Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Developing Documents Using the Research Optimizer

The National Cancer Institute (NCI) is developing new AI tools to help study teams create protocols, consent forms, and other research documents.

These tools are available to anyone with an NIH login, and you must be using NIH wifi or VPN to access the site.

ConsentCrafter (Available Now)

ConsentCrafter is a tool that uses generative AI to create a draft informed consent document directly from your protocol.

  • It uses the NIH-approved consent template
  • It pulls information directly from your protocol
  • It can also generate a lay summary of your study
Click here to access ConsentCrafter

Important to Know

ConsentCrafter provides a starting draft only. You must carefully review and revise the document before submitting it to the IRB.

Pay particular attention to:

  • The “What will happen during the study” section
  • Descriptions of research-specific procedures or testing
  • Completeness and accuracy of the risk information
  • Any details that require study-specific clarification

The final consent must accurately reflect the study and be understandable to participants.

Translator (In Pilot Phase)

NCI is also developing a Translator tool to assist with consent form translations.

Currently, this tool is being piloted for Spanish translations of English consent documents.

How It Works

  1. Your document is translated using AI
  2. A professional translator reviews and edits the translation
  3. The translation is certified for use

You will receive a final, certified translation that is ready for IRB submission—meeting the same standards you are used to.

Click here to request a Spanish translation of your consent document

Key Takeaway

These tools can save time and improve consistency, but they do not relieve the investigator of responsibility.

You are responsible for:

  • Ensuring completeness and accuracy
  • Adding missing study information
  • Confirming the document is clear and appropriate for participants

Contact the Research Optimizer team with any questions or issues.