Do I Need IRB Review?
A short decision tool grounded in 45 CFR 46. Answer six questions to see whether your project needs no review, exempt, expedited, or full board.
IRB Resource Hub
Every free resource on this site, organized so you can find what you need at the stage you're in — from "do I even need IRB review?" to continuing review on an approved study.
Start here
Review Categories
Plain-language guides to exempt, expedited, and full board review — eligibility criteria, timelines, and what to submit.
Frequently Asked Questions
Twenty-nine of the questions IRB applicants actually ask, answered in one page.
Preparation guides
Deep-dive walkthroughs covering the skills every IRB applicant needs.
Protocol Writing
Section-by-section walkthrough of a complete IRB protocol with required elements and common mistakes.
Consent Forms
All required elements of 45 CFR 46.116, annotated examples, and guidance on reading level.
CITI Training
Which modules you need, how long it takes, and how to prepare efficiently.
Special Populations
Extra protections under Subparts B, C, and D for pregnant individuals, prisoners, children, and cognitively impaired adults.
Data Management
Security, anonymization, storage, and destruction — what the IRB will ask about.
Amendments & Modifications
When you need to amend an approved protocol and how to do it without delaying your work.
Single IRB & Reliance
NIH sIRB policy, SMART IRB reliance, and what stays with the local site in multi-site studies.
Decentralized & Digital Research
Remote consent, wearables, telehealth visits, at-home biospecimen collection.
Templates & checklists
Eight ready-to-adapt documents, licensed CC BY-NC 4.0. Free for non-commercial educational and research use with attribution.
IRB Protocol Template
Complete protocol with background, aims, design, participants, procedures, risks, data management, and analysis.
Informed Consent (Adult)
Plain-language consent form covering every required element of 45 CFR 46.116.
Assent Form (Minor)
Age-appropriate variants for participants ages 7–12 and 13–17.
Parental Permission
Parent or guardian permission form with one-parent vs. both-parents language.
Recruitment Script
Three variants — email, flyer, and verbal script.
Debriefing Form
For studies using deception — purpose disclosure, data withdrawal, and support resources.
Pre-Submission Checklist
Investigator qualifications, protocol, consent, recruitment, and data-security review before you submit.
Data Management Plan
Collection, storage, access, retention, sharing, destruction, and breach response.
All templates licensed CC BY-NC 4.0 by Angel Reyes / Subthesis. Browse the template index for downloadable Markdown versions.