Submit With
Confidence.
You Protect Human Subjects.
Let AI Protect Your Time.
Every regulation checked. Every gap found. In minutes.
Your first-pass reviewer. So your team focuses on what actually requires their expertise.
Upload your IRB submission — protocol, consent form, or any of 9 submission types. In minutes, get every finding mapped to the exact federal regulation and document section — so you fix everything before your IRB sees it.
Submissions arrive incomplete, inconsistent, and missing required elements — and your reviewers spend hours catching problems that never should have made it to their desk. Sunethics.ai scans every submission against federal regulations and your institution's custom rules in minutes, so your team knows exactly what needs attention before they start their review.
Two minutes that will change how you think about IRB compliance
Watch how Sunethics.ai catches compliance gaps before they become delays — for researchers, coordinators, and sponsors.
Watch Sunethics.ai work through a submission
See how Sunethics.ai triages a real submission — flagging missing elements, inconsistencies, and regulatory gaps — so your team starts every review with a clear picture of what needs attention.
From document to regulatory report in minutes
Triage every submission before your team touches it
Upload your research document, let Sunethics.ai analyze it against federal regulations and institutional rules, and get a detailed regulatory report — whether you're preparing a submission or reviewing one.
When a submission lands on your desk, run it through Sunethics.ai first. In minutes, you'll know exactly what's missing, what's inconsistent, and what's ready for substantive review — before your team spends a single hour on it.
Choose your submission type
Select from 9 submission types — initial protocol, consent form, amendment, continuing review, and more. Each triggers its own regulatory rule set.
Sunethics.ai reviews against federal regulations and your custom rules
Dual-layer review: 45 CFR 46, 21 CFR 50/56, ICH E6(R2), and HIPAA as the federal baseline — plus your institution's custom rules layered on top.
Get a finding-level report with exact citations
Every PASS, WARN, and FAIL maps to the specific CFR section and the exact page and section in your document — so you know precisely what to fix and where.
Upload the submission you received
Drop in the protocol, consent form, HIPAA authorization — whatever the researcher submitted. Select the submission type and let Sunethics.ai go to work.
Sunethics.ai flags what's missing, inconsistent, or non-compliant
Sunethics.ai checks every document against 45 CFR 46, 21 CFR 50/56, ICH E6(R2), HIPAA — and your institution's own custom rules. You get a complete regulatory triage in minutes, not hours.
Your reviewers start with a clear picture
Send it back for revisions with specific citations — or move clean submissions straight to substantive review. Either way, your team spends their time where it matters.
Stop reviewing the old way
Every revision cycle costs weeks. Every missed finding costs more.
Your reviewers are too valuable for this
Most of the time your team spends on submissions goes to problems that Sunethics.ai catches in minutes.
Manual review
- 3-4 weeks per submission cycle
- 2-3 rounds of revisions before approval
- Inconsistent feedback across different reviewers
- Stipulations discovered at committee — back to square one
- No traceability — "which regulation did we check?"
- Comprehensive review in minutes — not weeks
- Every finding cites the exact regulation and document section
- Consistent checks every time — no reviewer variability
- Catch every issue before it reaches the committee
- Audit-ready reports with full regulatory traceability
Without Sunethics.ai
- Your reviewers spend hours just identifying what's missing
- Consent forms that don't match the protocol they came with
- The same basic errors — over and over, from different researchers
- Growing volume, same staff — something eventually gets missed
- No time left for the complex ethical reviews that actually need your judgment
- Sunethics.ai triages every submission in minutes — your team starts informed
- Send incomplete submissions back immediately with specific citations
- Every regulation checked the same way, every time — no reviewer variability
- Handle growing submission volumes with confidence
- Your experts spend their time on the reviews that actually need human judgment
Built for everyone in the research compliance process
Built for your office. Useful for everyone.
Whether you're preparing a submission or reviewing one, Sunethics.ai helps you get it right the first time.
Sunethics.ai is your team's first-pass reviewer — and when researchers use it too, every submission that reaches your office is already better.
Researchers & Students
Submit right the first time
Pre-check your protocols and consent forms against federal regulations before you submit to the IRB. Catch issues early, reduce revision cycles, and get to approval faster.
