Informed Consent

Informed consent is critical to any research project. Consent is required for any human subjects research project. The consent must be delivered in an easy to read format that clearly outlines the purpose of the research, procedures, costs and remuneration, alternatives to participation, any risks, benefits, time, the potential for placebo placement, withdrawal process and consequences. 

In addition to creating the informed consent documentation, the researcher must manage the participant review and signature process as well as any revocation, or withdrawal of consent. Traditionally, this has been done using paper consent or cumbersome, disconnected software systems. 

The Precision Health Cloud’s FDA Title 21 CFR Part 11 compliant eConsent streamlines the informed consent process by enabling researchers to easily create and manage the consent process all from within the PHC. All consents are automatically associated with a patient in the central repository, so information about who has consented to which studies co-exists with additional clinical, survey, sequencing, imaging and any other data in the Precision Health Cloud.  

You can create the informed consent with a simple graphical editor. Additionally, you can choose whether you require a button, typed or mouse / finger signature.

Once created, for unsupervised consent, you can invite individuals to the project with the push of a button. They will receive an email where they can review and sign the consent. 

For supervised consent, where a researcher or medical professional reviews the consent in person with the participant, the supervisor can walk the participant through the consent process on a computer, tablet or phone.  

The Precision Health Cloud supports the following informed consent features: 

  • Unsupervised and supervised consent workflows
  • Easily manage the consent forms including versioning and updates
  • Invite participants directly via the Precision Health Cloud 
  • Dashboard to see consent status and time / date stamps and audit trail
  • Management of consent withdrawal
  • Consent templates that can be easily modified for your specific project
  • FDA Title 21 CFR Part 11 Compliant
  • Support for mobile, tablets and desktop web as well as fully integrate into LIFE Extend
Informed Consent in the Precision Health Cloud
Informed Consent

We know security is your top priority. Ours too. The Precision Health Cloud’s eConsent can be configured to meet United States (U.S.) Federal Regulation Title 21, Chapter 1, Part 11 – commonly referred to as 21 CFR Part 11. You can rest assured the document security and authenticity are adequately maintained as part of our electronic records process.

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