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Exempt 4 Determination Secondary ResearchSecondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens that are publicly
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The Common Rule is a federal policy regarding the protection of human subjects involved in research. It aims to ensure ethical standards in research practices, requiring institutions to follow specific guidelines for the protection of participants.
Researchers and institutions conducting federally funded research involving human subjects are required to file an overview under the Common Rule.
To fill out the overview of the Common Rule, researchers must gather all relevant information regarding the research project, including the study's purpose, methodology, and participant protection measures, and then complete the required forms provided by their institution or IRB.
The purpose of the overview of the Common Rule is to ensure that research involving human subjects is conducted ethically and that participants are adequately informed about their rights and protections.
The overview must report information such as the research objectives, the procedures involved, potential risks and benefits, informed consent processes, and any measures taken to protect participant confidentiality.
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