1. Career Development Awards (K series) and Research Project Grants (R series) Thomas Mitchell, MPH Department of Epidemiology & Biostatistics University of California San Francisco March 2015

2. Every fundable K award begins with “a great candidate” Evidence of recent productivity At least one first-author publication of original research in a peer-reviewed journal. A track record of training and research consistent with the mission of your Institute. Credible plan for achieving independence as an investigator. A career development plan and a research plan that will prepare you to compete successfully for an R01 grant.

3. Career development training plans for a K award Develop a training plan that is uniquely suited to you. Propose a mix of didactic training and “hands- on” research experience that make perfect sense for you (and only you), given your previous training and research experience and your short- and long-term career goals. Degree-granting programs (e.g., MPH, MAS) are appropriate for candidates with little or no previous formal training in research, but even these programs should be “customized” whenever possible.

4. Training plans for K awards (cont’d) A training plan that emphasizes “hands-on” research experience is appropriate for candidates with substantial previous formal training in research. Reviewers expect you to fully exploit the training resources that are available to you at UCSF. You can propose to use training resources outside UCSF, but choose the best available. Your training plan should be as strong as your research plan.

5. Designing a research plan for a K award application The research plan is a training vehicle. The research plan should provide an opportunity to acquire new skills and should be well integrated with your career development training plan. The research plan is a means to achieve independence. The research plan should be viewed as a precursor for a subsequent R01 application. Mentored K awards provide limited funding. The scope of the research plan needs to be appropriate and feasible, given the modest resources available in a mentored K award.

6. Developing Specific Aims for a K award Because a mentored K award is a precursor for a subsequent R01 award, each specific aim should contribute to achieving that goal. Given the modest resources available in a mentored K award, a “modular” approach is often used, in which several small projects are proposed. Examples: Secondary analyses of existing data, leveraging ongoing cohort studies or clinical trials, or conducting a small pilot study. Each project (or specific aim) should provide you with either key preliminary data or an essential skill needed for the R01.

7. Building your team for a K award Choose a primary mentor who is a senior investigator with a track-record of NIH funding Your primary mentor should be at UCSF. Include co-mentors who will complement the primary mentor’s strengths. Avoid including co-mentors from institutions outside the Bay Area. If you include an outside member, call them a scientific or technical advisor rather than a co-mentor. Establish a relatively small (3-5) mentoring team. Each member of your team should play a role in your training plan.

8. Choosing the right funding mechanism: K01, K08, or K23? K01: Mentored Research Scientist Development Award Some NIH institutes use this award for individuals who propose to train in a new field or to increase research workforce in particular types of research. K08: Mentored Clinical Scientist Development Award Clinical training required; not patient-oriented research K23 : Mentored Patient-Oriented Research Career Development Award Clinical training required; must be patient-oriented research

9. Every fundable R01 begins with “a great idea” The idea must be creative, exciting, and worth funding. 1. Concentrate ideas in your area of expertise that would make an impact on public health. 2. Do your homework; make sure your project fills a gap in the existing literature. 3. Brainstorm potential ideas with mentors and colleagues in your field.

10. Designing a research plan for an R01 1. Address a clearly defined research problem that is a high priority in your field. 2. Build on previous research and pose interesting, important, and testable hypotheses. 3. Propose a scope of work that is appropriate to the track record of the investigator(s).

11. Developing Specific Aims for an R01: Two Approaches “Value-added” approach In this approach, specific aims typically address an array of related questions relevant to a topic of interest to an NIH institute. Each specific aim is designed to address an important gap in our knowledgebase. Each additional specific aim is thought to increase the potential “value” of the project.

12. Developing Specific Aims for an R01 Value-added approach (cont’d)  As additional aims are added, however, the project can easily become “overly ambitious” in scope.  Because these projects often lack a unifying central “problem” or research question, they may be viewed as “lacking focus.”

13. Specific Aims for an R01 (cont’d) “Less is best” approach In this approach, you address a clearly defined research problem or challenge (i.e., a critical barrier that prevents further progress in your field).  This ensures focus. Each specific aim addresses some critical aspect of that problem; when taken together, they are adequate to address the problem.  This ensures integration. As a consequence, these applications are easier to write and easier to understand.

14. Building your team for an R01 1. Seek opportunities for collaboration. 2. Identify co-investigators who fill gaps in your expertise, especially a collaborator who is well known. 3. Consider multidisciplinary approaches. 4. Recruit senior colleagues who can provide advice and periodic peer-review of your grant application (e.g., overall scope, specific aims, methods)

15. The Multiple PI Option If you lack key competencies with regard to the approach you’re proposing in the R01, you might consider the “multiple PI” option. This option should be used only in circumstances where “team science” is employed. These projects require 2 or more equally important areas of expertise that would normally not be found in a single investigator. Recruit an investigator whose expertise complements yours and addresses critical competencies that you lack.

16. Choosing the right funding mechanism: R01, R03, R21? R01: Research Project Grant Definition: “Supports a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing the investigator's specific interest and competencies, based on the mission of the NIH.” Funding 3 - 5 years Most R01s use “modular budgets” ($250K/year or less in direct costs) Special permission is required to submit an R01 if any year exceeds $500K/year in direct costs.

17. Choosing the right funding mechanism: R01, R03, R21? R03: Small Grant Definition: Supports small projects that can be carried out in a short period of time with limited resources. Funding: Up to $100K in direct costs for 2 years ($50K/year) Appropriate projects Pilot or feasibility studies Secondary analysis of existing data Small, self-contained research projects Development of research methodology or new research technology

18. Choosing the right funding mechanism: R01, R03, R21? R21: Exploratory/Developmental Grant Provides support for the early or conceptual stages of development. Funding: Up to $275K in direct costs over 2 years. Appropriate projects: Should address the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. The NIH parent announcement describes this research as “High Risk – High Impact.” However, some Institute-specific program announcements may not emphasize this requirement. Warning! Not all NIH institutes support R21s!