Mentored Quantitative Research Career Development Award (K25) Guide for Written Review

PA Number: PA-06-087
Complete details at: http://grants2.nih.gov/grants/guide/pa-files/PA-06-087.html

In an effort to advance research relevant to the mission of the NIH, the K25 mechanism is meant to attract investigators whose quantitative science and engineering research has thus far not been focused primarily on questions of health and disease.  Examples of quantitative scientific and technical backgrounds considered appropriate for this award include, but are not limited to: mathematics, statistics, economics, computer science, imaging science, informatics, physics, chemistry, and engineering.

The K25 award will support the career development of such investigators who make a commitment to basic or clinical biomedicine, bioengineering, bioimaging, or behavioral research.  This award provides support for a period of supervised study and research for productive professionals with quantitative backgrounds who have the potential to integrate their expertise with NIH-relevant research and develop into productive investigators or play leading roles in multidisciplinary research teams. It is intended for research-oriented investigators from the postdoctoral level to the level of senior faculty.

• Candidates must have demonstrated research interests with an advanced degree in a quantitative area of science or engineering: MSEE, PhD, DSc, etc. and have demonstrated research interests in their primary quantitative discipline.
• Candidates must identify a mentor with extensive behavioral, biomedical, bioengineering, or bioimaging research experience.
• Candidates must be make a commitment of at least 75% effort to research and research career development.
• Applicants must be US citizens or noncitizen nationals, or must have verification of legal admission as a permanent resident.
• Former principal investigators on R01, R29, sub-projects of P01 or center grants, K01, K08 or K23 awards, or the equivalent are not eligible. Candidates must not concurrently apply for any other PHS award that duplicates the provisions of this award nor have any other application pending award. Former principle investigators of R03, SBIR/STTR (R41, R42, R43, R44) remain eligible.
• Candidates may be at any level of experience, from the postdoctoral to senior faculty level.

Each major review element within the Mentored Quantitative Research Career Development Award application (Candidate, Career Development Plan, Research Plan, Mentoring, Environment and Institutional Commitment, and Budget) should be commented on in a separate section of your written critique. For revised applications, also comment briefly on whether the application is improved, the same, or worse. 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. Budget considerations should not factor into the score. Please note that your comments will be used essentially unedited in the final summary statement sent to the candidate.

In one paragraph, provide your overall evaluation of the application. Briefly summarize the most important points of the Critique, and indicate the major strengths and weaknesses of the proposed program as a means of enhancing the candidate's research career and how these factors determine your overall merit rating of the application.  Each application will receive a numerical rating that will reflect your opinion of its merit.

• Quality of the candidate's academic and research record;
• Potential to develop as an independent quantitative biomedical or bioengineering researcher or to play significant role in multidisciplinary research teams; and
• Commitment to a career in quantitative biomedical or bioengineering research.

• Likelihood that the career development plan will contribute substantially to the scientific development of the candidate;
• Appropriateness of the content and duration of the proposed didactic and research phases of the award; and
• Consistency of the career development plan with the candidate's career goals and prior research experience.

• Quality of the proposed plans for instruction in the responsible conduct of research.

Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Although it is understood that K25 applications do not require the level of detail necessary in regular research grant applications, a fundamentally sound research plan must be provided. In general, less detail is expected with regard to research planned for the later years of the award, but the application should outline the general goals for these years.

• Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills as described in the career development plan;
• Scientific and technical merit of the research question, design and methodology;
• Relevance of the proposed research to the candidate's career objectives; and
• Adequacy of the plan's to include both genders, minorities, and children and their subgroup as appropriate for the scientific goals of the research when human subjects are used. Plans for the recruitment and retention of subjects will also be evaluated, when applicable.

• History of research productivity and support in the area of basic or clinical biomedical, bioengineering, bioimaging or behavioral research;
• Appropriateness of mentor's research qualifications in the area of this application;
• Quality and extent of mentor's proposed role in providing guidance and advice; and
• Previous experience in fostering the development of researchers

• Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program;
• Adequacy of research facilities and training opportunities (including access to such facilities or opportunities in other institutions);
• Quality and relevance of the environment for the candidate’s scientific and professional development; and
• Institution's commitment to an appropriate balance of research and other responsibilities.

Budget

• Justification of the requested budget in relation to career development goals and research aims and plans.

Other Considerations

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".

NOTE: To the degree that acceptability or unacceptability affects the investigator's approach to the proposed research, such comments should appear under the "Research Plan" section of the criteria, and should be factored into the score as appropriate.

Animal Welfare

Evaluate as Acceptable, Unacceptable (expressed as concerns), or Comments. Express any comments or concerns about the appropriateness of the responses to the five required points, especially whether the procedures will be limited to those that are unavoidable in the conduct of scientifically sound research.

Biohazards

Note any materials or procedures that are potentially hazardous to research personnel and indicate whether the protection proposed will be adequate.

Further information about NIH research training and career development opportunities can be found at http://grants.nih.gov/training.