Human Subjects Risk Assessment Document
Project Information
Project Title
Principal Investigator
Date
1. Project Description
Briefly describe the purpose and design of the research
2. Human Subjects Involvement
Describe the human subjects to be involved
Describe recruitment and selection methods
3. Potential Risks to Subjects
Describe any potential risks (physical, psychological, social, legal, or privacy)
4. Risk Minimization
Describe procedures to minimize risks
5. Benefits
Describe any expected benefits to subjects or others
6. Confidentiality
Describe how subjects' data and identity will be protected
7. Informed Consent
Describe the process for obtaining informed consent
8. Additional Comments
Any other relevant information