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BBAER Pre-Application Webinar FAQ

Eligibility

 

Can a MPI be from a non-eligible institution?

Yes, an applicant may propose multiple principal investigators (MPI) and include an MPI from an organization that is not eligible to apply. The organization submitting the application will be considered the lead organization. The Contact PI must be affiliated with the applicant organization. PIs from collaborating organizations will be supported through subawards. Note, the total amount across all proposed subawards cannot exceed 40% of total direct costs.

 

Can organizations outside of the United States (foreign organizations) apply to this funding opportunity?

No, organizations outside the U.S. and its territories are not eligible to apply to the BBAER Program. Eligible applicants must be a domestic organization located in the United States and its territories that received less than $30 million per year for the past three fiscal years in total NIH funding.

 

Can subaward organizations be outside the United States? Can the projects be implemented outside the U.S.?

Yes, eligible applicant organizations may propose subawards to organizations outside the U.S. and its territories. However, subawards may not implement research capacity building activities under Element D. These activities must be implemented within the applicant organization. A foreign organization may assist the applicant organization as it works to build internal capacity, but BBAER funding may not be used to build research capacity within a foreign organization.

 

For any proposed partners, foreign or domestic, applicants should provide a rationale for the involvement of each collaborator with clearly described contributions, roles, and responsibilities. Applicants should include letters of support from proposed collaborators, if any.

 

Applicants considering subawards to organizations outside the U.S. or implementation of project activities outside of the U.S. must be familiar with NIH’s policies regarding “foreign component” as defined by the NIH Grants Policy Statement. Applicants may want to view the NIH webinar on International Collaborations: Policies, Processes, & Partnerships.

 

Applicants may contact Dr. Rene Sterling at Rene.Sterling@nih.gov with programmatic questions regarding foreign components. Applicants should contact Ms. Devon Bumbray-Quarles at devon.bumbray@nih.gov with financial or grants management questions regarding foreign components.

 

My organization received less than $30M per year in total NIH funding for the past three fiscal years and meets the eligibility criteria, but it is part of a larger system of organizations that does not meet the eligibility criteria. May I apply under my organization separate from the larger system?

To apply for funding under RFA-HG-24-026, the organization submitting the application must meet theeligibility criteria outlined in the Notice of Funding Opportunity and must be a registered entity within eRA Commons (see NIH Grants Policy Statement 2.2.1 eRA Commons Registration).

 

You will need to obtain authorization from the larger system to register with NIH as a separate entity and clear the registration process before you can apply for NIH funding.

 

All eligibility determinations are made regarding the applicant organization.

 

Registration in multiple systems is required to submit a grant application. Organizations that are not yet registered should allow six weeks in their application planning to complete all registrations. During the registration process, NIH may make a preliminary assessment of applicant organization eligibility.

 

For more information on how to determine an applicant organization, see NIH Grants Policy 2.5.3 Determining Applicant Organization Eligibility.

 

For more information on how to register your organization, see Grants and Funding: Register.

 

I missed the deadline to submit a letter of intent to apply. Can I still apply?

Yes, you can still apply even if you did not submit a letter of intent by the deadline. Furthermore, an organization may submit a letter of intent and ultimately decide not to apply. Letters of intent are not required and are not binding, but are very helpful for our internal planning. All applicants are encouraged to email Dr. Rene Sterling at rene.sterling@nih.gov at any time to express interest or discuss ideas.

 

Program Elements

 

What counts as a relevant community?

For purposes of the BBAER Program, “relevant communities” are defined as a group or groups of people who are 1) affiliated by geographic proximity, special interest, or similar situations, and 2) affected by and have interest in the research topics under study. Applicants must identify members from the relevant communities who will be represented as community experts on their research teams and discuss why their engagement is important given the proposed ELSI research projects.

 

With this definition, the group or groups who are members of a relevant community could vary widely across BBAER applications based on the research topics proposed for study.

 

Applicants should contact Dr. Rene Sterling at Rene.Sterling@nih.gov with any questions or concerns regarding the appropriateness of a relevant community.

 

Is there a preference for applications to have one large research project with multiple specific aims or multiple smaller research projects under one theme?

