Additional Review Criteria
Human Subjects
Most Training grant application packages do not include the PHS Human Subjects. Although not required, applicants can provide additional information regarding potential or current involvement of appointed trainees in human subjects research in the "Proposed Training" section of the "Program Plan."
- In many instances, trainees supported by institutional training grants will participate in research that is supported by separate research project grants for which IRB approval or a determination of exemption exists.
- Existing IRB approval may be sufficient for trainees, provided that the IRB determines the research would not be substantially modified by the participation of a trainee.
- The appropriate grants must be identified along with their IRB review dates or exemption designation. Ensure that trainees have received the proper training/education in human subjects research.
- Program should include examples of IRB projects that could be potentially supportive of trainee research associated with this training program.
Important Notes:
- Sample Text
- Human Subjects Office for Human Research Protections (OHRP) Federal-Wide Assurance Number: FWA00004495 (Expiration Date: July 17, 2029).
- NOTE: Due to a character limit in NIH ASSIST do not use the "FWA" prefix when entering the assurance number.
- NIH NRSA Policy - 11.3.16.7.1
- Refer to most recent NOT-OD-18-128 to see the corrected instructions from NIH.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
Generally not applicable.
Vertebrate Animals
In many instances, trainees supported by institutional training grants will participate in research that is supported by a separate research project grant for which the IACUC review and approval exist. This existing IACUC approval is sufficient for trainees provided that the research would not be substantially modified by the participation of a trainee.
Important Notes:
UCSD Animal Welfare Assurance # is D16-00020.
Important Notes:
UCSD Animal Welfare Assurance # is D16-00020.
Biohazards
Generally not applicable.
Training in the Responsible Conduct of Research (RCR)
Responsible Conduct of Research (RCR) refers to the practice of conducting scientific research with integrity, adhering to established ethical principles and professional standards across all stages of the research process.
Include:
- A comprehensive plan describing how the program will provide instruction in the Responsible Conduct of Research (RCR).
- Coverage of the five required instructional components:
- Format of instruction
- Subject Matter - Describe the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, and research ethics.
- Faculty Participation - Describe the roles of mentor(s) and other faculty involvement in the instruction
- Duration of instruction - Describe the total number of contact hours of instruction
- Frequency of instruction - Instruction must occur during each career stage and at least once every four years. Document any prior instruction during the applicant’s current career stage, including the inclusive dates instruction was last completed.
- Description of how trainee participation in RCR instruction will be monitored and documented.
- For renewal applications:
- Evidence of prior RCR instruction
- Description of any changes or improvements made in response to feedback or evolving RCR issues
Writing Guidance:
- Define RCR as the practice of scientific investigation with integrity, including adherence to professional norms and ethical principles in all aspects of research.
- Describe interactive, face-to-face instruction (e.g., lectures, seminars, small-group discussions). Online instruction may supplement but cannot replace in-person training, except in rare circumstances.
- Ensure the plan is tailored to the trainee career stage (predoctoral, postdoctoral).
- Include a broad range of subject matter, such as:
- Conflict of interest
- Authorship and publication practices
- Data acquisition and management
- Human subjects and animal research
- Laboratory safety
- Research misconduct
- Research ethics
- Clearly describe:
- Total contact hours
- Frequency of instruction (at least once every four years and at each career stage)
- Emphasize the role of faculty and mentors as instructors and role models in RCR training.
- Incorporate institutional resources and policies (e.g., UCSD training programs, ethics courses) and adapt them to fit program needs.
Important Notes:
- The RCR plan is a required component of T32 applications and is formally evaluated during peer review.
- Applications that do not adequately address all five required instructional components may be considered incomplete or noncompliant.
- RCR instruction must include interactive, discussion-based engagement (in-person or real-time virtual such as Zoom). Fully asynchronous or self-paced online-only instruction is not sufficient.
- RCR training must occur:
- At each career stage, and
- At least once every four years
- Faculty participation is expected and critical to demonstrate program quality.
- Renewal applications must demonstrate:
- Prior compliance
- Monitoring of participation
- Continuous improvement of the RCR plan
- Applicants are encouraged to use institutional templates (e.g., UCSD RCR resources) but must customize the plan to reflect the needs of their specific program.
- Refer to:
Training in Methods for Enhancing Reproducibility
Scientific rigor is the strict application of the scientific method to ensure unbiased and well-controlled experimental design, methodology, analysis, interpretation and reporting of results. Scientific rigor also includes transparency in reporting full experimental details so that others may reproduce and extend the findings.
