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Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments
IRB Standard Operating Procedures
AHRQ: Mandatory Use of Data Safety and Monitoring Plans
Payment to Research Participants
Clinical Trials with No/Low Enrollment: Guide for Departments
CBR Use Proposal Form
Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources
Data & Biospecimen Sharing Checklist
Statement of Practice: Remote Study Procedures
Secondary Use Research

Human Subject

Human Subject means:

  • OHRP: “A living individual about whom an investigation conducting research obtains (1) Data through intervention or interaction with the individual or (2) identifiable private information.” 45 CFR 46.102 (f)
  • FDA: “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.” 21 CFR 50.3 (g) and 21 CFR 56.102 (e)