Novel Collaborations Across Training Programs to Support Mentoring in Sex Differences Research

Introduction

The systematic study of sex differences and incorporation of sex as a biological variable (SABV) in research are integral to understanding the full spectrum of health and disease ¹ ; as such, it is essential to grow and sustain a capable, dedicated, and diverse translational workforce with the training and expertise needed to incorporate these considerations as essential elements of their research. To accomplish this goal, the Office of Research on Women's Health (ORWH), in partnership with other National Institute of Health centers, requires inclusion of a Career Enhancement Core (CEC) within each of its Specialized Centers of Research Excellence (SCORE) on Sex Differences. The CEC must be maintained throughout the center funding period, and provide opportunities for training in rigorous research methodologies, understanding women's health, and incorporation of SABV in planning of projects, analysis of data, and reporting of results.

The Medical University of South Carolina (MUSC) SCORE CEC provides 50% salary support for 2 years and research project funding for promising junior faculty committed to conducting sex differences-focused work. The overall MUSC SCORE focuses on integrating basic, clinical, and behavioral approaches to gain insight into sex differences and the relationship between substance use, stress, and underlying neural circuitry. Although funded as a National Institutes of Health (NIH)-supported center since 2002, the MUSC CEC was established in 2018 with the NIH transition from the P50 to U54 mechanism for SCORE support.

While complementing existing NIH-supported research training programs at MUSC, the MUSC SCORE CEC addressed a previously unmet need for research career development in the areas of sex and gender differences and understanding SABV particularly as it pertains to the role of stress in human health and disease. The MUSC National Institute on Drug Abuse (NIDA) K12 and Building Interdisciplinary Careers in Women's Health (BIRCWH) K12 awards focus on preparing early career faculty for research careers focused, respectively, on addictive disorders and interdisciplinary training in sex and gender differences. In addition, MUSC's Clinical and Translational Science Award (CTSA) program has a KL2 faculty development component and the MUSC College of Medicine supports institutionally funded K12 physician scholars. Finally, the MUSC Hollings Cancer Center has a National Cancer Institute (NCI)-funded K12 program.

This rich portfolio of early career training programs at MUSC presented a unique opportunity for development of efficiencies, synergies, and networking across programs. Leaders of MUSC K-level programs across campus (CTSA KL2, NIDA K12, BIRCWH, NCI K12, and SCORE CEC), through the support of the MUSC CTSA, created a Joint K Program Directors Council to promote shared resources across the programs and create new forums for collective mentoring and group interactions. The council, led by the MUSC CTSA KL2 program director, meets biannually and has launched several collaborative initiatives, including a joint K orientation program, a grant discussion forum (K-to-R club), and mock study sections.

Program leadership has also collaborated to develop common curricular standards to provide and augment scholar education in shared areas of need across training programs to ensure NIH compliance and enhance potential for trainee success, including training in the responsible conduct of research (RCR), a grant writing course, mock study sections, and a science writing course. Below, we share brief descriptions of these four programs and metrics of scholar satisfaction collected since initiation of the SCORE CEC program. The aim of this article is to describe operationalization of these synergistic cross-program collaborations to optimize use of mentoring resources across MUSC and provide a supportive community for translational researchers.

Training in the RCR

Training in the RCR was first required for National Research Service Award research training grants in 1990. In 2009, NIH released an updated policy requiring that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, or dissertation research grant must receive instruction in RCR and providing guidance on required RCR training components (NOT-OD-10-019). In 2022, an updated policy was released (NOT-OD-22-055) reaffirming the principle that education in RCR is a fundamental element of research training and announcing updates to the existing policy and guidance for such instruction to leverage video conferencing and other technological advances.

To facilitate compliance with this NIH requirement, the Joint K Program Directors Council recently developed a K RCR Course, developed specifically for K and SCORE CEC Scholars. The course consists of four weekly, 2-hour sessions and incorporates didactic instruction and small-group discussions. It utilizes real-world, deidentified case studies of the scholars' choosing as a basis for concept exploration. Program faculty (consisting of K and SCORE CEC program leaders) identify topics for review based on NIH guidelines for best practices in RCR instruction, and scholars are responsible for selecting (or writing) a relevant case to review during the course. They are required to lead a discussion of scholarly literature on their assigned topic(s).

