So, by the end of this talk, I hope that you will have a better understanding of the NIH system in general. The other objectives will be to learn about funding opportunities within NIH, as well as to become familiar with other research opportunities within the federal government. Dr. Maslundust? Yes. I'm sorry to interrupt you. It looks like your presentation is in, with the notes are visible. Is it possible for you to switch to, yeah, oftentimes double screen, sometimes you can switch to full screen, and sometimes it's a little tricky and difficult to show. Thank you for letting me know, because that would be lovely. All right. So, let's share. Better? Perfect. All right. Thank you. So, as I was mentioning, so let's go back a slide for our objectives. By the end of this talk, I hope that you will have a better understanding of the NIH system in general. The other objectives will be to learn about funding opportunities within NIH, as well as become familiar with other research opportunities within the federal government. Also, we are going to review NIH history and basics, as well as grant mechanisms and other opportunities such as using data that's already been collected. So, as a fellow, I didn't really have to think much about funding. Many of you probably don't either, because most fellows don't necessarily have to look for funding during training. Perhaps there's institutional grants to which you can apply. You may be doing research that doesn't require it, such as a chart review, or you have exposure to funding through attendings. So, what do you do when you get out? There's many options for funding. There's federal, there's institutional, industry, and other organizations like PCORI. So, one resource that can link you to many of these federal agency fundings is grants.gov, which is publicly available. This is going to give you access to applying to 26 federal agencies, such as the HHS, which is what houses NIH, the National Science Foundation, as well as the CDC. Some of you may also have attendings who have DOD funding as well, Department of Defense. Let's talk a little bit about the NIH specifically. I think it helps to understand the history, as well as the general role of NIH in medical research to better understand its purpose. The NIH roots stem from the Marine Hospital Service, or MHS, which also led to the development of the Public Health Service. MHS was established in 1798 to provide medical care for merchant seamen and was charged by Congress to examine passengers on arriving ships for diseases such as cholera and yellow fever to help prevent epidemics. In 1887, an MHS physician, Joseph Kinyon, was authorized to set up a one-room laboratory in Staten Island, New York. The facility was called the Laboratory of Hygiene and later referred to as the Hygiene Laboratory. It was intended to replicate the German facilities that served the public's health. In 1891, the Hygienic Laboratory was moved to Washington, D.C., and in 1901, it was recognized in law, where Congress authorized $35,000 for construction of a new building. The laboratory was charged with the goal to investigate infectious and contagious diseases and matters pertaining to the public health. Some of the lab's early work were during World War I, where they discovered anthrax outbreaks among troops that had traced back to contaminated shaving brushes, as well as bunion pads that had widely been used to cover smallpox vaccinations that they determined could harbor tetanus spores. And in 1918, the laboratory was put to test. As the influenza pandemic hit Washington, D.C., the Hygienic Laboratory physicians were pushed into service to treat patients as local doctors fell ill, and unfortunately, this is something we can all appreciate in our current ongoing pandemic. So recognizing the importance of the need for the Hygiene Laboratory, Congress acted. After no sponsors were found to endow the institute publicly, Louisiana Senator Josephine Ransdell and proponents sought federal sponsorship in 1926, and in 1930, the Ransdell Act changed the name of the Hygiene Laboratory to the National Institute of Health. This act demonstrated an attitude shift in the scientific community towards public funding of medical research, which was prior to this not a common concept. So as I mentioned, the NIH started as one institute. We'll go over this in a little bit. Now it holds 27 and is referred to as the National Institutes of Health. It's the largest public funder of biomedical research in the world and funds billions of dollars in the U.S. as well as across the globe. Greater than 80 Nobel Prizes have been awarded to NIH-supported research, five of those within the NIH community investigators. Successes of NIH-funded research include deciphering of the genetic codes, establishing a greater understanding of genetically-based diseases, development of drugs designed to target specific proteins and disease processes, improved cancer treatments, reduction of deaths from heart attacks and strokes, and prevention strategies reducing the need for expensive therapies. And because of its large influence, NIH policies impact many researchers. Investigators may be bound to NIH policies because their institutions receive NIH funding. So for example, the common rule, which is the federal policy for the protection of human subjects, applies to all researchers at institutions receiving any NIH funding, even if that particular researcher is not the recipient of that funding. So let's review the organization of the NIH. So as I mentioned, it's comprised of 27 institutes or centers, and we call those ICs. Each IC has a separate appropriation from Congress, which means Congress determines how much money they get annually. The IC director decides which grants it will fund, taking into consideration input from staff such as myself, scientific peer review, public health needs, scientific opportunity, and the need to balance its scientific portfolio. Each IC has its own distinct mission, focusing either on a specific disease area, organ system, or stage of life. And we'll get to my specific institute in a minute. Each institute is broken down into an extra and intramural branch. So intramural means the research is conducted