Draft 118 determination notice (3)

The document is a draft notification of "Preliminary Approval" from an Institutional Review Board (IRB) concerning an NSF-funded project that currently lacks immediate plans for the involvement of human subjects, their data, or specimens. The IRB has conducted an expedited review of the proposed scope of activities, in accordance with federal regulation 45 CFR 46.118, and has granted preliminary approval for the project as described. This preliminary approval does not authorize the initiation of any research activities involving human subjects, including recruitment procedures. The approval is valid for a specified period, after which the principal investigator must submit either an amendment or a new application for full IRB review and approval if human subjects research is to begin. This process ensures regulatory compliance while the research protocol is finalized, safeguarding ethical standards prior to human subject involvement.