Institutional Review Board/institutional Ethics Committee (Irb/iec) Roles And Responsibilities

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Institutional Review Board/Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities (7%-11%)

Roles and Responsibilities of an IRB/IEC:

What is and IRB? What do they do?

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The Institutional Review Board (IRB) is a committee that reviews, approves, and monitors a clinical trial. The primary goal is to protect the rights and safety of human subjects who participate in clinical trials.

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Institutional Review Board/Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities (7%-11%)

Roles and Responsibilities of an IRB/IEC:

What is and IEC? What do they do?

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The Ethics Review Committee (ERC) is the term used for IRB for countries outside of the United States.

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Institutional Review Board/Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities (7%-11%)

Roles and Responsibilities of an IRB/IEC:

What is FDA 21 CFR 56?

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FDA 21 CFR 56 covers IRB related topics.

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Institutional Review Board/Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities (7%-11%)

Roles and Responsibilities of an IRB/IEC:

What is the definition of IRB according to 21 CFR 56.102(g)?

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"The Institutional Review Board (IRB) means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act."

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Institutional Review Board/Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities (7%-11%)

Roles and Responsibilities of an IRB/IEC:

What is a centralized IRB?

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A Centralized IRB (aka Independent IRB) do not have affiliation to any institution. Centralized IRBs can review, approve, and monitor any clinical trials that are within the geographical area under their regulatory allowance. One of the largest Centralized IRBs is WIRB (Western Institutional Review Board in Puyallup, WA).

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Institutional Review Board/Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities (7%-11%)

Roles and Responsibilities of an IRB/IEC:

Name some of the responsibilities of an IRB/IEC.

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• Protect the rights, safety, and well-being of subjects - Review, approve, or disapprove all research activities based on benefits and risks per 21 CFR 56.109(a) + conduct continuing review of research activities at least once per year per 21 CFR 56.109 (f)
• Oversight of ICF Process and all documents used [21 CFR 56.109(b) while determining what level of consent is required [21 CFR 56.109 (c) and evaluating amount and method of payment to avoid coercion.
• Monitor all deviations and/or safety hazards to subjects and terminating any research that is not following regulations or causing unexpected serious harm to subjects while reporting any issues to appropriate agencies
• Maintain compliance with policies and standards of practice witl regulatory agencies per 21 CFR 56.101