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Good Documentation Practices for Human Subject Research Bridget M. Psicihulis, RHEA, CCC Quality Improvement Unit Coordinator Human Research Protection Program Wheaton Franciscan Healthcare(last updated
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How to fill out for human subject research

01
First, identify the purpose of the human subject research.
02
Next, review the ethical guidelines and regulations set forth by the relevant governing body.
03
Obtain the necessary approval or consent from the appropriate institutional review board.
04
Prepare the research proposal and ensure it includes detailed information about the study design, methodology, and potential risks to participants.
05
Recruit eligible human subjects for the research project by following the predetermined criteria.
06
Inform the participants about the research objectives, procedures, potential risks, and benefits involved.
07
Have the participants sign informed consent forms before proceeding with the research.
08
Collect data from the participants using various methods such as surveys, interviews, or observations.
09
Ensure the confidentiality and anonymity of the participants' data during data collection and analysis.
10
Analyze the gathered data using appropriate statistical or qualitative analysis methods.
11
Interpret the results objectively and draw conclusions based on the findings.
12
Share the research outcomes through publications, presentations, or other suitable means.
13
Continuously monitor and evaluate the ethical considerations throughout the research process.

Who needs for human subject research?

01
Researchers involved in scientific studies and experiments that involve human participants.
02
Institutions, organizations, or companies conducting clinical trials or medical research.
03
Psychologists, sociologists, anthropologists, or other social scientists studying human behavior.
04
Educational institutions performing research on students or educational interventions.
05
Government agencies or regulatory bodies overseeing research projects involving human subjects.
06
Healthcare professionals conducting studies on patient populations.
07
Non-profit organizations addressing societal issues through research involving human subjects.
08
Individuals or groups seeking to better understand human experiences and improve knowledge in a specific field.
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Human subject research involves studying individuals to contribute to general knowledge and understanding.
Researchers conducting studies involving human subjects are required to file for human subject research.
To fill out for human subject research, researchers need to provide detailed information about the study protocols, risks, benefits, and participant consent forms.
The purpose of human subject research is to advance scientific knowledge and improve human health outcomes.
Researchers must report detailed information about the study design, potential risks to participants, methods of data collection, and informed consent procedures.
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