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These guidelines assist instructors and students at the University of North Florida in developing the knowledge and skills necessary for conducting research involving human participants while ensuring
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How to fill out Waiving IRB Review of Class Projects in Research Methods and Similar Courses

01
Obtain the Waiving IRB Review form from your institution's website or the IRB office.
02
Fill out your name and contact information at the top of the form.
03
Provide a clear and concise description of your class project, including research objectives and methods.
04
Indicate that the project is part of a course and does not involve vulnerable populations or sensitive data.
05
Specify any data collection methods to be used, such as surveys or interviews, and ensure they comply with ethical guidelines.
06
Include the expected benefits of the project for educational purposes.
07
Review the form for completeness and accuracy.
08
Submit the completed form to the appropriate IRB office or department as instructed.

Who needs Waiving IRB Review of Class Projects in Research Methods and Similar Courses?

01
Students enrolled in research methods and similar courses who plan to conduct projects that require minimal ethical review.
02
Instructors overseeing class projects that involve research activities but do not pose significant risks to participants.
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Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.
Exempt Review. Studies that receive an exemption determination from IRB are exempt from the specific regulations and requirements in Title 45, Part 46 of the Code of Federal Regulations. Please note, however, that they are still considered human subject research.
Thus, if a study is conducted outside of an academic institution, is not federally funded, and is not related to an FDA or EPA-regulated product, it need not undergo IRB review.
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.
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.
Waiver of All Consent In certain cases, federal regulations allow the IRB to waive the requirement to obtain any informed consent. Most complete waivers of consent involve studies in which there are minimal risks to subjects, but complete waivers are also possible in emergency care and other limited circumstances.
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.

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Waiving IRB Review of Class Projects in Research Methods and Similar Courses refers to a process that allows specific educational research activities that involve minimal risk to participants to bypass the formal review of an Institutional Review Board (IRB). This is often applicable to class assignments designed to teach students about research methods.
Instructors or faculty members overseeing courses that involve research projects typically file for a Waiving IRB Review. This is particularly necessary for projects that adhere to established guidelines regarding minimal risk and educational purposes.
To fill out the waiver, faculty should provide detailed information about the class project, including the objectives, study design, expected outcomes, participant information, potential risks, and how consent will be obtained. Templates or forms provided by the institution's IRB office should also be followed.
The purpose of waiving the IRB review is to streamline the process for educational projects that present minimal risk to participants, ensuring that instructors can focus on teaching research methods without the lengthy approval processes typically required for more extensive research studies.
Information that must be reported includes the project's title, description, research goals, methods used, participant demographics, informed consent process, and any potential risks or ethical considerations involved in the research.
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