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Michigan Institute for Clinical & Health Research Career Development Awards Mission: Why We’re Here Career Development Awards Institutional Review MICHR Resources Q & A MICHR’s Mission

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slide2
Mission: Why We’re Here
  • Career Development Awards
  • Institutional Review
  • MICHR Resources
  • Q & A
michr s mission

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

part of a larger community of universities involved in translational research ctsa awardees
Part of a Larger Community of Universities Involved in Translational Research: CTSA Awardees
translational research
“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.

slide6
Mission: Why We’re Here
  • Career Development Awards
  • Institutional Review
  • MICHR Resources
  • Q & A
what are nih career development k awards
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
mentored career development k awards
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
who qualifies
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
nih career development awards
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

nih considerations
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/

career development awards
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
personal statement
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. 
developing a career plan
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
career development plans
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
things to think about
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
career development plan
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

what research education do i need
What research education do I need?
  • What purpose?
  • What area(s)?
  • How intense?
  • What format?
  • Desired deliverable?
overwhelming number of research training opportunities
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.
areas to consider when developing the education plan
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
career plan resources at um
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
training in the responsible conduct of research
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
research plan
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
besides good research you need
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!
mentors don t grow on trees
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
things to consider
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.
before you start writing do your homework
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

write with reviewers in mind
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
slide33
Mission: Why We’re Here
  • Career Development Awards
  • Institutional Review
  • MICHR Resources
  • Q & A
q what do i need to route for institutional approval
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
how much
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
q when do i need to start
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
timing continued
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

medical school grant proposal sampler
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
medical school grants office
Medical School Grants Office
  • Email us with questions!

msgrants@umich.edu

slide42
Mission: Why We’re Here
  • Career Development Awards
  • Institutional Review
  • MICHR Resources
  • Q & A
michigan clinical research unit
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

pilot grant program
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

community engagement partnerships

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

research management services
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

biorepository
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

michr education program
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
institutional career development awards
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

research development
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

why come to rdc
Why Come to RDC?

Over the past three years we have assisted nearly 100 faculty and trainees to obtain more than $48 million in funding

contacting rdc
Contacting RDC
  • Lead time = at least a month
  • The sooner the better!
  • Send us an abstract or outline
  • Follow-up phone conversation
  • Proposal review or RDC meeting
what to expect in an rdc meeting
What to expect in an RDC meeting
  • Send your ideas, proposal in advance
  • Meeting will be with:
    • Faculty with NIH Study Section experience
    • Methodologists/statisticians/design experts
    • CTSA program faculty
    • Staff with expertise in grant development
k awards how michr helps
K Awards: How MICHR Helps
  • Examples of successful K proposals
  • Guidance on how to narrow the research focus
  • Advice on how to tell a story in the career plan
  • Review budget and timeline
  • Biostatistics
  • Link to CTSA experts
  • Read and review drafts
  • Link with education resources (courses and mentoring)
success story maria muzik assistant professor of psychiatry on her second try
Success story: Maria Muzik (Assistant Professor of Psychiatry) on her second try . . .

“Hi, thanks for checking in. I got a score of 135 and am anticipating to get funded!!! My Program Officer was positive. I want to thank your group again for the help--it was invaluable!!!!”

Start date 7/01/2008

resources for new investigators
Resources for New Investigators
  • NIH New Investigators Program

http://grants.nih.gov/grants/new_investigators/

  • NIH Grant Writing Tips

http://grants.nih.gov/grants/grant_tips.htm

  • Website for NIH Application Forms and Instructionshttp://grants.nih.gov/grants/funding/phs398/phs398.html - toc
  • K Kiosk - Info about K Awardshttp://grants.nih.gov/training/careerdevelopmentawards.htm
  • NIH Career Award Wizardhttp://grants.nih.gov/training/kwizard/index.htm
  • UM Research Information

http://www.research.umich.edu/

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