Overall Impact. Reviewers are asked to provide an overall impact/priority score to reflect their assessment of the likelihood for the project to promote the training of pre- and postdoctoral fellows in biomedical, behavioral and clinical research, in consideration of the following five core review criteria, and the additional review criteria (as applicable for the project proposed).

1. Training Program and Environment. 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 positions, 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; and does the program include features to encourage short-term trainees to consider careers in health-related research?

2. Training Program Director/Principal Investigator. Does the Training PD/PI have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration to the proposed research training program? Does the 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 PD/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 PD/PIs?

3. Preceptors/Mentors. 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?

4. Trainees. 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?
For competing renewal applications, how successful has the program been in attracting and retaining individuals from diverse populations, including populations underrepresented in science?

5. Training Record. 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 renewal applications, does the application describe the program’s accomplishments over the past funding period(s); are there changes proposed that would improve/strengthen the training experience? 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? 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?

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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 Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Budget. The reasonableness of the proposed budget and the requested period of support will be assessed in relation to the proposed research training program and the number of proposed trainees at the requested levels.

Recruitment and Retention Plan to Enhance Diversity. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups.

Training in the Responsible Conduct of Research. Peer reviewers will assess the applicant’s plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

Additional Comments to the Applicant. Reviewers may provide guidance to the applicant or recommend against resubmission without fundamental revision.

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