Frequently Asked Questions for the Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging
This page covers FAQs about three separate, but interrelated funding opportunities related to the Edward R. Roybal Centers:
- RFA-AG-24-006: Roybal Centers for Translational Research on Aging (P30 Clinical Trial Required)
- RFA-AG-24-007: Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, and Prevention of Alzheimer’s Disease and Related Dementias (AD/ADRD) (P30 Clinical Trial Required).
- RFA-AG-24-008: Edward R. Roybal Coordinating Center (R24 - Clinical Trial Not Allowed).
Browse FAQs by section:
General Information
Q: What are the Roybal Centers?
A: The Edward R. Roybal Centers refer to three separate but interrelated components:
- RFA-AG-24-006: This RFA is for P30 Centers that focus on the development of behavioral interventions that improve the health and well-being of people as they age.
- RFA-AG-24-007: This RFA is for P30 Centers that focus on the development of behavioral interventions that improve the health, well-being, and/or capacity of persons living with dementia and individuals and/or systems that provide care to persons with Alzheimer’s disease and related dementias (AD/ADRD), as well as behavioral interventions to help prevent or delay cognitive decline and AD/ADRD.
- RFA-AG-24-008: This RFA is for an R24 Coordinating Center that will serve as the hub for the Roybal Center grant program.
Q: What is the main goal of the Roybal Centers?
A: The overall goal of the Roybal Centers is to conduct foundational research to develop potent and scalable principle-defined behavioral interventions, programs, or practices that promote healthy aging at the individual, group, systems, institutional, or population level. Roybal Centers offer research infrastructure organized in accordance with the NIH Stage Model to provide the necessary scientific expertise and resources to conduct clinical trials at Stages 0, I, II, III, IV, and/or V of the translational behavioral intervention development pipeline.
Q: What is the NIH Stage Model?
A: The NIH Stage Model is a conceptual framework for behavioral intervention development that supports the development of potent and scalable behavioral interventions that are defined by their principles. Learn more about the NIH Stage Model.
Q: Who should I contact if I have further questions?
A: Investigators are highly encouraged to contact Dr. Onken during the planning stages of an application.
Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: lisa.onken@nih.gov
For Financial or Grants Management issues, please contact:
Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: ryan.blakeney@nih.gov
For questions regarding Peer Review, please contact:
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: ramesh.vemuri@nih.gov
Q: What is the difference between the three separate, but interrelated RFAs?
A: Brief explanations of each RFA are below:
- RFA-AG-24-006 invites P30 Core Center Grant applications for Roybal Centers for Translational Research on Aging, which focus on conducting foundational research to develop potent and scalable principle-defined behavioral interventions, programs, or practices that promote healthy aging at the individual, group, systems, institutional, or population level.
- RFA-AG-24-007 invites P30 Core Center Grant applications for Roybal Centers for Translational Behavioral Research on Dementia Care, Caregiver Support, and Prevention of Alzheimer’s Disease and Related Dementias (AD/ADRD), which focus on developing behavioral interventions that improve the health, well-being, and/or capacity of persons living with dementia and individuals and/or systems that provide care to persons with AD/ADRD, as well as developing behavioral interventions to help prevent or delay cognitive decline and AD/ADRD.
- RFA-AG-24-008 invites applications to establish a Roybal Center Coordinating Center, serving the needs of the Roybal Centers for Translational Research on Aging as well as the AD/ADRD Roybal Centers, to facilitate and coordinate trans-Roybal activities, foster collaboration, highlight and disseminate significant Roybal Center Program research and findings, establish procedures for ongoing evaluation of program processes, and create and maintain a database of Roybal Program activities and accomplishments to facilitate NIA’s evaluation of Roybal Center progress and products.
Q: What is the difference between the "Overall" Core and the other two Cores?