within the NIH campus by NIH investigators. Extramural on the other hand means that NIH is funding research conducted outside of the NIH system. More than 80% of the NIH budget supports extramural research, which is ongoing at over 2,500 universities, medical schools, as well as other research organizations around the world. And over 90% support scientists at the NIH labs, which are mostly in the Bethesda, Maryland campus. And here's where I'm located, which is in the programs. So when you apply for funding, you're assigned a team. And this is comprised of a scientific review officer, a program officer, and a grants management specialist. The SRO directs the review process. The program officer provides advice to applicants and grantees, making funding recommendations to the institute, oversees grantees' progress, and facilitates scientific opportunities. A medical officer is a specific subset of program officers who hold a medical degree. The grants management specialist manages and coordinates the financial aspects of the grants. So whenever you have questions during your application process, you would want to actually seek the help of the person associated with that specific application step. So what do I do? I'm a medical officer in the extramural branch at NIH. So as I mentioned, medical officers are a specific subset of program officers that must hold a medical degree. Some of us are clinically active as well, such as myself. Extramural medical officers basically serve as a consultant and clinical investigators in their area of expertise. They use their medical expertise to administer extramural research grants and or contracts in a major program area. In the area of our assigned responsibility, we work to evaluate activities of funded investigators and make recommendations regarding the contribution of the research to the goals and objective of the program. And so part of my role is to help and advise those applying for grants and then monitor progress once somebody does get funding to ensure that the project is moving along as it should. My institute is the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, which was founded in 1962. It's a unique biomedical and behavioral research enterprise which focuses on understanding human development throughout the entire life process. So we don't have a specific disease or organ system that we are focused on, but rather the developmental health of individuals. The mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. And the vision is simple, healthy pregnancies, healthy children, healthy and optimal lives. The strategic plan was just published in September of 2019 for the latest strategic plan. It was developed to guide the institute's activities over the next five years. It proposes key scientific and public health priorities to advance research, methods by which to enhance scientific stewardship, and goals to support innovation and management practices and accountability. The plan establishes the ambitious goals to fulfill NICHD's scientific mandate. Five themes were developed to guide the mission. These are to understand the molecular, cellular, and structural basis of development, promote gynecologic, andrologic, and reproductive health, set the foundation for healthy pregnancies and lifelong wellness, improve child and adolescent health in the transition to adulthood, and to advance safe and effective therapeutics and devices for special populations such as pregnant and lactating women, children, and people with disabilities. And these underrepresented populations are very important to NICHD. Cross-cutting themes emerged during the discussions of NICHD's public health and scientific priorities. In order to be successful and advance its scientific goals, it was determined the following would need to be integrated into each scientific research theme, and this includes health disparities, disease prevention, infectious disease, nutrition, and global health. The reason why we're talking about all of that is it's important to understand what the priorities of each institute are. The aspirational goals of theme two, as we just discussed, as they relate to pelvic floor disorders, which is of interest to most of this audience, is to train the next generation of scientists to harness techniques necessary for future investigations such as machine learning and artificial intelligence. My branch within NICHD is the gynecologic health and disease branch, as Dr. Swanson mentioned, which supports basic translational and clinical research programs related to gynecologic health throughout the reproductive lifespan, including conditions that are impacted by menopause. Our overarching mission is to improve women's reproductive health by guiding and supporting gynecologic research and career development programs with the vision of a future in which women lead lives free of the effects of gynecologic disorders. Very aspirational, but hopefully obtainable. As it relates to pelvic floor disorders specifically, our branch supports accumulation and analysis of good quality evidence to inform directed methods for the prevention, diagnosis, and treatment of pelvic floor disorders. While we do tend to fund studies more related to prolapse, we do address all pelvic floor conditions, including fistulas and female genital cutting. We also support the Pelvic Floor Disorders Network, a collaborative, multi-centered network that has been very productive with regards to pelvic floor research. So as a brief overview of the PFDN, NICHD established it in 2001. The initiative was to encourage collaborative research on pelvic floor disorders and to improve patient care. The PFD currently includes eight clinical centers and a data coordinating center, or DCC, located at U.S. universities and medical centers, and is currently finishing its fifth five-year cycle that included an additional sixth year of bridge funding. Support at each clinical site is provided by a principal investigator who's a practicing physician with substantial expertise in treating PFDs. A research coordinator oversees the progress of clinical trials under the supervision of this PI and a multidisciplinary team. The PFDN is currently funded through what is called