Additional Review Criteria

Refer to most recent NOT-OD-18-128 to see the corrected instructions from NIH

• 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

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.  The appropriate grants must be identified along with their IACUC review dates.

Include the "Vertebrate animals," attachment if you answered "yes" to the question "Are vertebrate animals used?"

Describe how the institution will ensure that trainees participate only in IACUC-approved vertebrate animal research if the following two conditions apply:

• 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.

Provide a detailed description of the proposed use of the animals for the work outlined in the Research Strategy section:

• 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.

More detailed information

IACUC Approval Date

• Leave blank if pending.

UCSD Animal Welfare Assurance # is D16-00020.

Do not use the Vertebrate Animals section to circumvent the page limits of the Program Plan.

• 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)

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.

• 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.

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.

For Renewals, the committee will consider the progress made in the last funding period, including:

• 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?