After deciding which mechanism is best for you, you will
want to begin writing your application. Review applications
of colleagues who have had successful review and funding. Creating
a well-organized and well-designed research plan is critical
to successful peer review. Be specific in describing
what you are proposing to do, why this research is important
and how you will do it.
There are a number of resources available to you to help
you in this process. You will want to begin with the PHS
398 or SF424 form
and its instructions. Read the instructions carefully
before developing your research plan. The instructions
give details about page limitations, format specifications,
Human Subject research requirements, and budget. Some
types of mechanisms are now using Electronic
Submission of Grant
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102
and full 45 CFR 46
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers
that conduct and support biomedical and behavioral research. NIH Homepage
Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
Organize your research plan in a logical fashion. NIAID
has created a detailed tutorial called NIH Grant Cycle: Application to Renewal that takes you through the
Include enough information to show you know what you're
talking about. Tell them how your early work prepares
you for the new project.
Grant Writing Tutorial from the National Library of Medicine
Grant Writing Tips from OER
NIH Regional Seminar Presentations: Grant Writing for Success(7 MB)
Center for Scientific Review (CSR) Advice to Investigators Submitting Clinical Research
the portal for NIH grant applications and their review for scientific merit. It organizes the peer review groups that evaluate the majority (70%) of the research grant applications sent to NIH. CSR Homepage
Clinical Research Applications
patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects.
Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov