NIH Pathway to Independence (PI) Award (K99/R00) Guide for Review

PA NUMBER: PA-07-297

The purpose of the NIDCR K99/R00 mechanism is to generate a Pathway to Independence Award Program (PI) designed to assist new investigators in transitioning to stable independent research positions at an earlier age and facilitate receiving an R01 award earlier in an investigator’s research career.  Prospective candidates must have an advanced doctoral degree (DDS, DMD, PhD or equivalent) and have no more than 5 years of postdoctoral training.   Applicants must demonstrate a commitment to a career in oral health research, and funding priority will be given to applicants holding a dental degree.

This mechanism provides up to five years of supports in two phases.

Mentored Phase: The initial mentored phase will provide support for salary and research expenses for up to 2 years for the most promising and exceptionally talented new investigators who have no more than 5 years of postdoctoral research training experience at the time of initial application or subsequent resubmission(s). This initial phase of mentored support will allow the candidate time to complete research, publish results, and obtain an independent research position.  The candidate must document a need for additional mentored training.  As part of the application, the candidate must propose a research project that will also be pursued as an independent investigator during the second phase of the award.  The candidate and mentor(s) together will be responsible for all aspects of the mentored career development training and research proposal.  An individual may submit an application from an extramural or intramural sponsoring institution or organization. The individual must select an appropriate mentor with a track record of funded research related to the selected research topic and experience as a supervisor and mentor. The sponsoring institution must ensure that the candidate has the protected time needed to conduct the proposed research.

Budget:  Salary is limited to $75,000 plus applicable fringe benefits and up to $25,000 for research support costs for a 12-month budget period. Candidates are required to commit a minimum of 75% of full-time effort during the mentored phase. 

Transition from the mentored phase (intramural NIH or extramural institution) to the independent scientist phase is NOT automatic and is subject to review of the success of the awardee’s research training and career development accomplishments, and the evaluation of a research plan to be carried out at the extramural sponsoring institution at which he/she has been recruited.

Independent Phase: Following the mentored phase, the individual may request up to 3 years of support to transition, as an independent scientist, to an extramural sponsoring institution/organization to which the individual has been recruited.  This support is to allow the individual to continue to work toward establishing his/her own independent research program and prepare an application for a regular research grant support (R01).  Support for the independent phase, however, is not automatic and is contingent upon being offered and accepting an independent tenure-track or equivalent position at an extramural institution and the successful NIH programmatic review of the individual’s mentored phase progress.

The applicant should describe his/her research that is relevant to the proposed R00 research plan. Ideally, this would include a brief description of research performed prior to the mentored phase, a description of the research planned during the mentored phase and a detailed description of the research planned for the independent phase. This narrative should describe what the applicant will accomplish during the mentored phase research that will enable him/her to launch an independent research program (i.e. what does the applicant still need to accomplish during the mentored phase in order to compete successfully once independence is achieved).  The research description should demonstrate not only the quality of the applicant’s research thus far but also the novelty, significance, creativity, and approach of the R00 phase research, as well as the ability of the applicant to carry out the research. Consequently, the research plan should provide a detailed rationale, experimental approach and plan for the independent phase research.

Budget: The total cost for the independent investigator phase may not exceed $249,000 per year. This amount includes salary, fringe benefits, research support allowance and applicable F&A costs.
 

REVIEW FORMAT

SUMMARY and RECOMMENDATION: Provide your overall evaluation of the application. Summarize the most important points of the Critique, addressing the strengths and weaknesses of the application in terms of the review criteria. Each scored application will receive a numerical rating that will reflect your opinion of its merit. Provide the key reasons for your recommendation of a level of merit based on the NIH rating scale. Each major review element: Candidate, Career Development Plan, Research Plan, Mentor, and Environment and Institutional Commitment, should be considered in determining the overall score.

CRITIQUE:

Each major review element should be commented on in a separate section of your written critique. Do not describe the investigator’s plans. Instead, make evaluative statements about the strengths and weaknesses based on the criteria. For revised applications, comment briefly on whether the application is improved or not. In addition, provide a one-sentence summary of your evaluation at the end of each section. After considering all of the review criteria, briefly summarize the strengths and weaknesses of the application and recommend an overall level of merit in a section titled Summary and Recommendations (see above).

CANDIDATE:

• Potential to carry out independent research, based on the candidate's experience level and research training background leading up to the current application.
• Candidate’s potential for becoming an outstanding successful independent investigator who will contribute significantly to a chosen health-related research field.
• Evidence of the candidate’s research productivity, including quality of peer-reviewed scientific publications.
• The overall quality of the candidate's pre- and postdoctoral research training experience including expertise gained at the current stage of his/her career.
• How this experience will prepare the candidate to implement successfully the independent phase project.
• Need for the candidate to have this additional mentored research and career experience.
• Letters of reference from well-established scientists addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator.
• Mentor’s (sponsor) statement, and statement from the institutional training grant director (if applicable). 

CAREER DEVELOPMENT PLAN: 

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH:  

• Evaluate the appropriateness and adequacy of training in the responsible conduct of research.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISKS:

Evaluate the application with reference to the following criteria: risk to subjects, adequacy of protection against risks, potential benefit to the subjects and to others, importance of the knowledge to be gained. (If the applicant fails to address all of these elements, notify the SRA immediately. If all of the criteria are adequately addressed, and there are no concerns, write "Acceptable Risks and/or Adequate Protections." A brief explanation is advisable. If one or more criteria are inadequately addressed, write "Unacceptable Risks and/or Inadequate Protections" and document the actual or potential issues that create the human subjects concern.

If the application indicates that the proposed human subjects research is exempt from coverage by the regulations, determine if adequate justification is provided. If the claimed exemption is not justified, indicate "Unacceptable" and explain why you reached this conclusion.

Also, if a clinical trial is proposed, evaluate the Data and Safety Monitoring Plan. (If the plan is absent, notify the SRA immediately). Indicate if the plan is "Acceptable" or "Unacceptable" and, if unacceptable, explain why it is unacceptable.

GENDER, MINORITY, AND CHILDREN SUBJECTS:

Public Law 103-43 requires that women and minorities must be included in all NIH-supported clinical research projects involving human subjects unless a clear and compelling rationale establishes that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. NIH requires that children (individuals under the age of 21) of all ages be involved in all human subjects research supported by the NIH unless there are scientific or ethical reasons for excluding them.

Each project involving human subjects must be assigned a code using the categories "1" to "5" below. Category 5 for minority representation in the project means that only foreign subjects are in the study population (no U.S. subjects). If the study uses both then use codes 1 thru 4.

Examine whether the minority, gender, and children characteristics of the sample are scientifically acceptable, consistent with the aims of the project, and comply with NIH policy. For each category, determine if the proposed subject recruitment targets are "A" (acceptable) or "U" (unacceptable). If you rate the sample as "U", consider this feature a weakness in the research design and reflect it in the overall score. Explain the reasons for the recommended codes; this is particularly critical for any item coded "U".