K01. Does the candidate have the potential to develop as an independent and productive researcher? Is the candidate’s academic, clinical (if relevant), and research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research? Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

K02. Reviewers should evaluate the candidate’s capacity to carry out independent research as an outstanding scientist making significant contributions to the field. Does the candidate have demonstrated capacity to carry out independent research? Does the candidate have potential to become an outstanding scientist who will make significant contributions to the field? Is there evidence of past and present research productivity as evidenced by contributions to the scientific literature, and success in obtaining independent funding? Does the candidate have demonstrated ability to conceptualize and organize a long-term research approach? Is there evidence of current independent, peer-reviewed research support? Is the candidate’s level of training, experience, and competence commensurate with the purposes of the award?

K07 Development Award. Does the candidate show potential to become an outstanding investigator, teacher, resource person, and leader in research, educational and (where appropriate) clinical programs related to the mission of the NIH awarding component? Is there likelihood that the award will contribute substantially to the academic and research career development of the candidate? Do the letters of reference on behalf of the candidate express the potential and commitment to the planned academic career program and the likelihood that the program will meet the candidate’s career goals? Are sufficient additional relevant information/recommendations submitted by mentor and/or others for review consideration?

K07 Leadership Award. Does the candidate show potential to continue as an outstanding investigator, teacher, resource person, and leader in research, educational and (where appropriate) clinical programs related to the mission of the NIH awarding component? Is there likelihood that the award will contribute substantially to the academic and research career of the candidate? Is there adequate past experience in teaching, curriculum development and leadership? Does the candidate have the ability and commitment to work cooperatively with other scientists to develop innovative curricula, educational materials, and programs?

K08. Does the candidate have the potential to develop as an independent and productive researcher? Is the candidate’s academic, clinical, and (if relevant) research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research? Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

K23. Does the candidate have the potential to develop as an independent and productive researcher focusing on patient-oriented research? Is the candidate’s academic, clinical, and (if relevant) research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator focusing on patient-oriented research? Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

K24. Is there evidence of ongoing high quality patient-oriented research, and what is the relationship of that research to this K24 proposal? Is there evidence of the candidate's capabilities and commitment to serve as a mentor for new clinical investigators in the conduct of patient-oriented research? Does the application demonstrate that the proposed program and protected time will relieve the candidate from non-research patient care and administrative duties and allow him/her to devote additional time and to augment his/her capabilities in patient-oriented research? Does the application demonstrate a record of independent peer-reviewed support for patient-oriented research that is likely to continue during the K24 award?

K25. Does the candidate have the potential to develop as an independent and productive quantitative biomedical, behavioral, bioimaging or bioengineering researcher or to play a significant role in multi-disciplinary research teams? Is the candidate’s academic, clinical (if relevant), and research record of high quality? Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research? Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

K99. What is the candidate’s record of research productivity, including the quality of peer-reviewed scientific publications? What is the quality of the candidate's pre- and postdoctoral research training experience, including expertise gained? Based on the postdoctoral candidate’s experience, track record and prior research training, what is the candidate’s potential to become an outstanding, successful independent investigator who will contribute significantly to his/her chosen field of biomedical-related research? To what extent does the application provide evidence of the candidate’s research creativity, and does this evidence suggest that the candidate has the potential to develop a creative, independent research program? Evaluate the letters of reference. Are there letters from at least three well-established scientists? Relative to the above review criteria, how do these scientists evaluate the candidate? Do the letters provide strong evidence that the candidate has a high potential to become an independent investigator? Given the candidate’s prior training, proposed career development plan, and the referees’ evaluations, is it reasonable to expect that the candidate will be able to achieve an independent, tenure-track or equivalent position within the time period requested for the K99 phase of this award?

K01. What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence? Is the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence? Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?

