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Human Subjects Research Proposal Evaluation form - dyc 2025

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The document is a Human Subjects Research Proposal Evaluation form from D'Youville College's Institutional Review Board. It outlines the necessary considerations for researchers regarding risks, benefits, vulnerable populations, deception, coercion, data management, and informed consent in research involving human subjects.

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Click ‘Get Form’ to open the Human Subjects Research Proposal Evaluation form in the editor.
Begin by entering your name and the date at the top of the form. This personalizes your submission and ensures proper identification.
In section 1, assess whether subjects are exposed to any risks or discomforts. Check 'Y' for yes or 'N' for no, and provide a detailed description of how you will protect subjects if risks are present.
For sections 2 and 3, articulate the potential benefits for both subjects and the research itself. Be clear and concise in your explanations.
In section 4, indicate if subjects belong to a vulnerable population. If so, explain why alternative populations were not used and detail any special protections in place.
Continue through sections 5 to 13, addressing questions about deception, coercion, data maintenance, storage duration, dissemination of findings, and consent processes. Ensure all fields are completed thoroughly.

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How to write an IRB research proposal?

Institutional Review Boards (IRBs) review research involving human subjects to ensure protection of research participants from potentially harmful research. Research involving human subjects obtains information through interventions or generates identifiable private information (including bio-specimens).

How often does the IRB need to review research that involves human subjects?

When an IRB approves a study, continuing review should be performed at least annually. All of the records listed in 21 CFR 56.115(a)(1) - (4) are required to be maintained. The clock starts on the date of approval, whether or not subjects have been enrolled.