Funding For Clinical Research: The NIH And Beyond

1. Funding For Clinical Research: The NIH And Beyond Anita Liberman-Lampear, M.A. Administrative Director, UMOPC University of Michigan Health System With very special thanks to: Elaine Brock, Senior Associate Director, Research Administration Julie Feldkamp, Managing Project Representative, DRDA Jennifer Griggs, Associate Professor of Medicine Steven Katz, Professor of Medicine and Health Management and Policy University of Michigan

2. Grant Hunting at NIHhttp://grants1.nih.gov/grants/oer.htm

3. Career Development Grants • Purpose: To propel the investigator towards independence as a funded researcher • Developing skills to gain independence • Developing networks/resources helpful in gaining independence • Strengthening candidate’s abilities to apply for additional funding

4. NIH Budgets by Institute FY 2009ChangeRequest 98-09 % (in millions of current dollars) Cancer 4,81088.8% Allergy and Infectious Disease 4,569 237.9% Heart, Lung and Blood 2,925 91.0% General Medical Sciences 1,93881.8% Diabetes, Digestive, Kidney Disease 1,872 106.3% Neuro. Disorders and Stroke 1,545 97.9% Child Health & Human Dev. 1,25687.5% Aging 1.048102.0% Arthritis, Musculoskeletal & Skin50985.1% Total NIH Budget 29,457 115.4% (Minus training & overhead 791 39.9%) http://www.aaas.org/spp/rd/health09p.pdf

5. NIH Budgets by Funding Mechanism(sampling) FY 2009ChangeRequest 98-09 % (in millions of current dollars) Research Project Grants14,90397.2% SBIR/STTR* Grants 620 130.5% Research Centers2,963 153.7% R&D Contracts3,275303.4% Total NIH Budget29,457115.4% *Small Business Innovative Research Grant (SBIR) http://www.sbir.gov/ Small Business Technological Transfer Grant (STTR) http://grants.nih.gov/grants/funding/sbir.htm

6. Position Your Research For Success • Find the vision; Find the inspiration • Find the opportunities at NIH • Engage mentors about strategic planning • Engage the NIH staff about opportunities • Understand the review process at NIH • Write the best proposals • Build a track record

7. Investigator Initiated Research Proposals • Unsolicited • Response to a PA (program announcement) • Describes institute research priorities • Intended to motivate proposals in the research area • Stipulates grant mechanisms (R01, R21, R03) • PAs are generally ignored in the section review process • May help in close call funding decisions • Response to a RFA (request for applications) • Separate allocation of funds for the initiative • Ad hoc study section assembled • Response to a RFP (request for proposals) • A call for contracts

8. Engage the NIH staff • Learn about the organizational chart • Contact project officers • Get to know program directors • Meet and greet at NIH • Consider organizational dynamics • Staff perspectives • Staff turnover

9. Center for Scientific Review at NIH • Manages the review process for most research applications at NIH • Reviewers are organized in multidisciplinary sections • Regular standing (“chartered”) sections • Receive applications across institutes • Develop greater continuity and cohesive culture • Special Emphasis Panels • Ad hoc with less continuity • May review applications from within or across institutes • Chartered sections: http://www.nih.gov/icd/

10. Chartered Sections by Category

11. Understanding the NIH review process • General structure and process of review • Role of SRA (scientific review administrator) • Role of PO (program official) • Section Review Processes • Merit score measures • Review guidelines for R mechanism • Considerations for new investigators • New multiple PI option

12. Priority score measures • Significance • Innovation • Approach • Conceptual framework • Design and feasibility • Data collection methods • Analysis plan • PI and research team • Environment • Protection of human subjects

13. Review criteria for different Rs • R21- exploratory grants • The goal is research development leading to larger studies • More emphasis on significance in the context of next steps • Less emphasis on details of methods • Preliminary studies are not required • Limited budget • R03 • More emphasis on significance and conceptual approach • Less emphasis on detail of methods • Limited budget • R01 new investigator category • less emphasis on preliminary studies and experience of the PI • Percentile pay line may be higher

14. Attributes of Strong Proposals • Appealing formats • Crisp specific aims and hypotheses • Compelling and concise background section • Thoughtful conceptual model • Preliminary studies section that addresses challenges to the proposed research • Measures linked to variables and analysis plan • Crisp description of data collection procedures and data management using figures

15. Attributes of Strong Proposals (cont’d) • Clear power analyses with tables of effect sizes anchored by text addressing clinical importance • Protection of human subjects described using PHS application instructions to the letter • Figure of the timeline with few stretch marks • Requested resources are appropriate for scope of work

16. Funding Decisions • Priority scores are used to calculate a percentile rank • Funding decisions are made by institute staff based on the rank score of the grant against the payline • Rank scores just above the payline occasionally are selected for funding • Unfunded proposals may be resubmitted twice

17. New investigators • New investigators are encouraged to apply • New investigator category for R01s • Less emphasis on preliminary data • Higher payline • R03 and R21 applications are limited to 10 pages and do not require deep preliminary data sections • Demonstrated collaboration on a productive team in a related area is a key ingredient to success • Get some experience on a study section

