R03) within the same funding call?
Yes, you can apply for two different funding opportunities at the same time as long as the two applications are scientifically distinct. NIH does not allow scientific overlap, meaning you cannot propose the same research in more than one application pending review or submit the same application to two or more funding sources. Specifically, two applications with highly overlapping aims cannot be under review at the same time, even if:
- they are for different activity codes (e.g., R01 and R21), or
- they are submitted to different funding opportunities, or
- one application was submitted before the other but is still under NIH review at the time the overlapping application is submitted.
Learn more about overlapping applications
How do I select a funding opportunity for my project?
A variety of factors can impact which funding opportunity is best for an applicant or for a particular project. We encourage all applicants to reach out to one of the scientific contacts in the NOFO early in your thought process.
Some of the factors that are important to consider when selecting a funding opportunity include the scope and scale of the proposed project, whether and how it builds upon prior scholarship in the area, your prior funding history, research interests, and short- and long-term goals, other NIH funding opportunities available at the time of application, whether an Institute that may be interested in your work is list
Scope of Project
Can STEM education components be incorporated in the R01 or R21 applications or would this fall under a different area?
Maybe. These three ELSI funding opportunities are for research grants. If the project is for applied research and relates to both ELSI and genomics, then a STEM education component may be acceptable. Please contact one of the program officers listed under Scientific/Research contacts prior to application to make sure your research project is a good fit.
If an R01 proposal is primarily going to consist of secondary data analysis and ethical, social, and legal analysis, what sort of preliminary data are expected?
Preliminary data for projects with secondary analysis can include key features of the data set, descriptive statistics for variables of interest, discussion of data cleaning efforts, anticipated modifications to the data set, results from other analyses using similar data sets, or other efforts to demonstrate familiarity with the dataset, suitability of data for the proposed research questions or analyses, and feasibility of using the data as proposed in the timeline. Applicants may also want to demonstrate that they have access or approval to the secondary data that is proposed for analysis.
Changes in NOFOs
In general, how do these NOFOs differ from the previous versions?
There are several key differences in the current PARs when compared to previous versions. For all three PARs, you must submit a Data Management and Sharing Plan, per NIH policy. All applications must have a Data Management and Sharing Plan regardless of your approach. In addition, all three PARs encourage community involvement, where appropriate. Community involvement is not required but encouraged.
For the R01 and the R21, if you propose a project that will use population descriptors in analysis, then you are asked to describe the population descriptors you are using and a rationale for their use. There are specific review criteria pertaining to population descriptors that appear in Section V of the Notice of Funding Opportunity, under Approach.
For the R01 only, you must submit a Plan for Enhancing Diverse Perspectives. Your application will not be reviewed if it does not include a PEDP.
Finally, for applicants submitting R01 grants to NHGRI, if you want to request a 5-year project period, you must have a strong justification and discuss your proposal with a program officer before you submit your application.
Last updated: January 18, 2024