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Get the free Checklist for Research Qualifying as Exempt from IRB Review - brynmawr

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This document serves as a checklist and guideline for researchers to determine if their project qualifies for exempt review by the Institutional Review Board (IRB). It outlines the applicable criteria,
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How to fill out checklist for research qualifying

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How to fill out Checklist for Research Qualifying as Exempt from IRB Review

01
Identify the research project and its purpose.
02
Review the criteria outlined by the IRB to determine if your research qualifies as exempt.
03
Gather all relevant documents related to your research (e.g., proposal, consent forms).
04
Fill out the checklist form by addressing each item systematically.
05
Provide clear explanations for how your research meets each exemption criterion.
06
Ensure all investigators involved in the research are listed.
07
Submit the completed checklist along with any required documentation to the IRB.

Who needs Checklist for Research Qualifying as Exempt from IRB Review?

01
Researchers conducting studies that may qualify for exemption.
02
Institutions or organizations that require IRB review for research activities.
03
Graduate students and faculty planning to conduct human subjects research.
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IRB approval is required when research involving human subjects: Receives federal funds either directly or indirectly. Takes place at a university or hospital. Tests therapies that will require U.S. Food and Drug Administration (FDA) marketing approval.
Thus, if a study is conducted outside of an academic institution, is not federally funded, and is not related to an FDA or EPA-regulated product, it need not undergo IRB review.
Examples of Commonly Exempted Research The following types of research are commonly processed under exempt review: Research on educational practices or educational curriculums. Benign behavioral interventions with adult subjects. Anonymous surveys or interviews on non-sensitive topics.
Checklists are used by the IRB staff and reviewers to document required IRB determinations. Investigators may consult the checklists to understand the regulatory requirements related to research, however, Investigators are not required to complete the checklists: HRP-410 - Waiver or Alteration of the Consent Process.
IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.

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The Checklist for Research Qualifying as Exempt from IRB Review is a document used to determine whether a research study meets the criteria for exemption from Institutional Review Board (IRB) scrutiny based on regulatory guidelines.
Researchers who are conducting studies that involve human participants and believe their research qualifies for exemption under federal regulations are required to file this checklist.
To fill out the checklist, researchers must carefully read the criteria for exemption, answer relevant questions truthfully, and provide necessary details about the research design, participant involvement, and data handling.
The purpose of the checklist is to streamline the process of assessing whether research can be exempted from the full IRB review, ensuring that ethical standards are upheld without unnecessary delays.
The checklist typically requires details about the research study's purpose, methodology, participant demographics, potential risks, consent process, and how the data will be managed and protected.
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