4

Crosscutting Topics

The Clinical and Translational Science Awards (CTSA) Program has demonstrated progress in three crosscutting domains that the Institute of Medicine (IOM) committee believes are integral to effectively advancing clinical and translational science: training and education, community engagement, and child health research. These efforts, along with the program’s contributions in building infrastructure and providing a range of research resources, make the CTSA Program a unique national resource within the clinical and translational research landscape. As with all such activities, each of these functions can be strengthened in a variety of ways. The committee provides a brief overview of each of these areas, followed by its recommendations for next steps.

TRAINING AND EDUCATION

The health needs of the nation call for a generation of scientists trained in “interdisciplinary, transformative translational research” (Meyers et al., 2012, p. 132; Van Hartesveldt et al., 2008) and in the leadership and team skills to engage in effective collaborative partnerships. A major challenge in rapidly translating research findings into health care practice is the concomitant need for support of clinician scientists in order to overcome the growing divide between clinical (M.D.) and research (Ph.D.) careers (Roberts et al., 2012). Further, emerging and growing areas of research (including comparative-effectiveness and community-engaged research) are emphasizing skills and collaborations integral to both clinical and translational research.



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4 Crosscutting Topics The Clinical and Translational Science Awards (CTSA) Program has demonstrated progress in three crosscutting domains that the Institute of Medicine (IOM) committee believes are integral to effectively advancing clinical and translational science: training and education, community en- gagement, and child health research. These efforts, along with the pro- gram’s contributions in building infrastructure and providing a range of research resources, make the CTSA Program a unique national resource within the clinical and translational research landscape. As with all such activities, each of these functions can be strengthened in a variety of ways. The committee provides a brief overview of each of these areas, followed by its recommendations for next steps. TRAINING AND EDUCATION The health needs of the nation call for a generation of scientists trained in “interdisciplinary, transformative translational research” (Meyers et al., 2012, p. 132; Van Hartesveldt et al., 2008) and in the leadership and team skills to engage in effective collaborative partner- ships. A major challenge in rapidly translating research findings into health care practice is the concomitant need for support of clinician sci- entists in order to overcome the growing divide between clinical (M.D.) and research (Ph.D.) careers (Roberts et al., 2012). Further, emerging and growing areas of research (including comparative-effectiveness and community-engaged research) are emphasizing skills and collaborations integral to both clinical and translational research. 105

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106 THE CTSA PROGRAM AT NIH Background and Context Sustaining a vibrant clinical and translational research enterprise in the future depends on building and retaining a diverse research work- force. Education and training in clinical and translational research are priorities for the CTSA Program. All CTSA institutions are expected to provide robust postgraduate training (NIH, 2012c), and many have ex- tensive training programs that often include undergraduate and predoctoral student training as well as training for research staff and community collaborators. In addition, the CTSA Consortium has identi- fied “training and career development of clinical and translational scien- tists” as a consortium strategic goal and has devoted considerable resources to enhancing the effectiveness of training and education pro- grams across institutions (CTSA Central, 2013a,e). CTSA Training Awards and Programs Since the inception of the CTSA Program, the training of new clini- cal and translational science investigators has been an integral part of the program. The KL2 Mentored Clinical Research Scholar Program is a required part of all individual CTSAs (NIH, 2012c). This career devel- opment program provides awardees who have a doctoral degree (M.D., Ph.D., or equivalent) with formal research training experience and fund- ing support to help them become independent investigators (NCATS, 2013). The TL1 Clinical Research Training Program provides an intro- duction to clinical and translational research to pre- and postdoctoral candidates or others who want to learn more about these types of re- search. For example, the TL1 program can provide medical students with a structured year-long research opportunity. In fiscal year (FY) 2011, 501 scholars participated in the KL2 program, and 469 trainees participated in the TL1 program through the CTSA Program (Collier, 2013a). Many CTSAs offer a master’s level degree in clinical and translational research. In 2011, Westat provided its findings from an online survey of CTSA-supported scholars, trainees, and mentors from CTSAs funded between 2006 and 2010 (Miyaoka et al., 2011). A total of 665 mentors (56 percent response rate) and 553 scholars and trainees (43 percent re- sponse rate) completed the surveys. Overall, the results were positive. Mentors reported providing a range of support in key areas for career development, and they reported benefits to their own professional devel- opment. Scholars and trainees reported developing more skills and hav-