- Sunethics.ai reviews your document against the same regulations your IRB uses
- Every finding cites the exact regulation and document section
- Reduce back-and-forth and speed up the path to approval
IRB Offices & Review Teams
Handle twice the volume with less effort
Handle growing submission volumes with confidence. Sunethics.ai pre-screens every document against federal regulations and your institution's custom rules — surfacing potential issues so your team can focus expertise where it matters most.
- Every regulation checked consistently, every time
- Add your institution's custom rules on top of federal baselines
- Audit-ready reports with full traceability
CROs, Sponsors & Contract Research Teams
Faster approvals. Happier sponsors.
Pre-screen every IRB submission package before it goes to the board. Run multi-site consistency checks across different consent forms and protocols. Every day your package sits in revision is a day your sponsor isn't enrolling patients.
- Pre-screen submissions against the same rules the IRB uses
- Multi-site consistency checks across all your study locations
- Reduce rejection rates and compress approval timelines
One platform. Every submission type. Every regulation.
Each submission type triggers its own regulatory rule set — different CFR sections, different required elements, different cross-document checks. This isn't a one-size-fits-all review. It's 9 specialized regulatory engines on one platform.
Initial Protocol
New research protocol for full board or expedited review
Full BoardProtocol Amendment
Modifications to a previously approved protocol
ExpeditedInformed Consent
New or revised informed consent documents
RequiredContinuing Review
Annual renewal for ongoing research studies
RequiredAdverse Event Report
Report unanticipated problems or serious adverse events
UrgentProtocol Deviation
Report deviations or violations from the approved protocol
ExpeditedRecruitment Materials
Ads, flyers, scripts, and participant recruitment materials
ExpeditedHIPAA Authorization
Authorization forms or waiver requests for protected health info
RequiredStudy Closure
Final report and closure documentation for completed studies
ExpeditedA regulatory AI, built for clinical research
Comprehensive regulatory analysis in minutes — plus the tools to manage your entire compliance workflow.
Submission-type-aware AI reviews
The core of Sunethics.ai. Upload any research document and get a detailed compliance report in minutes — every finding mapped to the exact regulation, section, and page.
Your rules on top of federal regulations
Add your institution's specific requirements on top of federal regulations. Organization rules, site-level overrides.
Watch findings appear in real time
Watch your review run live — see every PASS, WARN, and FAIL finding as it's discovered. Full transparency, no black boxes.
Submission WorkflowPlus
Need workflow too? Route documents through reviewers with built-in approval tracking, comments, and full history.
Audit-Ready Reports
Every review is logged with rule version snapshots. Show auditors exactly what was checked and when.
Multi-Site ManagementPlus
Running multiple sites? Manage AI reviews, rules, and teams across all your research locations from one dashboard.
Not another AI wrapper. A regulatory intelligence engine.
We didn't bolt AI onto a document checker. We built an AI that understands federal research regulations at the rule level — purpose-built to think like a compliance reviewer, not a chatbot.
Choose the right path for you
Whether you're an individual researcher or a large organization, we have a plan that fits.
For students, PIs, postdocs, and independent researchers. Sign up instantly — no setup call needed.
For individual reviewers, coordinators, and compliance officers. Sign up instantly — no setup call needed.
All plans include monthly quota reset. Upgrade anytime to get more reviews instantly.
IRB offices, research sites, health systems, CROs, and sponsors — we'll configure everything for you.
For IRB offices, ethics committees, and institutional review teams — we'll configure everything for your workflow.
Built for your organization
- Dedicated onboarding with a Compliance Advisor
- Custom user quotas and site configuration
- Volume pricing for your team
- AI Reviews + Workflow, configured to your needs
- Cross-site management and custom rule authoring
- Priority support with a dedicated account manager
Talk to a Compliance Advisor
Prefer email? Reach us at [email protected]
Thank you!
A Compliance Advisor will reach out within one business day.
We built an AI that understands regulatory compliance — so you don't have to start from scratch every time
Every day, dedicated professionals work to ensure clinical research meets the highest ethical and regulatory standards. But growing submission volumes, evolving regulations, and limited resources make it harder than ever to be thorough.
That's why we built Sunethics.ai from the ground up — not as a generic AI tool with a compliance skin, but as a purpose-built regulatory intelligence engine trained on the specific rules, frameworks, and cross-document logic that govern human subjects research. Every finding cites the exact regulation. Every review reflects the depth your work demands. Better tools. Smarter reviews. More time for what truly matters: advancing healthcare for the communities that need it.
