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This document provides guidance on navigating Institutional Review Board (IRB) resources, focusing on the informed consent process for research participation. It includes best practices, sample consent
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How to fill out Navigating the IRB Resources - Session 3 Guided Notes Booklet
01
Begin by reading the title of the booklet and familiarizing yourself with the overall structure.
02
Proceed to each section and read the introductory information provided.
03
Follow the prompts in the guided notes to fill in any required responses.
04
Input data into the designated spaces, ensuring that you follow the instructions for each section.
05
Review your entries for clarity and completeness before submission.
Who needs Navigating the IRB Resources - Session 3 Guided Notes Booklet?
01
Researchers preparing to submit studies to the Institutional Review Board (IRB).
02
Students conducting research that involves human subjects.
03
Faculty members overseeing research involving human subjects.
04
Administrative staff tasked with coordinating IRB submissions.
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What is the difference between a legally authorized representative and a power of attorney?
The Key Differences between a POA and a PR: Purpose: A Power of Attorney is often used for incapacity planning or to facilitate decision making during the individual's lifetime, while a PR is appointed to handle the affairs of a deceased individual's estate after their death.
What is a legally authorized representative in the WCG?
The definition of “legally authorized representative,” as described in FDA 21 CFR § 50.3 is: “An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.”
What is the first step in the IRB process is for a student to?
The first step of the process is to plan the research project involving human participants or subjects. This needs to be well conceptualized before the process can go forward. If it is a student project, a faculty advisor must be included for consultation in the development of a protocol to be submitted to the IRB.
What is a legally acceptable representative?
A legally authorized representative is an individual who, under law, has the ability to act on behalf of another person (such as a minor study participant). The LAR may be a parent, grandparent, caregiver who has the legal authority to grant consent on behalf of another who has been invited to participate in research.
How do you choose which IRB should review your project?
There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt. The review path is determined by: Level of risk to subjects associated with the project. The type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
Who is an authorized representative?
An I-9 authorized representative is someone designated by your company who can fill out and sign Form I-9 (Employment Eligibility Verification) on your behalf.
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What is Navigating the IRB Resources - Session 3 Guided Notes Booklet?
The Navigating the IRB Resources - Session 3 Guided Notes Booklet is a resource designed to assist individuals in understanding the processes and requirements associated with Institutional Review Boards (IRBs), particularly in the context of research involving human subjects.
Who is required to file Navigating the IRB Resources - Session 3 Guided Notes Booklet?
Individuals involved in conducting research that requires ethical review and oversight, including faculty, staff, and students planning to submit research protocols to an IRB, are required to fill out the Navigating the IRB Resources - Session 3 Guided Notes Booklet.
How to fill out Navigating the IRB Resources - Session 3 Guided Notes Booklet?
To fill out the Navigating the IRB Resources - Session 3 Guided Notes Booklet, individuals should carefully read each section and provide their responses based on their specific research protocols and compliance with ethical standards. It typically includes guided questions and sections for documenting relevant information.
What is the purpose of Navigating the IRB Resources - Session 3 Guided Notes Booklet?
The purpose of the Navigating the IRB Resources - Session 3 Guided Notes Booklet is to provide a structured framework for researchers to understand their responsibilities in protecting human subjects and ensuring their research meets ethical guidelines.
What information must be reported on Navigating the IRB Resources - Session 3 Guided Notes Booklet?
The booklet requires researchers to report information pertaining to the research study design, potential risks to participants, informed consent procedures, and any other relevant ethical considerations, ensuring full transparency in the research process.
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