Other Research Plan Sections
This section is required for applicants answering “yes” to the question “Are vertebrate animals involved?” on the R&R Other Project Information form.
If Vertebrate Animals are involved in the project, address each of the five points below. This section should be a concise, complete description of the animals and proposed procedures. While additional details may be included in the Research Strategy, the responses to the five required points below must be cohesive and include sufficient detail to allow evaluation by peer reviewers and NIH staff. If all or part of the proposed research involving vertebrate animals will take place at alternate sites (such as project/performance or collaborating site(s)), identify those sites and describe the activities at those locations. Although no specific page limitation applies to this section of the application, be succinct. Failure to address the following five points will result in the application being designated as incomplete and will be grounds for the PHS to defer the application from the peer review round. Alternatively, the application’s impact/priority score may be negatively affected.
If the involvement of animals is indefinite, provide an explanation and indicate when it is anticipated that animals will be used. If an award is made, prior to the involvement of animals the grantee must submit to the NIH awarding office detailed information as required in points 1-5 above and verification of IACUC approval.
The five points are as follows:
1. Provide a detailed description of the proposed use of the animals in 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.
2. 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.
3. Provide information on the veterinary care of the animals involved.
4. 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.
5. Describe any method of euthanasia to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines on Euthanasia. If not, include a scientific justification for not following the recommendations.
Select agents are hazardous biological agents and toxins that have been identified by DHHS or USDA as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. CDC maintains a list of these agents. See http://www.cdc.gov/od/sap/docs/salist.pdf.
If the activities proposed in the application involve only the use of a strain(s) of select agents which has been excluded from the list of select agents and toxins as per 42 CFR 73.3, the select agent requirements do not apply. Use this section to identify the strain(s) of the select agent that will be used and note that it has been excluded from this list. The CDC maintains a list of exclusions at http://www.cdc.gov/od/sap/sap/exclusion.htm.
If the strain(s) is not currently excluded from the list of select agents and toxins but you have applied or intend to apply to DHHS for an exclusion from the list, use this section to indicate the status of your request or your intent to apply for an exclusion and provide a brief justification for the exclusion.
If any of the activities proposed in your application involve the use of select agents at any time during the proposed project period, either at the applicant organization or at any other performance site, address the following three points for each site at which select agent research will take place. Although no specific page limitation applies to this section, be succinct.
1. Identify the select agent(s) to be used in the proposed research.
2. Provide the registration status of all entities* where select agent(s) will be used.
• If the performance site(s) is a foreign institution, provide the name(s) of the country or countries where select agent research will be performed.
*An “entity” is defined in 42 CFR 73.1 as “any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.”
3. Provide a description of all facilities where the select agent(s) will be used.
• Describe the procedures that will be used to monitor possession, use and transfer of the select agent(s).
• Describe plans for appropriate biosafety, biocontainment, and security of the select agent(s).
• Describe the biocontainment resources available at all performance sites.
If you are responding to a specific funding opportunity announcement (e.g., PA or RFA), address any requirements specified by the FOA.
Reviewers will assess the information provided in this Section, and any questions associated with select agent research will need to be addressed prior to award.
For applications designating multiple PD/PIs, a leadership plan must be included. For applications designating multiple PD/PIs, all such individuals must be assigned the PD/PI role on the Senior/Key Profile form, even those at organizations other than the applicant organization. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PD/PIs and other collaborators. Do not submit a leadership plan if you are not submitting a Multiple PD/PI application.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PD/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Grant Award.
Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee. The signature of the Authorized Organization Representative on the SF424 (R&R) cover component (Item 17) signifies that the applicant and all proposed consortium participants understand and agree to the following statement:
The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the agency’s consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy.
Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as senior/key personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services.
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. See Part III, 1.5 Sharing Research Resources.
1. Data Sharing Plan: Investigators seeking $500,000 or more in direct costs (exclusive of consortium F&A) in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Specific Funding Opportunity Announcements may require that all applications include this information regardless of the dollar level. Applicants are encouraged to read the specific opportunity carefully and discuss their data-sharing plan with their program contact at the time they negotiate an agreement with the Institute/Center (IC) staff to accept assignment of their application. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
2. Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms or state why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
3. Genome Wide Association Studies (GWAS): Applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or an appropriate explanation why submission to the repository is not possible. GWAS is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://gwas.nih.gov/.
Only one copy of appendix material is necessary. Use the Add Attachments button to the right of this field to complete this entry.
A maximum of 10 PDF attachments is allowed in the Appendix. If more than 10 appendix attachments are needed, combine the remaining information into attachment #10. Note that this is the total number of appendix items, not the total number of publications. When allowed there is a limit of 3 publications that are not publicly available (see below for further details and check the FOA for any specific instructions), though not all grant activity codes allow publications to be included in the appendix.
Do not use the appendix to circumvent the page limits of the Research Strategy or any other section of the application for which a page limit applies. For additional information regarding Appendix material and page limits, please refer to the NIH Guide Notice NOT-OD-11-080, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-080.html.
Appendix material may not appear in the assembled application in the order attached, so it is important to use filenames for attachments that are descriptive of the content. A summary sheet listing all of the items included in the appendix is also encouraged but not required. When including a summary sheet, it should be included in the first appendix attachment. Applications that do not follow the appendix requirements may be delayed in the review process.
New, resubmission, renewal, and revision applications may include the following materials in the Appendix (note, however, that some FOAs do not permit publications):
• Publications – No longer allowed as appendix materials except in the circumstances noted below. Applicants may submit up to 3 of the following types of publications:
o Manuscripts and/or abstracts accepted for publication but not yet published: The entire article should be submitted as a PDF attachment.
o Manuscripts and/or abstracts published, but a free, online, publicly available journal link is not available: The entire article should be submitted as a PDF attachment.
o Patents directly relevant to the project: The entire document should be submitted as a PDF attachment.
(Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.)
• Surveys, questionnaires, and other data collection instruments; clinical protocols and informed consent documents may be submitted in the Appendix as necessary.
• For materials that cannot be submitted electronically or materials that cannot be converted to PDF format (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Officer for instructions following notification of assignment of the application to a SRG. Applicants are encouraged to be as concise as possible and submit only information essential for the review of the application.
Items that must not be included in the appendix:
• Photographs or color images of gels, micrographs, etc., are no longer accepted as Appendix material. These images must be included in the Research Strategy PDF. However, images embedded in publications are allowed.
• Publications that are publicly accessible. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References cited section, the Progress Report Publication List section, and/or the Biographical Sketch section.