The scholars' mentors are encouraged to attend when their mentee is presenting to help facilitate the conversation and to provide their perspectives and insight. Holding the seminar series as a joint K initiative has helped tailor the discussion to precise training needs of scholars and ensured that each scholar benefits from intensive, hands-on instruction. The cross-disciplinary structure has also encouraged the inclusion of diverse clinical and research perspectives, such as appropriate inclusion of females and women in research.

Post-course assessments found that all course participants (n = 5) agreed or strongly agreed that the course provided a good overview of relevant RCR topics, the structure of case studies and open discussion was useful to understanding RCR topics, and that the faculty leads were valuable in helping to facilitate discussion. Course components that were considered most useful by participants included the group discussions, interactions with other K-level scholars and faculty, and the participant-led format. The interdisciplinary aspect was also considered highly beneficial.

Grant Writing Course

Transitioning from a mentored career development award to independent funding has been recognized as critical for sustaining a translational workforce. ² Nationwide, R01 award attainment 5 years after receiving an individual career development award has been reported to be ∼20%, and ∼40% at 10 years. ³ A recent analysis of CTSA KL2 awardee transition from mentored to independent funding also found ∼20% attainment of NIH R01 or equivalent awards; however, transition success rates were higher (35%) when attainment of extramural individual career development (e.g., K08 and K23) and non-NIH awards were included. ⁴ Although published studies of biomedical grant writing interventions are limited, available data support improvements in grant attainment rates with focused training initiatives, including among women and individuals underrepresented in science. ^5,6

SCORE CEC and institutional K awardees participate in an intensive 8-week grant writing course, during which the scholars and directors of the MUSC K programs meet weekly. This course was developed to improve the planning, formulation, structure, and writing quality of scholars' extramural grant applications. The first four sessions focus on preparing to write a grant (e.g., finding the right grant mechanism, understanding the NIH review process, creating a writing schedule), effective ways to write the various grant sections (including incorporation of SABV), developing and justifying budgets, and maximizing the application's competitiveness. Sessions are trainee-led, with each trainee asked to summarize the relevant section from “The Grant Application Writer's Workbook”. ⁷

During the final four sessions, two to three scholars per session present specific aims for a planned research project incorporating elements from the course. Peers and program directors offer suggestions to improve the aims, especially the clarity, flow, and logic of the writing.

Trainees (n = 13) were asked to gauge their level of grant writing skills before and after taking the course. The percentage of trainees ranking their skills as very good or excellent increased from 30.8% to 84.6% following course completion. Further, 92% of participants responded that the course was useful in improving their skills for preparing an extramural grant application and 77% agreed or strongly agreed that the course format (didactic sessions on grant composition and scholar presentations) was an effective approach to cover the material. Qualitative feedback on most useful aspects of the course included having mentors and faculty leads from different scientific backgrounds providing their perspectives, interactions and discussions with other K scholars, and receiving constructive peer feedback, especially from individuals outside of their primary fields. An area for potential improvement was inclusion of more faculty expertise in preclinical research.

Mock Study Sections

To provide further training and mentorship in grantwriting, an internal NIH mock study section program was developed. This interactive session is scheduled at least 1 month before the grant application deadline to enable scholars to incorporate constructive criticism by reviewers of their draft grant applications into their final applications. The mock study section not only mimics actual NIH study sections, but also provides several unique features to facilitate understanding of the review process and allow for peer mentoring. For example, the scholar submitting the proposal and primary mentor(s) are present for the review to hear the reviewers' comments and are provided an opportunity to discuss aspects of the grant with the reviewers.

Further, the reviewer panel consists of two to three ad hoc faculty with scientific expertise in the area of the grant submitted, as well as two institutional K or SCORE CEC scholars, each of whom review and discuss the grant using NIH scoring criteria to provide trainees with experience participating in a study section. Finally, other institutional K scholars and trainees are encouraged to attend the mock study sections to learn from the review process.

Since initiation of the program in February 2021, six institutional K or SCORE CEC scholars have submitted grant applications for review. Of these, two of the subsequent extramural grant applications were funded (K08 and R03), two received competitive scores (both R01s) and will be resubmitted, and two are in review at NIH. All scholars, including those submitting grant applications and those participating as reviewers, have given positive feedback on the helpfulness and usefulness of the mock study sessions.

