Basic Elements for Informed Consent

For Minimal Risk Activities:

Required for recruitment of subjects in verbal scripts/cover letters, and in consent letters (activities not exceeding minimal risk)

• Who you are
• What you are doing
• Why you are doing it
• Benefits/Risks for participation
• What subjects will be asked to do and how long it will take
• Participation is voluntary
• No penalty for nonparticipation/withdrawal from study
• How confidentiality/anonymity will be handled
• Who to call if any questions regarding research design

Exceeds Minimum Risk

Additional elements are required, as appropriate, if activities exceed minimal risk.