a Cooperative Clinical Research Award Mechanism. We'll talk about that a little bit later. And a steering committee guides the development and conduct of research protocols, as well as the preparation of PFDN publications. The network is overseen by an advisory board, as well as a data and safety monitoring board. And the funding was just renewed in October of last year for a sixth five-year cycle to begin in July of this year, and we'll get back to how this impacts your research a little bit later. So let's talk a little bit about what happens after you decide to apply for NIH funding. The first step is to apply to the right place, and we'll talk about these funding announcements in a minute, but it's important to apply to the IC that would be interested in your proposal from a topic perspective, as well as to make sure that that IC is listed as a participating organization on the funding opportunity announcement. Otherwise they can't even consider your application. So how do you figure this out? Well, you can call your friendly local program officer, such as myself, or you can actually even start with any PO if you're really not sure where to start, and they can direct you to the right place if you contact somebody who's not in that division that's appropriate for you. You can also use a tool called Reporter, which is basically an NIH online tool that can help match your idea with an appropriate IC for your application. But as a strong word of advice, I would always reach out to a program officer before you submit an application just to make sure that that is the appropriate, both institute as well as the appropriate announcement to which you're applying. This diagram is a little bit busy, but it sort of shows you the steps in how you apply and what happens after that. So first you come up with an idea and apply. Then a group of qualified specialists will review the application and rate it based on its scientific merit. After they discuss this, your program officer can help you interpret any of their reviews and comments as necessary. The application then goes to council, which is comprised of another group of experts who then approve the application for funding. And then ultimately the institute director decides who gets funded and allocates the appropriate funds. And this is important because the director has to be able to justify the expenditure to Congress, because ultimately Congress will decide how much money each NIH institute gets. So back to reviewing some of the terminology behind how grants are announced to the general public. So a funding opportunity announcement is how a federal agency announces its intention to award funds. They may be program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the agency as well as the program type. Program announcements identify areas of increased priority for a specific area of science. These are usually accepted on a standard receipt date, which is on an ongoing basis. Back in the day of actual postal mail, these were considered postmark dates, but now everything is online. So there's a specific due date for the application, but there are typically several due dates within the fiscal year. Program announcements can remain active for three years unless the announcement indicates a specific expiration date. Notices on the other hand do what they actually say they do. They announce policy and procedures, changes to announcements, requests for proposals, and other general informational items. A request for application is a little bit different because it identifies a more narrowly defined area for which one or more NIH institutes have set aside funds for awarding grants. So these are specific ideas that the institute wants to fund. RFAs usually have a single receipt date, which means the application must be received by the state, and this is specified in the RFA announcement. These grant applications are usually reviewed by a scientific review group convened by the issuing awarding component, which is the originating institute, such as NICHD. Another way to look at it is whether the grant is initiated by the investigator or the NIH institute. So parent announcements are how an investigator with a specific idea should apply for funding. So you want a specific idea to be evaluated, but the institute hasn't necessarily set aside money for that, you would apply under this type of announcement. If the institute has a topic they wish to fund, they can be announced through the mechanisms that we talked about, an RFA, a PA, or a PAR. Foreign scientists are also eligible to apply for certain grant mechanisms, but they must have a formal written appointment with a U.S. institution, they can't apply for training or many career awards, and their visas can't be extended because of the grant. When reviewing applications, NIH considers the significance of the science, the approach, innovation, the qualifications of the investigator, and the institution associated with the grant application. So it's not just important that you have a solid idea and that you are a reliable researcher, but you also need to be at an institute that's going to be supportive and allow you to be able to conduct that research. For planning purposes, it's really important to note that it can take at least 9 to 10 months before a grant is awarded from the time of an application and perhaps even longer until the money is actually in your hands. So it's really important to consider this when determining if or even when to apply. Let's talk about the specific grant mechanisms. So briefly, grants can be research or what are called R-grants. They can be training, such as F or T grants, career development, such as the K awards, and then cooperative agreements, which you likely know as the networks such as the PFDN, the UITN, and LEARN. This graphic helps represent which mechanisms are most appropriate for each stage of your training. So for example, for a grad student, a T32 or T35 may be appropriate. A T32 institutional training grant or an F32 is good for somebody who is in their fellowship. Or an early instructor may want to consider one of the K awards. And then as a faculty member, typically a K award if you're still in a training position or