Additional Review Criteria

• Forms E for training grant application packages no longer require an attachment for Human Subjects under the "Program Training Plan."
• Most Training grant application packages do not include the PHS Human Subjects and Clinical Trials Information form. 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.
• Use this link as a quick decision tool that will assist you to know if your research involved human subjects or not https://humansubjects.nih.gov/questionnaire.
• Program should include examples of IRB projects that could be potentially supportive of trainee research associated with this training program.
• Sample Text
• Human Subjects Office for Human Research Protections (OHRP) Federal-Wide Assurance Number: FWA00004495 (Expiration Date: March 3, 2020).

• NIH NRSA Policy

• The training program uses live vertebrate animals only as part of other research project grants.
• The training grant does not support the purchase, use, or husbandry of live vertebrate animals.

• Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.
• Justify the use of animals, the choice of species, and the numbers to be used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers.
• Provide information on the veterinary care of the animals involved.
• Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research.
• Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.  Describe any method of euthanasia to be used and the reason(s) for its selection. State whether this method is consistent with the recommendations of the AVMA Guidelines on Euthanasia. If not, include a scientific justification for not following the recommendations.

• Leave blank if pending.

• 3 page limit
• Definition of Responsible Conduct of Research:
  • The practice of scientific investigation with integrity.  It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.

• RCR is an essential component of research training. Therefore, instruction in RCR is an integral part of all research training programs, and its evaluation will impact funding decisions.
• Active involvement in the issues of RCR should occur throughout a scientist’s career. Instruction in RCR should therefore be appropriate to the career stage of the individuals receiving training.
• Individuals supported by individual funding opportunities such as fellowships and career development awards are encouraged to assume individual and personal responsibility for their instruction in RCR.
• Research faculty of the institution should participate in instruction in RCR in ways that allow them to serve as effective role models for their trainees, fellows, and scholars.
• Instruction should include face-to-face discussions by course participants and faculty; i.e., on-line instruction may be a component of instruction in RCR but is not sufficient to meet the NIH requirement for such instruction, except in special or unusual circumstances.
• Instruction in RCR must be carefully evaluated in all NIH grant applications for which it is a required component.
• The RCR Plan needs to include how applicants plan to incorporate the five instructional parts outlined in NIH Policy:
  1. Format  - Describe the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups. A plan with only on-line instruction is not acceptable.
  2. 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.
  3. Faculty Participation - Describe the roles of mentor(s) and other faculty involvement in the instruction.
  4. Duration of instruction  - Describe the total number of contact hours of instruction.
  5. 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.

Renewal applications:

• Does the progress report document acceptable RCR instruction in the five components described above? 
• Does the plan describe how participation in RCR instruction is being monitored?
• Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to RCR?
• UCSD specific information regarding policy and procedures for adhering to the highest standards of integrity in proposing, conducting, and reporting research.

See Also

• NOT-OD-10-019
• NIH POLICY
• Blink Page on Responsible Conduct of Research.
• A copy of the RCR template can be obtained by visiting UCSD ethics website.  It can be used as a starting point for addressing the ethics portion of a training grant proposal.  PD/PI's are encouraged to customize the RCR template to represent the needs of their program while including the courses and resources provided by the University. 

Attachment is limited to 3 pages

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.

• ­The plan must describe how trainees will be instructed in principles important for enhancing research reproducibility.  These principles include, at a minimum, the following:
  • Evaluation of the foundational research underlying a project (i.e., the rigor of the prior research);
  • Rigorous experimental design and data interpretation
  • Consideration of relevant biological variables such as sex
  • Authentication of key biological and/or chemical resources
  • Transparency in reporting
• Include a description of how instructional strategies will be integrated into the overall training program at multiple stages of trainee development and in a variety of formats and contexts. 
• Describe how program faculty will reiterate and augment key elements of methods for enhancing reproducibility in the context of trainees' research projects.

Drs. Steffanie Strathdee and Robert (Chip) Schooley have provided a template that can be used as a starting point for addressing this portion of the training grant proposal.

See Also

Ethics Courses ​  @ UCSD
NIH Policy

• An "Introduction to Application" attachment is required only if the type of application is resubmission or revision or if the FOA specifies that one is needed. 
• An introduction is not allowed for new or renewal applications. 
• Follow the page limits (usually 3 pages)

• For resubmission changing from a single PD/PI to MPI, changing the number or makeup of the MPIs, the applicant must provide a rationale for the change in the introduction and include the required MPI Leadership Plan. A rationale for a change from a MPI to a single PD/PI application must also be provided in the introduction.

• Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research.
• Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its training objectives?
• Has the program evaluated the quality and effectiveness of the training experience and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon?
• Are changes proposed that are likely to improve or strengthen the research training experience during the next project period?
• Does the program continue to evolve and reflect changes in the research area in which the training occurs?