Michigan Institute for Clinical & Health Research Career Development Awards

1. Michigan Institute for Clinical & Health Research Career Development Awards

2. Mission: Why We’re Here • Career Development Awards • Institutional Review • MICHR Resources • Q & A

3. MICHR’s Mission To improve the quality, quantity, and overall positive impact of clinical and translational research at the University, and in the communities it seeks to serve. Mission: Why We’re Here

4. Part of a Larger Community of Universities Involved in Translational Research: CTSA Awardees

5. “Translational” research T1 T2, T3, T4 Basic Research Clinical Research Improved Health Translation from basic science to human studies Translation of new knowledge into clinical practice Adapted from Sung et al. (2003) JAMA, 289, 1278-89.

6. Mission: Why We’re Here • Career Development Awards • Institutional Review • MICHR Resources • Q & A

7. What are NIH Career Development (K) Awards? • Institutional or individual • Basic science or patient – oriented • Mentored, non-mentored, or both • Targeted to provide training in a specific area of research

8. Mentored Career Development (K) Awards • Support the career development of investigators who have made a commitment to focus their research endeavors on patient-oriented or basic science research. • 3-5 Years of supervised study and research • Non-renewable • Initiation of an independent research career

9. Who qualifies? • Must be a U.S. citizen or non-citizen national, or lawfully admitted permanent resident • Degree requirement varies depending on type of K award • Research professional doctorate (K01) • Clinical Research Scientist (MD, DO, DDS, Pharm.D., doctoral degree in nursing research or practice, clinical psychologist, social workers, clinical geneticists, etc) (K08, K23) • Be able to commit no less than 75% full time professional effort (mentored Ks) toward research

10. NIH Career Development Awards • K01 Mentored Research Scientist Development Award • K02 Independent Research Scientist • K08 Mentored Clinical Scientist Development Award • K12/KL-2 Institutional award-Mentored Clinical Scientist • K22 Career Transition Awards • K23 Mentored Patient-Oriented Research Development Award • K25 Mentored Quantitative Research Development Award • K99/R00 Pathway to Independence Award • 1-2 yr mentored, up to 3 yrs independent support • K05 Senior Scientist Research and Mentorship • K24 Midcareer Investigator Award in POR Guidelines are institute specific http://grants1.nih.gov/training/careerdevelopmentawards.htm

12. NIH Considerations • 27 separate Institutes and Centers • Each with its own: • mission • budget • activities and program priorities • way of doing things • Get to know the different institutes and centers! http://www.nih.gov/icd/

13. http://grants.nih.gov/training

14. Career Development Awards 12 pages • Candidate Information and Career Development Plan • Candidate Background • Career Goals and Objectives (immediate and long term goals) • Career Development Plan • Training in the Responsible Conduct of Research • Research Plan • Statement of Support (mentors, consultants, etc.) • Environment and Institutional Commitment • Letters of reference (3-5) • Mentors can submit letters but these can not be one of the 3 required letters • Budget • Resource Sharing Plan

15. Personal Statement • Candidate background: • Commitment to an academic career in POR • Description of candidate's professional responsibilities and relation to award • Evidence of ability to collaborate with other scientists. • Describe prior training and how it relates to career plans. • Describe the candidate's research efforts to this point in his/her research career • Provide evidence of the candidate's potential to develop into an independent investigator. • Statement of commitment to 75% effort • Career Goals and Objectives: (Systematic Plan) • Shows a logical progression from prior research and training to award career development to independent investigator. • Justify need for further career development • Demonstrate you are utilizing relevant research and educational resources of the institution. 

16. Developing a Career Plan • Required for Career Development Awards but also useful as a: • Planning guide for your development • Communication document to seek feedback and support • Personal commitment to your future

17. Career Development Plans • Identify educational goals/ intended learning outcomes • Link educational goals to career goals • How will these outcomes be achieved? • Link educational goals to research experience

18. Things to think about. . . • A good career development plan is usually built around a research experience • The research serves as a vehicle for your training • A “safe” study is more important than ground-breaking science • Should be a study that leads to other studies, no matter what the results • Education • Should ideally encompass all of the elements of a research project, especially those that you have inadequate experience with

19. Career Development Plan Work with mentor(s) to tailor it to your specific career goals Discuss prior relevant research and training experience Systematic Plan – Use a timeline and breakdown into a logical progression of training and research leading to you being an independent investigator Don’t just list courses and course descriptions Didactic and research goals need to be in concert to develop the necessary knowledge and research skills relevant to career goals

20. What research education do I need? • What purpose? • What area(s)? • How intense? • What format? • Desired deliverable?

