IRB Protocol Template and Consent Outline
Create a sourced protocol or consent outline with institutional and jurisdiction fields. One free input set; review every unfinished section.
What this is not: a clearance, approval, consent, signed record or submission. Responsible professional review is required. Jurisdiction: US Common Rule where applicable; ICH guidance depends on local adoption.
Structured information
Only de-identified, non-confidential information. No names, birth dates, contact details or patient record numbers. Examples are synthetic.
Provider: local deterministic template engine; no AI call or document upload. Inputs and drafts remain in this tab’s memory; reload clears them. Only the allowance and input hash are stored in your browser. Copy or download before leaving. Not a controlled clinical record system.
Build the supporting evidence
Copy or download your draft first. Signup opens the AnswerThis app and does not transfer this result.
How to use this workspace
- Choose the document and confirm its jurisdiction and institutional owner.
- Enter structured information or load the synthetic example, then confirm the de-identification attestation.
- Generate the outline and complete the unfinished prompts in the editor.
- Review the result with its responsible owner and export it into the controlled project workflow.
What to check
- Source edition and local applicability are distinct from the date of your document.
- Use only supported facts; a blank does not establish a negative finding.
- Keep identifiers, population, document versions and evidence consistent.
- Review drafts in the responsible institution’s controlled system before use.
Choose a protocol or a consent working document
The protocol option creates an organised plan for institutional discussion. The consent option creates a separate participant-information working outline. Both use the same entered study metadata, but they have different audiences and purposes. The protocol helps the research team specify what it intends to do. The consent outline helps identify information that prospective participants may need to understand before deciding whether to take part. Neither option records ethics approval or obtains consent.
Enter the jurisdiction and sponsor or institution before generating. These fields identify who must resolve local requirements; they do not automatically adapt the outline to national law or a particular institution. The protocol prompts link to ICH E6(R3) Appendix B and related ethics guidance. The consent prompts identify Common Rule elements under 45 CFR 46.116 and the ICH consent-process anchor where relevant. Confirm which framework applies to the actual study rather than treating every source as universally binding.
Keep document version dates separate from participant dates. The identifier field is for a study or public product reference, never a patient record number. Use an aggregate population description. Do not put investigator or participant contact information into this public form. Where a completed institutional document needs contact details, the outline leaves that work for the authorised local system.
Complete the substantive decisions
A useful protocol needs a coherent relationship between rationale, objectives, design, eligibility, procedures, endpoints, safety oversight and analysis. The generated sections make those decisions visible but leave their content unfinished. Start with the research question and trace each procedure to its purpose. If a procedure adds burden without addressing an objective or a safety need, raise that issue with the research team. A polished document does not resolve a weak or inconsistent study design.
The consent outline separates key information, the basic Common Rule elements and additional elements that may be appropriate. Review the prompts concerning future use of information or biospecimens, commercial profit, return of results and sequencing when relevant. Do not delete a conditional topic merely because the example leaves it blank. Your institution must decide applicability and approved wording for the study. A short public outline is not the full text of the regulation.
Use language appropriate to the intended participants and the actual consent discussion. Readability alone does not establish understanding or voluntary participation. Translation, accessibility, legally authorised representatives, assent, vulnerable populations and any proposed waiver or alteration require local review. A generated consent outline cannot decide that these protections are unnecessary. Keep approved institutional statements and supporting review records in their controlled environment.
Reconcile the documents before handoff
Switching from protocol to consent for the same input set is free. The second outline carries the same metadata, which helps expose inconsistent identifiers and dates, but the page does not compare the substantive content of two completed documents. Check that participation duration, procedures, risks, withdrawal arrangements and data use agree across the final protocol and participant materials. Track any institutional changes in both places.
Every unfinished prompt displays [To be completed]. Replace each with supported content or a reviewer-approved explanation of why it does not apply. Do not replace a blank with an invented approval number, sample-size calculation or statement that consent has already been obtained. Editing and downloading the existing output do not consume another run. Use the Markdown or Word-compatible text export to move the outline into your institution’s authoring process.
The public template runs locally in the browser and does not call an AI provider. It provides no signature collection, version-controlled ethics submission, audit record or evidence of participant agreement. The draft header remains in every export. Signup opens AnswerThis separately and does not transfer the document. Before any real use, have the responsible research and ethics teams check the current rules, institutional template, supporting documents and completed text together.
Sources, versions and jurisdiction
Jurisdiction: US Common Rule where applicable; ICH guidance depends on local adoption. Source review as of 2026-09-14. Source retrieval: 2026-09-13T22:50:11Z (editorial review, not a live document lookup). No agency endorsement. Original concise outlines with links; source documents remain the work of their respective owners. ICH materials © ICH; prompts are adapted summaries, not official templates.
- ICH E6(R3), principles and Annex 1 — 2025; corrected 2025-10-24
- HHS Common Rule, 45 CFR 46.116 — 2018 Common Rule; check current applicability
Frequently asked questions
How do protocol and consent outlines differ?
The protocol describes study conduct for investigators and reviewers. Consent explains participation for a prospective participant. For example, a visit schedule becomes operational procedures in the protocol and a plain-language time commitment in consent.
Can this replace my institution’s IRB forms?
No. Map the working outline into your institution’s current forms and review process, including required local language, approvals and document controls.
Do the Common Rule prompts apply outside the US?
They identify US consent elements, while ICH E6(R3) provides a separate trial framework. Entering another jurisdiction does not adapt either source to local law; the institutional owner decides applicability.
How do I keep protocol and consent versions aligned?
Check identifiers, visits, procedures, risks and version dates together. Each document keeps its own edits. Export and reconcile both in the controlled study system.
Can I enter patient records or confidential information?
No. Use only de-identified, non-confidential information. Do not enter names, birth dates, contact details, record numbers, signed forms or source records. The tools do not de-identify records for you.
How many free runs are included?
This page includes one successful free input set per browser. Failed requests and re-exporting a result are free. Subtemplates share the allowance; the same inputs can be used across them freely.
Does signup transfer my work or unlock more page runs?
Signup opens the AnswerThis app. It does not unlock more runs here or transfer your draft. Copy or download the result first.