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CROSSCUTTING TOPICS 107 ing enhanced opportunities for career development. Areas for improve- ment included the need for greater diversity among mentors, scholars, and trainees; increased emphasis on team science; and additional focus on the development of skills related to technology transfer, commerciali- zation, and communicating with policy makers. Box 4-1 presents a few highlights from this evaluation. CTSA Consortium Efforts on Training and Education At the consortium level, the Strategic Goal Committee on Training and Career Development has developed and disseminated core compe- tencies in clinical and translational science for master’s degree students (CTSA Central, 2011), as well as core competencies in specific areas, including child health translational research, T1 research, academia- industry drug development, and medical device innovation and technolo- gy transfer (CTSA Central, 2011). BOX 4-1 Selected Highlights from the CTSA National Evaluation Education and Training Study  CTSAs are engaging scholars and trainees across the spectrum of translational research (21 percent basic biomedical research; 52 percent clinical research; 26 percent postclinical research).  Trainees report positive experiences in educational activities. For exam- ple, 92 percent responded that building relationships with mentors was useful; 96 percent were positive about working as a member of a re- search team.  Evidence of success was found in obtaining R01 funding (47 percent of R01 applications were funded). The rate of submission was low, how- ever (16 percent of scholars or trainees reported submitting an R01 application).  Clear benefits were noted by mentors (97 percent of mentors rated their experience as positive) and trainees or scholars (83 percent assessed their levels of training and expertise in clinical research as moderate or high after participating in the CTSA Program, compared with a baseline 33 percent).  Most scholars and trainees reported serving as the PI on their first (79 percent) and second (72 percent) grant/award applications. SOURCE: Miyaoka et al., 2011.

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108 THE CTSA PROGRAM AT NIH The additional goals of the strategic goal committee are to provide CTSA-wide access to training resources, develop a core curriculum, im- plement a mentoring training program that shares best practices, and de- velop metrics and criteria for recognizing success and achieving career promotion in clinical and translational research (CTSA Central, 2013e). Opportunities and Next Steps CTSA 2.0 should build on the successes of the training and educa- tion components of individual CTSAs and the consortium-level work. This calls for new and innovative training and education approaches and methodologies. Training and education efforts are a prime area for col- laboration with NIH institutes and centers to monitor, track, and adopt best practices and successful models in education, mentoring, and career development. Presentations to the IOM committee and peer-reviewed publications highlighted a range of innovative training opportunities that could be brought to scale for greater impact. These include training and education across the educational spectrum (i.e., from undergraduate to postgraduate levels) and learning opportunities for community partners, faculty, and research administrators. Academic training options also exist across lev- els of intensity, from individual courses to certificate programs to ad- vanced degrees. Innovative Curricula and Team-Based Education and Training The excitement and the challenge of clinical and translational science is that it requires approaches to training and education that are outside of traditional scientific fields. The focus on a truly team-based and interdis- ciplinary approach to science requires collaborations that go far beyond lip service and necessitates relationship building between and among professional schools (e.g., medicine, nursing, business, law, engineering, public health), as well as with a range of community partners (from pa- tients and families to health care providers). Learning in this field is of- ten through and by experience. Further, the topics to be covered stretch beyond traditional ones to include, for example, entrepreneurship, intel- lectual property, regulatory science, health equity, unconscious bias, and community engagement.

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CROSSCUTTING TOPICS 109 In a number of CTSAs, innovative efforts to develop new courses and curricula are already under way. For example, the CTSA partnership in which the University of Washington is involved implements a team- based translational educational program with a clinical and translational research boot camp workshop and several active seminar series, includ- ing a monthly clinical research education series focused on conveying practical information and tools (ITHS, 2013). The goal is for translation- al scientists to have competencies related to key questions at each phase of the translational research cycle, including  Which problems will we tackle? (discovery phase);  How will the handoff happen to move discoveries into human studies? (development phase);  Can we scale up into clinics or communities? (delivery phase); and  How will we know we are making a real impact? (outcomes phase) (Edwards, 2013; Kelley et al., 2012). In another innovative training model, the University of Pennsylvania offers a variety of training options for undergraduates; predoctoral, grad- uate, and postdoctoral students; fellows; clinical residents; and faculty with several types of certificates or advanced degrees offered. In addition to general training in clinical and translational science, this program of- fers a concentration in translational therapeutics that includes public- private partnerships for industry internships and training in intellectual property and commercialization (Meagher, 2011; University of Pennsylvania ITMAT, 2013). CTSA 2.0 should build on these and other innovative training and education programs that are bridging the gap between the basic and clin- ical sciences. Emphasis on experiential and team-based learning and in- corporating topics outside the traditional realm will provide the solid foundation needed to spur clinical and translational research. CTSAs have the potential both to create learning cultures that embrace innova- tive teaching methods and content (e.g., gaming, flipped classrooms,1 mini-institutes) and to disseminate those innovations rapidly and effectively. 1 Flipped classrooms typically offer instruction online and doing homework in the classroom.

