NIH Proposal Tool Kit
If you are submitting a proposal to the National Institutes of Health, there are a variety of required forms, as well as instructions and hints on the Sponsored Programs website that will help you in this process. Following below is a list of links to the forms that you may need, and other resources. Please also remember to call your Grant and Contract Specialist or Grant and Contract Administrator for assistance in this process.
- Instructions for completing PHS 398 grant application
- Other Support Page
- Instructions for completing PHS 2590 non-competing grant progress report
- Instructions for submitting e-SNAP non-competing grant progress report via NIH Commons
- Fringe Benefit Rates
- F&A (Indirect) Cost Rates
- Information on Human Subjects
- Certification of Training in Human Subjects
- NIH Statement on Sharing Research Data
NIH believes that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve human health. The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers. Starting with the October 1, 2003 receipt date, applicants seeking $500,000 or more in direct costs in any year of the project period are expected to include a plan for data sharing or state why data sharing is not possible. Applicants responding to an RFA or RFP will find instructions related to data sharing in the specific announcement.
- Inclusion of Women/Minorities as Subjects in Clinical Research
These guidelines require that women and members of minority groups and their subpopulations (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html) be included in any NIH-supported biomedical and behavioral clinical research project involving human subjects, unless a clear and compelling rationale and justification establishes, to the satisfaction of the IC Director, that inclusion is inappropriate with respect to the health of the subjects, the purpose of the research, or other circumstances. Cost is not an acceptable reason for exclusion, except when the research would duplicate data already available from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. The guidelines should be reviewed for policy concerning inclusion of these groups in all NIH-supported clinical trials. This policy applies to subjects of all ages.
- Amended Women and Minorities
- Confidentiality of Patient Records
NIH expects grantees and others involved in NIH grant-supported research to take appropriate actions to protect the confidentiality of information about and the privacy of individuals participating in the research. Investigators, DSMBs, IRBs, and other appropriate entities should ensure that policies and procedures are in place to protect identifying information and must oversee compliance with those policies and procedures.
- Data and Safety Monitoring
For all federally funded research involving human subjects, the regulations for the protection of human subjects (45 CFR 46) specify criteria for IRB approval of research and require, at 45 CFR 46.111(a)(6), that ?When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.?
NIH requires oversight and monitoring of all human intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. The NIH policies on data and safety monitoring specify that the level of monitoring should be commensurate with the risks and the size and complexity of the clinical trial, and are in addition to any monitoring requirements imposed by FDA or the NIH Guidelines for Research Involving Recombinant DNA Molecules.
- Certificates of Confidentiality
Section 301(d) of the PHS Act provides that the Secretary may authorize people engaged in biomedical, behavioral, clinical, or other research activities to protect the privacy of research subjects by withholding the names and other identifying characteristics of those subjects from individuals not engaged in the research. Individuals that have authorization may not be compelled to disclose subjects? identities in any Federal, State, or local civil, criminal, administrative, legislative or other proceeding. CoCs may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.
- Ban on Human Research and Cloning
NIH funds may not be used to support human embryo research under any extramural award instrument. NIH funds may not be used for the creation of a human embryo for research purposes or for research in which a human embryo is destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204 and 46.207 and subsection 498(b) of the PHS Act. The term ?human embryo? includes any organism not protected as a human subject under 45 CFR 46, as of the date of enactment of the governing appropriations act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.
- Information on NIH Modular Grants
- SPS Guide to Sponsored Programs: Preparing a Proposal
- SPS Guide to Sponsored Programs: Preparing the Budget
- NIH's Web Page on Modular Research Grant Applications
- The Original How to Write a Research Grant Application (NIH)
- PHS Proposal Cycle Dates
Draft Budget Checklist
F&A (Indirect) Cost Waiver Request Form
Subaward Selection Justification
PHS 398 Application Packet
- PDF (PHS's Forms)
PHS 398 Budget Forms