More than 60 attendees learned what it takes to develop a successful NIH mentored patient-oriented research career development award (K23) application. A real-world grant that initially received an impact score of 39, then improved to an outstanding, fundable impact score of 13 after the applicant worked closely with her mentors and CCTS experts to submit a revised application, served as the focus of the review.

CCTS Training Academy Director Dr. David Chaplin provided an overview of an NIH study section’s goals and processes. He and the other panelists, including Drs. Karen Cropsey, associate professor, psychology and behavioral biology, and Gareth Dutton, associate professor, preventive medicine, then took turns acting as primary and secondary reviewers. Dr. Peter Smith, professor, cell developmental and integrative biology, served as the panel moderator and role played the chair of a review section.  

Attendees learned about the different sections of a K23 grant and how they are scored, from initial impact score and individual criterion scores to the overall impact score given to career development awards. Panelists reviewed each section of the K23, explaining their mock scores for the candidate, career plan, research plan, mentors, and institutional environment sections. They stepped out of their roles to discuss with the audience several areas that can weaken a K23 grant: whether the number of subjects chosen is high enough to produce meaningful results and if it is clear the applicant had a firm foundation for a well-conceived power calculation; failure to thoroughly address human subjects protection; not providing a clear description of appropriate statistical analyses that will be performed; and assembling a mentor team that lacks sufficient expertise in the areas of training the applicant is seeking via the grant. By appropriately addressing these areas, K23 applicants "will greatly strengthen their grants." The panelists also described the need to address NIH’s new rigor, reproducibility, and transparency requirements, which apply to most K applications, including the 23, just as they do to R series applications.

After reviewing the initial application, the mock panel performed a similar review of the resubmission, noting areas of improvement and key steps taken by the applicant that helped significantly improve the score. As is the case for other grant mechanisms, they pointed out that all K award resubmissions are allowed an extra page and explained it should be used to highlight responses to reviewer concerns and to note any changes that may have occurred in the time between initial submission and resubmission (K award applicants are allowed up to 3 years to resubmit).

For the grant being reviewed, a pilot study (cosponsored by the CCTS) was conducted after the initial submission, producing new data that resulted in changes to the research plan, which were articulated in the extra page. The applicant had also taken advantage of the CCTS career development team, which strengthened several areas of the grant.

The panelists answered several questions after the mock review, including why the grant under review sought only four years of funding instead of five (the applicant had been awarded a K12 previously, which counted toward the five years of total K support allowed by the NIH); if IRB approval is required prior to submission (no, but it must be secured prior to the release of funding, as part of the “just-in-time” requirements in advance of award letters); how to strengthen the candidate section of an application (not impossible to do but takes time and may require new department letters, additional publications, and/or advancement along the career track); and how NIH program officers can help applicants (they can review an applicant’s grant aims prior to submission, helping to assure that the application focuses on a topic that is a priority for the funding agency, and can help interpret the summary statement afterwards).

In summary, Dr. Chaplin noted CCTS offers numerous services via its Research Commons to assist K award grant writers with research design, biostatistics, power calculation, rigor and transparency checks, the IRB process, and other grant-related stumbling blocks. He also pointed out that the application under review was one of many samples available via the CCTS Grant Library.

CCTS is grateful to its cohosts, the UAB Minority Health and Health Disparities Research Center and UAB Center for Outcomes and Effectiveness Research and Education. We also wish to thank Dr. Jessica Merlin, whose K23 application, "Development of a Behavioral Intervention for Chronic Pain in Individuals with HIV," served as the before and after model in the mock review. For those who missed this event, the video will be posted soon on the CCTS YouTube channel.