Promoting Research on Music and Health Technical Assistance Webinar
Friday, January 18, 2019
Purpose of the Webinar:
On Friday, January 18, 2019, the National Institutes of Health (NIH) National Center on Complementary and Integrative Health (NCCIH) hosted a preapplication technical assistance webinar to provide information for applicants about three music and health funding opportunities:
- Promoting Research on Music and Health: Fundamentals and Applications (R01 Clinical Trials Optional) – RFA-NS-19-008
- Promoting Research on Music and Health: Fundamentals and Applications (R21 Clinical Trials Optional) – RFA-NS-19-009
- Promoting Research on Music and Health: Phased Innovation Award for Music Interventions (R61/R33, Clinical Trial Optional) – RFA-AT-19-001.
- Thomas Cheever, Ph.D., Staff Assistant to the NIH Director for the Sound Health partnership and Program Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Robert Riddle, Ph.D., Program Director, National Institute of Neurological Disorders and Stroke (NINDS)
- Wen Chen, Ph.D., Acting Branch Chief for Basic and Mechanistic Research in Complementary and Integrative Health, NCCIH
- Pamela Jeter, Ph.D., Scientific Review Officer, NCCIH
- Anita McRae-Williams, M.A., Outreach Communications Program Manager, NCCIH (Webinar Moderator).
Background on the Sound Health Initiative
NIH’s partnership with other agencies to study the effects of music on health began when NIH Director Dr. Francis Collins joined with renowned soprano and Kennedy Center artistic advisor-at-large Renee Fleming in 2017 to initiate a collaboration to promote research on the health effects and potential therapeutic applications of music. This led to the Sound Health program, a partnership that includes NIH, the Kennedy Center, and the National Endowment for the Arts (NEA).
An international panel was convened at a 2017 workshop to discuss the state of the science and identify research opportunities related to music and health. A summary of this workshop, including a list of the identified research opportunities, was published in the journal Neuron in 2018. A trans-NIH working group on music and health has been formed; it includes most NIH institutes and centers (ICs).
General Information on the New Funding Opportunities
As a response to the workshop recommendations and after discussions within NIH and with NEA, the three funding opportunity announcements (FOAs) being discussed today were published. The FOAs involve different grant mechanisms and are intended to support investigators at different stages of the research process. Important considerations for potential applicants include the following:
- Not all ICs are participating in all three FOAs. A list of participating ICs is provided at the beginning of each FOA.
- Be mindful of whether your application includes a clinical trial. The NIH website on clinical trials policy can help you make this determination. Contact a program officer if you need help.
- It’s helpful to contact an NIH program officer for help in determining responsiveness and IC fit. Contact information for the program officers at each of the participating ICs is listed at the bottom of each FOA. You can use NIH Matchmaker to help you find the best initial contact.
- Some ICs have provided specific language about their research interests.
- As with all NIH applications, be careful to address all review criteria related to the rigor and reproducibility policies, as well as, any additional review criteria related to the RFA.
The R01 and R21 Funding Opportunities
The goals of this initiative are to determine how music affects the brain, body, and behavior and to use that knowledge to develop evidence-based music interventions to enhance health or treat medical conditions. Much remains to be learned about the mechanisms by which music exerts its effects, and there are many opportunities for research.
A broad spectrum of proposals is allowed under the R01 and R21 FOAs. Possible projects may range from basic, mechanistic research to better understand how the brain and body receive music, to development of a new music intervention, to clinical or translational studies of a known intervention in healthy individuals or those with a medical condition. Your study could focus on any one of these aspects. All studies should be grounded in science and be able to rigorously test an idea. Successful proposals are likely to coincide with the recommendations from the 2018 workshop.
Both animal models and/or human subjects are allowed for these two funding opportunities. If you plan to use human subjects, check out NIH’s recently revised language on clinical trials.
Collaborations are encouraged. International collaborations are permitted, but applications must be submitted by U.S. institutions.
It is not appropriate to address capacity building and infrastructure in proposals submitted in response to these FOAs. Proposals should be about scientific topics, where you’re trying to develop an understanding of some mechanism of action.