Science Writing Skills

Effective writing skills are critical to become an independent investigator and succeed in a scientific environment ⁸ ; however, formal instruction in this area is rarely provided to biomedical trainees. ⁹ To address this gap, the MUSC CTSA KL2 program developed a science writing initiative entitled (Re)Writing Science, which is available to all institutional K awardees and SCORE CEC scholars. Participant trainees meet 10 times per year to “workshop” articles, grant proposals, or other scholarly writing. These meetings are facilitated by a medical science writer with the MUSC CTSA who acts as a writing coach to complement the roles of SCORE CEC and other program mentors. Each trainee is asked to provide drafts on which he or she is currently working for at least two of these meetings.

Before class, peers provide at least a paragraph of initial feedback to a discussion board, making at least two specific suggestions for improvement. The facilitator also suggests relevant stylistic resources. Trainees are expected to come to sessions prepared to provide pertinent written and oral feedback, and the facilitator directs the conversation to ensure that essential points about content and style are addressed. The book “Writing Science: How to Write Papers that Get Cited and Proposals that Get Funded” ¹⁰ is provided to trainees as an additional resource.

All participants (n = 7) in the course agreed or strongly agreed that feedback received was useful for improving their scientific writing. Eighty-six percent of participants agreed or strongly agreed that the course structure (book review, interactive discussions during sessions, and providing feedback via a virtual platform) was an effective way to cover the material. When queried as to the most useful aspects of the course, responses included the individualized feedback received and interactive format, the small group size, and the discussions with other trainees.

Discusssion

Metrics collected to date support the feasibility and benefits of implementing an intrainstitutional training platform to enhance career development of biomedical trainees, including investigators focusing on sex differences research. Overall, trainees were highly satisfied with the courses and programs offered. Further, these collaborations have reduced burden on individual program leaders to provide training in key areas demonstrated to be critical for trainee success in biomedical research.

A common qualitative theme in participant feedback across the training courses was the benefit of cross-disciplinary exposure and interactions. Although some programs are focused solely on patient-oriented research (NIDA K12, NCI K12, MUSC College of Medicine K12), other programs also include preclinical researchers conducting translational work (CTSA KL2, BIRCWH K12, SCORE CEC). Trainees participating in these institutional training programs also span numerous disciplines (e.g., medicine, nursing, public health) and specializations. Given the increased emphasis on collaborative research at NIH, there is a recognized need for multidisciplinary opportunities ¹¹ to promote team science. The opportunities provided to receive and provide peer mentorship were also frequently cited by trainees as beneficial components of the course offerings. Peer mentorship through the participatory forums facilitated by training grants and formal career development programs provides benefits beyond typical hierarchal mentorship, and may have particular salience for individuals typically underrepresented in medicine. ¹²

Further, NIH expects SABV to be factored into research designs, analyses, and reporting in both preclinical and clinical studies. As such, mentorship from and interactions with established and emerging investigators that have SABV expertise, such as the program faculty and trainees involved with the SCORE CEC, can be beneficial across the training spectrum. Forums such as the RCR and grant writing courses are utilized to provide training and facilitate discussions on sex differences and women's health research. In the future, it would be useful to amend our evaluation process to collect additional data on endpoints specifically related to competency in inclusion of SABV in grant writing, trial design, and analyses.

As the MUSC SCORE CEC program is relatively new, a limited number of SCORE CEC trainees have participated in these training initiatives to date, and as such there are not adequate metrics to assess SCORE CEC trainee outcomes alone. We are also unable to determine impact at this time on SCORE CEC scholar funding attainment. However, data available from the other participating programs suggest that the training provided effectively contributes to scholars establishing independent research careers, as ∼90% of KL2 and NIDA K12 program graduates have received extramural funding. Further, metrics on scholar satisfaction to date and the qualitative data collected support the benefits of cross-training program collaboration to promote development of the biomedical workforce. Coordination across programs and incorporation of peer mentorship opportunities may be useful mechanisms for other institutions with multiple early career training and mentoring programs for translational researchers, including SCORE CECs.