mentoring in a mentored program from a research perspective can be beneficial. So we're going to talk about each of these grants in a little bit of further detail here in a second. And then we also have the research grants as we talked about, which we'll also go over in a second. So let's talk about the individual mechanisms. The R01 is what you've most likely heard the most about. It is one of the more competitive mechanisms, but it does support a project up to five years and can be renewed. They have higher levels of financial support compared to other awards. They do tend to be the most appropriate, but they often do require preliminary data to demonstrate feasibility given the financial commitment the institute is going to be putting forward. An R03, on the other hand, is intended to support smaller projects that can be carried out in a shorter time period. They're limited to two years. They cannot be renewed and are maxed out at $50,000 a year. And some of these dollar components that I'm going to talk about do have exceptions and they will change over time. This is a general overview. R03 grants are appropriate for pilot or feasibility studies, limited research studies, development of research methodology, or even reanalysis of existing data. They can be used to provide preliminary data when this may be needed in order to support an R01 submission. Preliminary data is typically not required, but it is advised if available to apply with that. Then there's the R21, and this supports exploratory research. This has more funding associated with it, but still has the two-year time limit as well as an inability for renewal. This grant is eligible for what we call high-risk, high-reward grants that may venture into a new area, paradigm, agent, or technology. They are good for a novel study that hasn't been previously introduced. These wouldn't be appropriate for projects in a well-established area, which would otherwise be better for an R01. And this table shows the breakdown and the comparison of these three mechanisms and their differences with regards to both length and financial payout. But note that an R01 doesn't typically have a budget limit unless specified in the announcement. There's no preliminary data that's required for the R03 or R21 in contrast to an R01, so this can be a little bit helpful in determining what you might be most appropriate for. And of note, there is special consideration sometimes given to new investigators. So new investigators are those who haven't previously had independent research awards versus an early investigator, which are those who are within 10 years of their training or their terminal degree. So it actually sometimes can be to your advantage to not have had previous funding or to be in the early stages of your career. So training and career development awards are intended to help somebody advance their training or career. The National Research Service Awards are training awards for U.S. citizens or permanent residents. They support full-time work designated at 40 hours per week, even though we all know that typically physicians work longer than 40 hours a week. The institution is allowed to provide additional support and the recipient can't have similar concurrent federally funded awards. The grants can be awarded to individuals and these are called, for example, an F32 grant within NICHD or they can be directly awarded to institutions such as the T32. And there are different F and T grants but we're overviewing ones that the NICHD primarily supports. F32 fellowships provide a stipend for salary support as well as a small institutional allowance to partially offset the costs of research, tuition, and health insurance. The goal is to support promising applicants with the potential to become productive investigators in the future. The F32 covers living expenses based on the year postdoc experience as well as locality. The coverage is published yearly and will be different from what I've listed here, which is from fiscal year 2017, but it gives you an overview. There is a service obligation with the F32 which requires one month of service for each month of support. For the first 12 months the grant is valid. So basically you would need to pay back one year after one year of the award. A two-year fellowship would satisfy this obligation. The T32 promotes institutions to develop or enhance research training opportunities. So as we mentioned this funding is given directly to the institution and it supports up to three years. And again like with the F32 there is a service payback. Trainees would apply directly to the sites for this, not NIH. So let's talk a little bit about career awards or the K awards. K awards can be mentored and are based on your stage of career development. It's intended to protect the time of a mid-career investigator as well as mentor young investigators. Mentored K programs include the K08, K23, and what some of you may be more commonly familiar with are the K12 which includes the Birch and the Werher programs. There's also something called a pathway to independence award which is the K99 R00 award. This includes years of mentored research with a transition to independent research. So K awards require some sort of clinical doctoral degree. U.S. citizens, non-citizen nationals, and permanent residents are eligible. No concurrent or pending NIH career development awards can be held. Previous NIH PIs on R01, R29, P01, and other K award grants are not eligible, but a previous R03 or R21 are still eligible. K awards require at least one mentor. The duration is typically three to five years with a maximum of six. It requires full-time employment with a 75% research effort typically, so up to 25% of your time can be dedicated to clinical duties. There are some exceptions for surgical fields such as ours where the clinical effort can actually be increased, but it would be important to discuss this with your program officer or institution. Recipients are encouraged to apply for independent research grants support sometime during that period such as an R03 or even an R01. The applications are reviewed by an NICHD committee based on the merits of the candidate, career development plan, research plan, mentor