K02. Evaluate the likelihood that the plan will contribute substantially to the continued scientific development and productivity of the candidate. What is the likelihood that the award will contribute substantially to the continued scientific development and productivity of the candidate? Are the career goals and objectives consistent with the candidate’s career goals? Is there evidence that the award will enable the candidate to devote full time (at least the required minimum of 75% of full-time professional effort) to research and related duties by release from teaching, administration, clinical work, and other responsibilities?

K07 Development Award. Is the candidate’s career development plan, including plans for after termination of the award, of high quality and sufficient feasibility? Are the content and duration of the proposed didactic and curriculum development components appropriate and reasonable? Do the structured activities such as coursework (including course numbers and descriptive titles), seminars or technical workshops, etc., meet the career goals of the candidate? Are there appropriate timelines planned for the candidate’s progress? Is there a satisfactory and appropriate relationship of the research plan to the career development goals and the candidate’s previous experience?

K07 Leadership Award. Are the proposed curriculum and educational experiences therein distinct from other curricula and federally funded educational experiences within the existing educational infrastructure and framework of the candidate/participating institution(s)? Is it likely that the developed curriculum contributes to an increase in the pool of individuals with academic and research expertise and/or enhances the educational or research capacity at the sponsoring institution? Is the proposed plan to enhance pedagogical and leadership skills of the candidate of high quality? Are the plans for enlisting the support of professional and other organizations involved in medical education, as determined essential, in these efforts appropriate? Are the plans and milestones for institutionalizing the curriculum changes feasible and appropriate? Are the plans and procedures for evaluating the process, progress, and outcomes of this curriculum development initiative feasible and appropriate? Are the plans to share curricula and any education materials developed as a result of this award appropriate and adequate? Are the plans for collaboration(s) with other individuals to develop course(s) and curricula adequate and appropriate?

K08 and K25. What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence? Is the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated didactic and research objectives for achieving research independence? Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?

K23. What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence? Is the candidate's prior training and research experience appropriate for this award? Are the goals and scope of the plan when considered in the context of prior training/research experience and the stated training and research objectives, appropriate? Are the content and duration of the proposed didactic research activities during the proposed award period clearly stated and appropriate? Are there adequate plans for evaluating the candidate's research and career development progress?

K24. Are the plans to provide mentoring or supervising new clinical investigators in patient oriented research adequate? Are plans to integrate appropriate clinical research curricula, such as those offered by available K30 programs at the institution, into the mentoring plans adequate? Is an appropriate level of effort proposed for the mentoring component?

K25. See K08 and K25 above.

K99. Are the content and duration of the proposed didactic and research components of the career development plan appropriate for the candidate’s current stage of scientific and professional development and proposed research career goals? Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate including his/her successful transition to independence? For individuals currently supported by research training programs, how does the proposed career development plan enhance or augment the applicant’s training to date? Is the additional proposed training needed and appropriate for the proposed research plan and the applicant’s future career plans? To what extent are the plans for evaluating the K99 awardee’s progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award? Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for the K99 phase of the award?

K01. Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan?

K02. The reviewer’s assessment of the research plan should take into account the scientific significance and merit of the proposed research question, design, and methodology, as well as its relevance to the candidate’s research career objectives, and whether the research plan has potential for advancing the field of study. Is the research plan of high quality, and does it have potential for advancing the field of study? Is the scientific and technical merit of the proposed research plan of significance? When applicable for the specific candidate and situation, do the letters from consultant(s) and collaborator(s) adequately document their willingness to participate in the independent scientist award program?

K07. The reviewer’s assessment of the research plan should take into account the scientific significance and merit of the proposed research question, design, and methodology, as well as its relevance to the candidate’s research career objectives, and whether the research plan has potential for advancing the field of study. Is the research plan appropriate for the candidate’s past experience and current academic/research goals? Is the scientific and technical merit of the research plan appropriate and adequate for developing new or enhancing existing skills needed to meet the candidate’s career goals? Is the plan for coupling the research with other planned activities, appropriate and adequate for providing the experience, knowledge, and skills necessary to achieve the objectives of the award?

K08. Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the plan for developing/enhancing the candidate’s research skills appropriate and adequate?

