Instructions & Guidance

Emory Informed Consent Form and Process Guidance

• Use of Electronic Informed Consent (PDF) Revised on 10-3-2020
• Using Family Members and Study Staff as Interpreters during Research Procedures, Including Consent Process, in Research conducted at Emory (DOCX)
• Enrolling subjects with diminished capacity for consent (PDF)
• Informed Consent Basic Elements (DOCX)
• Emory IRB Training on Lay-friendly ICFs (PPT)

Federal & Other Consent Guidance

• FDA: A Guide to Informed Consent
• FDA: A Guide to use of Short Form (Non-English Speaking Subjects)
• OHRP Tips on Informed Consent
• Office For Civil Rights: Nondiscrimination in Health Programs and Activities
• NCI/Clinical Trials Cooperative Group Guide to Lay Terms for Informed Consent (Excel File)
• PHS Grant Application Instructions for the Human Subjects Section (PDF)
• Genomic Data Sharing Provisions - NIH Policy Information
  • See also the Modular Language for Informed Consent tab in the Consent Toolkit