18. Hunting for Support Outside the NIH Forest

19. Federal Agencies • Discovery Driven, e.g.: • National Science Foundation (NSF)http://www.nsf.gov/funding/ • National Institutes of Health (NIH) • Program Driven, e.g.: • Department of Defense (DOD)http://www.federalgrantswire.com/department-of-defense-federal-grants.html • National Aeronautics & Space Administration (NASA)http://science.nasa.gov/researchers/research-opportunities/ • Environmental Protection Agency (EPA)http://www.epa.gov/epahome/grants.htm

20. GO TO http://grants.gov/ • Key benefits include: • A single source for finding grant opportunities. • A standardized manner of locating and learning more about funding opportunities. • A single, secure and reliable source for applying for Federal grants online. • A simplified grant application process with reduction of paperwork. • A unified interface for all agencies to announce their grant opportunities, and for all grant applicants to find and apply for those opportunities. • In addition to simplifying the grant application process, Grants.gov also creates avenues for consolidation and best practices within each grant-making agency.

21. Trade & Professional Associations and Public Charities • American College of Surgeons • Oral and Maxillofacial Surgery Foundation • Health Insurance Association of America • American Cancer Society • American Medical Association • Plastic Surgery Educational Foundation • American Orthotics & Prosthetics Association

22. Finding an Industry Sponsor • personal contacts of the investigators • other faculty - search of internal databases, websites • location of graduates • encounters at conferences and papers • search of external on-line databases, websites • announced opportunities • books, publications

23. Statement of Work The statement of work in an industry sponsored project is critical since it determines: • Sponsor’s interest in the project • Intellectual property rights that will be offered to sponsor • Publications that may be reviewed by the sponsor • Overlap with other research • Need to use existing intellectual property • Need to access sponsor confidential information • Cost of and use of various personnel • Appropriateness of activity in the university • Appropriateness of student participation

24. Industry sponsorship requires a balance between what the Investigator wants (i.e., research $$ now) versus what the industry sponsor wants (i.e., direct benefit from data, or intellectual property very soon)Maintaining a realistic perspective about potential outcomes in industry-sponsored research is important for both parties.

25. Materials Transfer Agreements, Nondisclosure Agreements, and other Agreements with Industry In addition to funding from industry universities actively solicit proprietary materials, software, data, equipment, etc. and are able to accept proprietary information from our industry partners.

26. NIH COMPETING R01-EQUIVALENT* APPLICATIONS: TRENDS IN NUMBER, AWARDS AND SUCCESS RATES FY 1998-2007 Success Rate * R01-Equivalent Grants include R01, R23, R29, and R37 mechanisms

27. Section pearls: Help your reviewers help you • Write with clarity, grace, and humility • Direct their attention through appealing formats • Summarize key concepts throughout the application • Teach them in the background section • Consider KISS to avoid the death spiral • Follow NIH instructions on description of protection of human subjects • Justify your budget with detailed timeline and clear description of resources

28. Section pearls for investigators: Understand your reviewers • You are seeking to impress 3 people who are pressed to read 8 grants in 2 weeks • Imagine your reviewers will read your grant on a Sunday afternoon instead of spending time with their kids • Reviewers have a few minutes to justify their score and influence the section. They have a couple of minutes in rebuttal. • Reviewers have known skills and interests

29. Foundations

30. Foundations • Foundations are often known for donations to the arts, hospitals, education, etc. • More foundations are also giving to the sciences for various reasons. To get started go to: • http://foundationcenter.org/

31. Foundations • Foundation Center’s Proposal Writing Short Course • http://foundationcenter.org/getstarted/tutorials/shortcourse/ • It is a different source of funding that might be more viable to the non-academic setting wishing to do research. • Some large insurers have foundations such as BCBS.

32. Foundations • You might also try disease-specific organizations/foundations such as the Muscular Dystrophy or American Diabetes Associations. • How are foundations most different? • Some are not peer-reviewed • Regional foundations • Family foundations

33. Foundations • Greater focus on long-term outcomes/impacts • Does this SOLVE the problem? How does it contribute? • Why should they care? • Often a great focus on underserved populations

34. Foundations • They also have different rules for funding then grants do – they may or may not pay for salaries, for example. • On the other hand they may allow expenses not allowed on federal grants.

35. Why do foundations give grants? • They must. Their tax exempt status requires that foundations spend or gift 5% of their asset base or pay stiff taxes and penalties. • Usually, the founder sets aside some wealth (for tax reasons or other), sets out a vision and priorities for “legacy.” These define a foundation’s programs.

36. Why do foundations give grants? • How the staff members tell this story speaks volumes about the values –learn about ‘why’ by listening closely and reading between the lines. • Often in foundations there are donors or descendants on the board or in other leadership positions, continuing to influence choices. The dynamics between board and staff can be challenging.

37. Final Notes • Can be overwhelming at best and darn right frustrating at worst. • If you are serious, take the time, follow the directions, the funding is there, you have to figure out how to be the winner • O&P needs more folks like you, we need to prove what we do is credible and reimbursement-worthy.

38. THANK YOU University of Michigan