For aspiring physician-scientists, securing grant funding early in their careers can make all the difference in establishing a thriving research program; however, the path from mentored career development awards, such as National Institutes of Health (NIH) K grants (career development grants) to independent research awards like R01 grants (research project grants for projects with mature ideas and preliminary data supporting a hypothesis) is extremely competitive. Even otolaryngology rock stars may struggle to land one.
Here are some dos and don’ts from ENT researchers who succeeded in getting these elusive multi-million dollar grants for their research.
Finding Good Research Topics
Getting an R01 grant starts with a research idea that tackles a significant issue, one that affects a large number of patients, such as hearing loss. “If the cause is a lethal disease like cancer, that makes it even more significant,” said Rick Nelson, MD, PhD, professor of otolaryngology–head and neck surgery at Indiana University in Indianapolis.
Dr. Nelson, who investigates the genetics of hearing loss, also emphasized the importance of working innovation into the proposal, such as new techniques or ideas on how something functions or can be treated. Dr. Nelson received his first R01 grant related to genetic hearing loss last year. The award was for $3.6 million and funds a study of the relatively common TMPRSS3 gene, which, when mutated, can cause congenital hearing loss as well as hearing loss in young children, depending on the variant (or mutation) in the TMPRSS3 gene.
“Certain mutations are what we call damaging, where they don’t allow the protein that’s made from the gene to function at all. We assume the more minor mutations cause less of an impact on the protein’s function,” Dr. Nelson said, adding that they are one year into a five-year grant, trying to understand what the TMPRSS3 gene does inside the inner ear and why it’s so important for hearing because the cellular function is still unknown.
Preliminary Research
“One of the rules of R01s is you always need more preliminary data than you think,” said Bradley Goldstein, MD, PhD, professor of head and neck surgery and communication sciences at Duke University in Durham, N.C. “Preliminary data gets at the approach and feasibility part of the grant, which helps convince reviewers that you can do the experiments you’re proposing. The best way to do that is having done some of these experiments that you can interpret and draw conclusions from.”
Preliminary data gets at the approach and feasibility part of the grant, which helps convince reviewers that you can do the experiments you’re proposing. The best way to do that is having done some of these experiments that you can interpret and draw conclusions from.” — Bradley Goldstein, MD, PhD
Getting that data, however, can be a bit of a catch-22, because the funding is needed to do preliminary research. While some academic departments help invest in their university’s research mission, foundations, and societies can also fill the gap.
Dr. Goldstein’s own first R01 grant, funded in 2018 for $1.9 million, studied some of the mechanisms that regulate how an adult’s olfactory epithelium can be regenerated after injury.
Prior to his R01, he had a K08 award, which is a mentored grant. His more recent grants focus on understanding olfactory damage and repair in humans using biopsy-based techniques and how olfactory neurons function in health and disease. So far, his R01 grants have totaled more than $5 million in funding.
Mentors and Collaborators
Building a collaborative team and seeking mentorship are also key parts of the grant proposal. Dr. Nelson collaborated with the University of Iowa, which has a large sample of known patients with genetic TMPRSS3 hearing loss. He also collaborated with Alan G. Cheng, MD, professor of otolaryngology–head and neck surgery at Stanford Medicine in Palo Alto, Calif., who has expertise in doing injections in the inner ears of mice. Collaborations like these can arise from reading publications and reaching out to the authors or attending conferences and hearing researchers speak about their work, then asking if they’re willing to collaborate.
Dr. Goldstein suggests having mentors look at a draft of your grant before submitting it and said the Triological Society is growing a mentoring network to help early-career otolaryngologists with exactly this. He also recommended getting feedback on pilot grants to submit to societies and the academy for preliminary research. These pilot grants usually include an aims page of what you’re proposing to do that includes the significance of the study, the innovation, and the approach.
“Usually, you’re going to ask people who have some expertise in the field so they can give you critical, meaningful feedback. The writing style has to be good, but it’s really about your ideas and how things are structured in the grant,” Dr. Goldstein said, adding that these experts can advise you on what to be sure to consider when you write this experiment.
And don’t forget to include colleagues from other fields. “Definitely have some colleagues who are not in your exact field read the key parts over,” said Justin S. Golub, MD, associate professor and vice chair of faculty development in the department of otolaryngology–head and neck surgery at Columbia University in New York. “Because at least some of the reviewers are not going to be in your exact field.”
Storytelling 101
When it comes to crafting a compelling R01 grant application, it’s important to think about winning over hearts and minds both in the medical community and in a wider circle. “It’s all about telling the story,” said Matthew Bush, MD, PhD, MBA, professor and chair of the department of otolaryngology–head and neck surgery at the University of Kentucky in Lexington, Ky. “Talk about how the study team is uniquely able, through innovative methods and research, to communicate the findings not only to a scientific audience but also to the greater public whose tax dollars will be used. You have to be convincing that this is the time and these are the people to support to make this work happen.”
