The following elements need to be included in the grant application as appropriate. Unless stated, these elements do not influence the rating (priority score) of the application. However, the reviewers are asked to comment on the adequacy of the information provided for each element. Any concerns the reviewers identify may negatively affect and postpone the granting of an award.
Bibliography & References Cited Provide a bibliography of any references cited in the Research Plan. Each reference must include the names of all authors (in the same sequence in which they appear in the publication; you can use “et al.” convention in place of listing all authors in a citation), the article and journal title, book title, volume number, page numbers, and year of publication. Make sure that only bibliographic citations are included. Be especially careful to follow scholarly practices in providing citations for source materials relied upon when preparing any section of the application. Visit Bibliography and Appendix from NIAID for information.
Care and Use of Vertebrate Animals in Research If you are planning to use live vertebrate animals in the project, you must adhere to the requirements in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy): HTML Version and PDF Version. For an overview of what is required in your application and detailed instructions, see the Vertebrate Animals Section webpage. Additional information can be found at:
Consortium/Contractual Arrangements Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s).
Consultants and Collaborators Attach appropriate letters from all consultants and collaborators confirming their roles in the project. For consultants, letters should include rate/charge for consulting services.
Facilities & Other Resources This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work.
Inclusion of Women, Minorities and Children in Research Peer reviewers will also assess the adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children, as appropriate, for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. Check out the NIH inclusion of women and minorities policy website which has resources such as a decision tree to help you determine which of your studies are subject to NIH’s inclusion policy.
Multiple PD/PI For applications designating multiple PDs/PIs, you must include a leadership plan.
Page Limits Follow the page limits specified for the attachments in your grant application, unless otherwise specified in the FOA.
Protection of Human Subjects from Research Risk Applicants must assure NIH that all human subjects are protected. Reviewers will assess the potential risk to human subjects in proposed research and evaluate what protections are in place to guard against any research-related risk. Awards cannot be made until assurances are on file with the Office for Human Research Protections (OHRP). Decision charts are presented that are helpful in thinking through relevant human subject protections issues. Also see Research Using Human Subjects: Note that even some work with samples qualifies as human subjects research; Research Using Stem Cells: See NIH Stem Cell Information.
Data Management and Resource Sharing Plan In addition to Resource Sharing Plan information, this section includes Data Sharing Plan, when applicable, and Sharing Model Organisms. For more information on data sharing, please see the NIH website at https://sharing.nih.gov/. The Data Management and Sharing Plan page provides a comprehensive source of information.
Select Agents Identify any select agents to be used in the proposed research. Select agents are hazardous biological agents and toxins that HHS or USDA have identified 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 HHS and USDA Select Agents and Toxins.
Use of Internet Sites NIH instituted a policy that prohibits the use of World Wide Web addresses (URLs) in grant applications in the place of text describing the same material. This is because of the potential for providing a large amount of extra material from a Web site beyond what would fit in the page limit, and thereby giving an unfair advantage to some applicants and a large additional burden for reviewers.
Specific Aims Recommended elements for writing a concise and compelling specific aims page (from Stanford University) provides a detailed description and samples to assist in writing this section. Introduction to the Specific Aims Page, a grant proposal article provides an overview and details on elements within the page.
Letters for Grant Applications Types of Letters for Grant Applications explains the difference in letters and usage. Also see Reference Letters or Letters of Support: What's the Difference?
PHS Assignment Request Form Use the optional PHS Assignment Request Form to list expertise needed to review your application, exclude reviewers, and request an institute assignment. For investigator-initiated R01, R21, and R03 applications, we also advise you to request assignment to the most appropriate study section of reviewers.In any case, it’s a good idea to consult a program officer to get his or her advice on the appropriate institute and study section assignments. In the absence of a request from you, NIH’s Center for Scientific Review (CSR) will assign your application to an institute and study section. CSR bases assignments on its referral criteria, relying on referral staff and knowledge-based technologies to decide.