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110 THE CTSA PROGRAM AT NIH Effective Mentoring and Coaching An emphasis on effective mentoring has also been a strength and in- tegral component of CTSA training programs. In 2008, the CTSA Educa- tion and Career Development Key Function Committee established a Mentor Working Group that has identified several key elements of suc- cessful mentoring programs: mentor selection and support, alignment of mentor and mentee expectations, mentor training, evaluation, and feed- back (Fleming et al., 2012). Recent surveys and interviews found that the active mentoring pro- grams that are in place at CTSAs for the KL2 awards differ widely re- garding policies on selecting mentors, criteria to qualify as a mentor, and processes to evaluate the mentoring relationships (Huskins et al., 2011; Silet et al., 2010; Tillman et al., 2013). Programs also varied on the for- mality of the mentoring program, with 30 percent reporting the use of mentoring contracts (Huskins et al., 2011). Two-thirds of the mentoring programs reported requiring or encouraging mentees to have multidisci- plinary mentors, with mentors or the program taking the lead to coordi- nate this effort to varying degrees (Silet et al., 2010). The same survey found that CTSA institutions infrequently provide tangible support for mentors, such as salary support, institutional recognition, and research support. Successful mentoring practices should be disseminated across the CTSA Program. While avoiding the pitfalls of just checking boxes, the CSTA Program should consider developing metrics for how mentoring is evaluated. Mentoring is not an inherent skill for many people, but it can be developed by training and alignment of incentives. Positive mentoring experiences appear to be linked to strong relationships with individual mentors. The time commitment made to mentoring should be recognized in decisions on the mentor’s career advancement. A new initiative being announced by the NIH Common Fund and the National Research Mentoring Network offers opportunities for focused efforts on mentoring and will aim to provide mentoring standards, train- ing for mentors, and opportunities to increase the diversity of participants involved in being a mentor or mentee (NIH, 2013b). CTSA Program par- ticipation in this network could be a benefit to furthering CTSA mentor- ing opportunities. Consideration could be given to trans-CTSA mentorships where predoctoral students in one institution would have mentors in multiple CTSA institutions, thereby sharing specific exper- tise, creating venues for innovative partnerships, and opening up a poten-

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CROSSCUTTING TOPICS 111 tial pipeline for recruitment across institutions when their predoctoral training is completed. Flexibility and Focus Consistency in key components of training and education, such as core competencies and standards, can be balanced with flexibility in the elements and focus of the training experiences. Input received by the IOM committee from those who had participated in the CTSA training programs identified many positive aspects of the training experience, including protected time to develop a programmatic research agenda and grant proposals; exposure to multidisciplinary perspectives; committed mentoring relationships; high-quality courses, seminars, and workshops; support for participation in national conferences; and access to pilot grant funding and core resources (Ceglia, 2013; IOM, 2013; Shackelford, 2013). Areas of concern included the lack of awareness of the range of core resources available through the CTSA and the extensive time com- mitment for completing an advanced degree in the CTSA institutions that require this as part of the training program.2 In moving to CTSA 2.0, the IOM committee urges increased flexibil- ity in training and education programs. The extensive list of competen- cies identified by the strategic goal committee (CTSA Central, 2011) offers many potential areas for program development. The objective should be to personalize training experiences to meet the needs and goals of individuals and focus on competency rather than on the absolute re- quirement of obtaining a master’s or other advanced degree. This flexi- bility will be valuable in attracting and retaining KL2 scholars and TL1 trainees and may be particularly pertinent to clinician-scientists, who can play a major role in the clinical and translational research enterprise. Disseminating Education and Training Materials The transformation of training and education is possible only through the dissemination of successful approaches and practices. Several efforts are under way to provide online repositories of CTSA training and edu- cation modules and materials. The Virtual University through the Uni- 2 CTSA institutions have the flexibility to decide how to structure their career develop- ment programs. In some CTSAs the KL2 participants are required to obtain a master’s degree as part of the KL2 program, and the degree is optional at other CTSA sites (Collier, 2013b).

