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protocol_minimal_risk_template_100224_ki.doc (165 KB)
Minimal Risk Research Protocol Template intended for studies that do not involve drugs, biologics, vaccines, or medical devices. The document includes:
- Instructions for investigators on how to structure a protocol for IRB submission.
- Definitions (e.g., what qualifies as “minimal risk”).
- A detailed outline with sections such as:
- Background and Scientific Rationale
- Objectives
- Anticipated Risks and Benefits
- Eligibility Criteria
- Study Design and Methods
- Data Analysis and Statistical Considerations
- Data Confidentiality and Storage
- Safety Monitoring Plan
- Regulatory Requirements (including informed consent, HIPAA, adverse event reporting)
- Appendices for consent forms, recruitment materials, etc.
It also provides guidance for specific study types (e.g., specimen collection, behavioral interventions, surveys, focus groups) and includes consent considerations for each.