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What is the role of the Principal Investigator/Institution in clinical research?

The institution or organization who receives the 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 
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
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 
    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 
    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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