Webinar Summary: Hu-manity Standardized Intentional Consent Framework

By Aimee Lee Russell, Programs Associate

On a March 5 webinar, Richie Etwaru, Chief Executive Officer of Hu-manity.co, and Angela Radcliffe, R&D, Practice Lead, Capegemini Invent, introduced the participants to the difference between traditional informed consent and new thinking about intentional consent. This new approach to informed consent enables patients to have choice and control, with transparency regarding the data they contribute to clinical studies.

In traditional informed consent, individuals usually know they are signing an important document, but they do not necessarily understand what the document says or its implications on their privacy. They may not have sufficient time to review lengthy documents. The language may not be understandable to them. The decision to sign the document is typically binary; one can choose to agree to the terms or choose not to. By not agreeing the person would then will be unable to access the service, participate in a study, or be part of other activities.

In contrast, intentional consent allows patients autonomy over what data can be used, who can use it, and what they can expect in return for their participation during a research study and after it has ended. Intentional consent is characterized by:

• Clarity – I can easily understand what is being exchanged.
• Courtesy – My legal language literacy level is respected.
• Control – I can say when and how my data is shared.
• Continuous – I can change my consent over time.

During the webinar, Etwaru and Radcliffe defined many of the terms and policies that should be included in a document with intentional consent and emphasized the importance of the patient’s understanding of these terms. When defining the parameters of a contract, intentional consent involves an ongoing conversation among stakeholders and patients. Intentional consent is an important goal to be achieved for patients and research.

To learn more, watch the full webinar here.