Both the R01 and R21 Requests For Applications (RFAs) must be within the mission and interests of the participating ICs, and the requirements for significance and rigor are the same for both RFAs. The impact/significance of the study is likely to be the most important score-driving factor. The two funding opportunities differ, however, in scope, approach, and size:
- For the R01, you must have preliminary data. Funding can be for up to 5 years, with a modular budget (up to $250,000 direct costs per year). The study would typically have multiple aims based on sound preliminary data.
- An R21 may be more exploratory, and preliminary data are not required. An R21 often takes the science in a new direction. Funding is for 2 years, with up to $275,000 in direct costs for both years combined. The focus needs to be tighter than for an R01 because the study would be smaller and shorter.
The R61/R33 Funding Opportunity
The R61/R33 is a relatively new funding mechanism, so the discussion here is more detailed than for the R21 and R01. Key points about this specific R61/R33 RFA include the following:
- This RFA has a stronger emphasis on developing music interventions, in contrast to the broader scope of the R01 and R21. The goal is to deepen understanding of the mechanisms of action or clinical applications of the intervention.
- No preliminary data are required. The R61 phase is designed to allow you to collect preliminary data. After that, you transition to the R33 phase, which is similar to a short-term R01 and allows you to build on the preliminary data collected during the R61 phase.
- Multidisciplinary collaboration, which may include basic researchers, translational science researchers, music intervention experts, other clinical researchers, music health professionals, and technology development researchers, is strongly encouraged.
- The R61 phase could involve animal models, human subjects, or technology development. The R33 phase must involve human subject research. This is an important difference between this RFA and the R01 and R21 funding opportunities.
- Prespecified Go/No-Go milestones established in the R61 will guide transition from the R61 phase to the R33 phase via administrative reviews by NIH program officers.
Expertise matters when developing collaborative teams. Applications should include evidence regarding the expertise of each team member, such as grants the team members have received, publication records, training records, or licensing. Teams can be assembled in different ways. For example, a team might include a basic research scientist, a music health professional, and an intervention expert. Or, in the case of a project involving technology development, the team might include a technology development researcher, a neuroscientist, and a music health professional. (Additional examples are given in the slide set.)
Examples of areas of science that could be studied in the R61 phase include:
- The mechanisms of a particular music intervention for pain, opioid use, management of other symptoms, or palliative care; or for sensory system or internal organ function and dysfunction; or for promoting well-being or related behaviors or improving the emotional/behavioral status of people with dementia or related clinical conditions; or for motor disorders, cognitive/memory impairment, or general brain disorders
- Individual differences in the mechanisms and outcome effects of music interventions
- Development and testing of new technology for music intervention delivery.
It may be helpful to think backward when developing your proposal, focusing first on what you want to study in the R33 phase and then thinking about what preliminary data you would need to collect in the R61 phase. For example:
- If the R33 phase involves a human mechanistic study of a music intervention, the R61 phase might involve a basic mechanistic study in an animal model.
- If the R33 phase involves optimization or an in-depth study of the mechanistic effects of a music intervention in human subjects, the R61 phase might focus on a preliminary mechanistic study in human subjects.
- If the R33 phase involves a pilot feasibility study of a music intervention, the R61 phase might involve novel technology development or basic research.
- If the R33 phase involves a proof-of-principle pilot clinical study, the R61 phase might focus on a basic mechanistic study in a human model.
Additional details about each of these examples are given in the slide set.
It is important to note that:
- All R33 projects must involve human subjects.
- Human mechanistic studies should be powered for the hypothesized mechanisms or processes.
- Pilot studies are not expected to be powered for mechanistic or clinical outcomes and should not examine clinical efficacy or effectiveness in an underpowered sample.
- Go/No-Go Milestones must be established for the transition from the R61 phase to the R33 phase. The transition from the R61 phase to the R33 phase will be conducted via administrative review by NIH program officers.
- Applications can be very creative, but please contact the appropriate program officer to discuss alignment with the mission and interests of the relevant IC.
The budget, duration, and page limit for the R61/R33 mechanism are as follows:
- The duration of the R61 is 1 to 2 years (typically 2 years), and this phase must not exceed $350,000 per year in direct costs.
- The duration of the R33 is up to 4 years, and this phase must not exceed $350,000 per year in direct costs.
- The R61 and R33 phases together must not exceed 5 years.
- The total page limit of the application is 12 pages, including both the R61 and R33 components and go/no-go milestones.
