№ lp_2_1_32582
Informational guidance document outlining regulatory criteria, ethical requirements, approval procedures, and exemption categories for minimal risk human subjects research under institutional and federal oversight.
Organization: Human Research Protection Program Office (HRPPO)
Institution: UT Southwestern
Regulatory Reference: 45 CFR 46.101(b)
Document Type: Tip Sheet
Subject: Exempt Review of Human Subjects Research
Related Bodies: Institutional Review Board (IRB); HRPP Office
Submission System: eIRB
Site Approval System: Velos
Contact Phone: 214-648-3060
Contact Email: [email protected]
Approval Validity Period: Up to 5 years unless extended
Scope: Minimal risk research involving human subjects
Restrictions: Not applicable to prisoner research; not FDA regulated research
Ethical Standards: Confidentiality, privacy, equitable subject selection, informed consent process when interaction occurs
Price: 8 / 10 USD
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