A: There is no "Overall Core." There is an "Overall Component," and there are two Cores: 1) The Administrative Core and 2) The Behavioral Intervention Development Core. Instructions for describing the Overall Component can be found in the RFA.
Component | Component Type for Submission | Page Limit | Required/ Optional | Minimum | Maximum |
---|---|---|---|---|---|
Overall | Overall | 12 | Required | 1 | 1 |
Admin Core | Admin Core | 6 | Required | 1 | 1 |
Behavioral Intervention Development Core | BID Core | 12 | Required | 1 | 1 |
Q: What kind of relationship should the Centers have with one another?
A: Collaboration among Roybal Centers is encouraged, to improve the quality of the science and the rigor of the study, to maximize generalizability and power, and to complete trials more expeditiously. Roybal Centers are expected to collaborate with and participate in meetings and calls facilitated by the Roybal Coordinating Center. Roybal Centers also must cooperate and collaborate with other centers under the purview of the Roybal Coordinating Center in 1) promoting diversity, equity, inclusion, and accessibility in the workforce supported by Roybal; 2) sharing of Roybal information; and 3) identifying and using common metrics and processes to inform future Roybal program evaluations by NIA.
Q: Can a Roybal Center faculty or staff member (with supported time in the administrative or overall budget) also receive effort as part of one of the proposed clinical trials?
A: Yes, a Roybal Center faculty or staff also can receive effort as part of one of the proposed clinical trials. Personnel can have an administrative role and also a role in a clinical trial.
Q: Can a Roybal Center application focus on arts-based interventions?
A: Yes, arts-based (e.g., music, painting, sculpting) interventions can be proposed in an application. Of course, all other criteria required by the request for applications must also be included, and all Non-Responsiveness Criteria must be addressed.
Q: Do trial timelines have to be restricted up to a year?
A: There is no one-year timeline required. The RFA states: "While clinical trials may be proposed for any duration within the grant funding period, it is expected that most will be proposed for and completed within 1-3 years."
Q: I am concerned about having power to test a full mediation model in 1-2 years. How essential is it to be sufficiently powered to test all mechanism pathways? How essential is it to test all mechanisms if we are proposing them?
A: Applications that do not state and propose to test, within their Specific Aims, hypotheses regarding the mechanism of behavior change of interventions for each of the clinical trials proposed, will be considered non-responsive and not reviewed. The RFA indicates that applications must describe two clinical trials with Stage of research defined, stating the hypothesized mechanism of behavior change (MoBC), and fully powered to test the MoBC. The RFA also requires that applicants explain how mechanism of action or principles will be tested in the clinical trial. However, the RFA does not require that all mechanisms or all mechanism pathways be tested.
Q: My research focuses on interventions that have multiple components. Will hypotheses about the essential components/ingredients of interventions be considered as hypotheses about mechanisms of behavior change?
A: The RFA states: "For interventions with multiple components, testing should seek to determine the essential components or "ingredients" of behavioral interventions." Hypotheses regarding the essential components or "ingredients" of behavioral interventions is often needed to understand the mechanisms of behavior change of an intervention and may therefore be considered as hypotheses about mechanisms of behavior change.
Q: The Roybal RFAs encourage collaboration with other NIA centers, but some of those centers have very different timelines for reviewing proposals. In our Roybal application, how do you recommend dealing with collaborations with other NIA centers?
A: For current Roybal Centers, there is an opportunity to highlight successful collaborations, but for new or renewal applications, we recommend that you do you propose anything you cannot be guaranteed, including collaborations with other centers who may not receive funding. As always, be sure to address all review criteria stated in the RFA, and specific to this question, review criteria related to collaborators.
Q: "External Advisory Committee" is not defined within the RFA. Can this committee include external and internal members?
A: The applicant may propose who sits on the External Advisory Committee, including how conflicts of interest will be handled. It is incumbent upon the applicant to justify their proposal.
Application Deadlines, Process, and Renewals
Q: When are applications due?
