Funding webinar for NIMH Career Enhancement Award to Advance Autism Services Research for Adults and Transition-Age Youth

Transcript

>> LAUREN HILL: Thank you for joining us today for this technical assistance webinar on the funding opportunity announcement entitled the NIMH Career Enhancement Award to Advance Autism Services Research for Adults and Transition-Age Youth. This is Lauren Hill speaking, Director of Research Training and Career Development Programs in the Division of Services and Intervention Research at NIMH. And co-presenting today's webinar is my colleague, Denise Juliano-Bult, Chief of Systems Research and Disparities in Mental Health Services Research Programs, also from the Division of Services and Interventions Research. Also, today Ms. Nikki North is here with us to help broadcast the webinar and to help monitor questions coming in during the session.

Recent studies indicate that there are 5.3 million adults over the age of 20 in the United States diagnosed with autism spectrum disorders or ASD. And that about half a million youth with ASD will enter adulthood over the next decade. In recognition of the need for evidence-based ASD services across the lifespan, the Interagency Autism Coordinating Committee Strategic Plan for ASD has articulated research objectives for adult and transition-age youth services across multiple domains. To help address a need for additional research, NIMH previously issued two requests for applications or RFAs -- That was RFA-MH-17-200 and RFA-MH-172-05. Applicants to this current career enhancement award are encouraged to review these two RFAs for more information pertaining to NIMH research priorities in services research for transition-age youth and adults with ASD.

Among the growing number of studies developing and testing the effectiveness of services for people with autism spectrum disorders, the vast majority have focused on children. Because the impairments associated with the core deficits of ASD typically last into adulthood, research focused on developing effective services for adults and transition-age youth with ASD is also needed.

As such, the overarching goal of this initiative this, this K18 request for applications, or RFA, is to increase the capacity of the research workforce as rapidly as possible to conduct NIMH-supported research project grants that investigate the effectiveness of a broad range of services that address the needs of adults and transition-age youth with ASD.

The career enhancement award mechanism, or K18, will support part-time, short-term, mentored research training with experienced investigators at a 50 to 75 percent effort for a period of no less than 12 and no more than 24 months. The purpose is to allow K18 supported investigators to receive an intensive, individually-tailored period of mentored and research training providing the opportunity to redirect or expand their research program through the acquisition of new skills and knowledge that will provide the scientific competencies to then conduct services research relevant to adults and transition-age youth with ASD.

There will be two receipt dates for this funding opportunity announcement. Applications are due October 22, 2018, and June 21, 2019, by 5:00 pm local time of the applicant organization. Please remember to submit early enough to allow adequate time to correct any errors found in the application prior to the due date. Scientific merit reviews will occur in February 2019 and October 2019, respectively. The advisory council review will be in May 2019 and January 2020, respectively. And the earliest anticipated start dates will be July 2019 and April 2020, respectively. Applications that are not selected for funding for the first submission date can be revised and resubmitted for the second submission due date.

Individuals eligible for this K18 are experienced investigators at any faculty rank or level, from assistant professor to full professor. Applicants should have the skills, knowledge, and resources to be principal investigators on the proposed project. Applicants should have a research or health professional doctoral degree and a record of independent peer reviews, federal or private research grant funding. Please note that other mentored career development, or K awards, are not considered independent funding. Those eligible to apply should have not only a history of funding, but of currently funded independent research, along with evidence of productivity and research excellence.

As always with NIH funding opportunity announcements, individuals from underrepresented racial and ethnic groups and individuals with disabilities are encouraged to apply. For this funding opportunity announcement, multiple PDs or PIs are not allowed. By the time of the award, the individual must be a citizen or non-citizen national of the United States or have been lawfully admitted for permanent residence. And importantly, principal investigators who have had a NIMH grant or contract with one or more specific aims related to autism spectrum disorder services research for adults and/or transition-age youth are not eligible for this grant mechanism.

In keeping with the goal of the mechanism to increase the capacity of the workforce by providing support to experienced investigators to develop additional research skills, applicants to this FOA should construct a program of career development or career enhancement activities that redirect or expand their current research programs. Career development activities should be designed to provide investigators with new skills and areas of knowledge in an area of autism services research for adults or transition-age youth.