When deciding which RFA is most appropriate for your project, consider the following:
- If your application involves animal models only, you may not use the R61/R33 mechanism.
- If you have strong preliminary data to support the feasibility of your project, the R01 mechanism may be most suitable.
- If you do not have strong preliminary data, the R21 mechanism may be most suitable. Alternatively, if your proposed research involves human subjects only or both animal models and human subjects, you could use the R61/R33 mechanism, which allows for a potentially longer duration with a larger budget and a milestone mechanism.
- Contact an NIH program officer listed under the “Scientific Contacts” section of the RFAs for consultation on the most appropriate mechanism
The official deadline for submitting letters of intent was earlier this week (January 15th), but letters are still being accepted up to 30 days before the deadline. We welcome letters of intent because they help us gauge review needs. The application due date is February 28. Review will take place in May/June 2019, with grants awarded in September 2019.
Annual grantee meetings will be included in this program, and applicants need to budget accordingly.
Key points to remember include:
- Read the FOAs carefully, especially for IC interest areas and clinical trial policies.
- Reach out to NIH scientific contacts with questions.
- This set of FOAs provides many scientific opportunities for basic, translational, and clinical research. The grant mechanisms are intended to be flexible.
- Remember to budget for the annual meeting.
- A brief letter of intent is welcome but not required, and letters are still being accepted.
- We hope you will consider submitting an application.
Summary of Questions and Answers
Will applications for these RFAs go to existing study sections or will a specific study section be convened?
Two specific Special Emphasis Panels (SEPs) will be assembled and convened for these RFAs, one for the R01 and R21 and a second one for the R61/R33. The study sections will be assembled after the applications are received. Potential reviewers for each panel will be determined based on a variety of factors. Applicants for either RFA are not eligible to be reviewers on either panel since this introduces a conflict of interest per NIH policy.
How is the NEA involved in funding decisions for these RFAs?
The NEA is an integral partner and has contributed funding for this initiative. The NEA will be a part of the funding decisions.
If I have two ideas, one of which is appropriate for an R01 and the other for an R21, may I submit two applications?
Yes, if they are two truly distinct ideas with no overlap. You cannot submit two overlapping ideas (for example, proposals with overlapping aims).
Experience shows that when an investigator submits more than one application to the same study section, they tend to become conceptually linked and therefore they compete against each other. So, there may be disadvantages to submitting more than one application to the same study section.
Will the government shutdown affect the grant funding process for these awards?
Unless unexpected challenges occur, this funding process should be able to go forward. NIH has already received appropriations for Fiscal Year 2019.
You said that we can submit only one funding application to NIH for a single project. What are the differences between the R61/R33 funding opportunity and the Small Business Innovation Research (SBIR) program?
Small business applicants may apply to both the R61/R33 opportunity and the SBIR program but not at the same time for the same idea. NIH policy states that the same idea can’t be actively reviewed by two programs at the same time. If you have an SBIR application pending but you would prefer to apply for the R61/R33 with the same idea, you can withdraw your SBIR application.
R61/R33 and SBIR grants have different budgets, and the duration of funding may be different. These factors should be taken into consideration when choosing which one to apply to.
Is it acceptable to submit a similar proposal for an R15, and then, if it is not funded, revise it based on feedback and submit it in response to one of these RFAs?
If the review of the prior application has been completed, a similar application would no longer be overlapping, so it is acceptable. However, it would be a good idea to reach out to a program officer because there may be hurdles to overcome, such as making sure that the prior application won’t be funded. Also, you can’t reference anything that happened in the previous review in your new application. All applications under these RFAs must be new applications. You may use the information gained from the previous review, but your application must not refer to it.
Can a business with a large employee population submit an application for a translational study related to music and stress/anxiety with no preliminary data from another study? Is the lack of preliminary data a major disadvantage?
As indicated in the FOAs, for-profit organizations are eligible for funding, but the organization needs to obtain a Dun and Bradstreet Universal Numbering System (DUNS) number and be in the NIH system. This process takes some time, and it may be unfamiliar.
The lack of preliminary data may be acceptable under some of the RFAs if you can design your experiments rigorously. It is not necessarily a barrier to funding. Options are available for applicants who don’t have preliminary data.
What review sections will be participating in the review of the proposals?
