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Human Subjects Protection
Update (Special Communication)September 2014IRB (Institutional Review Board)IRB Staff
Tina YoungPoussaint, MD,
Chair
Carlo Burglary, MD, Vice Chair
Thomas Marcus, MD, Vice
Chair
Peter
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How to fill out human subjects protection
How to fill out human subjects protection
01
Determine if you are conducting research on human subjects.
02
Familiarize yourself with the ethical principles and regulations related to human subjects protection.
03
Identify the appropriate Institutional Review Board (IRB) that oversees the protection of human subjects for your research.
04
Complete the necessary training on human subjects protection, if required by your institution or the IRB.
05
Obtain informed consent from the participants before involving them in the research.
06
Ensure the privacy and confidentiality of the collected data.
07
Regularly monitor and review the ethical aspects of your research to address any potential risks to the human subjects.
08
Report any adverse events or non-compliance to the IRB as required.
09
Submit all necessary documentation and protocols to the IRB for review and approval.
10
Follow the approved procedures and guidelines for human subjects protection throughout the research process.
11
Maintain proper records and documentation related to the research and human subjects protection.
Who needs human subjects protection?
01
Researchers who conduct studies or investigations involving human participants require human subjects protection.
02
Academic institutions and organizations that receive federal funding for research involving human subjects must also adhere to human subjects protection guidelines.
03
Clinical trials, behavioral studies, social science research, medical experiments, and any research that involves interaction with human beings often fall under the scope of human subjects protection.
04
Even if the research involves minimal risk to the participants, it is recommended to follow human subjects protection guidelines to ensure ethical practices.
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What is human subjects protection?
Human subjects protection refers to the policies and procedures in place to ensure the safety, rights, and well-being of individuals participating in research studies.
Who is required to file human subjects protection?
Researchers, institutions, and ethics committees involved in conducting research studies are required to file human subjects protection.
How to fill out human subjects protection?
To fill out human subjects protection, researchers must follow the guidelines set forth by their institution's Institutional Review Board (IRB) and provide detailed information about the study protocol, risks, benefits, and informed consent process.
What is the purpose of human subjects protection?
The purpose of human subjects protection is to minimize harm and protect the rights, safety, and dignity of individuals participating in research studies.
What information must be reported on human subjects protection?
Researchers must report information about study procedures, potential risks and benefits, informed consent process, data handling procedures, and plans for monitoring and reporting adverse events.
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