21. Overwhelming Number of Research Training Opportunities • Focus of Education • Identifying a great research idea • Funding opportunities • Understanding the grant review process • Navigating the NIH • Grant Writing/Proposal Development/Budgets • Grant writing • Statistical issues • Appropriate design • Sample size • Data measures • Analysis techniques • Ethics, research integrity and regulatory issues • Focus of Education • Science/methodology specific • Dissemination of science • Team science • Intensity of Training • Degree, certificate, workshops, individual courses/seminars, etc. • Format and logistics • Time commitment (amount/when) • Learning format • Where • Cost • Deliverable of program • Awareness, knowledge, skill, mock grant, your grant, funding, research project, etc.

22. Areas to consider when developing the education plan • Grant writing • Statistics • Ethics, research integrity, regulatory • Science/Methodology • Laboratory • Clinical • Population • Community based participatory • Study Design • Data Management

23. Career Plan Resources at UM • MICHR Education, Career Development and Mentoring Programs • School of Public Health: • Masters in Science in Clinical Research Design and Statistical Analysis • Graduate Summer Session in Epidemiology • Masters in Health Service Administration • Masters in Public Health – Environmental, Health Management & Policy, etc. • Institute for Social Research Summer Institute in Survey Research Techniques • CSCAR Workshops and Seminars

24. Training in the “Responsible Conduct of Research” • Document prior RCR training • Description of formal RCR training • Areas to consider: • Conflict of interest • Responsible authorship • Misconduct • Policies regarding the use of human and animal subjects • Data management policies • Link to research

25. Research Plan • A “safe” study is more important than ground-breaking science. • Consistent with candidate’s level of research development • Consistent with career objectives • Should be a study that leads to other studies, no matter what the results. • Structure of Section: Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Design and Methods (Also include DSMP if applicable) • Describe relationship between mentor’s research and candidates proposed research plan • If more than one mentor– describe their expertise and responsibilities

26. Besides good research, you need: • Communication Skills • Marketing Skills • Management Skills • Flexibility and ingenuity • Ability to follow directions, even the apparently meaningless ones • Ability to plan ahead and commit significant time • Great Mentors!

27. Mentors don’t grow on trees. . . • …so finding good ones is key, then build your program from there. • Qualities to look for: • Recognized as an accomplished investigator in the research area. • Established track record in training independent investigators • Has sufficient independent research support (could cover the additional costs of your project) • Commitment to trainee success

28. Things to consider. . . • Clearly highlight mentor expertise in application and why they are your mentor (i.e., what will you learn from them) • Increasing preference for mentoring “teams” • Letters are extremely important, and read for any nuances • If your mentor cannot take the time to write a strong > 2 page letter, they may not have the time or commitment to mentor you • Not a letter of reference! This should be a letter of strong commitment and support.

31. Before you start writing, do your homework! • What has the agency funded recently? (CRISP, Community of Science). • Read recent successful applications by colleagues and mentors • The program officers are your resource, contact them early and often. • Colleagues are essential for collaboration and consultation; senior colleagues may know who will likely review your grant. • Consult a biostatistician early in the process (MICHR, CSCAR). • P.S. Do not attempt to contact reviewers! Inouye, S.K., Fiellin, D.A. An Evidence-Based Guide to Writing Grant Proposals for Clinical Research, Ann Intern Med. 2005;142:274-282

32. Write with reviewers in mind! • They are… • Overworked • Not interested in doing outside ‘homework’ in a new topic area just so they can understand your proposal • Mature • Translation: they don’t want to strain their eyes deciphering figures and captions that you’ve shrunk down to 8-point font! Assume reviewers are intelligent and savvy about research… • ..but perhaps have little in-depth experience in your area of interest. • Most will review your grant in a few hours (at the most). • Avoid jargon and topic-specific abbreviations. • Many reviewers will read only the abstract and/or specific aims. • Adapted from Chris Black presentation

