FAQs for the Roybal Center RFAs

Questions related to RFA-AG-19-006, RFA-AG-19-007, RFA-AG-19-008

Question: RFA-AG-19-006 and RFA-AG-19-007 say that application budgets are limited to $500,000 in first-year direct costs (for Management and Administrative Core and Pilot Core), but out-years are not specified.

Answer: Out-year caps are the same as the first-year caps. Application budgets are limited to $500,000 in direct costs in the first year and in the out-years.

Question: In section IV.2 (Content and Form of Application Submission) in the instructions for the Overall Component and the instructions for the Pilot Core, there are directions under the Research Strategy Sections of each part to "Describe two Pilot Studies proposed for Year 1" and "For Year 2 and thereafter, propose and justify an anticipated pathway through the Stages of the NIH Stage Model, of the two interventions proposed to be studied in Year 1." Is it the case that the narrative is to be repeated in each component or is something else intended?

Answer: Regarding the description of pilots and pathways, the RFAs do not specify how the applicant must respond. Although technically, the narrative could be repeated, the two sections provide an opportunity for the applicant to provide complementary detail in one section, and other complementary detail in another section so only minimal redundancy may be necessary. For example, in the Pilot Core section, more specific details regarding the nature of the two pilot studies proposed can be provided, and relatively less detail may be provided on the proposed pathways for future pilots. In the Overall Component section, relatively more details regarding the proposed pathways for future pilots proposed can be provided, and relatively less detail may be provided on the nature of the two pilot studies.

Question: The instructions appear to indicate that in years 2 and beyond, pilots are expected to be of a year's duration. Am I reading this correctly?

Answer: The RFAs state: "While pilot projects may be proposed for one to three years' duration, it is expected that most will be funded for one year." So, while one-year pilots are expected, the RFA does not indicate that this is a requirement. In fact, the RFA indicates pilots may be proposed for one to three years, so two-year or even three-year pilots may be proposed. Of course, whatever is proposed must have a compelling rationale.

Question: Should there be study records for each project in the project (pilot) core or are the pilots considered delayed onset (since the projects require prior approval by NIH)?

Answer: Pilots may be considered delayed onset.

Question: Are separate bibliographies allowed? For example, if references are cited in any of the components, should they be listed in the bibliography attachment for the component in which they are referenced?

Answer: References cited are allowed for every core and component.

Question: In RFA-AG-19-008, does the bullet point under Research Objectives refer to two annual meetings or only one annual meeting?

Answer: The issue of annual meetings is addressed in a couple of places in RFA-AG-19-008.

"The Coordinating Center will provide logistical support to the individual Roybal Centers by performing the following necessary functions:

• Make arrangements for a yearly Roybal meeting where scientific advances are shared. In coordination with Roybal and AD-ADRD-Roybal PD/PIs and NIA program staff, the CC will create the agenda for and chair that meeting. The CC will set aside a portion of its funds to support the Annual Investigators' meeting.

The CC will be responsible for organizing and attending annual face-to-face meetings. These meetings are meant to facilitate coordination among Roybals, AD-Roybals, and any subcommittees in which they participate. The CC application budget should include funds for organizing the annual meeting and for travel of the CC PD(s)/PI(s) and key CC personnel to the meeting. The CC is not responsible for the travel of participants from individual Roybal and AD-Roybal sites."

"Research Strategy: Describe plans for accomplishing the following four objectives of the Roybal CC:

1. Working in collaboration with approximately 12-16 traditional Roybals and AD-ADRD-Roybals in order to facilitate and coordinate trans-Roybal activities including: providing logistical support to the Roybals and the NIA Program Officer to arrange a yearly Roybal meeting; developing and maintaining a database for collecting information from the Roybal Research Education Components on research advances from pilot projects and Roybal scholar progress; fostering communication and collaborative arrangements between Roybals and other NIA research Centers; and arranging for and hosting monthly PD/PI conference calls, as well as arranging for similar calls and support for the various Cores, as needed."

Please note that complementary language in the companion RFAs, RFA-AG-19-006 and RFA-AG-19-007, says:

"Funds should be set aside for annual travel to Center meetings. The meetings will be held at the NIH in Bethesda, MD, or at another site agreed to by the PD/PIs and the NIA. The purpose of the meetings is to have investigators working in the same general area share information about NIH Stage Model translational research methods and findings."

All of this language refers to one annual meeting per year.

Question: Does Form E need to be completed if a proposed pilot study is not a clinical trial?

Answer: RFA-AG-19-006 and RFA-AG-19-007 indicate, "P30 Clinical Trial Required." If an RFA indicates that clinical trials are required, applications in response to that RFA must propose clinical trials. Applications that don’t submit clinical trials under Clinical Trial Required funding opportunity announcements (FOAs) risk not being sent forward to peer review. To answer to the question, "Does your human subjects research study meet the NIH definition of a clinical trial?", please see the linked page.