environment, and also the institutional commitment. The objective of the K-12 grants is to provide support to institutions to mentor clinical fellows and scientists and help them become independent research investigators. Again, the Werher and Birch programs are what you may have previously heard of. The Werher program initiated in 1998 and has had over 200 scholars since the inception. The program supports scholars for two to five years and covers up to $250,000 direct costs annually. Costs for each individual scholar are limited to $125,000 per year, which includes up to $100,000 for salary and fringe benefits. Scholars typically must devote 75% of full-time professional effort toward health-related research and career development activities, with the remaining effort being devoted to activities related to the development of a successful career as a physician scientist. As I mentioned previously, there are exceptions made for individuals in surgical fields as they will require a more dedicated clinical or operative time, and these are called surgeon scientists. There are currently 15 sites with 30 scholars across the country, and some of these figures are, of course, subject to change by the time you may apply. The Birch program was initiated in 2000 by the Office of Research and Women's Health, or ORWH. It is co-founded by the other institutions listed here. NICHD supports three sites. Again, the 75% research effort is expected. Scholars must be citizens, nationals, or permanent residents. The scholar position is a junior faculty appointment, so it's not a fellowship. At the time of the appointment, candidates must have no more than six years of research or research training experience beyond their last doctoral degree and have to identify mentors with extensive research experience. And then finally, the K99-ROO award, which is that Pathway to Independence award, it awards up to five years of support. It's conducted in two phases. So there's the mentored phase and then an independent research phase that is contingent on a position within the institution. Non-citizens are also eligible for this grant. So they must have less than four years of postdoctoral research experience for this grant. They can't have held previous major NIH awards. Applicants should be those that are in their final years of mentored research and on the cusp of independence, so it provides you just a little bit more mentorship prior to branching out on your own. Let's transition to small business grants, which may or may not be relevant to those of you at this point in your career. These grants were created by Congress to strengthen the role of small innovative companies and federally supported research and development. So small businesses are those that are organized for profit, have less than 500 employees, and have less than 50 percent participation by foreign businesses. The goal of a small business innovation research grant or SBIR are to stimulate technological innovation, increase private sector commercialization of innovations derived from federal funding, to foster and encourage participation in innovation and entrepreneurship by socially and economically disadvantaged people, and meet federal research and development needs. The small business technology transfer or STTR is similar in overall objectives and structure to the SBIR, but the STTR aims to facilitate cooperative research and development between small business concerns and U.S. nonprofit research institutions. STTR programs require the small business to formally collaborate with a research institution. So both programs include three phases. Phase one is the feasibility and proof of concept. The objective of this phase is to establish technical merit, feasibility, and commercial potential. This phase helps determine the quality of performance of the small business prior to any support for phase two. Phase two is the research and research and development phase. The objective is to continue the research and development efforts initiated in the phase one to develop the project's commercial viability. Funding is based on results achieved in phase one, the science and technical merit, as well as commercial potential of the project proposed in the phase two. Phase three is the commercialization, the objective of which is to pursue commercialization objectives. These activities are integral throughout the SBIR and STTR processes, and while NIH programs don't fund phase three trials, there are programs and resources available to awardees at various stages. So NIH does still continue to encourage and support the ultimate commercialization of these projects. Let's talk a little bit about the cooperative agreements. So U grants or cooperative agreements support specific projects to be performed by investigators in an area representing their specific interests and competencies. These grants are used when substantial programmatic involvement is anticipated between the awarding institute and center, which means somebody from the institute like myself will be directly involved with the network. So for example, in the case of the PFDN, NIH will assign one of their employees, me, to have a voting right in the network because of the large financial commitment NIH is giving to the network they want to ensure that the NIH priorities are well represented in how the funding is spent. So U mechanisms are just one of many types of cooperative agreements. No specific dollar amount limit is usually set unless it's specified in the FOA. So my role as the project scientist or program director at some institutes for this network is to be the NIH representative on the steering committee. So we reviewed previously how the PFDN is comprised and its mission to perform multi-center studies to improve the diagnosis, treatment, and prevention of female pelvic floor disorders. And the PFDN has been incredibly productive with over 100 peer-reviewed publications. You know these studies well, they're the game-changing landmark studies, and they have gotten tremendous attention from NICHD, which is good. But as we'll talk about a little bit later, that data is also available to you to use. Some of the recent studies include SUPRA, which compared native