33. Mission: Why We’re Here • Career Development Awards • Institutional Review • MICHR Resources • Q & A

34. Proposal Process

35. Q: What do I need to route for Institutional approval? A: Administrative Shell • Proposal Approval Form (PAF) • PAF covers basic disclosures to the University about your project • Administrative Shell • All sections that the NIH requests • A draft abstract may take the place of final abstract and final science • Form Pages, budgets, mentor letters, institutional letter of support

36. How much? • Non-uniform between NIH Institutes and Centers (IC’s), but generally includes: • Salary and fringes – minimum of 75% effort for mentored Ks (may have salary cap)—It is likely specified on the Institute website • Research Development Support ($20K-$50K) - defined by institute and specified on website • Tuition/Fees for Career Development • Research Expenses (supplies, equipment, personnel) • Travel to research meetings • Statistical services

37. Q: When do I need to start? A: Earlier than you think!! • Internal vs. External Deadlines • Should get science drafted in plenty of time to have others read final version, and the best people to read your grant have the least amount of time to do so • Administrative Shell may be completed and routed while you are still ironing out the final proposal plan

38. Timing (continued): • Medical School: 7-working day requested lead time (prior to submission)www.med.umich.edu/medschool/grants/policy.html • Some departments have (varied) requested lead times… but, Department Grant Administrators like to hear about potential projects as soon as you think of the submission!!! • Department Grant Administrators’ website http://med.umich.edu/medschool/grants/contacts.html

39. Medical School Grant Proposal Sampler • Repository of sample proposals and sections that have been donated by faculty • Looking for future sample 2010 K awards; Human Subject Protections sections, Vertebrate Animals, resource sharing, letters, etc. • https://www.umms.med.umich.edu/confluence//x/UZIgBQ

40. Medical School Grants Office • Email us with questions! msgrants@umich.edu

42. Mission: Why We’re Here • Career Development Awards • Institutional Review • MICHR Resources • Q & A

43. Nursing • Bionutrition • Human Applications Lab (HAL): for the culture and manipulation of human cells and the manufacture of gene transfer vectors • Specimen Laboratory • MCRU 2 U Mobile service Michigan Clinical Research Unit Research Innovation Resources

44. Offered twice yearly, August and February deadlines • Soliciting research projects across the full translational spectrum • Up to $50K total costs • Must have matching funds from department(s) of investigators • >3 million awarded! Pilot Grant Program Research Innovation Resources

45. Community Engagement - Partnerships • Connects investigators with community partners, such as schools, county social service agencies, faith-based groups, tribal communities, and others • Small grants for community-university research projects • 4 grants awarded annually, $5K-$25K, next application deadline February 1, 2010 • Free staff support for regulatory compliance and implementation throughout project Community Engagement Resources

46. Biostatistical design and analysis • Database development and data management • IND/IDE services • Regulatory management/monitoring for multi-site studies • Specialized Application Development (on a case-by-case basis) • Velos e-Research Electronic Data Capture system • [Services generally provided on a chargeback basis] Research Management Services Clinical Research Management Resources

47. Research Biorepository located at Traverwood (with courier services available) • Accepting biofluids and limited types of tissue samples • DNA and RNA analysis will be available • Modest chargebacks for storage and services • Anticipate opening for wider service in fall 2009 Biorepository Research Innovation Resources

48. MICHR Education Program • Degree programs, courses, workshops • Institutional Career Development Awards • Assistance: • Identifying educational needs • Resources for career development • Identifying courses and workshops • Preparing an educational plan • Identifying mentors/creating mentoring plans

49. MICHR K • K program provides 75% protected time for research • $50K-$55K in research expenses • 2 year appointment • Postdoctoral Translational Scholars Program • $100K total support for research and/or salary • 50% effort commitment • 2-3 year appointment Institutional Career Development Awards Education and Mentoring Resources

50. No-cost services and consultation to assist investigators in designing, writing, and submitting external grant proposals • Guidance with: • study design and scientific review, • advice for second round submissions • administrative and regulatory support • budgeting Research Development Education and Mentoring Resources