Talk about how the study team is uniquely able, through innovative methods and research, to communicate the findings not only to a scientific audience but also to the greater public whose tax dollars will be used. You have to be convincing that this is the time and these are the people to support to make this work happen.” — Matthew Bush, MD, PhD, MBA
Dr. Bush, whose research focuses on health equity and disparities, shared an example from his own R01 grant, the CHHIRP study. “We’re conducting a pragmatic clinical trial in state-funded public health centers in the commonwealth of Kentucky to see if a patient navigation program can improve diagnosis and treatment for kids who fail a newborn hearing screening,” he said. Additional components include implementation factors through qualitative and quantitative methods, assessing methods for success or failure while implementing in a community-based setting, and cost-effectiveness of the program.
“A patient navigator is a layperson who has personal experience with this type of healthcare scenario and wants to be involved in helping others,” he said. This comes out of the cancer world, where cancer survivors have been trained and are paid to support patients in acquiring care.
In Dr. Bush’s study, these patient navigators are often the parents of children who have gone through a pediatric hearing diagnostic pathway. The grant, which was for about $3.3 million, covers hiring and training navigators, participant payments, and staff. “The biggest cost for a pragmatic clinical trial like this is human resources: the staff collaborators, co-investigators, collaborators, interventionists,” Dr. Bush said.
One thing aspiring researchers may not consider is that grant program officers can provide a wealth of information if you just reach out to them. Dr. Bush says having a healthy dialogue with program officers can be immensely helpful in sharing some of the priorities of institutes or foundations. “They can often direct you to the best home for a particular grant,” Dr. Bush said, adding that while a program officer can’t review your science, they can really help to navigate the system of the grant review.
“This is public information for the NIH in that each grant mechanism and each institute has very clearly delineated individuals who serve as program officers,” he said. “You can request a meeting, and they are often more than happy to meet with investigators.”
If you do request a meeting, Dr. Bush advised sending a one-page aims document stating what you plan to do and why, along with a biographical sketch to help the program officer understand your background and your project. He also warned against proposing aims that are dependent on each other. For example, if you write two or three aims, and the second and third are dependent on aim one, the feasibility of the later aims are affected if that first experiment doesn’t pan out. “Make the aims clear, succinct, and independent,” Dr. Bush said.
Common Pitfalls
One thing to avoid in writing an R01 grant is what Dr. Nelson calls “fishing experiments.” These are experiments where you are essentially proposing casting a line and hoping for the best. These proposals are not usually viewed very well. “Do your fishing in preliminary experiments,” Dr. Nelson said. “Grant reviewers don’t want to hear that you’re going to screen 1,000 different things and hope you find something. They want you to come in with a candidate target that helps to increase the feasibility of the project.”
Grant reviewers don’t want to hear that you’re going to screen 1,000 different things and hope you find something. They want you to come in with a candidate target that helps to increase the feasibility of the project.” — Rick Nelson, MD, PhD
Likewise, an underlying message that reads like a patchwork quilt of multiple investigators’ expertise rather than a cohesive story will be difficult to follow and support. Other pitfalls to avoid include submitting proposals with typos, grammatical errors, and inconsistencies from one section of the grant to the next, as well as not following the grant’s instructions. “Each grant you apply for has explicit instructions about the priorities of funding in this particular grant mechanism,” Dr. Bush said. “If you don’t follow instructions on how the grant is assembled, that will be a fatal mistake.”
And don’t wait too late after getting a K grant to apply for an R01. Dr. Nelson said that when he was applying, the people who were successful tended to apply at the end of the third year of their K grant. “It could take almost two years to progress through grant reviews and resubmissions after revisions,” he said. “If you wait until the fifth year, then you will run out of funding. In my experience, the best predictor of success in securing an R01 is early application.”
Resilience and Perseverance
Rejection is a common experience in the world of grant funding, but it need not define your success. “Don’t give up or let rejection define you or your happiness. Take rejection as an opportunity for improvement and to expand your study team or your scientific approach,” Dr. Bush said. “Each time you write a grant, consider that as a success. It’s a labor of love. We may not have academic or funding success every time, but it’s a lot of work and an accomplishment just to finish and submit it.”
Additionally, it is critical to understand that no researcher is 100% successful with each grant they submit. “A lot of the overachievers and academicians submitting these grants are not used to rejection,” Dr. Nelson said. “They are top-of-their-class types of people, and to get a rejection is hard to swallow. But you have to learn to accept it, persevere, and reapply.” Dr. Nelson recalled his mentor telling him that grant applications are all about shots on goal; the more you shoot, the more likely it is that one will go in. And while it may be difficult to think about that in the aftermath of a rejection, it’s part of the process. Addressing reviewers’ critiques and potentially recrafting your proposal with additional data will improve your odds of success.
