# 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: name, credentials, department]
- **Co-Investigators / Study Staff:** [FILL IN: names and roles]
- **Funding Source:** [FILL IN: grant, department, self-funded, etc.]

## 2. Background and Significance
[FILL IN: 2–4 paragraphs summarizing the scientific or practical rationale, citing prior literature. Explain what is known, what is unknown, and why the study matters.]

## 3. Specific Aims / Research Questions / Hypotheses
- **Aim 1:** [FILL IN]
- **Aim 2:** [FILL IN]
- **Research Questions:** [FILL IN]
- **Hypotheses (if applicable):** [FILL IN]

## 4. Study Design and Methods
[FILL IN: qualitative / quantitative / mixed-methods design; cross-sectional, longitudinal, interventional, observational. Justify the design.]

## 5. Participants
- **Target Population:** [FILL IN]
- **Sample Size and Justification:** [FILL IN: power analysis, saturation rationale, feasibility]
- **Inclusion Criteria:** [FILL IN]
- **Exclusion Criteria:** [FILL IN]
- **Vulnerable Populations:** [FILL IN: minors, pregnant individuals, prisoners, cognitively impaired — or state "none"]

## 6. Recruitment
[FILL IN: recruitment methods — flyers, email, social media, snowball, gatekeeper organizations. Attach recruitment scripts as appendices.]

## 7. Procedures
[FILL IN: step-by-step participant experience from first contact through study completion. Include duration, location, frequency, and all instruments used.]

## 8. Risks and Protections
- **Physical risks:** [FILL IN or "None anticipated"]
- **Psychological risks:** [FILL IN]
- **Social/economic risks (confidentiality breach, employment):** [FILL IN]
- **Legal risks:** [FILL IN]
- **Protections:** [FILL IN: de-identification, secure storage, Certificate of Confidentiality, debriefing, referrals to support]

## 9. Benefits
- **Direct benefits to participants:** [FILL IN or "None"]
- **Societal benefits:** [FILL IN]

## 10. Informed Consent Process
[FILL IN: who obtains consent, where, how documented, how comprehension is verified. Attach consent form.]

## 11. Data Management
- **Data types collected:** [FILL IN]
- **Storage:** [FILL IN: encrypted cloud, institutional server, locked cabinet]
- **Access:** [FILL IN: list of authorized personnel]
- **Retention:** [FILL IN: typical 3–7 years post-study]
- **Destruction:** [FILL IN]
- **Sharing:** [FILL IN: data repository, journal supplement, none]

## 12. Analysis Plan
[FILL IN: statistical tests, qualitative coding approach, software, missing data handling.]

## 13. References
[FILL IN: citation list supporting background and methods sections.]

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(C) 2026 Angel Reyes / Subthesis — Licensed CC BY-NC 4.0. Not affiliated with OHRP or any IRB.