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Stanford IRB Definitions & Glossary Human Subjects IRB Form
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People also ask
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What is the IRB approval for human subjects?
Research involving human subjects requires submission of the following documents: Documentation of approval from an Institutional Review Board (IRB) or other determination (e.g., exemption or not research involving human subjects) IRB-approved informed consent. IRB-approved research protocol.
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What are the criteria for IRB approval of research?
In addition to evaluation of the risks in the research, the IRB determines, based on the materials submitted by the investigator, that research studies have the resources necessary to protect participants, such as adequate time for the researchers to conduct and complete the research, adequate number of qualified staff ...
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What language is required for Stanford IRB?
Investigators are encouraged to recruit and include all segments of our community in research, including individuals whose primary language is not English. Participants who do not speak English should be presented with a consent document written in a language understandable to them.
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How does the IRB define human subjects?
ing to 45 CFR 46, a human subject is "a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or.
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What are the three key principles for IRB approval?
IRB – Principles Respect for Persons. Acknowledgement of the autonomy of the individual and the responsibility to provide special protection for individuals with reduced autonomy. Beneficence. A responsibility to do no harm, to maximize possible benefits, and to minimize possible harm. Justice.
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What are the minimum elements that are typically required for an IRB?
The IRB templates will provide more specific requirements. Table of Contents. Introduction/Abstract. Hypothesis. Objectives and Rationale. Methods and Procedures. Subject Population Selection and Inclusion/Exclusion Criteria. Risks and Benefits. Provisions for Treatment of Adverse Events.
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What are the criteria for IRB approval of a human research study?
Research Requiring Comprehensive IRB Review Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits. The subject selection is equitable. Privacy and confidentiality are protected. Informed consent processes meet federal regulatory and U-M requirements.
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What is Stanford IRB?
The Research Compliance Office (RCO) is responsible for oversight and management of Stanford's Administrative (Compliance) Panels (Human Subjects (IRB), Stem Cell Research Oversight (SCRO), and Laboratory Animal Care (APLAC)) and ensures compliance with applicable policies, accreditation standards and external ...
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