tissue repairs to vaginal mesh hysterepexy. DEMAND used MRIs to look at vaginal wall descent. E-Optimal demonstrated, unfortunately, lower than desired surgical success rates following uterus sacroligament and sacrospinous surgeries. And ASPIRE is currently in an extended phase, and the data from most of these studies is available, which again I'll touch upon a little bit later. So let's say you get a grant but need more funding than what you initially asked for, which is unfortunately the case in a lot of grant processes. In this case, you would apply for something called a supplement, and I'm going to briefly discuss these funding opportunities. There's the Diversity in Health-Related Research Program, and this supplement can provide additional funds to the parent award, which was the original grant, and is geared to help underrepresented groups. So this award is to support the addition of somebody from these designated underrepresented groups to the project. And as I mentioned before, NICHD has a very strong commitment to these underrepresented groups. To their credit, Congress acknowledged that the escalating costs of advanced education and training in medicine and clinical specialties were forcing some scientists to abandon their research careers for higher-paying private industry or private practice careers. So the NIH loan repayment programs were established by Congress to try to recruit and retain these highly qualified health professionals into the biomedical or biobehavioral research careers. So each IC has their qualified areas in which the research needs to be performed. These can be through the extramural or intramural branches. Applicants do need to be a health professional as well as a U.S. citizen or permanent resident, and the educational debt must be greater than or equal to 20 percent of the salary. Specific programs may be related to a field or topic such as these that I've listed here, or they may be targeted to a particular group of under-resourced or disadvantaged individuals. Loan repayment programs repay up to $35,000 annually or 20 percent of the salary, and these figures are subject to change. NIH will offset federal tax liability in addition to the $35,000. Yep, $35,000. So the ultimate total could be more than that, and the investigator must be conducting qualifying research for at least 20 hours a week, which is deemed 50 percent effort by the federal government. Now remember, these programs aren't paying for the research. They're intended to offset the poor salary associated with those willing to do the research. These are great programs for those who do want to pursue research. They're, again, not intended to subsidize loan repayment for those in private practice. NIH considers this to be an investment in the future of health discovery and the well-being of the nation. So some miscellaneous information about NIH funding. Specifically for NICHD, there is a move away from a strict payline, which traditionally meant that only applications with a certain percentile of a score were funded. This ran the risk of not funding highly scored investigator-initiated projects that aligned closely with NICHD priorities but narrowly missed the payline. So rather, we now have the flexibility to reach for proposals that may be a higher scientific priority but had a borderline score. The bottom line is we will continue to welcome, encourage, and support investigator-initiated applications that help advance our mission goals. Application numbers, unfortunately, for those applying are increasing, fortunately, for the institutes, while the available dollar remains somewhat stable. So additionally, the payline is decreasing, though we are moving away from a strict payline. Many applications for good science are therefore not being supported. And specifically for NICHD, we have a very specific problem compared to other ICs because we do get more human subject studies with higher requested budgets, and we still have a high reliance on a definitive payline, ultimately. So as seen here, the payline has continued to decrease over the years, which means basically the criteria for getting funded requires better and better scores. While the number of applications has continued to rise, the number of awards has not. So we are having some difficulty funding a lot of high-quality studies, but this really isn't meant to be discouraging. It's overall a good thing that we have many more applications than we can fund, and I do definitely still encourage you to apply because the more applications we get, the more we can advocate for more money from Congress. I've thrown a lot of information out at you. Of course, this will be available later as a recorded webinar, but I will review a little bit about where to get more information if you do need it. And so first thing is you can search NICHD for information about their specific grants. All of this is available online. You can just Google that or go to the NICHD.NIH.gov website. So funding opportunities and mechanisms can be found there. Or you can search NIH in general for information on grants and funding, as I've shown to you here. Here are a few other resources. I'm, again, happy to provide these to you offline later. You can Google them and then they should be available through this webinar later. So if you can't obtain funding, what are some other options? And the last topic I'm going to share with you is data that's available to you for free, mostly because you've already paid for it with your tax dollars. So the Data and Specimen Hub, or DASH, was developed as a purpose to make available any federal-funded study data, which ultimately maximizes NICHD's investment in research studies through the promotion of data sharing. As we had talked about just briefly, NICHD has a broad research portfolio. There's over 2,000 clinical research studies conducted annually, and this generates a wealth of data that can be utilized for primary or secondary scientific discovery. Furthermore, DASH addresses current data sharing challenges. So, for example, data may be stored in silos or in different physical locations, and also on a variety of different devices. Often the storage locations are not catalogued, and the data may