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This document outlines the policies and procedures established by the EPA to protect human research subjects involved in research activities that are conducted or supported by the EPA. It supersedes
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How to fill out EPA Policy and Procedures on Protection of Human Research Subjects

01
Obtain the EPA Policy and Procedures document from the EPA website or your institution's research office.
02
Review the document to understand the requirements and procedures related to human research subjects.
03
Gather relevant materials and information regarding your research project, including protocols, consent forms, and risk assessments.
04
Fill out each section of the document step by step, ensuring to provide accurate and detailed information.
05
Clearly outline the purpose of the research, methodologies, potential risks, and how you will protect the rights of participants.
06
Include information on how informed consent will be obtained and documented.
07
Review your completed form for completeness and clarity.
08
Submit the filled form to the appropriate ethics review board or designated personnel for approval.

Who needs EPA Policy and Procedures on Protection of Human Research Subjects?

01
Researchers conducting studies involving human subjects under the jurisdiction of the Environmental Protection Agency (EPA).
02
Institutional review boards (IRBs) that oversee research involving human subjects.
03
Anyone involved in planning, implementing, or reviewing human research projects for compliance with ethical standards.
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EPA Order 3120.5 contains the Agency's policy and procedures for addressing research misconduct, including the requirement for EPA employees to immediately notify the OIG via the OIG Hotline of any allegation that involves any of the following: Risk to public health or safety.

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The EPA Policy and Procedures on Protection of Human Research Subjects establishes guidelines for the ethical conduct of research involving human subjects, ensuring their rights and welfare are prioritized in research activities.
Individuals and organizations conducting research involving human subjects that is regulated by the EPA are required to file under this policy.
To fill out the EPA Policy and Procedures, researchers must complete the required forms detailing their research methods, participant information, ethical considerations, and plans for oversight and reporting.
The purpose is to protect the rights and welfare of human participants involved in EPA-sponsored research while ensuring compliance with federal regulations.
Researchers must report information on study objectives, participant demographics, consent processes, data handling procedures, and any potential risks or benefits related to the research.
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