research - consent - ethics
ICF Studio
An informed consent form should feel like a conversation, not a contract. ICF Studio drafts a complete, structured, plain-language consent form from your study protocol - built to conform to the international standards ethics committees review against.
the problem nobody wants to admit
Consent forms are slow and error-prone
Every study needs an ICF that explains purpose, procedures, risks, benefits, and the right to withdraw in language a participant can understand. Miss an element and the ethics committee sends it back - costing weeks of revision cycles.
built on the frameworks reviewers check
Structured to recognized standards
Every draft is generated against the consent requirements of the world's research ethics frameworks - so your form contains what reviewers look for before it reaches them.
ICH-GCP E6(R3)
Documented consent in understandable language, free of coercive or exculpatory wording, covering all essential elements.
Declaration of Helsinki
Adequate disclosure of purpose, methods, funding, conflicts of interest, risks, benefits - and withdrawal without reprisal.
Belmont Report
Respect for persons, beneficence, and justice reflected in how participants are invited and informed.
CIOMS Guidelines
Consent as an ongoing process, sponsor and funding disclosure, and responsible data and sample handling.
21 CFR Part 50 - 45 CFR Part 46
The ten basic required elements of informed consent, with no waiver-of-rights language anywhere in the document.
Nepal NHRC Ethical Guidelines
Nepal-context requirements: institutional review committee approval, participant compensation norms, local relevance.
how it works
Six guided steps to a complete ICF
- Study detailsYou describe your study type, consent type, language, institution, and participants.
- Your protocol, not boilerplateYou upload your protocol. The draft cites your actual procedures, timelines, measurements, and risks - not generic text.
- Additional requirementsAdd institutional templates, biospecimen clauses, compensation details, or anything your review committee expects.
- Clarifying questionsThe AI asks targeted questions before drafting, so gaps surface early instead of at committee review.
- Working draft outlineYou preview and adjust the structure section by section before anything is written in full.
- Final editable documentA complete plain-language ICF you can refine per section, then export as .docx with versioned headers and footers.
checked after every generation
An automated essential-elements check
After each full draft, the tool verifies that the required consent elements are present and flags any that are missing - the same elements ethics committees check:
- Statement that this is research, and its purpose
- Duration and procedures of participation
- Foreseeable risks and discomforts
- Expected benefits - or an honest "none"
- Alternatives to participation
- Confidentiality of records
- Injury compensation (where risk requires it)
- Contact points: researcher AND ethics committee
- Voluntary participation and penalty-free withdrawal
- Cover page with title, version, PI, and committee
- No exculpatory or coercive language
- Plain language at a 6th - 8th grade reading level
Anything flagged appears in the job's verification notes so you can fix it before submission.
what it is worth to you
Fewer revision cycles, faster approval
Days of drafting become minutes of reviewing. Complete structure means fewer send-backs from the ethics committee. Plain language means participants sign informed, not merely signed.
Questions researchers ask
Is an ICF generated by AI acceptable to ethics committees?
Committees review the document, not the pen that wrote it. ICF Studio produces the same structured sections committees expect - but the researcher remains fully responsible for accuracy, reviewing every statement against their protocol, and obtaining final approval from their IRB/ethics committee before use.
Does using ICF Studio replace ethical approval?
No - and nothing should. Consent forms must always be reviewed by your institutional review committee (or NHRC-registered committee in Nepal). ICF Studio is a drafting aid that helps you arrive at that review with a stronger first draft.
Does it guarantee compliance?
No tool can guarantee compliance - requirements vary by institution and study risk level. What ICF Studio guarantees is structure: every draft targets the essential elements of the major international frameworks, and an automated check flags missing elements for you to address.
What happens to my protocol documents?
Your uploads are used only to generate your own consent form. They are stored on Saacho's infrastructure, are never shared with third parties, and are visible only inside your workspace.
Can it write assent forms and guardian permissions?
Yes. Beyond the main participant ICF, ICF Studio supports child assent (7 - 17), parent/guardian permission, special-procedure consent, and pregnancy partner consent - each adapted to its audience.
Honest limitations: ICF Studio is a drafting aid, not a legal or ethics authority. It does not provide legal advice, does not guarantee regulatory compliance, and does not replace review by your institution's ethics committee. Always have your consent forms reviewed and approved before using them with human participants.