also be stored in different formats and structure without uniformity, making it difficult to share easily. The purpose of DASH was to comply with federal as well as NIH policies. And so DASH provides a publicly accessible centralized resource for researchers to store and access de-identified data from NICHD-funded studies for use in secondary research. It provides a mechanism for NICHD-funded extramural and intramural investigators to share research data from studies and comply with the NIH data sharing policy and the NIH genomic data sharing policy that I had previously mentioned. It is governed by the DASH committee, composed of representatives across divisions, branches, centers, and offices of NICHD. And ultimately, DASH hopes to include the ability to view and request associated biospecimens, connect with related databases, view and use analytic tools, and visualize data as well. So how does the submission process work? The investigator obtains institutional approval as necessary and then submits the de-identified data to DASH. This goes through the committee to verify that the data is appropriately de-identified, which is a multi-step and very complicated process. Once approved, the NICHD division director or branch chief will sign off and the data is posted to the DASH website. So requesters have to submit an online data request form, a data use agreement, and IRB approval, if available. The data request approvals are granted by the DASH Data Access Committee, as well as any provisional study-specific approvals, so if they have requested a steering committee or a specific PI approval. Once the data request package is received, it's reviewed by the DASH Data Access Committee, and if approved, it proceeds to any further approval providers necessary, and then once the request is approved, the data is then provided to the applicant. The data use agreement is executed between the data recipient and NICHD. It's valid for three years and it is renewable. The terms of the agreement require the recipient to use data only for the approved research. The data can't be shared with anybody not listed in the request. There should be no attempt to identify the individuals in the study. The recipient must follow all applicable laws, regulations, and local institutional policies and procedures for handling data, and any violations of the data use agreement must be reported. Furthermore, the requester must acknowledge the contribution of the data submitters and NICHD DASH with regards to publication and intellectual property, and also provide annual progress reports on the research using DASH data. There are currently 191 studies available within DASH, with nine studies offering biospecimens. And remember that the biospecimens aren't housed within DASH, so they would have to be obtained from the physical site directly in which they're stored, but DASH does offer a catalog, which is still a little bit of a work in process. And 50 study topics are available, including pelvic floor disorders. You can Google DASH or go to the dash.nichd.nih.gov website. If you're unfamiliar with the website, the icon in the lower left can provide an overview. You can then search by topic, study type, or other filters to find studies that are available, and you will need to sign up if you haven't done so beforehand to make a request. There are currently nine studies performed by the PFDN whose data is available on DASH that you can use for secondary analyses. Biospecimens are also available, but we are still working on the availability of these specimens, but feel free to reach out to me if you have any questions about that. Along those lines, there are other databases that are out there that you can use. If you want to learn a little bit more about these opportunities, I can put in a plug for my webinar for the fellows that was given last week on January 25th, which is also why my voice and my brain are both cutting out for this one a little bit. Thank you again for inviting me to be here. My mother gave me this portrait, which is very applicable to my household, and these are my crazy kids from a few years ago. The irony is they're both self-initiated, and so they clearly get it from their dad's side. Thank you again for inviting me. If you can spell my last name, my email is easy. It's Donna.MaslumDeuce at NIH.gov, but most people know how to get in touch with me, and I welcome any questions that we have now or later on. Thank you very much. Thank you so much, Dr. MaslumDeuce. That was a fantastic presentation and overview, and personally, I found the history of the NIH really fascinating. I've never heard that before, so thank you for that background. A reminder to the attendees, just put your questions in the Q&A feature, and I will ask them as they come up. While we are waiting, I did have a couple of follow-up questions on the DASH. What is it called? The Data and Specimen Hub. Data Specimen Hub. Okay. Everything in the government has an acronym, and there's actually an entire binder this big on what those acronyms mean, so I do sometimes throw them out there and forget, so please stop me if I say something that doesn't make sense. No, I think you defined all of the acronyms. I just couldn't remember that one. What is the general timeframe from a request to an approval if you want to use data from one of those PFDN studies? The goal is actually approval, not necessarily data in hand, but the goal is actually three weeks. I do say that because sometimes there are little provisions in there, like I had mentioned, and so it can delay it, but it is a very quick turnaround, and really, really, really, really want everybody to use that data, so please, please reach out to me if you have any questions. Okay, that is very fast, and then is there any cost for the data, like for the biospecimen data? The biospecimens, because that's still a work in process, so there will probably be a cost associated with that, just more from a transportation perspective, but in general, any federally funded, obtained, whatever data, biospecimen, should be available to the public for free. Okay, that seems like a fantastic resource. Yeah, but biospecimens, there's a little bit of a difference in that just