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Get the free CSUF Human Subjects Research Exemption Statement and Reviewer Response - fresnostate

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This document is to be submitted by students at California State University, Fresno, seeking exemption from human subjects research review for their dissertation work, requiring input and signatures
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How to fill out CSUF Human Subjects Research Exemption Statement and Reviewer Response

01
Visit the CSUF website and locate the Human Subjects Research Exemption Statement form.
02
Read the guidelines regarding human subjects research to understand the exemption criteria.
03
Fill out the required information in the form, including your name, department, and a description of your research.
04
Clearly outline the purpose of your study and how it adheres to exemption criteria.
05
Detail any potential risks to participants and how you will minimize them.
06
Include information on participant consent and how it will be obtained.
07
Review your responses for accuracy and completeness.
08
Submit the completed form to the appropriate departmental review board or committee.
09
After submission, prepare a separate Reviewer Response that addresses any feedback or queries from the review committee.
10
Ensure that all responses in the Reviewer Response are clear and provide the necessary clarifications requested.

Who needs CSUF Human Subjects Research Exemption Statement and Reviewer Response?

01
Researchers at CSUF who are conducting studies involving human subjects and wish to apply for an exemption.
02
Students working on research projects that involve human participants and need to submit for ethical review.
03
Faculty members overseeing student research that involves human subjects.
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Institutional Review Boards (IRBs) assess the ethics and safety of research studies involving human subjects, such as behavioral studies or clinical trials for new drugs or medical devices.
The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

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The CSUF Human Subjects Research Exemption Statement is a document that allows researchers to assert that their study qualifies for exemption from the full IRB review process. The Reviewer Response is the feedback or evaluation provided by the Institutional Review Board (IRB) regarding the exemption statement submitted.
Any researcher at California State University, Fullerton (CSUF) conducting research involving human subjects that may qualify for exemption must file the CSUF Human Subjects Research Exemption Statement and submit it for review by the IRB.
To fill out the CSUF Human Subjects Research Exemption Statement, researchers should provide a detailed description of their research project, specify how it meets exemption criteria, and include information about the methodology, potential risks, and subject recruitment processes. After submission, the IRB will review and respond to the exemption request.
The purpose of the CSUF Human Subjects Research Exemption Statement is to determine whether a research project qualifies for exemption from full IRB review. The Reviewer Response serves to communicate the IRB's evaluation and approval or denial of the exemption request.
The information that must be reported includes the research title, principal investigator's contact information, a summary of the research design, the purpose of the study, methods for recruiting subjects, potential risks to participants, and how the study meets the criteria for exemption.
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