The new effort must be beyond and complementary to the investigator's current areas of expertise. The plan for expanding the applicant's capabilities should prepare him or her to make a significant contribution to research on services for transition-age youth and adults with ASD. The career development plan may include a combination of mentoring, didactic, and applied research experiences, and those activities should be selected and specifically tailored in terms of content, scope, and duration to meet the candidate's goals and be based upon the candidate's prior experience and career level. The activities, again, should contribute substantially to the research career enhancement of the candidate. Investigators should work with a mentor or mentors and the applicant organization to develop an application.

Eligible applicants must have a full-time appointment at the applicant's academic institution and they are expected to continue involvement in their ongoing research programs. It's required to commit a minimum of six person months to a maximum of nine person months professional effort on this K18, and the remaining time would be devoted to engaging in other professional duties, provided there is no interference with the proposed career development program. Candidates with VA appointments should contact NIMH staff directly to discuss eligibility.

The K18 will provide support for a period of no less than 12 months to no more than 24 months and it will provide salary support for that time in keeping with institutional salaries up to the maximum legislatively mandated salary caps in effect at the time of the award. NIMH will also contribute $50,000 per year towards research costs, which must be justified in the application. The K18 will not support salaries for mentors, secretarial, and administrative assistance.

In the application, the qualifications of the candidates should be made clear. This includes evidence of excellence as an independent principal investigator, including a record of research support and high quality and/or impactful peer-reviewed publications, prior research experiences that are complementary to the proposed program in ASD services research for transition-age youth or adults, and candidates should be able to show evidence of a high level of commitment to acquiring the skills, areas of knowledge, and other competencies necessary to conduct research relevant to this area.

Because mentors may come from disciplines other than that of the applicant, candidates should also demonstrate an ability to interact and collaborate with other scientists, particularly those from other disciplines. The need for the K18 to achieve the research training goals should also be clearly described. If responding to the clinical trial RFA, the candidate should describe his or her potential to organize, manage, and implement the proposed clinical trial, feasibility, or ancillary study. Since eligible applicants are experienced investigators with ongoing research, the mentor is not solely responsible for providing necessary resources. In this instance, the mentor and/or the candidate must document the availability of sufficient research support to conduct the proposed research.

Candidates for the K18 will need mentors to help them acquire the necessary competencies to conduct research in a new area. As such, the K18 requires the commitment of an experienced mentor or mentors from the proposed new discipline or disciplines. A mentor should be recognized as an accomplished investigator in the proposed research training area, and it is not required that the mentor receive primary research funding from the NIH. In addition to appropriate scientific expertise and time and availability, the mentor or mentors should show evidence of successfully mentoring faculty and of productive collaboration, and also be clearly committed to the candidate's career enhancement and direct supervision of the candidate's research. And as before, the mentor and/or candidate must document the availability of sufficient research support to conduct the project. Candidates may identify more than one mentor, a co-mentor or mentoring team for example. The mentor or mentoring team should be selected to provide expert advice in all aspects of the research career enhancement program that's proposed. If there is more than one mentor, one individual must be identified as the primary mentor.

It must be clear that the institution is committed to the applicant's career development and will ensure availability of time to devote the requisite effort directly to the research career enhancement activities described in the application. Statements about the institution from institutional representatives, department chairs, etc., should provide evidence of a commitment to fostering the candidate's advanced research career development and any features of the scientific environment of the institution that will benefit the proposed research and career development plan. For example, useful collaborative arrangements, special equipment or analytic methods, or technical support, or unique populations of research participants. The applicant should provide evidence that the resources and facilities available to the candidate-- I'm sorry -- the application should provide evidence that the resources and facilities available to the candidate are adequate for the proposed career enhancement experience. In situations where the candidate will train primarily at an institution other than the home institution, the home institution should provide assurances that the candidate will be relieved of responsibilities at his or her home institution as needed, so that he or she will be able to commit the requested level of effort to this career enhancement award. And finally, there should be assurance that the appropriate time and support will be available for any proposed mentors and/or other staff consistent with their level of involvement in the candidate's career development plan.

Importantly, this career enhancement award must include a project in the area of research on services for adults or transition-aged youth with ASD. The research should be timely and relevant, and address one of the research priorities articulated previously by the IACC and NIMH. Denise will say more about the project in a moment. As a career enhancement award, the research project should provide a vehicle and an applied experience for the new skills of the principal investigator. That is, the proposed career development activities are necessary to conduct the research project relevant to services for adults or transition-aged youth with ASD, and the small-scale research project will provide experienced investigators a chance to demonstrate and practice new scientific competencies. Applicants will serve as the lead investigator on either an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial as part of their research and career development, see RFA-MH-10-101. Or a study not involving an independent clinical trial, but proposing to gain research experience in a clinical trial led by another investigator. And that's pertinent to RFA-MH-19-100. And now I'm going to turn it over to my colleague, Denise Juliano-Bult.

