Glossary, CRG, NHLBI, NIH

Review

Peer review is one of the hallmarks of 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.

funding process. Applications are evaluated initially by review groups composed of extramural research scientists to rate the scientific and technical merit of the proposed research. This takes place either at CSR

Center for Scientific Review (CSR)
the portal for NIH 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.

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

or at the Institute ( 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.

The second level of peer review is carried out by the NHLBI Advisory Council. The Council

Council
also known as NHLBAC, this group considers applications and advises the Institute on research grants, training grants and cooperative agreements to recommend funding for applications that show promise of making valuable contributions.

is composed of scientists from the extramural research community and public representatives. Its purpose is to ensure that NHLBI receives advice from a cross-section of the US population in the process of its deliberation and decisions.

The review process can sometimes seem secretive but this section is designed to help you better understand the process and answer the following questions:

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

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Home » Clinical Research Guide» Review
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	Review Peer review is one of the hallmarks of 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. funding process. Applications are evaluated initially by review groups composed of extramural research scientists to rate the scientific and technical merit of the proposed research. This takes place either at CSR Center for Scientific Review (CSR) the portal for NIH 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. 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 or at the Institute ( 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. ). The second level of peer review is carried out by the NHLBI Advisory Council. The Council Council also known as NHLBAC, this group considers applications and advises the Institute on research grants, training grants and cooperative agreements to recommend funding for applications that show promise of making valuable contributions. is composed of scientists from the extramural research community and public representatives. Its purpose is to ensure that NHLBI receives advice from a cross-section of the US population in the process of its deliberation and decisions. The review process can sometimes seem secretive but this section is designed to help you better understand the process and answer the following questions: 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? Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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