Mentored Clinical Scientist Development Award (K08) NIDCR Guide for Written Review

PA-06-512

The purpose of the NIDCR K08 mechanism is to encourage dentists or other clinicians to pursue a career in oral health research.  The prospective candidate must have a DDS/DMD, MD or other clinical doctoral degree, and be willing to spend a minimum of 75% of full-time professional effort conducting research.  Priority will be given to dentists who wish to pursue a program that includes didactic and supervised basic or behavioral science research experiences that result in a PhD degree.  Health professionals who already have the PhD degree may use the award for the postdoctoral experience.  The NIDCR does not allow support for clinical specialty training to be provided under this program.  See NIDCR Policy Update: http://grants.nih.gov/grants/guide/notice-files/NOT-DE-05-001.html

This mechanism supports three to five years of supervised research experience that integrates didactic studies with mentored basic, behavioral or laboratory research.  An annual salary plus commensurate fringe benefits are provided.  Additional funds are available for training related expenses.

General Considerations when reviewing K08 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, K23), 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

In one paragraph, briefly 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. The five review components: Candidate, Career Development Plan, Research Plan, Mentor, and Environment and Institutional Commitment, should be considered in determining the overall score.

Each major review element within the Mentored Clinical Scientist Development Award application (Candidate, Career Development Plan, Research Plan, Mentor/Co-mentor, 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. 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).

The following review criteria will be applied:

• Quality of the candidate's academic and clinical record;
• Potential to develop as an independent researcher; and
• Commitment to a research career.
• Summarize awards and honors received, as well as letters of support.
• Career goals.

• Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence;
• Consistency of the career development plan with the candidate's previous training and career goals; and
• Likelihood that the plan will contribute substantially to the achievement of scientific independence.

Training in the responsible conduct of research: Quality of the proposed training in the responsible conduct of research (a required part of the career development plan).

Reviewers recognize that applicants will have variable amounts of previous research experience. Those with limited research experience are less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. All applications must include a fundamentally sound research plan but reviewers will consider the applicant's prior research experience in judging the level of detail 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 plans for these years.

• Scientific and technical merit of the research question, design and methodology;
• Relevance of the proposed research to the candidate's career objectives;
• Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills described in the career development plan; and
• Adequacy of the plan's attention to children, gender, and minority issues when human subjects are involved.

• 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 to the candidate;
• Previous experience in fostering the development of researchers;
• History of research productivity, especially success at obtaining grants from NIH, NSF private industry, etc. and
• Adequacy of support for the proposed research project.

• Adequacy of research facilities and training opportunities;
• Quality and relevance of the environment for scientific and professional development of the candidate;
• 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; and
• Applicant institution's commitment to an appropriate balance of research and clinical responsibilities including the level of at least 75 percent effort proposed by the candidate.

• Justification of the requested budget in relation to career development goals and research aims. Budget issues do not influence the scientific merit of the application.

Other Considerations

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.

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 "Research Plan" section of the criteria, and should be factored into the score as appropriate.

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.

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