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112 THE CTSA PROGRAM AT NIH versity of Iowa offers access to online courses relevant to clinical and translational sciences (University of Iowa ICTS, 2013). The National CTSA Educational Resource Program, developed by the University of Rochester’s Clinical and Translational Science Institute, provides links to educational modules from a number of CTSAs (University of Rochester CTSI, 2013). Online access to course materials on mentoring is available through the Mentor Development Program at the University of Califor- nia, San Francisco (University of California San Francisco CTSI, 2013). Notable in the information obtained by the IOM committee regarding training and education is frequent sharing of courses, seminars, work- shops, and other resources among the CTSA sites and other training and education programs within institutions. This sharing enhances cross- disciplinary training within individual institutions and across the CTSA institutions. The IOM committee notes that similarities in core curricula highlight opportunities for improving efficiencies in training as well as for exposing scholars and trainees to expertise in areas of particular strength from one CTSA institution to another. Increasing Diversity and Growth of the Clinical and Translational Research Workforce To date, scholars, trainees, and mentors in CTSA programs lack di- versity. The Westat evaluation showed that most mentors are white males, and most scholars and trainees are white females (Miyaoka et al., 2011). Bringing the brightest minds to research, which is critical for new discoveries to improve health, depends on creating a training and educa- tion environment that attracts and retains a diverse pool of scientists. In- novative education programs such as Harvard University’s Summer Clinical and Translational Research Program for undergraduate scholars have the potential to create a pipeline of diverse clinical and translational scientists (Harvard Medical School DCP, 2013), particularly if partner- ships are formed with colleges and universities that traditionally serve racial and ethnic minority students. Opportunities may also be available for CTSAs to connect with STEM (science, technology, engineering, and mathematics) initiatives within and across institutions. CTSAs need to take full advantage of ef- forts sponsored by the NIH and others to build diversity, and, moreover, they should lead in the implementation of these initiatives. An example is the BUILD Program (Building Infrastructure Leading to Diversity) and the National Research Mentoring Network (NIH, 2013a). The National

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CROSSCUTTING TOPICS 113 Institute on Minority Health and Health Disparities sponsors Research Centers in Minority Institutions (RCMI), which provide additional op- portunities for ongoing collaborations with the CTSA Program, particu- larly with the RCMI Translational Research Network (NIMHD, 2013). Metrics and Incentives for Careers in Clinical and Translational Research Traditional metrics have been used for the most part to measure the success of CTSA training and education programs. These metrics include  number of scholars and trainees;  conversion rate from K (training) to R (independent investigator) grants;  number of publications; and  number and types of degrees completed (Miyaoka et al., 2011). These metrics do not measure or provide incentives for the team- based and interdisciplinary approaches needed to accomplish clinical and translational research. If the CTSAs are to be centers for innovations in clinical and translational research, they should also lead in innovations in mentoring and its evaluation, including assessment of the professional career trajectory of those who have participated in the training programs, creation of networking opportunities, active participation in national pro- fessional organizations, and commitment or intention of the scholars and trainees to engage in clinical and translational research. Two groups within the CTSA Program have begun related efforts to examine the components of career success for clinical and translation scientists and the metrics needed to assess individual and organizational progress. The Research on Careers Workgroup at the University of Pitts- burgh identified personal factors (e.g., demographic and psychosocial factors, research experience) and organizational factors (e.g., training opportunities, financial resources, balance of research and clinical re- sponsibilities) contributing to career success for physician-scientists (Rubio et al., 2011). This information can provide training programs with insights on critical areas for working with scholars, trainees, and mentors. The CTSA Education Evaluation Working Group identified validated met- rics and measures for assessing personal and organizational determinants of career success for clinical and translational scientists (Lee et al., 2012).

