Data Security Assessment Form - Institutional Review Board 2025

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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.
There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt. The review path is determined by: Level of risk to subjects associated with the project. The type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
Institutional review boards (IRBs) or research ethics committees provide a core protection for human research participants through advance and periodic independent review of the ethical acceptability of proposals for human research.
Federal regulations for human subjects research require Institutional Review Boards (IRBs) to determine that adequate provisions to protect the privacy of subjects and the confidentiality of data are in place and that researchers include adequate provisions for monitoring the data collected to ensure the safety of
Institutional Review Board (IRB) The primary purpose of the IRB is to protect the rights and welfare of human subjects involved in research activities being conducted under its authority.
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This includes protection of data subjects and intellectual property rights, continued access to data for research purposes, and compliance with applicable laws, regulations and University policies.
The IRB is tasked with ensuring the protection of data and information related to human research protocols. Part of the IRB review and approval is to ensure that identifiable private information or identifiable biospecimens have the appropriate data security standards.

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