>> DENISE JULIANO-BULT: Hi. So Lauren was just underscoring an important distinction that is important across, now, most NIH applications. But we're going to talk about it specific to the K18 here. And that is, there's a newish requirement for all studies to distinguish between ones that are proposing something that meets the NIH definition of a clinical trial and other studies which are also of interest, but don't meet the NIH definition of a clinical trial. This new policy which comes down from the NIH level is intended to increase scientific rigor specific to clinical trials and also increase or facilitate the monitoring of clinical trial activities, data sharing, human subjects, etc. But the main point here is it is important for you to determine when you're applying under this K18 which type of study you're going to be proposing. Whether it's a clinical trial or not a clinical trial. And I encourage you to read each of those announcements with an eye toward which is the pathway you're going down. But also to confirm either with Lauren or with me that you've made the right decision about which announcement you're going to use. Because of this new requirement, there's the possibility that applications will be not accepted if they're not in compliance with the announcement that you're using. So we have a lot of experience with distinguishing this distinction for other applications and we can definitely help you in the case of this announcement.

So next slide. You see the titles of the two announcements and it's highlighted there that one is clearly labeled Clinical Trial Required and the other is clearly labeled Independent Clinical Trial Not Allowed. In either case, as Lauren pointed out earlier, you have to keep in mind that NIMH is supporting this K18 to rapidly increase the research workforce for adult and transition age youth, ASD services researchers. So that sets the stage for us to look at folks who already have research experience in some other area and, as she said, it doesn't require that you've had prior NIH experience. But that you already have some basis of research expertise and knowledge and you're using this very short term, one- to two-year K18 to get mentoring and research project experience to convert over and come and do this kind of research with us. So, in light of that, you want to make sure when you're writing your application that you have a convincing argument that NIMH is going to want to keep funding the kind of research and researchers that you're going to become. And Lauren pointed out, we have the Interagency Autism Coordinating Committee or IACC report which gives NIMH, among others, our marching orders about what kind of research we should be doing. And, of course, we also want people to be reviewing what's most current in the literature to contribute to their argument for why your research is relevant now and going to be relevant in the near future. And also keep in mind that NIMH has its own special mission in ASD research separate from the missions of other funding entities like NICHD, NINDS, CDC, Department of Ed, etc. But your research experience if you have it from those other entities is important and relevant to highlight.

So next slide. What is the NIH definition of a clinical trial? And I want to go over this because our definition is broader than some of what people may naturally think of. So this slide has the language from the NIH notice about clinical trials. So just in three parts, a research study in which one or more human subjects, as opposed to deidentified secondary data, are perspectively assigned to one or more interventions, meaning not a naturalistic study. And these assignments may or may not include a placebo or other control, but that there is assignment done to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. So in this definition, those interventions are not necessarily therapeutic interventions. The clinical trial definition includes if you're intervening with providers, or families, or systems level kinds of interventions, but that you're intervening. So this is a definition that is probably broader than what most people in the past have thought about in a clinical trial. And we're going to go over some examples which come from the announcements. That hopefully will make this distinction clearer. So all of my talk now is with respect to the research projects that you might be conducting as a part of your K18s. So for those that fall under the category of being a clinical trial, which is MH-19-101, the following slides are examples of research that we're soliciting under that announcement. And keep in mind, our goal is-- what we've reviewed here-- what might be relevant includes these bullets. But it's not limited to these bullets. In the case that you have additional ideas that are innovative and relevant, we're open to hearing about those.