A: There is a single receipt date: June 23, 2023.
- All applications are due by 5 p.m. local time of applicant organization.
- Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
- No late applications will be accepted.
Q: Are letters of intent required? When are they due?
A: Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By May 23, 2023, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the program directors(s)/principal investigators(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: lisa.onken@nih.gov
Q: Can one institution submit multiple applications?
A: Yes. An institution may submit more than one application, as long as they are scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Q: How should renewal applications report progress?
A: Renewal applications must include descriptions of successful behavioral intervention development activities during the previous funding period since the last competitive review only and may not include activities during the years prior to the previous funding period, before the last competitive review, as part of the progress report. Progress reports must fit into the Approach section of the Research Strategy within the prescribed page limits. Renewal applications must also justify continued funding of existing translation activities, in line with one or more of the focal priorities of this funding opportunity announcement.
Q: Is it possible to get more guidance on the national competition? Is there a structure or timing expected?
A: The RFA describes the requirements. Please note that while there is ample flexibility under the RFA, it is incumbent upon the applicant to provide an adequate justification and rationale for their proposal for how to organize and hold a national competition for trials.
Q: If a current Roybal Center that was funded under RFA-AG-19-006 (non-AD) wants to build upon what they've done, but wants to propose a theme that builds upon the science they've already conducted, but also consistent with the goals of RFA-AG-24-007 (AD) can they submit a renewal application in response to RFA-AG-24-007 (AD)?
A: Yes. Since the activity code is the same and the Notice of Funding Opportunity (NOFO) allows renewals and does not limit renewals to a specific NOFO, they can submit a renewal application to RFA-AG-24-007. As always, the PIs should take note of all review criteria specific to the NOFO to which they are applying.
Questions about RFA-AG-24-006 and RFA-AG-24-007 (Roybal P30 Centers)
Q: What is the structure of a Roybal P30 Center? What are the required components, and which component is the largest?
A: Centers (i.e., Roybals and AD/ADRD Roybals) are required to include the following Core components:(1) an Administrative Core and (2) a Behavioral Intervention Development Core (BID). In order to ensure adequately powered clinical trials, to seed several lines of research in the thematic area of focus, and to support all necessary clinical trials, applications must allocate a minimum of two-thirds of their Direct Cost budget to the BID
Q: What are the Non-Responsiveness Criteria for RFA-AG-24-006?
A: The following types of applications will be considered non-responsive to this funding opportunity announcement and will not be reviewed:
- Applications that do not have a primary focus on behavioral and/or social intervention development.
- Applications without goals to improve the health and well-being of individuals as they age.
- Applications that do not specify, within their Specific Aims, the Stage of research, as defined by the NIH Stage Model for each of the two clinical trials proposed.
- Applications that do not state and propose to test, within their Specific Aims, hypotheses regarding the mechanism of behavior change of interventions for each of the clinical trials proposed.
- Applications that do not address issues of statistical power for proposed clinical trials.
- Applications that do not allocate a minimum of two-thirds of their direct cost budget to the Behavioral Intervention Development Core, in each year.
Q: What are the Non-Responsiveness Criteria for RFA-AG-24-007?
A: The following types of applications will be considered non-responsive to this funding opportunity announcement and will not be reviewed:
- Applications that do not have a primary focus on behavioral and/or social intervention development.
- Applications without goals to improve the health and well-being of people living with dementia and/or their care providers, or without a focus on behavioral and/or social interventions to prevent or delay cognitive decline and/or Alzheimer’s disease and related dementias.
- Applications that do not specify, within their Specific Aims, the Stage of research, as defined by the NIH Stage Model, for each of the two clinical trials proposed.
- Applications that do not state and propose to test, within their Specific Aims, hypotheses regarding the mechanism of behavior change of interventions for each of the clinical trials proposed.
- Applications that do not address issues of statistical power for proposed clinical trials.
