Informed Consent Automation with AI Agents

Help clinical teams prepare clear, participant-centered consent documents aligned to study information—with source-aware drafting, review support, and.

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Informed consent document workspace with protocol alignment, plain-language review, and human approval checks

AI AGENTS TRUSTED BY LIFE SCIENCES ORGANIZATIONS

INFORMED CONSENT · COORDINATED AI AGENTS

Align. Clarify.
Review with care.

Purpose-built agents help teams transform approved study information into clear participant materials, check consistency, and support review—while investigators and ethics committees retain their essential roles.

Start from approved sources

Use protocol details, investigator materials, and sponsor-approved language as the foundation for participant documents.

Structure around participants

Organize key information into a readable sequence that addresses study purpose, procedures, risks, benefits, alternatives, and participant rights.

Improve clarity

Flag dense phrasing, unexplained terms, and long sentences for writer review while preserving the scientific meaning.

Check study consistency

Compare consent content with approved study materials to surface discrepancies, missing details, and points for follow-up.

Manage local versions

Prepare controlled document variants using approved translation and localization workflows, with qualified review before site use.

Keep approval with people

Support review and version control while investigators and ethics committees retain responsibility for approval before participants receive materials.

MEDICAL AUTHORING COMPANION · PARTICIPANT MATERIALS

Make study information easier for participants to understand.

Informed consent materials explain a clinical study to prospective participants so they can consider what taking part involves and make a voluntary decision. Documents commonly describe the study purpose, procedures, potential risks and benefits, alternatives, confidentiality, costs, contacts, and the right to withdraw.

Medical Authoring Companion helps teams organize approved study information into structured drafts, compare consent content with source materials, and review wording for clarity and consistency. Investigators, medical writers, and ethics committees remain central to evaluating the document and approving its use.

Participant-centered consent workflow from approved protocol sources through clear drafting and human ethics review

INFORMED CONSENT · FAQ

Clearer consent, with people in control.

Learn how AI-assisted workflows support participant information and informed consent document teams.

What is an informed consent document?

Informed consent materials explain a study to prospective participants, including what participation involves, potential risks and benefits, available alternatives, and participant rights. The consent process supports a voluntary, informed decision and includes an opportunity to ask questions.

How can AI agents support consent authoring?

Agents can help organize approved source information, prepare structured drafts, flag complex wording, compare content with study documents, and assist with document versioning. Qualified people review the results, make decisions, and approve materials for use.

How does the workflow help keep consent consistent with the protocol?

Source-aware checks can compare key study details—such as visits, procedures, risks, and study duration—across the consent draft and approved source documents, surfacing potential discrepancies for review.

Can AI make consent language easier to read?

AI assistance can flag long sentences, technical terms, and dense passages and suggest clearer alternatives. Medical writers and study experts must confirm that revisions remain accurate and appropriate for the intended participants and context.

Does an AI-generated consent form replace ethics committee review?

No. AI supports document preparation and review; it does not replace investigator oversight or institutional review board / independent ethics committee review and approval required for the applicable study and jurisdiction.

Can teams manage translations and consent updates?

Teams can use controlled workflows to prepare localized versions and incorporate study changes into revised documents. Translations require qualified review, and updated consent materials follow the applicable investigator and ethics review process before use.