Glossary, CRG, NHLBI, NIH

If this is your first attempt at writing an application, begin by finding a mentor. This person should be someone who has similar scientific interests and who has effectively obtained 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.

funding. You may find a mentor by:

Searching the RePORTER database which will allow you to search for individuals who are funded in your area of research.
Visiting professional society websites that may have a database of available mentors.
Contacting a researcher at your local or a nearby institution.

Ask for advice and review funded applications to help guide you towards your own successful application. Remember to include enough detail in your application about your proposed study to convince the reviewers of the significance of the problem. Be realistic about the amount of work that can be done during the grant

Grant
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 Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.

period.

Classes or seminars may be available to help you better understand the application process. NIH Office of Extramural Research sponsors Seminars on Program Funding and Grants Administration periodically at various locations.

The NIH New Investigators Program may be applicable to you. For the purpose of review and funding, applicants are considered New Investigators if they have not previously served as the Principal Investigator ( PI

Principal Investigator (PI)
a qualified person designated by an applicant institution to direct a research project or program, oversee scientific and technical aspects of a grant and the day-to-day management of the research.

) on any Public Health Service ( PHS

Public Health Service (PHS)
governmental division comprised of agencies related to health and human services such Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services ( CMS ), Food and Drug Administration (FDA), and National Institutes of Health (NIH) to name a few. DHHS Homepage

) - supported research project other than a small grant (R03), an Academic Research Enhancement Award

Award
provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.

(R15), an exploratory/developmental grant (R21), or certain research career awards directed principally to physicians, dentists, or veterinarians at the beginning of their research career.

It is to your advantage to identify yourself as a new investigator on the face page of the PHS 398 or SF424 application form and in your biosketch as reviewers will expect fewer prior achievements from you. Reviewers are instructed to put more emphasis on training, environment and innovation when assessing applications from new investigators. In addition, NHLBI

National Heart, Lung, Blood Institute (NHLBI)
a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage.

has a preferential pay line for new investigators; Information about this can be found on the NHLBI Funding and Operating Guidelines website.

NHLBI strongly supports the training and development of new investigators. Additional information which describes special funding consideration may be found in the Commitment to Early Stage Investigators.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

Skip to content past banner and navigation links U.S. Department of Health & Human Services National Institutes of Health Contact Us Get Email Alerts Font Size Accessible Search Form Advanced Search Search the NHLBI, use radio buttons below to select whole site or Disease and Conditions Index only NHLBI Entire Site NHLBI Entire Site1 Diseases & Conditions2
Home » Clinical Research Guide» Application» Am I a new investigator and what if this is my first NIH application?
CRG Home Contracts Overview What is clinical research? What is the role of NIH and NHLBI in clinical research? What are the Project Officer's responsibilities in clinical research? What is the role of the Principal Investigator/Institution in clinical research? Application How can I find funding opportunities (RFAs, RFPs and PAsG)? What do I need to know before submitting a clinical research application? Am I a new investigator and what if this is my first NIH application? Which NHLBI staff can help me? Is my study considered clinical research? Is my study observational or interventional? What is the best award mechanism for my clinical research proposal? What if my project exceeds $500,000 in direct costs in any given year? Where can I get help with writing the application? What must I include in "Protection of Human Subjects"? How and when do I submit my application? Review What happens to my grant after submission? Who will review my application and when? Did the reviewers like my application? What is a summary statement and what does it mean? What if I don't agree with the review? Funding How do I know if I am funded? Who needs human subjects protection training? Who approves my data monitoring plan? What is a Certificate of Confidentiality and do I need one? How do I develop consent forms and who reviews them? Are there ethical concerns and conflicts of interest I must consider? Do I need IRB, IEC or REB approval? What other approvals are needed? How do I track recruitment of research participants? My study involves Medicare or third party support. My study involves foreign grants and contracts. How do I register my study? When can I begin enrolling participants? Management How do I comply with Good Clinical Practices (GCP)? How do I manage changes to my grant? How do I report amendments, suspensions and terminations? Must I obtain continuing review from the IRB? Who should monitor subject recruitment/retention? How do I report adverse events? How is data quality monitored? What if I wish to add extra sites or studies to my project? How do I manage my budget and when are reports expected? What is HIPAA and how do I abide by the requirements ? Study Closure Tools & Training Glossary	Am I a new investigator and what if this is my first NIH application? If this is your first attempt at writing an application, begin by finding a mentor. This person should be someone who has similar scientific interests and who has effectively obtained 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. funding. You may find a mentor by: Searching the RePORTER database which will allow you to search for individuals who are funded in your area of research. Visiting professional society websites that may have a database of available mentors. Contacting a researcher at your local or a nearby institution. Ask for advice and review funded applications to help guide you towards your own successful application. Remember to include enough detail in your application about your proposed study to convince the reviewers of the significance of the problem. Be realistic about the amount of work that can be done during the grant Grant 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 Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. period. Classes or seminars may be available to help you better understand the application process. NIH Office of Extramural Research sponsors Seminars on Program Funding and Grants Administration periodically at various locations. The NIH New Investigators Program may be applicable to you. For the purpose of review and funding, applicants are considered New Investigators if they have not previously served as the Principal Investigator ( PI Principal Investigator (PI) a qualified person designated by an applicant institution to direct a research project or program, oversee scientific and technical aspects of a grant and the day-to-day management of the research. ) on any Public Health Service ( PHS Public Health Service (PHS) governmental division comprised of agencies related to health and human services such Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare & Medicaid Services ( CMS ), Food and Drug Administration (FDA), and National Institutes of Health (NIH) to name a few. DHHS Homepage ) - supported research project other than a small grant (R03), an Academic Research Enhancement Award Award provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity. (R15), an exploratory/developmental grant (R21), or certain research career awards directed principally to physicians, dentists, or veterinarians at the beginning of their research career. It is to your advantage to identify yourself as a new investigator on the face page of the PHS 398 or SF424 application form and in your biosketch as reviewers will expect fewer prior achievements from you. Reviewers are instructed to put more emphasis on training, environment and innovation when assessing applications from new investigators. In addition, NHLBI National Heart, Lung, Blood Institute (NHLBI) a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage. has a preferential pay line for new investigators; Information about this can be found on the NHLBI Funding and Operating Guidelines website. NHLBI strongly supports the training and development of new investigators. Additional information which describes special funding consideration may be found in the Commitment to Early Stage Investigators. Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
Twitter Facebook YouTube SEARCH \| ACCESSIBILITY \| READERS & PLAYERS \| SITE INDEX \| OTHER SITES \| PRIVACY STATEMENT \| FOIA \| CONTACT US \| OIG National Institutes of Health Department of Health and Human Services USA.gov

Am I a new investigator and what if this is my first NIH application?