Include:
- A plan describing how trainees will be instructed in principles that enhance research rigor and reproducibility.
- Coverage of the following required areas:
- Evaluation of foundational research underlying a project (rigor of prior research)
- Rigorous experimental design and data interpretation
- Consideration of relevant biological variables (e.g., sex, age)
- Authentication of key biological and/or chemical resources
- Transparency in reporting methods and results
- Description of how these topics are integrated across multiple stages of trainee development.
- Explanation of how program faculty reinforce and apply these principles in the context of trainees’ research projects
Writing Guidance:
- Define scientific rigor as the strict application of the scientific method to ensure unbiased design, methodology, analysis, interpretation, and reporting.
- Emphasize training in critical evaluation of published literature, including assessing strengths and limitations of prior studies.
- Describe how trainees will learn to design well-controlled, reproducible experiments and interpret data appropriately.
- Incorporate instruction on:
- Identifying and controlling for sources of bias
- Accounting for biological variables
- Ensuring resource authentication and validation
- Practicing transparent and complete reporting
- Describe a combination of instructional approaches, such as:
- Coursework
- Workshops or seminars
- Case studies
- Integration into lab meetings and mentoring
- Explain how faculty mentors will model and reinforce rigor principles during hands-on research training.
- Ensure the plan demonstrates progressive learning, tailored to each trainee’s career stage.
Important Notes:
- This attachment is limited to 3 pages.
- Instruction in scientific rigor and reproducibility is a required component of NIH training grants and is evaluated during peer review.
- The plan must clearly demonstrate integration into the overall training program, not as a standalone activity.
- Applicants should show how principles of rigor are revisited and expanded over time.
- Use of institutional templates (e.g., Strathdee/Schooley examples) is encouraged as a starting point, but the plan should be customized to reflect the specific program.
- Reviewers will assess whether trainees are prepared to conduct rigorous, transparent, and reproducible research.
Introduction to Application (Resubmissions and Revisions)
This attachment is required only for resubmission or revision applications, or if explicitly specified in the FOA.
Include:
- A concise summary of substantial changes made since the prior submission.
- Responses to reviewers’ comments from the previous scientific review.
- For resubmissions involving PD/PI structure changes:
- A clear rationale for changes (e.g., single PD/PI to MPI, changes in MPI composition, or MPI to single PD/PI)
- Reference to and inclusion of the required MPI Leadership Plan
- For revision applications:
- Description of the proposed expansion of the project scope
- Responses addressing prior review concerns, if applicable
Writing Guidance:
- Clearly and directly address major critiques from the previous review.
- Highlight improvements, additions, or revisions to the application.
- Organize responses to align with reviewer comments for clarity and ease of review.
- For revisions, explain how the proposed changes enhance or extend the original project.
- Ensure explanations are specific, evidence-based, and easy to track.
Important Notes:
- An Introduction must not be included for new or renewal applications.
- Follow FOA-specific page limits (typically up to 3 pages).
- Reviewers will evaluate the application as currently presented, while considering how well prior concerns have been addressed.
- For revisions, reviewers will assess:
- The appropriateness of the proposed scope expansion
- Whether prior concerns (if relevant) have been adequately resolved with substantial changes
Renewals
Reviewers will assess whether the program has demonstrated successful outcomes and continuous improvement.
Include:
- A description of the program’s accomplishments during the previous funding period(s).
- Evidence demonstrating progress toward training objectives and outcomes.
- Documentation of training in the Responsible Conduct of Research (RCR).
- Results of program evaluation efforts, including trainee feedback.
- Description of proposed changes or enhancements for the next project period.
Writing Guidance:
- Clearly summarize how the program has met or progressed toward its stated training goals.
- Provide evidence of trainee outcomes (e.g., completion, publications, career progression).
- Describe how the program has evaluated training quality and effectiveness, including formal and informal feedback mechanisms.
- Demonstrate that evaluation results have been used to inform program improvements.
- Highlight any programmatic changes implemented in response to prior feedback or evolving needs.
- Describe how the program continues to adapt to advances in the research field.
Important Notes:
- Applications must show evidence that:
- The program is achieving its training objectives
- Evaluation processes are in place and actively used
- Feedback from trainees has been incorporated
- Proposed changes for the next funding period should be clearly justified and likely to strengthen the program.
- The program is expected to evolve in response to scientific advances and workforce needs.
- Adequate and ongoing RCR training is required and will be evaluated as part of the renewal.