Mentored Patient-Oriented Research Career Development Award (K23) Guide for Written Review

PA Number: PA-05-143

The K23 award is intended to provide research-oriented clinicians the means to develop independent research skills and gain experience in experimental methods and approaches that will allow them to conduct patient-oriented research.  Please follow the review format outlined below in preparing your written comments for each K23 application assigned to you. Indicate additional headings when they seem appropriate to the review.

General Considerations when reviewing K23 applications:

• The candidate must be able to identify a mentor with extensive research experience.
• The candidate must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development.
• Ineligible individuals include current and former principal investigators on NIH research project (R01), FIRST Awards (R29), comparable career development awards (K01, K07, K08), sub-projects of program project (P01) or center grants (P50), and the equivalent.  Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible.
• Applicants must be US citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence.
  

REVIEW FORMAT

SUMMARY and RECOMMENDATION: Provide your overall evaluation of the application. 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. The five review components: Candidate, Career Development Plan, Research Plan, Mentor, and Environment and Institutional Commitment, should be considered in determining the overall score.

CRITIQUE:

Each major review 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. Please note that your comments will be used essentially unedited in the final summary statement sent to the candidate. 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:

• Describe and evaluate the candidate's qualifications and commitment to a career in patient-oriented research.
• For individuals having little or no prior research exposure, evaluate his/her quality and extent of past education and clinical training experience.
• For individuals having more research background, assess his/her quality and extent of past education, scientific training, and clinical research experience, and the quality of any independent research publications. 
• Weigh
  •  their commitment to a career in patient-oriented research and the need for further training
  • how the award will contribute to immediate and long-term career objectives
  • Letters of reference which must address their potential for a research career
• The candidate must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development.

CAREER DEVELOPMENT PLAN:

• Describe and evaluate the career development plan, incorporating consideration of the candidate's goals and prior experience.
• For individuals with limited or no prior research experience, the didactic component, proposed during the first year or two, must be integrated fully into the training program and justified on the basis of their needs.
• If course work is proposed for candidates with greater research experience, it must be integrated adequately into the training program.

RESEARCH PLAN:

• Assess the research plan outlined, including the specific aims, background and significance, progress report/preliminary studies, and research design and methods for its feasibility, scientific soundness, and potential to achieve the goal of this award.
• Determine the appropriateness of this project for the candidate at his/her stage of development and as a vehicle to acquire research skills necessary for independence.
• If plans for inclusion and protection of human subjects are inadequate, this should be considered a research design flaw.

MENTOR:

• Mentor's research qualifications in the area of the project
• Extent and quality of his/her proposed role in guiding and advising, previous experience in training researchers
• Mentor's history of research productivity and support.
• If more than one mentor is identified, the qualifications, role, and commitment of each must be discussed.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT:

• Institution's commitment to the candidate's career development.
• Indicate the types of facilities, resources, and training opportunities to be made available to the candidate
• Applicant's institution's assurance that 75 percent of the applicant's full-time effort will be protected for this program.

BUDGET:

• Comment on the appropriateness and justification of the budget request within the context of the goal of the award.
• The candidate's salary must be based on a full-time, 12-month appointment and not exceed $75,000. Up to $25,000 per year is allowed for tuition, fees and books related to career development; research-expenses such as supplies, equipment, and technical personnel; travel to research meetings or training; and statistical services including personnel and computer time.
• Justify any budget recommendations.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH:

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

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 through 4.

Examine whether the gender, minority, 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 "Research Plan" in the major review criteria above, and should be factored into the score as appropriate.

ANIMAL WELFARE:

Evaluate acceptability 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.