What is an Institutional Review Board?
Research with humans is critical to advancing scientific knowledge biology and behavior and to informing clinical practice and public health policy. Research with humans is a highly regulated enterprise, with a system of laws, regulations and policies, at the federal, state, and local levels. The Institutional Review Board (IRB) plays a central role in ensuring that human research conducted at their institution is in compliance with pertinent regulations and policies.
An Institutional Review Board—or IRB—is an ethical oversight committee that provides initial and ongoing review of research involving humans. It is sometimes called a Research Ethics Committee, or REC, outside of the United States. The IRB is responsible for safeguarding the rights and welfare of “human subjects” who take part in research. Some institutions refer to human subjects as research participants.
The IRB committee is responsible for ensuring that research studies involving human subjects are ethical and in compliance with federal regulations created by the Office for Human Research Protections (OHRP) or the Food and Drug Administration (FDA).
An IRB committee is a diverse group of researchers, ethicists, legal experts, community members, and healthcare professionals who work together to protect the rights and welfare of human subjects involved in research.
The IRB committee is responsible for ensuring that research studies involving human subjects are ethical and in compliance with federal regulations created by the Office for Human Research Protections (OHRP) or the Food and Drug Administration (FDA).
An IRB committee is a diverse group of researchers, ethicists, legal experts, community members, and healthcare professionals who work together to protect the rights and welfare of human subjects involved in research.
What is the Role of an IRB?
An IRB is needed for any study involving human subjects, including clinical trials, surveys, interviews, and observational studies that is federally funded. For a federally funded research study to occur, the IRB must review and approve the research protocol, the informed consent documents, and other research study materials..
Why is the IRB Important?
An IRB committee ensures that scientific research prioritizes protecting the rights and welfare of its subjects. In 1979 the Belmont Report laid out basic ethical principles needed to create federal regulations protecting human subjects in research. These principles are respect for persons, beneficence, and justice. As an independent body an IRB evaluates research proposals based on these ethical principles and 45 CFR 46, the federal regulation governing research involving human subjects. Other FDA regulations provide additional guidance specifically for clinical trials and the use of investigational drugs and medical devices.
IRBs ensure that the study design, methods, and procedures are ethical and that the risks to human subjects are reasonable when considering the potential benefits of the study. The IRB has the authority to approve, require modifications to, or disapprove research studies involving human subjects.
IRBs ensure that the study design, methods, and procedures are ethical and that the risks to human subjects are reasonable when considering the potential benefits of the study. The IRB has the authority to approve, require modifications to, or disapprove research studies involving human subjects.
Importance of Taking an IRB Training Course
To ensure that the IRB operates in compliance administrators and researchers must stay up to date with the latest guidelines and regulations set forth by the government.
PRIM&R, or Public Responsibility in Medicine and Research, is a leading organization that provides education and resources on research ethics and oversight. PRIM&R offers a variety of training opportunities for IRB professionals, researchers, and others who are interested in learning more about research ethics.
PRIM&R, or Public Responsibility in Medicine and Research, is a leading organization that provides education and resources on research ethics and oversight. PRIM&R offers a variety of training opportunities for IRB professionals, researchers, and others who are interested in learning more about research ethics.
Exploring the Common Rule Workshops
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Exploring the FDA Workshops
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IRB Core Training
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EROC
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Webinar
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Webinar
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