No, there is no preference for the number, size, or duration of projects proposed under Element B.

 

Applicants should think about which approach would best advance the applicant’s goal for developing an ELSI research agenda during the BBAER Program and maintaining or building upon that research agenda after funding for the BBAER Program ends.

 

Regardless of the number, proposed research projects must be transdisciplinary, integrating knowledge and approaches from different disciplines to generate new frameworks, hypotheses, theories, models, or methods that add novelty and nuance to ELSI scholarship. Proposed projects must require two or more academic disciplines or fields of knowledge, and multiple research approaches to fully address research questions of interest. Academic disciplines or fields of knowledge represented on research projects should help ensure various angles or perspectives on a topic can be interrogated.

 

Are eligible applicants expected to complete a needs assessment prior to application?

No. Eligible applicants are not expected to complete a needs assessment prior to applying for the BBAER Program. Applicants must submit a detailed and comprehensive plan for conducting a needs assessment that describes the structured approach, resources, and timelines required for implementation. Awarded BBAER Sites are expected to implement their needs assessments plan and submit a summary of findings to NHGRI within 12 months of the start of the federal award project period.

 

What should a needs assessment plan focus on?

The needs assessment plan is an opportunity for eligible organizations to think about their current capabilities and strengths, opportunities for their growth and development, and ways to increase their success in establishing and sustaining an ELSI research agenda. At the time of application, eligible organizations should have some idea of where they want to go, and the capacity needed to get there. A needs assessment plan may focus on a variety of areas, including, but not limited to, grants administration, research readiness, partnerships, staff recruitment and retention, and/or other areas relevant to developing and sustaining ELSI research. Needs assessment findings can help awarded applicants identify which capacity building efforts are likely to have the greatest impact.

Application Information

 

Does each Element require a separate attachment in the proposal? When aspects of our proposal overlap two or more elements, should we describe them only in one application attachment, or in each of the relevant Element attachments?

 

As outlined in the NOFO Section IV. Application and Submission Information, applicants must include the “PHS 398 Research Plan form.” The Research Plan form includes fields to upload several attachments, including the Specific Aims and Research Strategy. Applicants will provide narrative information for each of the five Elements A – E within the Research Strategy attachment. Each Element has a page limit, but only one Research Strategy is submitted. Use of Element headings and subheadings as they appear in the NOFO is recommended.

 

Narrative that is relevant to more than one Element may be cross-referenced and should not be repeated in full for each Element. Reminders of information presented under one Element may be mentioned with less detail under other Elements, as appropriate.

 

Please see all instructions in the How to Apply - Application Guide (R – Research Instructions) in addition to the specific instructions provided in the NOFO.

 

Can you please clarify if the organizational charts are or are not included in the 6-page limit for Element A?

No, the organizational charts are not included in the 6-page limit for Element A. Organizational charts should be included in the “Other Attachments” section using the file name “Organizational Chart” (without quotation marks). Both organizational charts should be included in a single file. Applicants should reference the organizational charts in the "Research Strategy" but should not repeat the information provided in the chart.

Partnerships

 

Can an applicant collaborate with any type of organizations?

Applicants may collaborate with a variety of organizations, groups, communities, or individuals across organization types or sectors (e.g., public, private, domestic, foreign, academic, industry, civic, community-based). Applicants should choose collaborators who would help accelerate goals, support implementation of activities, or add value to the applicant organization. The application should include letters of support from proposed collaborators, if any.

 

How can I find an eligible organization to collaborate with?

NHGRI funds the Center for ELSI Resources and Analysis (CERA) which created ELSIhub as an online resource for enhancing and promoting ELSI research, and connecting scholars interested in ELSI research. The ELSI Scholar Directory is a tool you could use to identify individual researchers who may have similar research interests. Feel free to contact ELSIhub for additional information
at info@elsihub.org.

 

What is an appropriate role for organizations that cannot apply but would like to support an eligible organization?

The role of any proposed collaborators is at the discretion of the applicant organization, and discussions regarding potential collaborations should be led by the applicant organization. Applicant organizations may propose collaborators to help accelerate BBAER Site goals or to support successful implementation of BBAER Site activities. If collaborators are proposed, then applicants should provide a rationale for the involvement of each collaborator with clearly described contributions, roles, and responsibilities. Note, the total amount across all proposed subawards cannot exceed 40% of total direct costs.

