December 12-13, 2022
Lindsey Criswell, M.D., M.P.H., D.Sc.
Gayle Lester, Ph.D.
Ricardo Cibotti, Ph.D.
Kristy Nicks, Ph.D.
The NIH K08 and K23 Mentored Research Career Development Awards provide support for a sustained period of “protected time” (3-5 years) for intensive research career development under the guidance of an experienced mentor, or sponsor, in the biomedical, behavioral, or clinical sciences leading to research independence. Previous discussions have identified the K-to-R01 transition as a critical point in the development of clinician-scientists’ independent research careers.
NIAMS held its first K Forum in 2012. Based on the positive feedback received from participants, NIAMS convened subsequent meetings in 2013, 2014, 2015, 2016, March 2018, December 2018, 2019, 2020, and 2021. The K Forum brings together clinician-scientists with a NIAMS K08 or K23 award. In 2022, the meeting included the 3rd year NIAMS K awardees as well as one NIAMS intramural research program scholar. The Forum also included established clinician-scientists as mentors, some of whom had NIH K awards in the past, and representatives of professional and voluntary organizations with an interest in research within the NIAMS mission.
The purpose of the meeting is to foster a shared, open discussion of challenges K investigators face in pursuing research independence. The Forum also provides an opportunity for the K awardees to network with other participants and interact with NIAMS leadership and staff. NIAMS long-term goal in holding this Forum is to enhance the Institute’s support of early-stage clinician-scientists by encouraging and enabling them to continue performing basic, translational, or patient-oriented research in their chosen fields.
Welcome and Research Presentations
The Forum started on December 12 with a welcome by the NIAMS Director, Dr. Lindsey Criswell. Her remarks were followed by introductory presentations from K award investigators and the NIAMS intramural scholar. The presentation session was moderated by Dr. Ricardo Cibotti. Each scientist briefly outlined their career path story, provided an overview of their research project and progress, and answered questions from the other participants. Dr. Gayle Lester closed the session with reflections on the presentations. She expressed the Institute’s appreciation to the speakers and commended them on their progress, especially considering the challenges that clinical researchers have faced during the COVID-19 pandemic. Dr. Lester also encouraged the investigators to engage with NIAMS staff and connect with the mentors and their peers for exchange of information and collaboration.
Presentation and Discussion of K Award Past Outcomes, Future Directions, NIH Policy Updates, and Continued Challenges Related to the COVID-19 Pandemic
After Dr. Lester’s remarks, Dr. Amanda Boyce, who for many years prior to her move to the National Institute on Aging had co-chaired the NIAMS K Forum, presented an overview of the K awards program. The presentation focused on outcomes of the program as well as information about related policies. Dr. Boyce highlighted analyses that were conducted to assess the success of the K awards and discussed some of the steps NIH and NIAMS are taking to address and overcome common challenges faced by early-stage clinician-scientists. Dr. Boyce then reported on policy updates that are relevant to clinician-scientists with career development awards and closed by briefly reiterating the goals and purpose of the K Forum.
A 2011NIH-wide evaluation of K01, K08, and K23 awards explored who applies for and receives mentored career development awards and the effects of the K award on research productivity and independent careers. The analysis compared outcomes of individuals who received a K award to those of similar individuals who applied for but did not receive a K award. The evaluation showed that K awardees:
- are more likely to have subsequent research publications;
- are more likely to apply for subsequent NIH research awards;
- have a higher R01 award success rate;
- have a higher percentage of years with subsequent NIH support; and
- are more likely to apply for and receive at least one competitive renewal of an R01 grant.
A small analysis was conducted by NIAMS in 2012 in collaboration with two rheumatology-related foundations. The results of the analysis suggested that individuals who received both foundation support and an NIH K award were more likely to apply for and receive R01 funding than K awardees that did not have such additional support. Additionally, the analysis identified the transition period between the K and the R01 awards as a vulnerable point in an investigator’s progression to independence.
Further, data from the 2014 Physician-Scientist Workforce Report showed that the numbers of first-time M.D. and M.D./Ph.D. NIH research project grant applicants had been stable for ten years, despite the increase in the total number of physicians.
Dr. Boyce discussed challenges facing early-career clinician-scientists, such as salary coverage, educational debt, transition to independence, time in training, mentoring support, protected time, clinical demands, and work-life balance. In recent years, NIAMS and/or NIH have made efforts to address these challenges by:
- increasing salary and research costs for K08 and K23 awards in 2016,
- clarifying supplemental salary and compensation policies for research career development awards,
- supporting an educational loan repayment program,
- offering a limited competition small grant program (R03) for NIAMS K08 and K23 recipients,
- supporting the Stephen I. Katz Early Stage Investigator Research Project Grant, named after NIAMS’ former director, for an innovative project in an area of science that represents a change in research direction for an early stage investigator and for which no preliminary data exist,
- setting a higher payline for early-stage investigators,
- supporting the NIAMS Supplements to Advance Research (STAR) from Projects to Programs for early-stage investigators, and
- supporting the NIH K24 program to provide support for mid-career researchers who would like to serve as mentors in patient-oriented research with or without a clinical trial.
