IRB Protocol Template (General)

Replace every [FILL IN: ...] placeholder with your study-specific content. Always check your institution's required format before submitting.

1. Study Title and Investigator Information

• Study Title: [FILL IN: descriptive working title]
• Principal Investigator: [FILL IN: name, credentials, department]
• Faculty Advisor (if student-led): [FILL IN]
• Co-Investigators / Study Staff: [FILL IN]
• Funding Source: [FILL IN]

2. Background and Significance

[FILL IN: 2–4 paragraphs summarizing scientific or practical rationale, citing prior literature.]

3. Specific Aims / Research Questions / Hypotheses

• Aim 1: [FILL IN]
• Aim 2: [FILL IN]
• Research Questions: [FILL IN]
• Hypotheses: [FILL IN]

4. Study Design and Methods

[FILL IN: qualitative / quantitative / mixed methods. Justify the design.]

5. Participants

• Target Population: [FILL IN]
• Sample Size and Justification: [FILL IN]
• Inclusion Criteria: [FILL IN]
• Exclusion Criteria: [FILL IN]
• Vulnerable Populations: [FILL IN]

6. Recruitment

[FILL IN: recruitment methods — flyers, email, social media, gatekeepers. Attach scripts.]

7. Procedures

[FILL IN: step-by-step participant experience from first contact through study completion.]

8. Risks and Protections

• Physical risks: [FILL IN]
• Psychological risks: [FILL IN]
• Social/economic risks: [FILL IN]
• Legal risks: [FILL IN]
• Protections: [FILL IN]

9. Benefits

• Direct benefits: [FILL IN]
• Societal benefits: [FILL IN]

10. Informed Consent Process

[FILL IN: who obtains consent, where, how documented, comprehension verification.]

11. Data Management

• Data types: [FILL IN]
• Storage: [FILL IN]
• Access: [FILL IN]
• Retention: [FILL IN]
• Destruction: [FILL IN]
• Sharing: [FILL IN]

12. Analysis Plan

[FILL IN: statistical tests, qualitative coding, software, missing data handling.]

13. References

[FILL IN: citation list.]