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IRB Use Only Approval Date: August 31, 2021, Expiration Date: August 31, 2022RESEARCH CONSENT FORM Title of Study: Predictors of Response to Insomnia Treatments for Gulf War Veterans Principal Investigator:
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To fill out protection of human subjects, follow these steps:
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Start by understanding the purpose and importance of protecting human subjects in research.
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Familiarize yourself with the regulations and guidelines set forth by relevant governmental and ethical bodies (e.g., Institutional Review Boards or IRBs).
04
Identify the type of research you are conducting and the potential risks or benefits it may pose to human subjects.
05
Develop a detailed protocol that outlines the study design, methodology, data collection procedures, and ethical considerations.
06
Clearly define the inclusion and exclusion criteria for selecting human subjects.
07
Obtain informed consent from the participants, ensuring they understand the nature of the study, any potential risks, and their rights as subjects.
08
Maintain strict confidentiality and anonymity of participant data during and after the study.
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Regularly monitor the study to ensure compliance with ethical guidelines and promptly address any issues or concerns.
10
Report any adverse events or non-compliance with regulations to the appropriate authorities.
11
Complete all necessary documentation, including consent forms, study protocols, and reports.
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Seek ethical approval from the IRB or other relevant bodies before commencing the study.

Who needs protection of human subjects?

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Protection of human subjects is needed in various research endeavors, including but not limited to:
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- Clinical trials: Research involving new drugs, medical devices, or treatment interventions.
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- Social or behavioral studies: Research focusing on human behavior, psychology, sociology, or education.
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- Biomedical research: Studies that investigate diseases, genetics, or physiological processes in humans.
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- Public health research: Investigations into the prevention, control, and treatment of diseases at a population level.
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- Surveys and interviews: Research that collects data directly from human participants.
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Anyone conducting these types of research or experiments that involve human subjects must adhere to ethical guidelines and ensure their protection.
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Protection of human subjects refers to the ethical guidelines and regulations put in place to ensure the safety, rights, and well-being of individuals participating in research studies or clinical trials.
Researchers, institutions, and organizations conducting research involving human subjects are required to file protection of human subjects.
Protection of human subjects forms typically require researchers to provide detailed information about the study design, risks and benefits to participants, informed consent process, confidentiality measures, and plans for monitoring and reporting adverse events.
The purpose of protection of human subjects is to ensure that research involving human participants is conducted in an ethical manner, with their safety, rights, and well-being as the top priority.
Information that must be reported on protection of human subjects forms include study protocols, informed consent documents, participant recruitment materials, data security measures, and plans for monitoring and reporting adverse events.
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