Dr. Boyce also mentioned several policy updates from the NIH related to K career development awards and early-stage researchers, including,
- an update of the NIH extension policy for early-stage investigators who take time off for various reasons (e.g., childbirth),
- an update on NIH’s interest in diversity,
- guidance and information for NIH applicants and recipients of NIH funding in response to the COVID-19 pandemic,
- a K Award policy update on concurrent support from a mentored K Award and research grant,
- an updated NIH extension policy for early-stage investigator status (ESI), and
- an update on the NIH policy for review and resubmission of new investigator R01 applications.
Tuesday Afternoon Welcome
On December 13, Dr. Criswell welcomed the group back and reiterated NIAMS’ commitment to developing clinician-scientists. Dr. Criswell noted that the unpredictability of the NIH budget, the current funding climate, and the continuing COVID-19 pandemic are challenges for researchers. She expressed the Institute’s concerns about how the pandemic is affecting early-stage researchers, such as K awardees. She reaffirmed NIAMS’ support for these early-stage investigators and encouraged them to contact their program officers for assistance if needed.
NIAMS Extramural Program Structure and Functions and K Awardee Meetings with NIAMS Extramural Staff
After Dr. Criswell’s remarks, Dr. Kristy Nicks provided an overview of the NIH and NIAMS with a focus on the activities of the NIAMS Division of Extramural Research and how the Division administers extramural grants. Following a brief introduction to the organizational structure of NIH and NIAMS, Dr. Nicks provided more information about the NIAMS extramural program. She discussed the Office of Extramural Operations (OEO), which manages the NIAMS grants policies and procedures, the receipt and review of grants, and the oversight and management of clinical studies. She also described the Program Division, which supports and oversees the scientific and technical aspects of awards and includes program officials who are the primary points of contact for investigators.
The K awardees then participated in a panel discussion with NIAMS program and clinical management staff, NIAMS grants management staff, and NIAMS review staff. Dr. Nicks moderated the discussion, which provided the K awardees with an opportunity to ask questions and interact with the NIAMS representatives.
Mentors and Professional and Voluntary Organizations Meeting with NIAMS Leadership
NIAMS leadership met with the mentors and representatives from the professional and voluntary organizations to discuss shared goals in training and workforce diversity. Dr. Criswell provided the group with updates on the NIH and NIAMS budget, programs for early-stage investigators, and the Team Science Leadership Scholars Program. She encouraged the participants to engage with NIAMS in the Institute’s ongoing and future strategic planning activities. After her presentation, Dr. Criswell led the group discussion focusing on research opportunities and partnership, support for trainees and early-stage investigators, as well as workforce diversity and health disparities within the NIAMS mission areas.
Breakout Sessions and Group Discussion: How to Maximize Chances to Get the First R01/U01 in the Next 2-3 Years
During the second breakout sessions, the K award investigators and NIAMS scholar met in small groups with the mentors to discuss strategies to maximize the chances of the K awardees getting their first R01/U01 in the next 2-3 years. After the small group conversations, the meeting participants reassembled, and each of the two small groups shared insights from their discussions.
The first group discussed the level of productivity expected during the K award period. They considered strategies to be productive and diversify their research portfolios while pursuing opportunities to work on different projects. The group noted the importance of communicating their science and research results, which led to a discussion about how to navigate authorship during the transition period of the K award. They exchanged thoughts and information about different paths and approaches to tenure, and how to navigate all these career steps while balancing priorities and commitments outside of work.
The second group talked about strategies to obtain long-term funding and how to organize various grants, projects, and the research lab. They noted that with remote working, where people are located might not matter as much and considered this new norm in the context of collaboration. The group also discussed how to support a research lab with start-up funds and hire the right team members. Other topics included balancing clinical duties, resources from NIAMS, funding gaps and how to address them, as well as balancing life and family responsibilities.
After the reports from the breakout groups, all participants had the opportunity to comment or ask questions. Some noted the importance of mentorship for advancing the science as well as for networking and obtaining career advice. Others suggested that while it is important to learn from the mentors, it is also critical to negotiate independent projects and resources. It was noted that mentoring is a partnership because mentors also learn from their mentees. Some encouraged the researchers to consider assembling a team of mentors that can provide different perspectives and offer advice on many aspects of their career. NIAMS staff mentioned their willingness to listen and support and encouraged the K awardees to reach out.
