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STANFORD UNIVERSITY - Research Consent Form Approval

STANFORD UNIVERSITY - Research Consent Form Approval 2025

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The document is a research consent form from Stanford University for a study titled 'Collection of Continuous Glucose Monitoring and Insulin Infusion Pump Data for Use in the Development of a Closed Loop Algorithm.' It outlines the purpose, procedures, eligibility criteria, potential risks, benefits, and confidentiality measures related to the study involving participants with Type 1 diabetes. The study aims to collect data on glucose fluctuations to develop simulated patient models for testing control algorithms. Participation is voluntary, and subjects can withdraw at any time without affecting their medical care.

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What are 5 important aspects of an informed consent form?

The informed consent process emerged out of the Nuremburg Trials to protect human research subjects. In the ensuing 60 years, it has become the ethical cornerstone of medical practice. Modern informed consent consists of five tenets: voluntariness, disclosure, understanding, competence, and consent.

Are research consent forms legally binding?

Fourth, consent forms are legal documents. Courts have characterized consent forms as establishing contractual relationships between investigators and subjects, which imply legal duties.

How long does IRB approval take Stanford?

How long does the review take? Although it is possible that the review process takes only a week or two, please also be aware that due to a high volume of submitted protocols, it can take up to 4-5 weeks before you receive notification that your protocol has been approved.

What are the requirements for informed consent in research?

The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.

What are 5 pieces of information that must be on a consent form?

Obtaining informed consent in medicine is a process that should include describing the proposed intervention, emphasizing the patients role in decision-making, discussing alternatives to the proposed intervention, discussing the risks and benefits of the proposed intervention, and eliciting the patients preference,

What are the 5 factors of informed consent?

All consent forms for non-Exempt research should include these elements: Title of the Research Study, Invitation to Participate, Basis for Subject Selection, Purpose of the Study, Explanation of Procedures, Potential Risks and Discomforts , Potential Benefits to the Subject, Potential Benefits to Society, Assurance of

STANFORD UNIVERSITY - Research Consent Form Approval 2025

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STANFORD UNIVERSITY - Research Consent Form Approval 2025

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What are 5 important aspects of an informed consent form?

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How long does IRB approval take Stanford?

What are the requirements for informed consent in research?

What are 5 pieces of information that must be on a consent form?

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