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Pre-Application Information for RFA-AG-20-026: A Collaborative Network to Optimize Emergency Care of Older Adults with Alzheimer’s Disease and Related Dementias (AD/ADRD) (R61/R33 Clinical Trials Optional)

The information on this site is meant to compliment and further detail that found in RFA-AG-026 (R61/R33) and will be updated intermittently until the due date for submission on February 3, 2020.

The goal of this RFA is to enhance collaboration between the research communities with expertise in Alzheimer’s Disease/Alzheimer’s Disease Related Dementias (AD/ADRD) and Geriatric Emergency Medicine (GEM) to develop a network to optimize the recognition and care of older adults with AD/ADRD. This mechanism is offered to create a transdisciplinary network with areas of expertise (assessment tools, clinical measures, biostatistics, research coordination, etc), the sum of which is greater than its parts and may be sustainable beyond the initial period of funding with additional resources from investigator initiated grants employing the network.

Research Centers, Networks and Resources

The following list include some, but not all, of resources of expertise in AD/ADRD and Geriatric Emergency Medicine:

Frequently Asked Questions

Please check this site periodically, as additional questions and answers may be posted.

Questions Related to the R61/R33 Phased Award Mechanism

What is an R61 and how is it different from an R21?

The R61/R33 Phased Development/Implementation mechanism is similar to the R21/R33 mechanism but the R61 code is used for the Phase 1 aspect when larger budgets and/or project periods are required to establish feasibility for the project. Thus, similar to the R21 Developmental Phase, the R61 can support activities to develop the network, provide support for meeting(s) to refine aspects of network integration/communication, and identify/refine priorities and goals of the network. Milestones reflect Phase 1 achievements must be stated, each with a clear, measurable demarcation of attainment. The Phase 1 R61 may be 1-2 years and the TOTAL costs (direct plus indirect costs) may not exceed $1,500,000/yr. The Phase 2 (R33) may be 3-4 yr and the TOTAL costs (direct plus indirect costs) may not exceed $1,500,000/yr.

How does the R61 transition to the R33?

Prior to the end of the R61 phase, awardees will submit a package that requests transition to the R33 phase. This package will include a progress report that describes accomplishments toward each of the R61 milestones and plans for studies during the R33 phase. This package will be reviewed by NIA program staff and, if approved, the grant will be transitioned to an R33 award without the need to submit a new grant application. Decisions on transitioning to the R33 phase will be based on the peer review recommendations of the original application, successful completion of the described milestones, NIA program priorities, and availability of funds.

How should I write the R33 aims if I do not know what I will find in the R61 phase?

The aims of the R33 portion of the application should be based on an expectation that the aims of the R61 Planning/Development Phase will be achieved. As noted in the RFA, achievement of the R61 aims should be reflected by specific milestones, and NIA program staff will determine whether the milestones have been achieved sufficiently to allow transition to the R33 Implementation Phase.

As an R61/R33 awardee, what happens if I do not complete the R61 phase before the scheduled end of the award period?

Awardees are encouraged to complete each phase during its expected award period. In certain cases, delays may cause a project to extend beyond the award period. Remedies are often available in such cases, and awardees can work with program staff to resolve the issues.

If we are proposing a multi-institutional collaboration, does the Principal Investigator have to be affiliated with the applicant organization?

Yes. NIH policy requires that the Principal Investigator, or at least one of the Principal Investigators in a multi-PD/PI arrangement, be affiliated with the applicant organization (the organization that receives the primary award). The applicant organization must have a leading role in the project, and not simply a conduit of funds to other organizations.

To what extent should the different activities be integrated with each other?

The overarching goal of this RFA, reflected in its title, is to create a “collaborative network” to optimize emergency care of older adults with AD/ADRD. Thus, the sum of the established network parts should exceed their individual areas of expertise. The network components should be well-integrated with a clearly articulated plan for network oversight, problem solving, quality control and maximal efficiency and productivity. Integration is part of the review criteria and will be an important consideration for selecting the awardee. It is expected that the network established through this RFA will continue to exist beyond the 5-year funding period through other investigator-initiated awards.

