Glossary, CRG, NHLBI, NIH

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.

staff plays different roles at each step of the way. Prior to submission, you may contact a Program Official (PO)

Program Official (PO)
staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer

Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ).

if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Director.

for questions about a particular research topic, suitability of your research idea for NHLBI, study design, collaborations with other institutions or meeting human subjects

Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction

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.

requirements. For questions about the submission or review process, you may contact a Scientific Review Administrator ( SRA

Scientific Review Administrator (SRA)
presides over a scientific review group, and coordinates and reports the initial peer review of each grant application assigned to it. They are intermediaries between applicants and reviewers, and prepare summary statements for all applications reviewed.

), either in our Scientific Review Branch or in NIH's Center for Scientific Review ( 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

), depending on where the application will be reviewed. 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.

Grants Management Specialists ( GMS

Grants Management Specialists (GMS)
staff members who are the focal point for all business and policy activities associated with the negotiation, award and administration of a grant or cooperative agreement, and who interpret and apply grants policies.

) can help you with questions related to business-type or budgetary questions. The Program Official (PO) will be able to direct you to the appropriate review and budget staff.

After peer review, your Program Official (PO) serves as your main contact for all issues related to the review, the summary statement and human subjects. He or she confirms the involvement of human subjects and looks at potential risks and proposed protection measures. He or she will advise you what documentation is needed before NHLBI can fund the grant.

If you would like to contact a Program Official (PO) see, NHLBI Program, Review and Budget Staff Contacts.

CSR Personnel Directory

NHLBI Review Branch in the Division of Extramural Research Activities contact list

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

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Home » Clinical Research Guide» Which NHLBI staff can help me?
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	Which NHLBI staff can help me? 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. staff plays different roles at each step of the way. Prior to submission, you may contact a Program Official (PO) Program Official (PO) staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer Project Officer the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ). if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Director. for questions about a particular research topic, suitability of your research idea for NHLBI, study design, collaborations with other institutions or meeting human subjects Human Subject Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 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. requirements. For questions about the submission or review process, you may contact a Scientific Review Administrator ( SRA Scientific Review Administrator (SRA) presides over a scientific review group, and coordinates and reports the initial peer review of each grant application assigned to it. They are intermediaries between applicants and reviewers, and prepare summary statements for all applications reviewed. ), either in our Scientific Review Branch or in NIH's Center for Scientific Review ( 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 ), depending on where the application will be reviewed. 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. Grants Management Specialists ( GMS Grants Management Specialists (GMS) staff members who are the focal point for all business and policy activities associated with the negotiation, award and administration of a grant or cooperative agreement, and who interpret and apply grants policies. ) can help you with questions related to business-type or budgetary questions. The Program Official (PO) will be able to direct you to the appropriate review and budget staff. After peer review, your Program Official (PO) serves as your main contact for all issues related to the review, the summary statement and human subjects. He or she confirms the involvement of human subjects and looks at potential risks and proposed protection measures. He or she will advise you what documentation is needed before NHLBI can fund the grant. If you would like to contact a Program Official (PO) see, NHLBI Program, Review and Budget Staff Contacts. CSR Personnel Directory NHLBI Review Branch in the Division of Extramural Research Activities contact list Page Last Updated: February 2011 Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov
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Which NHLBI staff can help me?