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114 THE CTSA PROGRAM AT NIH NCATS and individual CTSAs have the opportunity to lead changes in how training and education programs are assessed and in instituting incentives for the recognition and promotion of those involved. The tra- ditional benchmarks for academic promotion and advancement are fo- cused on individuals and products (e.g., publications, new grants). New benchmarks that value team-based efforts and collaborative approaches are needed to complement these traditional metrics. Changing those measures will be challenging because it is difficult to assess the depth or substance of collaborations. Identifying the right measures and incentives is a major challenge for CTSA 2.0. Examples of relevant measures might include the following:  evidence of interdisciplinary collaborations and of teams that cross disciplines and include community partners;  increases in the number of training and educational opportunities outside of KL2 and TL1;  increases in the number and level of involvement of community- based health care providers and other community stakeholders in the CTSA’s activities;  higher satisfaction with mentoring relationships and increases in trained mentors; and  the extent of public communication and knowledge transfer. Expanding Training Opportunities To date, CTSAs have made substantial progress in developing grad- uate and postdoctoral training in clinical and translational research. In addition to sustaining and building on those efforts, further work is needed to expand those opportunities, including training and continuing educa- tion for faculty, professional staff, and community partners. For example, substantive involvement of community partners in clinical and transla- tional science provides the opportunity for education in research meth- odologies and design, policy and regulatory aspects of clinical trials, and dissemination of clinical innovations. Community partner training generally appears rather informal across CTSA institutions. One example of a formal program is the Community Engaged Scholars Program developed and implemented by the South Carolina Clinical and Translational Research Center for Community Health Partnerships. This 18-month program focuses on developing competencies in community-based participatory research among teams

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CROSSCUTTING TOPICS 115 that must include at least one academic and one community partner. Pro- gram components include monthly sessions focused on problem-based learning, mentorship, and funding for pilot projects. An early evaluation found the program successfully recruited and retained teams that identi- fied and implemented community-based translational research pilot stud- ies (Andrews et al., 2012). As CTSAs continue to develop as strong networks of diverse stake- holders, there will be important opportunities to provide all participants with training and education on clinical and translational science. Mean- ingful involvement and collaboration among diverse groups require some common starting points, and CTSAs are the prime location for the train- ing needed. Conclusions and Recommendation Training and education in clinical and translational research is a core element of all CTSAs. To date, significant progress has been made in identifying core competencies and in developing curricula in clinical and translational research. CTSA 2.0 will require further efforts to develop and implement innovative education and training approaches that empha- size the unique aspects of clinical and translational science. The full range of stakeholders needs to have expertise so they can contribute fully to the accelerated development and implementation of new therapies, preventive measures, and devices to improve health. Recommendation 5: Advance Innovation in Education and Train- ing Programs The CTSA Program should provide training, mentoring, and education as essential core elements. To better prepare the next generation of a diverse clinical and translational science work- force, the CTSA Program should  emphasize innovative education and training models and methodologies, which include a focus on team science, lead- ership, community engagement, and entrepreneurship;  disseminate high-quality online offerings for essential core courses for use in CTSA and other institutions;

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132 THE CTSA PROGRAM AT NIH will allow pediatric health care providers, patients, and families to learn about new medications, therapeutics, and preventive measures. The Involvement of Children, Parents, Family Members, and Community Organizations Efforts to advance child health research need the active and direct involvement of patients, parents, family members, pediatric and family health care providers, and other community stakeholders in all phases of research. As a part of the team that guides clinical and translational re- search and encourages participation in this vital area, informed family and community participants will bring practical insights and dedicated commitment to setting research priorities, reviewing protocols, modify- ing trial designs, and ensuring adherence to research subjects’ protection policies for clinical research involving children. Further, these groups can promote research participation. Recent study findings suggest that families know little about potential opportunities for participation in clinical research and often do not understand its potential benefits (Davis et al., 2013). Conclusions and Recommendation Research is needed on medications, devices, and preventive measures that specifically assesses their impact on children, whether they are tar- geted to specific diseases of children or are adult treatments used for pe- diatric patients. Primarily because of the much smaller population affected with pediatric diseases, many of these diseases are “orphan con- ditions,” yet they can be life limiting or result in lifelong mental, physi- cal, or developmental disabilities. Because of the burden of these conditions, clinical and translational research is of special importance, and the IOM committee believes that the CTSA Program has placed an appropriate emphasis on accelerating clinical and translational research to improve child health. As a strong and vital part of the CTSA Program, the individual CTSAs and CC- CHOC have made important steps in this direction. The CTSA Program should continue its role in leading efforts to coordinate and advance child health research by building on the expertise of individual CTSAs and by ensuring that the CTSA Program continues to be a leader in developing and sustaining the collaborations necessary to move these efforts forward.