Professional and Voluntary Organizations Meeting with NIAMS Staff
NIAMS staff met with representatives from the professional and voluntary organizations to discuss how NIH and the organizations can work together to support K scientists. The organizations’ representatives briefly described their missions and resources available to early-stage investigators, some of which are specifically designed to supplement and support researchers with existing NIH career development awards. The resources discussed ranged from new investigator, bridge, and supplement awards to assistance in establishing mentor and peer networks and awards to help address COVID-19-related research delays. The organizations also highlighted their efforts to improve diversity and inclusion of women and underrepresented groups working in their mission areas. These efforts focus both on diversifying the scientific workforce, including awards to improve networking and mentorship opportunities, and on encouraging research that addresses health disparities through targeted funding opportunities. The groups also discussed awards to help retain researchers and support investigators whose grant applications fell just short of NIH paylines.
After the breakout sessions and discussion, the meeting continued with a panel on grantsmanship moderated by Dr. Cibotti. Panelists included the meeting mentors and Dr. Alexey Belkin, a NIAMS program director who previously worked at the NIH Center for Scientific Review. A brief summary of the panelists’ responses is provided below.
As a reviewer, what you would like to see on the aims page and the research strategy section of a competitive R01 application from a new principal investigator?
The mentors emphasized the importance of making the application clear and concise so that it is easy for reviewers to read and understand. It is important to start with a broad long-term goal, including context for why the goal matters and the significant knowledge gap that the proposal addresses. After defining the problem, it is important to present the research strategy that will be used, highlighting how the approach is innovative and explaining why a certain approach is chosen. One mentor also recommended including a brief introduction of those involved in the project if that is helpful.
What are the most common grantsmanship errors that you see in R01 applications from new principal investigators?
The mentors mentioned several common errors in first-time R01 applications. A very common error is submitting an application that is overly ambitious. Another mistake is including too much unnecessary information. In many cases, it is better to have a little data that is of high-quality than to include data where rigor is lacking. Applicants should refrain exaggerating or misrepresenting past data.
It is important to demonstrate rigor, including statistical rigor throughout the application, and to address pitfalls and alternative approaches. By noting different perspectives, the researchers help assure reviewers of their background knowledge and rigorous approach.
When you were a new PI, what common errors did you need to correct to get your first R01 award?
The mentors shared the challenges they faced when applying for funding as new investigators. One issue was demonstrating that their projects were feasible. Applicants should describe their most realistic plan to complete the project with the budget provided. One mentor emphasized that the rationale for the grant should be very clear. In this regard, it can be helpful to think carefully about the rationale for each specific aim and what accomplishing each aim would mean in terms of moving science forward. For example, each of the three aims in a competitive R01 application should be a small “story” or equivalent to a publication when completed. Another panelist noted that a competitive R01 grant can include only two aims instead of three. One mentor suggested that using diagrams to help explain a concept can be very effective.
How can you assess if your application is overly ambitious? How should the alternative approaches/competitive concepts pages be addressed?
It can be difficult to determine whether a grant is overly ambitious. For new applicants, getting feedback from colleagues, mentors, and others can be helpful in determining whether the applicant’s aims are reasonable. One sign that a grant is overambitious is that the section on pitfalls and alternative approaches is underdeveloped. It is important to address these pitfalls and alternative approaches at the end of each aim. They often can be addressed from a technology point of view but using different technologies alone might be insufficient. Applicants also should include strong preliminary data that demonstrates feasibility of the proposal, including negative data that can provide knowledge about clinical practice or lessons learned. It is important to convince reviewers that negative data also can be helpful, and applicants are cautious about wasting time and resources when their projects do not progress as planned. One mentor advised against overly exuberant alternative strategies.
How much preliminary data should be included in an application? How much do you really need and why are these data important?
Applicants need to provide enough data to support each aim. The goal is to show that the research proposed is feasible and the “signal” is worth pursuing. Researchers should include enough data to convince a reviewer that the applicant is qualified to do the research they are proposing. So, where possible, they should show data that indicate that the applicant or others on the application have experience conducting the types of studies proposed. This is particularly important if a new technique is proposed. One mentor also recommended highlighting any specific strength such as past records of meeting recruitment goals.
What do you need to show on rigor/reproducibility section that most early-stage investigators ignore?
One mentor suggested that rigor and reproducibility should be addressed throughout the application instead of in a separate general section that can be missed. Past publications also can help support the quality of data the applicant can generate.
How do you write the intro section to a revised application to respond to reviewer concerns?
The panelists emphasized the critical importance of the first page. One mentor suggested to start drafting this section early in the re-submission process to help organize the response. It might be helpful to find commonalities among the reviewers’ feedback. In addition, if the initial scores were relatively high, they should be included in a text box on in this section. The mentors also cautioned against misrepresenting reviewers’ comments and encouraged the applicants to be passionate without being emotional about their work.
How do you address premise or gaps in prior research and how it relates to significance?
