Definitions of Criteria and Considerations for T32, T35 and K12 Critiques |
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Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
1. Training Program and Environment.
T32. Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical scientists? Do the objectives, design and direction of the proposed research program ensure effective training? Is the proposed program of training likely to ensure that trainees will be prepared for successful and productive scientific careers? Do the courses, where relevant, and research training experiences address state- of-the-art science relevant to the aims of the program? Does the program provide training in inter- or multi-disciplinary research and/or provide training in state of the art or novel methodologies and techniques? Is a significant level of institutional commitment to the program evident?
For applications that request short-term research training position: Is this aspect of the program well designed and, where appropriate, integrated with other aspects of the training program? Are the numbers of short-term positions appropriate? Does the program include features to encourage short-term trainees to consider careers in health-related research?
T35. Are the objectives, design, direction, and quality of the proposed short-term research training program appropriate? Does the proposed program provide suitable training for the levels of trainees being proposed and the area of science to be supported by the program? Is the quality of proposed course contents and training experience appropriate for all levels of trainees to be included in the program? Does the program have access to candidates for short-term research training and the ability to recruit high quality, short-term trainees from the applicant institution or some other health-professional school? Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical scientists? Do the objectives, design and direction of the proposed research program ensure effective training? Is the proposed program of training likely to ensure that trainees will be prepared for successful and productive scientific careers? Do the courses, where relevant, and research training experiences address state- of-the-art science relevant to the aims of the program? Does the program provide training in inter- or multi-disciplinary research and/or provide training in state of the art or novel methodologies and techniques? Is a significant level of institutional commitment to the program evident?
K12. Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers? Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support? Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Are appropriate timelines indicated for career progression and transition to independence? Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success? Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities? When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?
2. Training Program Director(s)/Principal Investigator(s) (PDs/PIs).
T32 and T35. Does the Training PD/PI have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration to of the proposed research training program? Does the Training PD/PI plan to commit sufficient time to the program to ensure its success? Is sufficient administrative and research training support provided for the program?
For applications designating multiple PDs/PIs: Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees? Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and with the complementary expertise of each of the PDs/PIs?
K12. Do the PD/PI and Research Administrator (if applicable), have the experience to develop, direct and administer the proposed program? Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
3. Preceptors/Mentors.
T32 and T35. Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application? Do the preceptors/mentors have strong records as researchers, including successful competition for research support in areas directly related to the proposed research training program? Do the preceptors/mentors have strong records of training pre- and/or postdoctorates?
K12. Do the mentors have expertise and experience, as well as track records of past mentoring and training? Are the quality and extent of the mentors' roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?
4. Trainees or Candidates/Scholars.
T32. Is a recruitment plan proposed with strategies to attract high quality trainees? Are there well-defined and justified selection criteria and retention strategies? Is a competitive applicant pool in sufficient numbers to warrant the proposed size and levels (predoctoral, postdoctoral and/or short-term) of the training program in evidence?
For applications that request short-term research training positions: Does the program have the ability to recruit high quality, short-term trainees?
T35. Are the quality of the applicant pool and plans for the selection of individuals appointed to the short-term training program appropriate? Are the size and quality of the applicant pool adequate to support the program? Are the recruiting procedures, and trainee selection criteria, appropriate and well defined? Are there advertising plans or other effective strategies to recruit high-quality trainees?
K12. What is the quality of plans to identify, recruit, and select candidates, with a commitment to research relavant to the mission of the FOA, and the potential to develop as independent researchers? Is there an appropriate plan for the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates? How useful is the research plan as a vehicle for ensuring research training for all scolars as described in the career development plan? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars? Does the program include a plan to recruit, identify, and select scholars with a commitment to research relevant to the objectives of the FOA? Does the program description include a plan to recruit a diverse group of scholars locally and nationally? Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?
5. Training Record.
T32. How successful are the trainees (or for new applications, other past students/fellows in similar training) in completing the program? How productive are trainees (or for new applications other past students/fellows) in terms of research accomplishments and publications? How successful are trainees (or other past students/fellows) in obtaining further training appointments, fellowships, and career development awards? How successful are the trainees in achieving productive scientific careers, as evidenced by successful competition for research grants, receipt of honors or awards, high-impact publications, receipt of patents, promotion to scientific leadership positions, and/or other such measures of success? Does the program have a rigorous evaluation plan to review the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees and monitoring trainees' subsequent career development?
For programs that provide research training to health-professional doctorates: Is there a record of retaining health professionals in research training or other research activities for at least two years? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees and monitoring trainees' subsequent career development?
For applications that request short-term research training positions: Are plans presented to follow the careers of short-term trainees and to assess the effect of the training program on subsequent career choices? What is the success in attracting students back for multiple appointments? What is the effect of the short-term component on the overall training program?
T35. How successful are the trainees (or for new applications, other past students/fellows in similar training) in completing the program? How productive are trainees (or for new applications other past students/fellows) in terms of research accomplishments and publications? How successful are trainees (or other past students/fellows) in obtaining further training appointments, fellowships, and career development awards? How successful are the trainees in achieving productive scientific careers, as evidenced by successful competition for research grants, receipt of honors or awards, high-impact publications, receipt of patents, promotion to scientific leadership positions, and/or other such measures of success? Does the program have a rigorous evaluation plan to review the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees and monitoring trainees' subsequent career development? Are plans presented to follow the careers of short-term trainees and to assess the effect of the training program on subsequent career choices?
What is the success in attracting students back for multiple appointments? What is the effect of the short-term component on the overall training program?
For programs that provide research training to health-professional doctorates: Is there a record of retaining health professionals in research training or other research activities for at least two years?
K12. Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?
Protections for Human Subjects.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Inclusion of Women, Minorities, and Children.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer. For additional information to assist you in making these determinations, please refer to the Human Subjects Protection and Inclusion.
Vertebrate Animals.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Biohazards. Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Resubmission.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal.
For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment and Retention Plan to Enhance Diversity. Does the application describe the program's accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the training experience?
Additional Criteria for T35. What is the success in attracting trainees back for multiple appointments?
Revision.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Recruitment and Retention Plan to Enhance Diversity.
Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel's evaluation will be included in an administrative note in the summary statement.
Training in the Responsible Conduct of Research.
T. Taking into account the specific characteristics of the training program, level of trainee experience, and the particular circumstances of the trainees, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? If this is a renewal, is there a report describing past instruction in the five components described above? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus rating of the review committee.
K12. Taking into account the specific characteristics of the career development program, level of scholar experience, and the particular circumstances of the scholars, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? If this is a renewal, is there a report describing past instruction in the five components described above? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus rating of the review committee. Applications rated unacceptable will not be funded until the applicant provides an acceptable, revised plan.
Select Agent Research.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). For more details, please see Select Agents.
Budget and Period of Support.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. For more details, please see Budget Information.
Additional Comments to the Applicant. Reviewers may provide guidance to the applicant or recommend against resubmission without fundamental revision.
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