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Request for Approval: Investigation Involving Human Subjects

Request for Approval: Investigation Involving Human Subjects 2025

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The document is a request form (FORM OSPA-HS-1A) from the State University of New York at Buffalo for approval of research involving human subjects. It outlines the necessary information required from the project director, including details about the study's source of support, type, and protocol description. The form also addresses ethical considerations, expedited review criteria, subject categories, financial disclosures, and educational requirements for key personnel involved in the research. It emphasizes compliance with regulations protecting human subjects and requires signatures from both the principal investigator and an authorized reviewer.

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What projects need IRB approval?

All projects defined by the IRB as research involving human participants must be reviewed and approved by the IRB before any research activities involving potential participants are initiated.

Is it difficult to get IRB approval?

If your study is more than minimal risk, it will be harder for you to get IRB approval. You will need to justify why you are running the study. Less common types of risk for psychology studies are social, physical, and financial.

How long does it take to get an IRB approval?

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.

Who has authority to make decisions of approval for human subjects in research?

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In ance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

What is IRB approval for human subjects?

The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.