A team of NIH-funded researchers led by James DuBois at Washington University in St. Louis has developed ConsentTools, a toolkit created to help clinical research professionals understand and adopt three evidence informed practices for informed consent. The toolkit can be accessed at ConsentTools.org. Read below for more details about the toolkit and how it works.
Optimizing Key Information
The toolkit provides guidance on how to easily incorporate plain language and how to use evidence-based formatting to optimize key information.
Tools for Optimizing Key Information include:
- Brief videos with examples of how to implement plain language and evidence-based formatting.
- An example of key information that utilizes plain language and evidence-based formatting.
- Sample language for your Institutional Review Board (IRB) application.
Assessments
Many people are at risk of impaired decision-making capacity, and researchers often overestimate how well participants understand and appreciate consent information.
The toolkit provides guidance on how to administer a short validated assessment of consent understanding, including when and how to assess, and what to do with assessment results.
Tools for Assessments include:
- A sample validated assessment instrument, with instructions and scoring.
- Brief videos demonstrating how to administer and score the assessment.
- Sample language for your IRB application.
Legally Authorized Representatives (LARs)
The toolkit provides guidance on how to navigate this complex issue.
This includes guidance on whether your participants need an LAR, and how to help participants appoint an LAR.
Tools for Legally Authorized Representatives include:
- A tool to help educate participants and help with having the sensitive LAR discussion.
- A note to file template document to document participant’s wishes.
- Sample language for your IRB application.
To learn how to implement these practices into electronic consent, click here.
CTSA members are free to use or share Consent Tools materials for non-commercial purposes, with appropriate credit to ConsentTools and the Bioethics Research Center. Read more about Creative Commons here.
