“We help investigators and research teams evaluate the readability, understandability, and actionability of key information on their informed consent forms and communicate about their research in plain language so study participants can make informed decisions.”

Sabrina Kurtz-Rossi, MEd

Project Director, Informed Consent, Tufts CTSI

Overview

The complexity of research informed consent forms makes it hard for potential study participants to make informed decisions. In response, the Common Rule for human research protection requires informed consent forms to begin with a short key information section organized and presented to help subjects understand why they may or may not want to participate in research. The Tufts CTSI Informed Consent Project seeks to discover new approaches to reducing literacy, language, and cultural barriers to research participation and the informed consent process.

RUAKI Indicator

Plain language writing principles (e.g., avoiding jargon, writing in active voice) and design features (e.g., bullet points, bold headers) enhance understanding when used to create easy-to-read health information. The Readability, Understandability, and Actionability of Key Information (RUAKI) Indicator is an 18-item tool with evidence of validity and reliability that applies plain language principles to help investigators comply with the Common Rule and create easy-to-read key information that participants can read, understand, and use to make informed decisions.

Quick Links

Services

  • Guidance on applying the RUAKI Indicator
  • Evaluating the readability of research-related documents
  • Plain language writing and editing services
  • Clear communication skills training
  • Consultation with health literacy experts

Trainings

All trainings are offered virtually or in person and are tailored to meet the interests, experience, needs, and intended uses of participants.

  • Informed Consent: Communicating Key Information in Plain Language. In this training, participants learn about the new Common Rule for key information and how to apply plain language principles to improve the informed consent process.
  • Summary of Results: Easy-to-Read Findings for Patients and the Public. In this training, participants practice plain language writing and approaches to data visualization to communicate end-of-study results to participants and the public.
  • Health Literacy: A Strategic Response to Research Complexity. This training introduces health literacy interventions, including plain language and teach-back, to improve research recruitment, retention, transparency, and trust.

Who is eligible?

No-cost consultations are available to Tufts CTSI partner and collaborator organizations

Fee-for-service consultations are available to Tufts CTSI-affiliated organizations and non-affiliated individuals and groups

Contact

To contact us, please submit a service request. Please be sure to select General Consult and use the text box to describe your Regulatory question or request.

Andreas Klein, MD, Director, Regulatory Affairs

Sabrina Kurtz-Rossi, MEd, Project Director, Informed Consent