OVERVIEW
This QuickGuide provides guidance for the use of EULA language in consent forms.
STEPS
WHAT IS A EULA?
EULA, which stands for End User Licensing Agreement, is a legal contract entered into between a software developer or vendor and the user of the software. It specifies in detail the rights and restrictions which apply to the use of the software. EULAs are also referred to as Terms of Service or Privacy Notices.
WHAT IS THE EULA STANDARD CONSENT FORM LANGUAGE?
The EULA standard consent form language is:
As part of this study, we will collect information from a software application downloaded from the Internet and/or from a [insert type of device here, e.g. fitness tracker, smart watch].
[insert information about the specific device to be used (e.g. brand name), whether the study team will provide the device, and whether participants will be asked to return the device at the end of the study.]
The maker of the application and/or device may collect and store personal information, such as health information, location data, and internet usage. A complete description of what data will be collected and what the company will do with it can be found in the Terms of Service. You will need to agree to the Terms of Service to participate in this study.
The researchers in this study may not have any control over what the company does with your information. The application and/or device may collect and transmit more information to the company than is needed for this study.
WHERE IN THE CONSENT FORM SHOULD THE EULA LANGUAGE BE INSERTED?
The EULA language should be inserted at the end of the “Who will see my information?” section.
WHEN SHOULD EULA LANGUAGE BE ADDED TO A CONSENT FORM?
EULA language should be added to the consent form when study participation involves the use of software applications downloaded from the internet or mobile health (mHealth) devices that require the participant to sign a EULA, Terms of Service agreement, or Privacy Notice.
HOW WILL THE EULA LANGUAGE BE IMPLEMENTED?
For new studies, the EULA language should be incorporated into the consent form prior to CIRB Initial Review.
For active studies, an amendment should be submitted to the CIRB to add the EULA language to the consent form as soon as possible. In general, currently enrolled participants will not need to be reconsented; however, they should be provided with an information sheet describing the consent form revision.
WHAT WILL HAPPEN IF THE EULA LANGUAGE IS NOT ADDED TO THE CONSENT FORM?
If the EULA language is not incorporated in the consent form by the time of CIRB review, the CIRB will stipulate the language be added.