Midcareer Investigator Award in Patient Oriented Research (K24) Guide for Written Review

PA Number: PA-04-107

The NIDCR utilizes the K24 mechanism (Midcareer Investigator in Patient Oriented Research) to provide support for clinicians to allow them to devote protected time to patient oriented research and to serve as mentors for clinical residents, clinical fellows and/or junior clinical faculty.  The prospective candidate must have a DDS/DMD, MD, or other clinical doctoral degree, and be willing to devote between 25 and 50% of full-time professional effort mentoring junior clinical investigators. 

This mechanism provides support for 3-5 years and may be competitively renewed one time for up to an additional 5 years of support.  An annual salary (up to $75,000) is provided and additional funds (up to $50,000) are available for training, research, and development. 

General considerations when reviewing K24 applications:

• The candidate must have a clinical doctoral degree or its equivalent.
• The candidate should be at the associate professor level or functioning at that rank in an academic setting or equivalent non-academic setting.
• The candidate must have an established record of independent, peer-reviewed Federal or private research grant funding in patient-oriented research.
• The candidate must have a record of publications. 
• The candidate must commit 25 to 50 percent of full-time professional effort to conducting patient-oriented research and mentoring beginning clinical investigators.
• Applicants must be US citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence.

Eligibility for competitive renewal: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-095.html. During the course of the initial award, an investigator may be promoted from associate professor to full professor. Such investigators are considered to be eligible to apply for renewal of their support, as long as they meet all other eligibility requirements stated in PA-04-107. Renewal K24 applications will not be rejected, nor will they be unscored, solely based on the applicant’s academic rank. Reviewers will continue to apply their professional judgment in assessing the review criteria, and in assigning priority scores to specific K24 grant applications.

REVIEW FORMAT

SUMMARY AND RECOMMENDATIONS
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 its merit.  Provide the key reasons for your recommendation of a level of merit based on the NIH rating scale.  The four review components: Candidate, Research Plan, Mentoring Plan, and Environment and Institutional Commitment, should be considered in determining the overall score.

CRITIQUE

CANDIDATE:

• Evaluate the current patient-oriented research for scientific quality and applicability to mentoring
• Evidence of candidate’s ability and commitment to serve as mentor
• Demonstration the need for additional time for patient-oriented research
• Record of funding for patient-oriented research

RESEARCH PLAN:

• Research proposed that is not currently funded should include hypothesis and specific aims, background, preliminary studies and aims.  
• Appropriateness of the plan for demonstrating to and developing patient-oriented research skills in mentees
• Scientific merit may not be as detailed as other research grants but must be sound research.

MENTORING PLAN:

• Adequacy of the plans for mentoring or supervising beginning clinicians in patient-oriented research.
• Adequacy of plans to integrate appropriate clinical research curricula into the mentoring plans.
• Appropriateness of the proposed level of effort committed to the mentoring component.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT:

• 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 the availability of appropriate educational opportunities.
• Quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing patient-oriented research.
• Applicant institution's commitment to provide adequate protected time for the candidate to conduct the research and mentoring program.
• Applicant institution’s commitment to the career development in patient-oriented research of individuals mentored by the candidate.

BUDGET:

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

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 to determine if the application should be withdrawn.) 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 to determine if the application should be withdrawn.) Indicate if the plan is "Acceptable" or "Unacceptable", and, if unacceptable, explain why it is unacceptable.

Gender, Minorities 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.

The adequacy of plans to include subjects from genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398). 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".

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 procedure will be limited to those that are unavoidable in the conduct of scientifically sound research.

Biohazards:
If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.