- Applications that do not allocate a minimum of two-thirds of their direct cost budget to the Behavioral Intervention Development Core, in each year.
Q: Are applications under RFA-AG-24-007 required to focus on developing behavioral interventions that improve the health, well-being, and/or capacity of persons living with dementia (PLWD) and individuals and/or systems that provide care to persons with Alzheimer’s Disease and Related Dementias (AD/ADRD), AND developing behavioral interventions to help prevent or delay cognitive decline and AD/ADRD?
A: No. Applications under RFA-AG-24-007 are required to focus EITHER on developing behavioral interventions that improve the health, well-being, and/or capacity of PLWD and individuals and/or systems that provide care to persons with AD/ADRD, OR developing behavioral interventions to help prevent or delay cognitive decline and AD/ADRD.
Q: How much money should be allocated to funding clinical trials?
A: Each Roybal Center application must request funds to initiate clinical trials that are consistent with the theme of the Center grant. In order to ensure adequately powered clinical trials, to seed several lines of research in the thematic area of focus, and to support all necessary clinical trials, applications must allocate a minimum of two-thirds of their Direct Cost budget to the Behavioral Intervention Development Core (BID). This applies to the initial budget period, and this also applies to the Direct Cost budget for the BID, in each year.
Q: Does one of the clinical trials proposed have to be led by an investigator outside of our home institution?
A: No. Neither of the two clinical trials in the initial application are required to be led by an investigator outside of your home institution. However, as the RFA indicates, "Each Center must include a combination of investigators from within the Roybal institution(s) and from outside the institution." In addition, once established, the RFA indicates that Roybal Centers must conduct a national competition for clinical trials.
Q: Do the two clinical trials proposed have to be of the same size and duration (in other words, can we commit, say $300k to one in each of the first two years and $200k to the other for just one year)?
A: No. Clinical trials should be designed to test specific hypotheses, so clinical trials should be proposed for the size and duration required to test these hypotheses. As the RFA indicates, "While clinical trials may be proposed for any duration within the grant funding period, it is expected that most will be proposed for and completed within 1-3 years. Collaboration is encouraged, to improve the quality of the science and rigor of the study, to maximize generalizability and power, and to complete trials more expeditiously."
Q: Does a Stage I clinical trial need less power than a Stage II or Stage III clinical trial?
A: No. RFA-AG-24-006 and RFA-AG-24-007 both say, "All clinical trials must have adequate statistical power to test mechanism of behavior change and/or efficacy of the intervention. This includes Stage I "pilot" testing studies that include a specific aim to test the efficacy of an intervention, or the mechanism of behavior change of an intervention."
Q: For the two trials being proposed in my application to begin in Year 1, is the expectation that data collection be completed, or just initiated in year 1?
A: Initiated. The RFAs say:
- “Describe two clinical trials with Stage of research defined, stating the hypothesized MoBC and fully powered to test the MoBC, proposed for Year 1.”
- “For Year 2 and thereafter of the Roybal (after Year 1), propose and justify an anticipated pathway, through the Stages of the NIH Stage Model, of the two interventions proposed to begin in Year 1.”
- “While clinical trials may be proposed for any duration within the grant funding period, it is expected that most will be proposed for and completed within 1-3 years.”
Q: Will NOGA occur prior to IRB approval for these studies?
A: The RFA states, “Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC.” NOGAs are issued through the NIA Grants Management Office, in accordance with NIH policies. The Earliest Start Date is April 2024.
Q: Is the protocol that is reviewed by the IRB the same as the clinical trial protocol?
A: The protocol that is required by an IRB typically differs from the clinical trial protocol that describes research testing a behavioral or social intervention. Using the standardized BSSR Protocol Word Template, identifying the Stage of the NIH Stage Model, can be helpful and is encouraged but not required.
Q: For the competition trials, is the expectation that our Roybal center staff submit the monthly CROMS updates?