Addressing premise and gaps can be challenging for early-stage investigators. Newer applicants may focus too much on their own project and not enough on the broader context. It is important to convey why the project matters and discuss any existing controversies or different perspectives about the topics included in the project.
Dr. Jill Buyon, an established clinician-scientist, provided her perspectives on mentorship and building a career in clinical research. As part of her presentation, she wanted to reflect on her career journey “from aspiration to inspiration and back” with hopes that her thoughts and experience could help others as they progress in their careers.
Dr. Buyon mentioned her early aspirations and emphasized that at the current stage in their career, the K awardees are already successful. She discussed the next steps, milestones, challenges, and important decisions they would face while reminding them to develop a long-term plan and consider putting together a team of mentors who can both advise them and benefit from the two-way exchange in mentorship. Dr. Buyon also shared with the group about how to be successful in the grant process, including coping with rejections and serving as peer reviews.
Finally, Dr. Buyon talked about why she always loves what she does and acknowledged her own mentors, her mentees as her measures of success, and her inspirational colleagues. Mentorship is a lifetime process. It also is a bidirectional relationship; mentors get something out of the relationships too, and eventually the mentees one has successfully inspired will become one’s own inspirational colleagues.
Dr. Criswell noted that she enjoyed the K Forum and was impressed with the high quality and sophistication of the research being conducted by NIAMS K awardees. She thanked the mentors for sharing their insights and advice with the K researchers. She also thanked the NIAMS staff who worked with the K awardees and on the K Forum.
* BALEVIC, Stephen, M.D., Ph.D., Duke University
BARLIC-DICEN, Jana, Ph.D., Lupus Research Alliance
BARNADO, April L., M.D., M.S.C.I., Vanderbilt University
* BOOKER, Staja, Ph.D., R.N., University of Florida
BOYCE, Amanda, Ph.D., National Institute on Aging
* BROWN, David A., M.D., Ph.D., Duke University
BUYON, Jill P., M.D., New York University
CASTILLO, David, American Academy of Dermatology
* CHANG, Aileen Y., M.D., M.S.P.H., George Washington University
* DORSCHNER, Robert, M.D., University of California, San Diego
HOWARD, Leah M., J.D., National Psoriasis Foundation
KAHLENBERG, J. Michelle, M.D., Ph.D., University of Michigan
MARCHIOLO, Eryn, M.P.H., Rheumatology Research Foundation
* MCCOY IV, William H., M.D., Ph.D., Washington University in St. Louis
MINNILLO, Rebecca, D.M., M.P.A., Society for Investigative Dermatology
NELSON, Amanda E., M.D., M.S.C.R., University of North Carolina, Chapel Hill
* PAIK, Julie J., M.D., M.H.S., Johns Hopkins University
* PASCUAL-GARRIDO, Cecilia, M.D., Ph.D., Washington University in St. Louis
SCHARSCHMIDT, Tiffany C., M.D., University of California, San Francisco
SEYKORA, John T., M.D., Ph.D., University of Pennsylvania
SMITH-TERRY, Sharon, M.B.A., C.D.M., Orthopaedic Research Society
* TALABI, Mehret Birru, M.D., Ph.D., University of Pittsburgh
VASSILEVA, Maria T., Ph.D., Arthritis Foundation
* WAKEFIELD, Emily O., Psy.D., University of Connecticut
* WEI, Kevin S., M.D., Ph.D., Brigham and Women's Hospital
WHEATLEY, Mary J., I.O.M., C.A.E., Scleroderma Foundation
* YEUNG, Howa, M.D., M.Sc., Emory University
*Indicates current NIAMS K08 and K23 awardees.
AMBLER, William, M.D.
BELKIN, Alexey, Ph.D.
BHAUMIK, Suniti, Ph.D.
BURROWS, Stephanie Y., Ph.D.
CARTER, Robert, M.D.
CIBOTTI, Ricardo, Ph.D.
CRISWELL, Lindsey A., M.D., M.P.H., D.Sc.
DRUGAN, Jonelle K., Ph.D., M.P.H.
DUNDAS, Colleen, M.P.H.
GRAY, Jennifer Morgan
HAUSERMAN, Janelle, Ph.D.
JACKSON, Thomas, M.S., M.P.H.
LABBE, Colleen, M.S.
LESTER, Gayle, Ph.D.
LIN, Helen, Ph.D.
MANCINI, Marie, Ph.D.
MAO, Su-Yau, Ph.D.
NGUYEN, Van T., Ph.D.
NICKS, Kristy, Ph.D.
NYACK, Nicole, M.P.H.
PARK, Heiyoung, Ph.D.
ROBINSON, Daphne, Ph.D.
SERRATE-SZTEIN, Susana A., M.D.
WALKER, Robert, Ph.D.
WANG, Yan, M.D., Ph.D.