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IRB Application - Lourdes College

IRB Application - Lourdes College 2025

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The document outlines the application process for conducting research involving human subjects at Lourdes University. It includes a checklist of required submissions, such as the application form, CITI training completion, consent documents, and data collection instruments. The submission must be made both electronically and in hard copy to the Institutional Review Board (IRB). Additionally, it details the responsibilities of principal investigators and faculty advisors, as well as guidelines for ensuring participant safety and ethical compliance.

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What are IRB requirements for approval?

The regulations do outline the criteria for IRB approval of research. 21 CFR 56.111(a)(1) requires the IRB to assure that risks to the subjects are minimized. 21 CFR 56.111(a)(2) requires the IRB to assure that the risks to subjects are reasonable in relation to the anticipated benefits.

What happens if you dont get IRB approval?

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.

What are the IRB requirements for approval?

Education research usually requires IRB review because it meets the criteria of research with intervention and human subjects. In some circumstances, education research may qualify for the exempt category. The federal guidelines do not specify who at an institution must determine that research is exempt.

What are 2 things that IRB requires?

IRB review and approval is required for projects that: Meet the definition of research. Involve human subjects and. Include any interaction or intervention with human subjects or involve access to identifiable private information.

What research projects require IRB approval?

Research projects involving human participants that are conducted by students for the purpose of independent research papers, culminating graduate research papers, masters theses, and dissertations are all considered research and must be reviewed by the IRB.

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What are the 3 key principles for IRB approval?

When reviewing research IRBs are guided by three ethical principles that are fundamental to human subject protection - respect for persons, beneficence, and justice.

How long does the IRB approval process take?

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.

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