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Shortened Consent Validation Study


Title Development of a New Tool to Evaluate Readability, Understandability and Actionability of Key Information in Informed Consent Forms
Therapeutic Area Healthy Volunteers
Principal Investigator Andreas Klein, MD and Sabrina Kurtz-Rossi, MEd
Min Age 18 Years
Gender All
Contact Phil Oettgen
617-447-3260
coettgen@tuftsmedicalcenter.org

Overview

The purpose of the study is to evaluate a tool developed to evaluate whether information in an informed consent form is presented in plain language so that potential study participants can make informed decisions about whether to participate a clinical research study or not. Ultimately study teams will be able to use the tool to help guide them in creating easy to read and understandable research informed consent forms.  

Study Details

Inclusion Criteria

  • 18 years of age or older
  • Experience with informed consent in a research setting (writing, obtaining consent, etc.)
  • Proficient in English
  • Access to a computer with internet

Exclusion Criteria

  • Younger than 18
  • No access to computer with internet
  • Non-English speaker

Study Requirements

This study will require about three hours of your time and can be done remotely.

Upon completion of the study, you will receive a $25 gift card.

Participants will be asked to evaluate the readability, understandability and actionability of three informed consent forms using a newly developed tool (checklist).