Include clinical researcher training (icrt) - this new R25 program, responsive to PAR-22-195, plays a crucial role in the include project

The Include Clinical Researcher Training (ICRT) program, funded by the National Institutes of Health (NIH) Office of the Director under the Trans-NIH Research Support program (CFDA 93.310), received a Project Grant award of $866,506 on September 20, 2025. Administered by Magee-Womens Research Institute and Foundation with completion scheduled for August 31, 2027, this R25 training program recruits and trains 16 post-graduate participants annually in Down Syndrome (DS) clinical research methodologies and career development. The program delivers comprehensive hands-on laboratory instruction spanning the entire DS lifespan, led by a multi-institutional faculty team from the University of Pittsburgh, University of California-Irvine, Children's Hospital of Philadelphia, and University of Southern California-Keck, along with oversight by an external scientific advisory board.

Core deliverables include advanced clinical research lab courses with conceptual education and discussion sessions; ongoing post-course mentoring through annual reunions at INCLUDE-sponsored conferences and monthly online sessions; and personalized career guidance addressing both professional development and life-work balance considerations. The program aims to address workforce gaps in Down Syndrome clinical research expertise by developing new investigators and expanding the limited number of laboratories led by Down Syndrome expert scientists. All training is provided in compliance with federal civil rights requirements and is available to qualified American citizens and permanent residents.

Each year, we recruit, train, mentor, and provide career advice to cohorts of 16 post-graduate participants dedicated to mastering down syndrome (DS) clinical research. Despite the swift growth of include, there are still too few laboratories led by down syndrome expert scientists and too few new clinical trainees with expertise in down syndrome. In full compliance with not-OD-25-090 (notice of civil rights term and condition of award), this program is available for all qualified american citizens and permanent residents. Under the multiple PI direction of: ANN cohen, PHD (pitt); benjamin handen, PHD (pitt); elizabeth head, PHD (irvine); adam resnick, MD PHD (chop); jonathan santoro, MD (USC-keck) and gerald schatten, PHD, contact PI (pitt), with CO-i calvin simerly, PHD (pitt), icrt is overseen by an external scientific advisory board. They, along with the faculty, provide hands-on, face-to-face training in DS clinical research. Mentoring and career guidance, including balanced life choices, are considered both during the course, with on-going personal career guidance at annual reunions. The five specific aims are: i. Offer annual icrt advanced hands-on clinical research lab courses covering DS through the entire lifespan providing conceptual education and clinical research labs and discussions. Candidates apply on-line describing their DS research career trajectories and 16 participants are selected annually. Comprehensive training on fundamentals and methodologies necessary for flourishing careers. Participants implement career planning with senior and junior faculty, peer-to-peer and personalized coaching. II. Provide ongoing post-course mentoring at annual course reunions, held at include-sponsored conferences and monthly icrt online sessions. Participants are encouraged to articulate their own longer-term career trajectories and explore their career choices. III. Cultivate and enhance intra-include collaborations and cross-include training for all include scientists at courses and reunions. These create a dynamic, robust and meaningful include community, among colleagues and friends. IV. Demystify the changing regulatory oversight requirements in responsible conduct for research (RCR) to ensure full compliance with NIH and institutional guidance, regulations and law. Creating safe supportive research environments (along with a formal safety plan are presented. This is so that participants may begin their own research programs in the most effective, timely, and responsible manner. V. Provide unbiased, quantitative independent evaluations to track participants' careers, comprehensively and longitudinally, to ensure that icrt is a wise, effective investment. Icrt will meet and exceed the PAR's mandate of training the next generation of DS clinical researchers, 80 additional clinical investigators, and thereby improving the quality of life and health span of those with down syndrome as well as all americans.