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Date Approved: 6/22/2020 Study NCT: NCT02907944 Document: Protocol and SAPPage 1 of 39YALE UNIVERSITY HUMAN INVESTIGATION COMMITTEE Application to Involve Human Subjects in Biomedical Research 100
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Anyone involved in research that directly or indirectly involves human subjects needs to adhere to human subjects research integrity guidelines.
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Additionally, institutions and organizations that oversee or sponsor research projects also have a responsibility to ensure human subjects research integrity.
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Human subjects research integrity refers to the ethical principles and guidelines that govern research involving human participants, ensuring their rights, welfare, and safety are protected throughout the research process.
Researchers and institutions conducting studies involving human subjects are required to file human subjects research integrity reports to ensure compliance with ethical standards.
To fill out human subjects research integrity, researchers must follow specific guidelines set by regulatory bodies, providing details about the study, participant recruitment, informed consent processes, and ethical considerations.
The purpose of human subjects research integrity is to protect the rights and welfare of participants, maintain public trust in research, and ensure that studies are conducted ethically and transparently.
Information that must be reported includes study design, purpose, methodology, participant information, informed consent procedures, and any potential risks to participants.
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