Questions Related to Budget

What budget format should be used for an R61/R33 application?

A full budget format (i.e., not modular) should be used for both phases of an R61/R33 application

Can unspent funds from the R61 phase carry over into the R33 phase?

No, the R61 and R33 phases are two separate awards. All funds from the R61 should be spent down before the R33 phase begins.

If a conference/workshop is proposed in this application, do the funds from this RFA cover the cost of meals during the conference?

Grant funds may be used for meals with appropriate justification and consistent with the NIH Grants Policy Statement under “Meals”:

When certain meals are an integral and necessary part of a meeting or conference (i.e., a working meal where business is transacted), grant funds may be used for such meals only when consistent with terms of award.

The cost of meals served at a meeting or conference, for which the primary purpose is the dissemination of technical information, is no longer allowable on NIH grants where the primary purpose of the grant is to support a conference or meeting (see also Support of Scientific Meetings (Conference Grants) Section 14.10.1). However, when such a meeting/conference is an ancillary effort under a grant where the primary purpose is other than to support such a meeting/conference, then the cost of meals would be allowable. When allowable as a direct charge, the cost of any meal must meet a test of reasonableness. However, recurring business meetings, such as staff meetings, should not be broadly considered as meetings for the primary purpose of disseminating technical information in order to justify charging meals or refreshment costs to grants.

Is this RFA subject to the NIH salary cap limitations?

Yes.

Is co-funding from other sources allowed?

Yes, leveraging funds from other sources is allowed and could potentially strengthen your application. It should be made clear in your application which proposed activities will be funded by the R61/R33 award and which activities will be supported through other means. The budget in your application should reflect only those activities that will be supported through R61/R33 funds.

General Questions

Should applications focus only on Alzheimer’s dementia and AD related dementia?

The NIA recognizes that the spectrum from mild cognitive impairment (MCI) to dementia varies clinically and temporally. Moreover, MCI may result in different types of dementia (AD, Lewy Body, frontotemporal and vascular) which are challenging to diagnose prospectively. Thus, responsive applications to this RFA must focus on persons with cognitive impairment (MCI to dementia), whether it is diagnosed and undiagnosed. Patients who have been diagnosed with MCI or dementia who are unaware of their diagnosis, and who present to the ED alone, or without an accompanying person who can verify their cognitive impairment, are a particular focus of this RFA given their vulnerability in this setting.

What stages of care should an application address?

The overarching goal of this RFA is to improve recognition of cognitive impairment in persons presenting to the ED to improve care, diagnoses, disposition and safety. Additionally, applications are welcomed that focus on improving the care and/or disposition of persons with MCI or dementia, including pre-hospital care (paramedicine), which may provide an alternative to an ED visit. Applications are encouraged that address a range of care (paramedicine through disposition/discharge), and applications that address seamless integration of multiple steps in the emergency care process for persons with dementia are highly encouraged.

The RFA has a “Clinical Trial Optional” designation. What does that mean?

We have included the “Clinical Trial Optional” designation so that clinical trials can be accommodated as pilot projects if desired. Applicants may not know which pilot projects will be funded throughout the 5-year duration of the award, so the option of clinical trials is left open. Note: We do not envision that the main focus of this award will be on one or more large clinical trials.

Are collaborations with NIH intramural scientists allowed?

Yes. See the NIA Intramural Research Program for more information about NIA’s intramural scientists. Also, refer to the NIH grants policy statement for allowable and unallowable costs for Federal employees.

Can the same investigator(s) be included in more than one application?

Yes, in keeping with the collaborative intention behind this RFA, the same investigator(s) may be involved in multiple applications.

Where do letters of support belong?

Letters of support have their own section in the application and should be included there.

What materials may be included in the appendix?

NOT-OD-18-026 is the latest Notice describing allowable appendix materials.