Grants/Financial Management

 

How do I budget for capacity building when I am not sure what I need?

Applicants are not expected to predict perfectly how they will spend a grant award three, four, or five years down the road. However, applicants are expected to provide a reasonable approximation of anticipated expenditures. Applicants should be detailed enough to convince the reviewers that they have a good sense of the overall costs for what is proposed in the application across all Elements.

 

When preparing the budget and budget justification, applicants should round to whole dollars, use only U.S. dollars, and identify all costs that are necessary and reasonable to complete the work described in your proposal. In review of your proposed aims and activities, reviewers will assess whether your budget request is justified and consider whether the level of effort you have assigned to each senior/key personnel is appropriate.
Applicants should contact Ms. Devon Bumbray-Quarles at devon.bumbray@nih.gov with questions regarding budgeting or allowable costs.

 

Can budgets include funds for the implementation of capacity building plans?

Yes, budgets may include funds for implementation of capacity building plans, to include activities designed to establish, enhance, and sustain ELSI research within the applicant organization. Applicants should consider sustainability when developing their research capacity building plans, including 1) the potential to leverage the research capacity established beyond the federal award project period and 2) the potential for long-term maintenance and evolution of an ELSI research agenda.

 

Applicants should provide a single budget for all proposed activities across Elements. Budget justifications must be delineated by Element. Subaward budgets should follow the same format. See Section IV.2 Content and Form of Application Submission, R&R Budget of the NOFO for more information regarding budget preparation.

 

Applicants should contact Dr. Rene Sterling at Rene.Sterling@nih.gov with questions regarding their overall approach for building research capacity or implementation of capacity building plans.

 

What is F&A? What should an applicant do if their institution has not negotiated an F&A rate?

Facilities and Administrative Costs or F&A are indirect costs that go to funded organizations to support overhead costs. To receive funding from the NIH, applicant organizations must negotiate an F&A rate with the NIH. Prior to negotiation, the applicant organization can accept a 10% “de minimus” rate or propose a rate that can be updated post-negotiation. iThe “de minimus” rate might be raised to 15% in October 2024 if revised guidance in Title 2 of the Code of Federal Regulations (CFR) is incorporated into NIH policy (see NOT-OD-24-069). The process to get started depends on the institution and from which cognizant agency the applicant receives the majority of their federal funds. If this program would be the first federally funded project for an applicant organization, NIH Grants Management will provide the necessary requirements for negotiating a rate via the Terms and Conditions (T&C) of award and will also initiate the process with the Department of Health and Human Services’ (HHS) negotiating office.

 

Applicants should contact Ms. Devon Bumbray-Quarles at devon.bumbray@nih.gov with any questions regarding F&A rates or negotiation.
For more information regarding F&A, see NIH Grants Policy Statement, Section 7.4 Reimbursement of Facilities and Administrative Costs.

 

Can Institutional Review Board (IRB) costs be included in budgets?

Per the NIH Grants Policy Statement, Section 7.9 Allowability of Costs/Activities, costs associated with IRB review of human research protocols, or Institutional Animal Care and Use Committee (IACUC) review of animal research protocols, are not allowable as direct charges to NIH-funded research unless such costs are not covered by the organization's F&A rate.

 

Where single IRB or sIRB requirements apply, costs incurred by the sIRB organization to review for the relying organizations may be allowed as direct costs.

 

Applicants should contact Ms. Devon Bumbray-Quarles at devon.bumbray@nih.gov with any questions regarding allowable costs.

Peer Review

 

Are Elements reviewed separately?

No, BBAER Elements will not be reviewed separately; each reviewer will read and evaluate the entire application. They are not considered distinct “cores” or “components.” The five Elements of the BBAER Program are interrelated and are not designed to be funded or implemented separately. The NOFO does include review criteria in Section V that align with each Element and peer reviewers will use each and every criterion to assess the entire application in full. Applicants will receive one overall impact score for the entire application and one set of written critiques.

Last updated: September 20, 2024