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INDIANA UNIVERSITY SCHOOL OF MEDICINE RESEARCH ENHANCEMENT GRANT APPLICATION TO THE BIOMEDICAL RESEARCH COMMITTEEPRINCIPAL INVESTIGATOR NAME:RANK:era COMMONS:ORCHID ID:DEPARTMENT:DEPARTMENT CODE:CAMPUS
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New human subjects refer to individuals who participate in research studies where data is collected through intervention or interaction, or where identifiable private information is obtained. These subjects are essential in the field of clinical research.
Researchers, institutions, and organizations conducting studies involving new human subjects must file the necessary documentation to ensure compliance with ethical and regulatory standards.
To fill out new human subjects documentation, researchers must provide detailed information about the study, including its purpose, methodology, ethical considerations, and informed consent processes. Guidelines vary by institution, so following specific instructions is essential.
The purpose of filing new human subjects documentation is to ensure that the rights, welfare, and privacy of participants are protected during research, and to comply with regulatory requirements.
Information that must be reported includes the study's title, research objectives, participant selection criteria, potential risks and benefits, informed consent procedures, and data protection measures.
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