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CROSSCUTTING TOPICS 133 Recommendation 7: Strengthen Clinical and Translational Research Relevant to Child Health NCATS should collaborate with CC-CHOC to strengthen clini- cal and translational research relevant to child health through efforts to  identify and designate CTSAs with expertise in child health research as leaders in advancing clinical and translational research relevant to child health and as coordinators for CTSA programwide efforts and other collaborative efforts in this research; and  promote and increase community engagement specific to child health by o raising awareness of the opportunities for children and families to participate in research efforts with clear in- formation conveyed on the risks and potential benefits; and o involving parents, patients, and family members more fully at all stages of the research process, including iden- tifying priorities and setting research agendas. REFERENCES Andrews, J. O., M. J. Cox, S. D. Newman, G. Gillenwater, G. Warner, J. A. Winkler, B. White, S. Wolf, R. Leite, M. E. Ford, and S. Slaughter. 2012. Training partnership dyads for community-based participatory research: Strategies and lessons learned from the community engaged scholars program. Health Promotion Practice., October 22. Published online before print, doi: 10.1177/1524839912461273. Brady, K. 2012. CTSA strategic goal 4: Enhancing the health of our communities and the nation. PowerPoint presented at Meeting 1: IOM Committee to Review the CTSA Program at NCATS, Washington, DC, October 29. http://www.iom.edu/~/media/Files/Activity%20Files/Research/ CTSAReview/2012-OCT-29/CTSA%20presentations/5-Brady%20CTSA%20% 20SGC4%20slides%20for%20%20IOM.pdf (accessed March 25, 2013). C3 (Chicago Consortium for Community Engagement). 2013. Welcome to the C3 network. http://c3ctsa.org (accessed March 25, 2013). Carter-Edwards, L., J. L. Cook, M. A. McDonald, S. M. Weaver, K. Chukwuka, and M. M. Eder. 2013. Report on CTSA consortium use of the community

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136 THE CTSA PROGRAM AT NIH Eder, M., L. Carter-Edwards, T. C. Hurd, B. B. Rumala, N. Wallerstein. 2013. A logic model for community engagement within the CTSA Consortium: Can we measure what we model? Academic Medicine 88(10). Edwards, K. 2013. Using CTSAs to leverage change: New investigators, new science. PowerPoint presented at Meeting 3: Committee to Review the CTSA Program at NCATS, Washington, DC, January 24. http://www.iom.edu/ ~/media/Files/Activity%20Files/Research/CTSAReview/2013-JAN-24/Kelly %20Edwards.pdf (accessed April 10, 2013). Emmons, K. M. 2012. Harvard Catalyst response to RFI NOT-TR-13-001. Submitted to the IOM Committee on February 1, 2013. Available by request through the National Academies’ Public Access Records Office. ENACCT and CCPH (Education Network to Advance Cancer Clinical Trials and Community-Campus Partnerships for Health). 2008. Communities as partners in cancer clinical trials: Changing research, practice and policy. Silver Spring, MD: ENACCT. http://www.enacct.org/sites/default/files/ CommunitiesAsPartners_Report_12_18_08_0.pdf (accessed March 22, 2013). Fleming, M., E. L. Burnham, and W. C. Huskins. 2012. Mentoring translational science investigators. JAMA 308(19):1981–1982. Freeman, E. R., and S. Seifer. 2013. A Delphi process to solicit stakeholder feedback for the IOM Committee Review of the CTSA Program. Submitted to the IOM Committee on March 3. Available by request through the National Academies’ Public Access Records Office. HANC (HIV/AIDS Network Coordination). 2013a. Community Partners. https://www.hanc.info/cp/Pages/default.aspx (accessed March 22, 2013). ———. 2013b. The Legacy Project. https://www.hanc.info/legacy/Pages/ default.aspx (accessed March 22, 2013). Harvard Medical School DCP (Office for Diversity Inclusion and Community Partnership). 2013. The Harvard Catalyst Program for Faculty Development and Diversity. Program for college students: Summer Clinical and Translational Research Program. http://www.mfdp.medp.med. harvard.edu/Catalyst/CollegeStudents.html (accessed April 1, 2013). Hatcher, M. T., and R. M. Nicola. 2008. Building constituencies for public health. In Public health administration: Principles for population-based management. Vol. 2, edited by L. F. Novick, C. B. Morrow and G. P. Mays. Sudbury, MA: Jones and Bartlett. Pp. 443–458. Healing of the Canoe. 2013. The Healing of the Canoe Project. http://healingofthecanoe.org (accessed March 19, 2013). Hood, N. E., T. Brewer, R. Jackson, and M. E. Wewers. 2010. Survey of community engagement in NIH-funded research. Clinical Translational Science 3(1):19–22. Horowitz, C. R., M. Robinson, and S. Seifer. 2009. Community-based participatory research from the margin to the mainstream: Are researchers prepared? Circulation 119(19):2633–2642.