K23. Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives focusing on patient-oriented research? Is the plan for developing/enhancing the candidate’s research skills appropriate and adequate?

K24. Is the research plan an appropriate vehicle for demonstrating and developing the prospective mentee’s skills and capabilities in patient-oriented research? Are the scientific and technical plans of the proposed research of merit? Is the proposed research relevant to the candidate's career objectives? Are adequate resources available to conduct the research program? This includes adequacy of plans for continued support of the research during the funding period of the grant.

K25. Are the proposed research question, design, and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the research plan appropriate to the stage of research development and as a vehicle for developing the research skills described in the career development plan?

K99. Is the proposed K99 phase research significant? Are the scientific and technical merits of the K99 research question, experimental design and methodology appropriate for the candidate’s level of training, an appropriate vehicle for developing the research skills described in the career development plan, and appropriate for developing a highly successful R00 research program? Is the proposed R00 phase research scientifically sound and a logical extension of the K99 phase research? Is there evidence of long-term viability of the proposed R00 phase research plan? Evaluate the innovation and creativity of the proposed R00 phase research, i.e., does the project address an innovative hypothesis or challenge existing paradigms? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies? To what extent is the proposed R00 phase research likely to contribute significantly to our understanding of biomedical problems? To what extent is proposed R00 phase research likely to foster the career of the candidate as an independent investigator in biomedical research?

K01. Are the mentor's research qualifications in the area of the proposed research appropriate? Do the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? Is there evidence of the mentor’s, consultant’s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support? Is there active/pending support for the proposed research project appropriate and adequate? Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?

K02. Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality? Is there adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?

K07 Development Award. Are the mentor’s research qualifications including current and pending research support, prior research experience, and mentoring track record appropriate and adequate for guiding the candidate in meeting the goals of the Development Award? Do the mentor(s) adequately address the above review criteria including the candidate’s potential and his/her strengths and areas needing improvement? Does the mentor’s statement demonstrate a strong commitment to the candidate’s progression to independent academic investigator? Are the combined expertise, roles and responsibilities of any involved co-mentors, consultants, and/or collaborators likely to enhance the candidate’s career development?

K07 Leadership Award. Are the combined expertise, roles and responsibilities of any involved consultants, and/or collaborators likely to enhance the candidate’s career development?

K08. Are the mentor's research qualifications in the area of the proposed research appropriate? Do the mentor(s) adequately address the above review criteria including the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is there evidence of the mentor’s, consultant’s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support? Is there active/pending support for the proposed research project appropriate and adequate? Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?

K23. Are the mentor's research qualifications in the area of the proposed patient-oriented research appropriate? Do the mentor(s) adequately address the above review criteria including the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? Is there evidence of the mentor’s, consultant’s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support focusing on patient-oriented research? Is there active/pending support for the proposed research project appropriate and adequate? Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?

K24. Is there adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?

K25. Are the mentor's research qualifications in the area of the proposed research appropriate? Do the mentor(s) adequately address the above review criteria including the candidate’s potential and his/her strengths and areas needing improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is there evidence of the mentor’s, consultant’s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous productivity and peer-reviewed support in area of basic or clinical biomedical, bioengineering, bioimaging or behavioral research? Is there active/pending support for the proposed research project appropriate and adequate? Is the mentor’s description of the elements of the research career development activities, including formal course work adequate? Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?

K99. To what extent does the mentor have a strong track record in training future independent researchers? To what extent are the mentor’s research qualifications and experience, scientific stature, and mentoring track record appropriate for the applicant’s career development needs? Does the mentor(s) adequately address the above review criteria including the candidate’s potential as well as his/her strengths and areas needing improvement? Evaluate the nature and extent of the proposed supervision that will occur during the mentored phase of support, i.e. is it adequate, and is the commitment of the mentor(s) to the applicant’s continued career development appropriate? Does the mentor have a comprehensive plan to support the proposed K99 phase career development and research plans as well as the candidate’s efforts to transition to independence? Is this plan adequate and appropriate? Are the consultants’/collaborators’ research and/or mentoring qualifications appropriate for their roles in the proposed K99 phase of the award?