A: Yes. The RFAs state: “It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of CROMS data templates as specified,” and “ The Administrative Core is responsible for ensuring the accurate reporting of the progress of all clinical trials funded by the Roybal Center, and is responsible for ensuring that the written progress is consistent with the HSS Inclusion/Enrollment tables, with NIA’s Clinical Research Operations & Management System (CROMS), and with clinicaltrials.gov.”
Questions about RFA-AG-24-008 (Roybal Coordinating Center)
Q: What is the purpose of the Coordinating Center (CC)?
A: The Roybal CC is intended to serve as a hub and provide support for all Roybal Centers funded under RFA-AG-24-006 and RFA-AG-24-007 by reinforcing the goals of the NIH Stage Model and facilitating and coordinating trans-Roybal activities.
The Roybal CC will support the individual Roybal Centers by performing the following necessary functions:
- Administration: The CC will provide centralized administrative support across the distributed set of Roybal and AD/ADRD Roybal Centers.
- Coordination: The CC will create mechanisms for maintaining active involvement for all sites in all aspects of the program.
- Training: The CC will support education/training activities to foster rigorous, mechanism-focused intervention development science in accordance with the NIH Stage Model.
- Dissemination: The CC will be proactive in establishing a mechanism for informing and making visible scientific advances of Roybal scientists to the research community, policymakers, and other relevant stakeholders.
Eligibility
Q: Can a Roybal Center have more than one Principal Investigator? Should there be more than one?
A: Yes; however, the applicant organization must designate one of the program directors/principal investigators (PD/PI) as the Contact PD/PI to serve as a primary point of contact. As stated in section 9 Multiple Program Director/Principal Investigator Applications and Awards of the NIH Grants Policy Statement under “9.3 Application Requirements”:
“The decision to submit a multiple PD/PI application is that of the applicant organization and the PD/PIs, and should be consistent with the scientific goals of the project. A single applicant organization may designate multiple PD/PIs from the applicant organization or may designate multiple PD/PIs from multiple institutions. Multiple organizations may not submit the same multiple PD/PI application.”
Q: Can the PI of a Roybal Center also be PI on the Administrative and the Behavioral Intervention Development Core?
A: Yes.
Q: Can a Project PI have their time included in their proposed trial?
A: Yes.
Funding & Budget
Q: How many Centers will be funded in FY2024?
A: NIA intends to commit $10 million to fund 8-10 AD/ADRD Roybal Centers, $6.5 million to fund 5-7 Translational Roybal Centers, and $750,000 to fund one Roybal Coordinating Center.
Q: Are there application budget limits?
A: Yes. For RFA-AG-24-006 (Translational Roybals) and RFA-AG-24-007 (AD/ADRD Roybals) application budgets are limited to $750,000 in direct costs per year. For RFA-AG-24-008 (Roybal Coordinating Center), there is a total cost limit of $750,000 per year and it needs to reflect the actual needs of the proposed project.
Q: Are the salaries of the team members associated with the BID core included in the calculation of the 2/3 share or does the total 2/3s have to be spent only on the supported clinical trials?
A: When conducting administrative activities, such as monitoring the progress of a clinical trial, the salaries of the team members associated with the Behavioral Intervention Development (BID) core cannot be calculated in the 2/3 share of the BID core and must be included in the Administrative Core. However, when serving as the PI of a clinical trial, or serving in activities directly relating to conducting a specific clinical trial, then this part of the salary of a team member can be included in the 2/3 share of the BID core. In the budget justification of the applications, it is expected that there will be a clear description of how the 2/3 for the BID core is calculated.
Q: Do applicants to RFA-AG-24-006 and RFA-AG-24-007 need to budget for Data and Safety Monitoring Boards for their clinical trials?
A: No. The RFA for the Coordinating Center (RFA-AG-24-008) is required to support a standing Data & Safety Monitoring Board (DSMB) to serve all Roybal Centers.