Grant Writing for Projects Involving Human Subjects A case study of a junior investigator Leticia Manning Ryan, MD Children’s National Medical Center Washington, DC

Case summary A 29 yo (?) physician nearing completion of a clinical fellowship training program She has an idea for a clinical research project that she is considering submitting an application for a K23 award. Personal interest in injury prevention and public health. Past research experience is limited. Current medications include caffeine.

Research experience Late residency/early fellowship project Case-based questionnaire on fracture recognition and diagnosis Administered to pediatric residents and pediatric emergency attendings at three training programs

Lessons learned from project Development of idea Survey development and administration Human subject IRB submission and approval Multicenter IRB submission and approval Collaboration Data analysis and management Submission and presentation of abstract Submission and publication of paper

New research idea develops Case-control study to evaluate the role of bone health in pediatric fracture risk –Bone mineral density –Vitamin D status –Diet –Physical activity –Body mass index –Sun exposure –Genetic analysis

Getting it started: Project challenges for a junior investigator Multidisciplinary collaboration/mentorship Human subject risk: IRB approval and consent process Subject recruitment Cost (approximately $35K excluding genetic studies) Time

Challenge: Multidisciplinary collaboration/mentorship Consider internal and external opportunities for collaboration/mentorship Review literature and CRISP to identify external experts Show initiative in requesting feedback Use group s, group meetings and conference calls to sustain communication Maintain control over your project

Challenge : Human subject risk: IRB approval and consent process Educate yourself about the human subject risks associated with your project Seek advice/language from others who have projects using similar methods Meet directly with IRB before submitting to request assistance and identify correctable issues

Challenge : Subject recruitment Seek advice from others with projects involving recruitment Discuss project with your public relations department Consider opportunities within other clinical settings- anesthesia/OR, emergency department, inpatient wards, outpatient clinics

Challenge : Cost Make it known that you intend to apply for external funding with pilot results from this study Explore internal and external small grant funding opportunities Identify available resources that could be shared from co-investigators, your training program, GCRC, etc

Challenge : Time Make it known that you intend to apply for external funding with pilot results from this study Negotiate with department for “protected time” with contingencies for K submission, etc Structure recruitment/project management around your availability

Back to our case: Assembled team/mentorship Obtained IRB approval Used available (but limited) research assistant staff Received 3 small grants (4K, 11K, 13K) to cover study expenses Initiated study and successfully recruited patients Prepared for submission of career development award application

K23 submission: Strategies that worked Recognize and address weaknesses –Lack of research experience Emphasize the positive –Present comparable accomplishments –Highlight pilot results to demonstrate feasibility Detailed and relevant educational plan

General advice for grant submissions Seek out both field experts and non-experts to review and critique your proposal Attend grant-writing workshops which offer proposal review Discuss your proposal prior to submission with the program officer (or comparable position) Be open to constructive criticism Re-write, re-write, re-write

Case summary Application submitted for intramural career development award was unsuccessful Application submitted for K23 career development award was successful Project is progressing well and approaching 75% of goal for recruitment Preliminary results suggestive that suboptimal bone health may be associated with fracture risk in children