Applications submitted under the R61/R33 RFA will be reviewed by a Special Emphasis Panel organized by NCCIH review staff. Proposals submitted under the R01 and R21 RFAs will be reviewed by a new study section organized by NINDS review staff. For all three RFAs, applications will not be reviewed by standing study sections.
It is important for applicants to read the RFAs, including the review criteria, very carefully. Particularly for the R61/R33, there are additional review criteria beyond those usually used by NIH, including the go/no-go milestones criteria.
Does the R33 need to be a powered trial?
This depends on your goals, and you should be very explicit about those goals in your application. If your proposed study focuses on feasibility or acceptability, it does not need to be powered. But if you have a mechanistic or clinical primary outcome, your trial must be powered for that aim. This is essential for scientific rigor. If you have those types of primary aims, you would typically be expected to conduct a controlled trial.
Do you suggest calling or emailing program officers?
Email is best to start, and then you can set up a time for a phone conversation. Don’t hesitate to email several times if the response to your first email is slow. If you have a draft of your abstract or aims, it’s a good idea to include it. This can lead to a better and faster discussion and may allow the program officer to loop in other relevant NIH staff.
If you’re applying to the R61/R33, do you have to submit for both phases if you’ve already collected and published the mechanistic data?
An R61/R33 research proposal must include both phases, both on your aims page and in your research strategy section. You also need to include information about your milestones.
The phased milestone approach is an essential part of the R61/R33 RFA. If you already have strong preliminary data, you may want to consider the R01 instead, unless you think your preliminary data are insufficient and you need additional preliminary data, which you would like to collect in the R61 phase. Interventional studies with human subjects are within the scope of the R01 and R21.
What is an example of active music engagement? Would dance to music be acceptable if the focus is on sensory-motor cognitive engagement with musical stimuli?
Dance alone, if it has no music component and is purely a form of exercise, is outside the scope of these particular RFAs. However, if you’re studying the musical components of the dance, such as the rhythm or melodies, or emotional well-being related to the music, that may be acceptable. However, it must be clear from your application that your focus is not on the motor aspect. It would be a good idea to talk with a program officer to see whether your proposed project would be acceptable. There may be other FOAs at NIH that would be more relevant to your proposed research.
The examples given throughout the webinar seemed to focus on the impact of music on the brain and behavior. Are other topics, such as music interventions in an aging population with cardiovascular disease, acceptable?
Topics other than the impact of music on the brain and behavior are acceptable if they are within the area of interest of one of the participating ICs listed in the RFAs. The topic suggested in the question would be of interest to the National Institute on Aging, which is participating in all three RFAs. Reach out to program officers at the ICs with interests closest to your own to see whether your proposed idea is within their scope.
For the R61/R33, is there just one aims page, or should applicants submit separate aims for each phase?
You need to get the aims and the go/no-go milestones for both phases on one page. The entire application must be no more than 12 pages long for both phases.
If a business partners with an academic institution as a research site of a study rather than being the primary driver of a study, does the business still need to apply for a DUNS number, etc., to be registered in the NIH system?
This depends on who is submitting the grant application. It might make sense for the academic institution to submit the application, especially if that institution is already in the NIH system. You would need to talk with the academic institution about how they could establish a collaboration with you. This should be doable, but it may be institution dependent.
Could an R61 focus on development and feasibility testing of a novel music intervention in a small sample of human patients and the R33 focus on a pilot trial of that intervention, following up on the R61 data?
Yes, but if you propose a trial for the second phase, it needs to be powered.
Is it necessary to have all the resources for an R33 in place at the time of application, such as clinical contacts and access to clinical populations, or could resources be added at the time of the milestone review?
It would be best to have all the resources in place at the time of application, but it would be possible to make acquisition of some resources a milestone.
When responding to the RFA, do we identify the specific Participating Organizations that we wish our application to target?
Applicants can request assignment to a specific IC on the PHS Assignment Request Form in the application and could also include requests in their cover letter. It’s important to discuss this with IC program staff ahead of time to ensure that the IC would consider the research project within their mission.
How many of each RFA are you expecting to fund?
The issuing ICs and partner components intend to fund up to an estimate of 9 to 12 awards, corresponding to a total of $5 million for Fiscal Year 2019 across all 3 related RFAs.