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CROSSCUTTING TOPICS 137 HPS (Hermansky-Pudlak Syndrome) Network. 2013. Hermansky-Pudlak Syndrome Network, Inc. http://www.hpsnetwork.org (accessed March 18, 2013). Huskins, W. C., K. Silet, A. M. Weber-Main, M. D. Begg, V. G. Fowler, J. Hamilton, and M. Fleming. 2011. Identifying and aligning expectations in a mentoring relationship. Clinical and Translational Science 4(6):439–447. Huskins, W. C., C. D. Sullivan, J. Wang, M. Aitken, S. R. Alexander, L. G. Epstein, A. Hoberman, E. Neufeld, A. Philipps, T. P. Shanley, P. Szilagyi, M. Purucker, and S. L. Barkin. 2012. Tracking the impact of the National Institutes of Health Clinical and Translational Science Awards on child health research: Developing and evaluating a measurement strategy. Pediatric Research 71(5):619–624. Indiana University CTSI (Clinical and Translational Sciences Institute). 2012. CORUS (Community Research Utilities and Support): Working together to advance community engaged research. https://ctsacorus.org/home (accessed March 25, 2013). IOM (Institute of Medicine). 2012a. Primary care and public health: Exploring integration to improve population health. Washington, DC: The National Academies Press. ———. 2012b. Safe and effective medicines for children: Pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Washington, DC: The National Academies Press. ———. 2013. Responses to public input questions regarding the CTSA Program at NCATS. Submitted to the IOM Committee between December 17, 2012–March 1, 2013. Available by request through the National Academies’ Public Access Records Office. ITHS (Institute of Translational Health Sciences). 2013. Education core. www.iths.org/ED (accessed April 10, 2013). Kagan, J. M., S. R. Rosas, R. L. Siskind, R. D. Campbell, D. Gondwe, D. Munroe, W. M. K. Trochim, and J. T. Schouten. 2012. Community- researcher partnerships at NIAID HIV/AIDS clinical trial sites: Insights for evaluation and enhancement. Progress in Community Health Partnerships: Research, Education, and Action 6(3):311–320. Katz, S., J. Anderson, H. Auchincloss, J. Briggs, A. Guttmacher, K. Hudson, R. Hodes, W. Koroshetz, R. Ranganathan, G. Rodgers, and S. Shurin. 2011. NIH CTSA/NCATS Integration Working Group recommendations. http://www.ncats.nih.gov/files/recommendations.pdf (accessed April 8, 2013). Kelley, M., K. Edwards, H. Starks, S. M. Fullerton, R. James, S. Goering, S. Holland, M. L. Disis, and W. Burke. 2012. Values in translation: How asking the right questions can move translational science toward greater health impact. Clinical and Translational Science 5(6):445–451.