While reapplying for R01 funding, researchers need additional funding to generate preliminary data and should explore alternative funding sources to keep their work moving forward. The Triological Society offers several grant opportunities tailored to junior faculty (see sidebar). Dr. Nelson also suggested looking into smaller NIH grants like R03 or R21 or funding from other agencies and foundations. These could include the Department of Defense, tumor foundations, or professional societies, as long as your research fits what they want to fund. Many academic centers have bridge funding to help sustain research between grants.
Landing that first R01 grant is certainly cause for celebration, but it also marks the beginning of a new chapter that requires careful planning and management. Dr. Bush highly recommends beginning the celebration by giving thanks to family and friends who have not seen you because you’ve been sequestered in your office or lab as well as thanking collaborators and administrators who helped to assemble the many pieces. “This is not the success of one individual, even though one individual is listed as the PI,” Dr. Bush said. “It takes a village to raise a grant.”
The next steps are to set up an infrastructure for accountability so that the work is done right and you’re responsible about how you spend the funds. “Make sure you have the administrative support and financial oversight in place to carefully follow that budget and move through the next five years,” Dr. Bush said.
Keep in mind that although you are a team leader as a physician, running a randomized controlled trial is very different from being a clinician. “As a physician, the team has obvious roles. Everyone knows what the medical assistant, practice assistant, scrub tech, and operating room nurse is supposed to do,” said Dr. Golub. “When you build a research team, you have to hire people and assign their roles, and then make sure they do their roles, but you
don’t want to micromanage, and you don’t want to be too hands-off, giving no direction or timeline. It’s an acquired skill, and having some role models or mentors helps with that.”
Carrie Nieman, MD, MPH, associate professor at Johns Hopkins University School of Medicine in Baltimore, said the process should also begin with getting the Institutional Review Board application in order and submitted and then mapping out the manuscripts you plan to submit and discussing authorship with collaborators early in the process. “Prioritize protocol and recruitment papers as materials that can be published prior to trial completion,” she said.
Dr. Nieman, who co-leads two R01-funded studies on addressing hearing loss, advised engaging a range of stakeholders in the planning process, ranging from patients to community members and policymakers, to review your measures and ensure you are capturing meaningful outcomes that position the trial to have the greatest impact. Other key priorities include strategizing to diversify your research portfolio and developing good time management practices.
While R01 grants may be considered the “coin of the kingdom,” they are not the only path to a successful research career. Other grant mechanisms like U01s and R21s can provide valuable opportunities, as Dr. Bush discovered in his own journey.
“There are so many different research funding mechanisms and grant opportunities that can support researchers,” he said, likening diversifying a research portfolio to protect the financial security of your lab to diversifying your personal financial portfolio.
Dr. Bush has a U01 with co-PI Susan D. Emmett, MD, MPH, an otolaryngologist at the University of Arkansas in Fayetteville, Ark., focused on the transformation of school-based hearing healthcare for children in rural communities. He also received an R21/R33 grant from the National Institute on Deafness and Other Communication Disorders to promote better access to hearing healthcare for adults. “This funding mechanism supports researchers conducting exploratory work in the R21 phase, and then facilitates the study of a clinical intervention in the R33 phase,” he said. “That was a specific mechanism that allowed us to expand our research to address access and affordability of rural adult hearing healthcare.”
Dr. Bush recommends signing up for NIH funding opportunity announcement emails at NIH.gov.
Ultimately, getting an R01 funded involves passion, perseverance, and a strong support system to help during the tough times.
“As otolaryngologists, the path for clinician–scientists can be difficult and can feel lonely,” Dr. Nieman said. “Wherever you are along that path, from just starting to well into the grind that is the funding cycle, know you are not alone. We serve an invaluable role in our departments and in our field, advancing what is known, what we offer our patients, and how we deliver care.”
Renée Bacher is a freelance medical writer based in Louisiana.
Triological Society Grants to Support Research Career Development
The Triological Society is committed to supporting the research efforts of otolaryngologists earlier in their careers through grant funding. Two key opportunities:
The Research Career Development Award provides $40,000 for one to two years to junior otolaryngology faculty who have not yet obtained NIH funding. It supports the generation of preliminary data to aid in the development of a research program and enhance a physician–researcher’s competitiveness for NIH grants.
The Triological Society/American College of Surgeons Clinical Scientist Development Award provides $80,000 per year for the remaining duration of an existing NIH K award to boost research productivity and competitiveness for an R01 grant. The funds are fairly unrestricted and can be applied to protecting research time, carrying out experiments, or both.
Bradley Goldstein, MD, PhD, professor of head and neck surgery and communication sciences at Duke University in Durham, N.C., who serves as the research coordinator for the Triological Society, said these grant mechanisms have a track record of success, with many prior recipients obtaining subsequent NIH funding.