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This document outlines the guidelines and requirements for undergraduate research projects involving human subjects that may be exempt from Institutional Review Board (IRB) review, including the necessary
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How to fill out Undergraduate Research Projects Involving Human Subjects Guidelines for Projects Exempt from IRB Review

01
Review the guidelines provided for research involving human subjects.
02
Determine if your project meets the criteria for exemption from IRB review.
03
Complete the requisite documentation including a description of your project.
04
Clearly outline the purpose of your research and its benefits.
05
Specify the participant selection criteria and how you will recruit participants.
06
Provide details on how you will ensure the confidentiality and anonymity of participants.
07
Include information on potential risks to participants and how you will mitigate them.
08
Submit the completed guidelines to the appropriate authority for approval.

Who needs Undergraduate Research Projects Involving Human Subjects Guidelines for Projects Exempt from IRB Review?

01
Undergraduate students conducting research involving human subjects.
02
Faculty advisors overseeing undergraduate research projects.
03
Academic departments requiring compliance with ethical research standards.
04
Research institutions that mandate adherence to federal guidelines.
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Research studies involving human subjects require IRB review. Evaluative studies and activities do not. It is not always easy to distinguish between these two types of projects and projects frequently have elements of both.
Therefore, as a rule, student class assignments do not fall under the jurisdiction of the IRB and do not require IRB application, approval, or oversight. Most student class assignments pose little or no risk to students or others.
Examples of Studies that Generally Do Not Require IRB Review Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc. Activities designed solely for quality improvement or evaluation of a program, course, etc.
Examples of research that does not require IRB approval include: Internal management projects, such as program evaluation, quality assurance, quality improvement, or marketing studies. Projects that only document or report on events, situations, policies, institutions or systems without the intent to form hypotheses.
Which human studies don't need IRB approvals? Some human research methods have no or minimum risk to the human subjects. For example, anonymized questionnaires, anonymized routine clinical exams (with no clinical tools, no touch, and with no cross-contamination risk), etc.
Exempt Review Categories Include: Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn or the assessment of educators.
Exempt Categories: Education research. Surveys, interviews, educational tests, public observations (that do not involve children) Benign behavioral interventions. Analysis of previously-collected, identifiable info/specimens. Federal research/demonstration projects. Taste and food evaluation studies.

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The Undergraduate Research Projects Involving Human Subjects Guidelines for Projects Exempt from IRB Review outlines the criteria and processes that undergraduate researchers must follow when conducting studies with human subjects that do not require full Institutional Review Board (IRB) oversight.
Undergraduate students conducting research projects involving human subjects that fall under the exempt category are required to file these guidelines to ensure compliance with ethical standards.
To fill out the guidelines, researchers must provide details about their project, including the study's purpose, method of participant selection, informed consent process, and any potential risks to participants, ensuring all information is accurate and complete.
The purpose of these guidelines is to ensure that undergraduate research involving human subjects is conducted ethically, protecting the rights and welfare of participants while allowing for necessary exemptions from full IRB review.
Researchers must report information including the title of the project, research objectives, methodology, participant demographics, consent processes, and how data will be collected and handled, along with a statement justifying the exemption.
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