But from whatever topic you choose to pursue, from these examples or something different of your own, you have to in your application make the argument for public health significance of the line of research that you're pursuing. And we're thinking of this project as just a beginning experiential developmental project to help you learn to become the kind of researcher you're proposing to become. We should be interested in your current project, but it should mark the beginning of a new direction in your career of research that will be of continuing interest to us. So you should provide evidence that you're addressing a significant and mutable problem that's experienced by a significant proportion of the subject population. You want to convince NIMH and the reviewers who are going to be reviewing your application that we should want to fund this area and continue funding this area. So the examples on this slide - and I'm not going to read them - are examples of research areas related to transition-age youth. Transition planning is an area that has a lot of focus now because of studies that we've seen about the services cliff that people fall off of. High school is a time where people get a lot, in fact, the majority usually, of their autism-related services. And there is a documented gap that happens to folks once they graduate before they're able to transition into the adult system and take up services in the adult system. And so the time of transition gives us an opportunity to intervene and try to prevent that gap. Along those lines, once people transition out of high school there's typically, to stay on a normative trajectory anyway, a higher set of expectations for independent functioning that might include things like employment, education, managing one's own health or having independent housing. And in addition, when services move from being centered in a place like the education system going into the adult system they tend to be dispersed. There is no autism services treatment system or service system like there is, for example, a mental health service system. So when the services get dispersed in that way there's a need to try to coordinate, collaborate or communicate at least across those services to have a coordinated care plan for folks with ASD.

So next slide. Let's see. This is a review of some of the areas we highlighted that are service needs for adults, and I want to underscore what we list for transition age youth and what we list for adults here are not mutually exclusive, and we have a recognition that many of these needs continue across these age differences. Just as an example, systems-level interventions are going to be relevant for all the age groups. The challenge - and again I'm not going to read these bullets, and I think the slides are going to be available somewhere, yes - the challenge for research on adults is there's very little empirical research that's been published from which to build the next generation of research so that challenge is going to require some creativity on the part of those of you applying in the adult area to draw threads from related but not directly targeted on adult services in order to really build an argument for what do we need to know, what kinds of services do we need to have in order to help adults with ASD function independently if possible in the community? And that includes the challenge that there are a number of people who are now adults who were not diagnosed as children because the diagnosis of autism wasn't widely used when they were children, and that creates a challenge. It also creates, obviously, a really driving need for us to know how to serve this population and optimize their outcomes.

Next slide. So now I'm going to focus on examples from the announcement that's labeled independent clinical trials are not allowed and you can see that the examples that we have there are all basically one step removed from human subjects research. They could be precursors to human subjects research that will be happening farther down the line. The initial bullet there is essentially focused on hypothesis generating studies so not testing the effectiveness of an intervention but really looking for intervention targets or studies that will amplify knowledge in specific areas that will give us a basis for building interventions and services that can be tested later on. In addition, bullet two is focused on new research tools, measures, or methods. Keep in mind if you're going to focus on something like developing a measure, you want to be mindful that you are likely not to be proposing a career in measurement development. You're going to be proposing developing a measure as a component of what you're anticipating your future research will be. So you want to be careful about the balance of experiences that you propose and that the measurement or research tool isn't the exclusive experience that you're getting with the K. And finally, the final bullet is integrating existing datasets. And again, that would be probably studies that are looking at hypothesis development.

So, more bullets in this area. And just in thinking about whether you're going to be proposing any of these type of studies, keep in mind our rapid approach to developing the workforce. So you want to think strategically about what skills and experience you already have and can rapidly build from. And remember that a big part of your argument and what you're proposing in the application is that in two years you will become an involved kind of researcher. That this experience that you propose is going to put you in a position to apply to NIMH for further funding to support ASD research, either for adults or transition age youth. So next slide.

So thinking along those lines, you're going to be writing an application that is going to go to a review committee. And the review committee is going to critique you. So just as you're developing your application, keep in mind what is written into our announcement in terms of the scored review criteria. It helps the reviewers review you easily and helpfully in if it's easy for them to find within your application how you're responding to the announcement and the criteria they're supposed to be using.

So let's see. I think we don't need to go in much more detail on that. If so, we can address it in the questions that folks have. The next slide just highlights-- is there mainly to say that there are more and more instructions and requirements all the time for applying. So know and follow the rules laid out in the announcements. When you look at the application instructions, if you have questions, there's a help desk or helpline associated with each of them. Please use that helpline. And in addition, your office of sponsored research should be familiar with many or all of those requirements and also be a resource to you in making sure you get the application in correctly.

The next slide just lists several options that you have for how you might submit your application to us. As Lauren pointed out, it's good to submit early because the system may identify some mistakes or problems in your application. And you want to have enough time to fix those before the deadline and I think, for me, we can take questions now. And there's also a final slide. Maybe we can leave it on the final slide for who the contact folks are.

[silence]

Just a reminder, if you have questions, we're taking them in writing through the Q and A box.

>> NIKKI NORTH: So we did just get a question about if a copy of this presentation will be available [inaudible].