K01. Is there clear commitment of the sponsoring institution to ensure that a minimum of 75% of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? Is the institutional commitment to the career development of the candidate appropriately strong? Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate? Is the environment for scientific and professional development of the candidate of high quality? Is there assurance that the institution intends the candidate to be an integral part of its research program?

K02. Is the level of the applicant institution’s commitment to the scientific development of the candidate appropriate? Is the level of assurance from the institution that they intend the candidate to be an integral part of its research program adequate? Are the research facilities, resources and appropriate educational opportunities available to the candidate appropriate and adequate? Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing research appropriate and adequate? Is the commitment from the sponsoring institution to provide adequate protected time for the candidate to conduct the research program adequate?

K07. Is there merit to the institution’s plan and commitment to strengthening research and education activities beyond the current status of activities and capacities? Is there a strong statement of commitment by the institution to the levels of effort required for this career award? Is the scope and nature of collaboration among participating schools and departments appropriate and adequate? Are there adequate research facilities and training opportunities for the award? Is the quality of the scientific environment and relevance to the candidate’s professional academic and scientific development, including any unique features of the scientific environment beneficial to the candidate, adequate and appropriate?

K08, K23, and K25. Is there clear commitment of the sponsoring institution to ensure that a minimum of 75% of the candidate’s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? Is the institutional commitment to the career development of the candidate appropriately strong? Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate? Is the environment for scientific and professional development of the candidate of high quality? Is there assurance that the institution intends the candidate to be an integral part of its research program?

K23. See above for K08, K23, and K25.

K24. Is the level of the applicant institution’s commitment to the scientific development of the candidate appropriate? Is the level of assurance from the institution that they intend the candidate to be an integral part of its patient-oriented research program adequate? Are the research facilities, resources and appropriate educational opportunities available to the candidate appropriate and adequate? Are the size and quality of the pool of clinician investigators to be mentored by the PI/PD adequate? Are the quality and relevance of the environment for continuing the scientific and professional development of the candidate and for others pursuing patient-oriented research appropriate and adequate? Is the commitment from the sponsoring institution to provide adequate protected time for the candidate to conduct the research and mentoring program adequate? Is the level of commitment of the candidate’s institution to the career development in patient-oriented research of new clinical investigators mentored by the candidate adequate?

K25. See above for K08, K23, and K25.

K99. To what extent does the institution provide a high quality environment for the candidate’s development? To what extent are the research facilities and educational opportunities, including collaborating faculty, adequate and appropriate for the candidate’s research and career development goals during the K99 phase of the award? What evidence is provided that the K99 sponsoring institution is strongly committed to fostering the candidate’s development and transition to the independent (R00) phase? Is there adequate assurance that the required (minimum of 75%) effort of the candidate will be devoted directly to the research training, career development, and research activities described in the proposed career development and research plans?

K01, K07, K08, K23, K25, K99. This award may not be renewed.

K02. The reviewers will evaluate whether there has been adequate progress in achieving the research career objectives of the previous award period, and evidence of the PI’s continuing leadership in research and/or mentorship and evidence of a continuing need for protected time to conduct research and mentor early career investigators.

K24. Has there been adequate progress in achieving the K24-supported career, research and mentoring objectives of the previous award period? Is the justification provided for an additional 3 to 5 years of support adequate? (This requires that the recipient continue to have independent peer-reviewed patient-oriented research support at the time of submission of the renewal application; and documentation of a continuing need for protected time to expand the POR program and the mentoring activities supported during the prior funding period of the award). Does the PD/PI adequately demonstrate the continuing need for protected time to expand his/her research and mentoring program? Is there evidence of the PD/PI’s continuing leadership in patient-oriented research through, for example, being principal investigator on new independent peer-reviewed research grants and providing high quality mentorship?