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OHSU Human Subject Research: Tips for Modifying the Consent Process

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The document outlines guidelines for modifying the consent process in human subject research at OHSU, particularly focusing on minimal and greater than minimal risk research. It details conditions under which the Institutional Review Board (IRB) may waive or alter informed consent requirements, including the use of short forms for oral consent and exceptions for emergency research. The document emphasizes the importance of protecting subjects' rights and welfare while ensuring compliance with regulatory standards.

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How to obtain consent for research?

Obtaining consent involves explaining the research and assessing participant comprehension using a consent document, usually a written consent form or information sheet, as a guide for the verbal explanation of the study.

How do you ask for research consent?

Explain to the participant what the research is about and what it will involve. You usually ask the user to complete and sign a consent form to confirm their permission and document their preferences for how we can save and share their information, including video and audio recordings.

What should be included in the informed consent process and document in human subject research?

For an ethically valid consent, information provided to a research subject should include, but not be limited to: information about the health condition for which the research is proposed; details of the nature and purpose of the research; the expected duration of the subjects participation; a detailed description of

What are the 5 requirements for informed consent?

Function The nature of the procedure or intervention. The risks and benefits of the procedure or intervention. Reasonable alternatives. The risks and benefits of alternatives. An assessment of the patients understanding of these elements [10][11]

How do you take consent for research?

The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subjects questions, ensuring that the subject has comprehended this information, obtaining the subjects voluntary agreement