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138 THE CTSA PROGRAM AT NIH Kon, A. A. 2008. Real pragmatism, kids, and the Clinical and Translational Science Award (CTSA). American Journal of Bioethics 8(4):45–47. Lee, L. S., S. N. Pusek, W. T. McCormack, D. L. Helitzer, C. A. Martina, A. M. Dozier, J. S. Ahluwalia, L. S. Schwartz, L. M. McManus, B. D. Reynolds, E. N. Haynes, and D. M. Rubio. 2012. Clinical and translational scientist career success: Metrics for evaluation. Clinical and Translational Science 5(5):400–407. Martinez, L. S., B. Russell, C. L. Rubin, L. K. Leslie, and D. Brugge. 2012. Clinical and translational research and community engagement: Implications for researcher capacity building. Clinical and Translational Science 5(4):329–332. Meagher, E. A. 2011. Training translators in the PENN CTSA. Clinical and Translational Science 4(5):314–316. Meyers, F. J., M. D. Begg, M. Fleming, and C. Merchant. 2012. Strengthening the career development of clinical translational scientist trainees: A consensus statement of the Clinical Translational Science Award (CTSA) research education and career development committees. Clinical and Translational Science 5(2):132–137. Michener, L., J. Cook, S. M. Ahmed, M. A. Yonas, T. Coyne-Beasley, and S. Aguilar-Gaxiola. 2012. Aligning the goals of community-engaged research: Why and how academic health centers can successfully engage with communities to improve health. Academic Medicine 87(3):285–291. Miyaoka, A., M. Spiegelman, K. Raue, and J. Frechtling. 2011. Findings from the CTSA National Evaluation Education and Training Study. Rockville, MD: Westat. https://ctsacentral.org/sites/default/files/documents/education TrainingReport_20111228.pdf (accessed April 1, 2013). NCATS (National Center for Advancing Translational Sciences). 2012a. FAQ about CTSA RFA-TR-12-006. http://www.ncats.nigh.gov/research/cts/ctsa/ funding/faq/faq.html (accessed March 22, 2013). ———. 2012b. Request for information: Enhancing the Clinical and Translational Science Awards Program. http://www.ncats.nih.gov/files/ report-ctsa-rfi.pdf (accessed April 8, 2013). ———. 2013. Scholar and research programs. http://www.ncats.nih.gov/research/ cts/ctsa/training/programs/scholar-trainee.html (accessed March 11, 2013). NIH (National Institutes of Health). 1998. NIH policy and guidelines on the inclusion of children as participants in research involving human subjects. http://grants.nih.gov/grants/guide/notice-files/not98-024.html (accessed March 20, 2013). ———. 2009a. RFA-RM-09-004: Institutional Clinical and Translational Science Award (U54). http://grants.nih.gov/grants/guide/rfa-files/RFA-RM- 09-004.html (accessed March 22, 2013). ———. 2009b. RFA-RM-09-019: Institutional Clinical and Translational Science Award (U54). http://grants.nih.gov/grants/guide/rfa-files/RFA-RM- 09-019.html (accessed March 22, 2013).

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CROSSCUTTING TOPICS 139 ———. 2012a. Enhancing the health of our communities and the nation. Chapter 5. In Progress Report 2009–2011 Clinical and Translational Science Awards: Foundations for accelerated discovery and efficient translation. http://www.ncats.nih.gov/ctsa_2011/ch5.html (accessed April 1, 2013). ———. 2012b. Request for information: Enhancing community-engaged research through the Clinical and Translational Science Awards (CTSA) Program. http://grants.nih.gov/grants/guide/notice-files/NOT-TR-13-001. html (accessed March 22, 2013). ———. 2012c. RFA-TR-12-006: Institutional Clinical and Translational Science Award (U54). http://grants.nih.gov/grants/guide/rfa-files/rfa-tr-12- 006.html (accessed February 13, 2013). ———. 2013a. Increasing the diversity of the NIH-funded workforce: Program initiatives. http://commonfund.nih.gov/diversity/initiatives.aspx (accessed March 11, 2013). ———. 2013b. Notice of intent to publish a funding opportunity announcement for planning grants for the NIH National Research Mentoring Network. http://grants.nih.gov/grants/guide/notice-files/NOT-RM-13-009.html (accessed April 30, 2013). NIMHD (National Institute on Minority Health and Health Disparities). 2013. NIMHD Research Centers in Minority Institutions Program. http://www.nimhd. nih.gov/our_programs/research_centers.asp (accessed April 30, 2013). Parsons, S. 2013. Responses to committee questions. Submitted to the IOM Committee on February 26. Available by request through the National Academies’ Public Access Records Office. Portman, R. 2012. Children’s health research: Role of the CTSA Program in pediatric drug development. PowerPoint presented at Conference Call Meeting 2: IOM Committee to Review the CTSA Program at NCATS, Washington, DC, November 30. http://www.iom.edu/~/media/Files/Activity %20Files/Research/CTSAReview/2012-NOV-30/Ronald%20Portman.pdf (acc- esssed March 20, 2013). Pulley, J. 2013a. CTSA essays and worksheets. Submitted to the NIH CTSA/NCATS Integration Working Group, July 2011. Submitted to the IOM Committee on January 7. Available by request through the National Academies’ Public Access Records Office. ———. 2013b. CTSA PI response to RFI NOT-TR-12-003. Submitted to the IOM Committee on January 6. Available by request through the National Academies’ Public Access Records Office. PXE International. 2012. PXE International Blood and Tissue Bank. http://www.pxe.org/blood-tissue-bank (accessed March 22, 2013). Research Toolkit. 2012. Research toolkit: An active, growing library of resources for conducting health research. http://www.researchtoolkit.org (accessed March 25, 2013).

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