Glossary, CRG, NHLBI, NIH

The institution or organization who receives 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

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.

or contract

Contract
award instrument establishing a binding legal agreement between NIH and an award recipient for products or services. The Office of Acquisition

Office of Acquisition (OA)
OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy)

Management and Policy (OAMP) web site provides additional information

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.

is responsible for fulfilling all financial and administrative aspects of the award. 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.

) is the individual responsible for the scientific or technical aspects of the clinical trial or study and for day-to-day scientific management of the project or program. The Principal Investigator works closely with the institution or organization to meet all the applicable requirements and terms of the grant.
The PI’s responsibilities include, but are not limited to, the following:

Design and implement ethical research
Comply with applicable federal human subject protection regulations and obtain a Federal Wide Assurance (FWA)
Comply with NIH, State and Local regulations
Ensure investigators and research staff complete human subjects protection training
Ensure that research involving 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.
is approved by the appropriate IRB
Comply with IRB
Institutional Review Board (IRB)
a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).
policies, procedures, decisions, conditions, and requirements
Implement research as approved and obtain prior IRB approval for changes
Create and implement a Data and Safety Monitoring Plan
Document informed consent and assent
Assent
child's agreement to participate in research, which is not just a failure to object.
per Federal regulations and as approved by the IRB
Report progress of approved research to the IRB, as often as and in the manner prescribed by the IRB
Report to the IRB and NIH any injuries, adverse events, or other unanticipated problems involving risks to subjects or others
Retain signed consent documents and IRB research records according to regulations

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Home » Clinical Research Guide » Overview » What is the role of the Principal Investigator/Institution in clinical research?
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	What is the role of the Principal Investigator/Institution in clinical research? The institution or organization who receives 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 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. or contract Contract award instrument establishing a binding legal agreement between NIH and an award recipient for products or services. The Office of Acquisition Office of Acquisition (OA) OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy) Management and Policy (OAMP) web site provides additional information 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. is responsible for fulfilling all financial and administrative aspects of the award. 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. ) is the individual responsible for the scientific or technical aspects of the clinical trial or study and for day-to-day scientific management of the project or program. The Principal Investigator works closely with the institution or organization to meet all the applicable requirements and terms of the grant. The PI’s responsibilities include, but are not limited to, the following: Design and implement ethical research Comply with applicable federal human subject protection regulations and obtain a Federal Wide Assurance (FWA) Comply with NIH, State and Local regulations Ensure investigators and research staff complete human subjects protection training Ensure that research involving 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. is approved by the appropriate IRB Comply with IRB Institutional Review Board (IRB) a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC). policies, procedures, decisions, conditions, and requirements Implement research as approved and obtain prior IRB approval for changes Create and implement a Data and Safety Monitoring Plan Document informed consent and assent Assent child's agreement to participate in research, which is not just a failure to object. per Federal regulations and as approved by the IRB Report progress of approved research to the IRB, as often as and in the manner prescribed by the IRB Report to the IRB and NIH any injuries, adverse events, or other unanticipated problems involving risks to subjects or others Retain signed consent documents and IRB research records according to regulations
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What is the role of the Principal Investigator/Institution in clinical research?