because of the processing and getting into other places. Yes, I would imagine so. Okay, we have a question here about K awards for mid-career people. If you had a K award as an early career investigator, are you no longer eligible to apply for a mid-career K award, or what are the regulations in terms of time frame that you can have a K? Yeah, that's a great question because basically there's a maximum, and all of this is subject to change at any other point, but there's a maximum amount of time that you can spend in any K award, which is six years. So just depending on what you had previously had and what you're applying for and how long, that would be the biggest limitation. So it's just the maximum number of years that you can spend under a K award. Okay, great. And you mentioned that the NICHD pay lines are dropping and applications are increasing. Are other institutes able to offer funding to more applications, or is there more opportunity for funding at other institutes? So it depends on the mechanism. The R01 is the most competitive. And remember, so what this means for people who aren't familiar, I'm going to review again because I found this very, very confusing. When you get a score from your application, basically there's a percentile, and traditionally there may have been specific, and there still are for some mechanisms where you have to achieve at least this score or else you can't be eligible. So NICHD has moved away from that, especially for like the R01, but some things do apply to that. So that sounded really discouraging. But it's really not intended to be. All the institutes sort of have the same problem, because if you can imagine where our research was 50 years ago and where it is now, we just have much higher quality research and much more experienced and brilliant researchers applying. So it seems discouraging. But the more you apply to an institute, the more they can actually argue for more money. So it's still to all of our benefits for people to apply. But that was really intended to just say, you know, we have a very unique problem because of the large number of clinical trials and how much funding most projects will need. So that puts us at a little bit of a disadvantage. I can't really speak to where other institutes are, but my guess is they're not going to be too far off. But the most important thing when you're applying is not so much the numbers of grants, but more what the topic interest is. Like I said, if it hits a priority for the institute or for the division, like my gynecologic health and disease branch, then you're going to have a much better chance at getting funded, even if you compare to maybe another institute that may not be as competitive. Does that answer the question? Yeah, absolutely. And kind of leads me to another question about the institute that is most appropriate to fund your proposed study. If there is a question about, you know, is it NICHD, NIDDK, NIA, what's the best way to figure out where your study would be most likely to succeed? So the reporter tool, and again, I'm happy to send this out, but you can also just Google matchmaker tool NIH or reporter. And that will help, you know, if you put in a study topic, it can give you an idea of how many topics of that same nature were funded within the different institutes. So it can help at least narrow it down. I would say that most pelvic floor disorder conditions would be relative to NICHD. So you're always welcome to just email me and say, hey, is this appropriate for NICHD? And like I mentioned before, if I don't think it is, then I'll direct you to the PO at NIDDK or NIA. So you can pretty much reach out to anybody at NIH and just say, you know, if you happen to accidentally Google and find somebody at the IAEA Institute, like hopefully they would direct you to the right person. But I think the safest answer is when in doubt, you're welcome to email me and I can direct you towards where it might be the most appropriate because there is some overlap for sure between some of the other institutes and NICHD. Thank you. That's very helpful. Answer my question. The last question that I have was about a slide you showed early on about pelvic floor disorders and then it was priorities were like machine learning and artificial intelligence. Can you talk a little bit about is that, are those the domains in which the NICHD is interested in funding pelvic floor research or talk a little bit more about that? Yeah, not particularly just that, but there are, you know, so when NICHD put out their strategic goals, it was sort of the ambition of where the research wants to go in the future. And so these are newer things that haven't been studied as much with regards to pelvic floor disorders. So it doesn't mean it has to be within machine learning or artificial intelligence, but we would be very excited about. It's probably the better way to state that about projects that would include that. So hopefully that stimulates some interest for the bright minds out there. That's definitely good to know. All right, everyone out there listening, get your machine learning gears going. Yeah, and the priorities and even the strategic plan can change. So the strategic plan changes every five years, but the priorities of the branches do change. So again, it always comes back to just talk to the program officer and see what is their interest of late. Well, this has been such a great talk. I really thank you for putting this together in the midst of everything else you have going on. My apologies for my stuttering and my brain function today. Don't apologize at all. It was a fantastic talk. It was, it was great. And, you know, we, on behalf of the Augs Early Career Research Leadership Program, we want to thank you and thank you to everyone who joined us tonight. I just want to let you know that we have plans. The plans are underway for the webinar series for 2022 so please stay tuned. We'll have a good lineup for you coming shortly. And thank you again to everyone who participated and to Dr. Mazloom-Dust and good night. Thank you.

NIH

grant mechanisms

funding opportunities

research opportunities

DASH

de-identified data

program officers

application process

existing data