>> LAUREN HILL: We'll be working on making a copy of this presentation available. I'm not quite sure of the timeline of that. It involves a few different steps, but we can certainly send out a notification when it becomes available to those of you who have registered for the webinar.

>> DENISE JULIANO-BULT: Yes, and also to underscore that both Lauren and I are available resources and we encourage anyone who's interesting in applying to contact one or both of us about how to respond to-- this is a somewhat unusual mechanism for NIMH to be using so we'd like to be as helpful as possible in getting people to understand how to apply.

>> NIKKI NORTH: There's a question. "My department is advising me that having a remote mentor is tricky. Do you have any advice for applications with a remote mentor?"

>> LAUREN HILL: Certainly. Having a remote mentor as a primary mentor may indeed be quite tricky and may or may not be feasible depending upon the specifics of what you're proposing, the activities in which that mentor would need to be involved, etc. As I said earlier, there's certainly the option to have co-mentors or a mentoring team. So that would be something that we could perhaps discuss offline with your particular situation based on the resources that you have available at your institution and other resources or opportunities outside of your institution.

>> DENISE JULIANO-BULT: And I would just add to that, for whoever you're proposing as a mentor or mentors, you need to include a very concrete description of how and when you'll be interacting with that person, what specifically are they mentoring you on? How frequently are you in contact with them? So that the review committee and program staff can assess how realistic it is that that mentor will be able to do what we would like them to do in helping you develop your career.

>> NIKKI NORTH: Will the two announcements be reviewed by separate review panels or the same one?

>> DENISE JULIANO-BULT: Well, I think probably the same panel.

>> NIKKI NORTH: If someone is on a No-Cost Extension for a K01, could they still receive this K?

>> LAUREN HILL: It would depend on what other funding they've acquired. So, for example, if you're on a No-Cost Extension from a K01 and you already have an R01 or an R34, that would make you eligible because you have independent research funding. If the No-Cost-Extension of the K01 is the only funding that you have, in other words all of your funding is mentored funding, you would not be eligible.

>> NIKKI NORTH: The ultimate target NIMH wants to prioritize improving -- just mental health outcomes or also functional outcomes like employment and community participation? If the latter are included, then do we have to explicitly connect to MH?

>> DENISE JULIANO-BULT: Yes, we are interested in improving functional outcomes. So employment, education, and housing are mentioned in there. And what was the second part of the question?

>> NIKKI NORTH: Do you have to explicitly connect to MH?

>> DENISE JULIANO-BULT: No, you don't have to explicitly connect with a psychiatric disorder in the case of ASD, if you should be connecting with an ASD type of disorder. And what we're interested in is services and interventions that are targeting known and documented deficits that people with ASD experience. So yes, we're the mental health institute, but this is a component of the institute where an exclusive focus on ASD symptoms would be acceptable. We also have in the past had folks focusing on people with ASD who have co-occurring psychiatric disorders. For example, anxiety disorders are commonly co-occurring, and that is also acceptable. But we've also had studies focused on folks with ASD learning to manage their own medical conditions. For example, seizure disorders are very commonly co-occurring disorder for folks with ASD. And dental health is a challenge often for people with ASD. So the areas that you focus on, you should be able to cite some existing data or literature that indicates these are challenges that are once you develop services, or interventions that are effective, they have the potential to benefit a lot of people with ASD.

>> NIKKI NORTH: So this is regarding eligibility. What if you have federal funding as a co-investigator and external funding as a principal investigator that is non-federal money?

>> LAUREN HILL: Okay. So as a co-investigator, we would not consider that independent funding. We'd like to see you be an independently funded investigator as a principal investigator. It sounded like the second part of the question would make one eligible. So you do not have to be a principal investigator on a NIH or a federal grant, just a principal investigator on a foundation grant is fine. Just something that is substantial and demonstrates your track record of productivity and your ability to be a PI on an independent grant.

>> NIKKI NORTH: No more questions? None are coming in.

>> DENISE JULIANO-BULT: Anybody else have a burning question or a non-burning question?

>> LAUREN HILL: Okay. As Denise said, we certainly encourage you to contact us. Email contact is preferred to phone contact, especially for an initial inquiry. And these contact names and numbers and help desk, etc., you can find them in the bottom of the funding opportunity annoucement. So why we wait for the slides to be released, all of this information is available in the FOA in one form or another. Thank you for joining us today. This will conclude our webinar.