Sage Bionetworks developed and maintains the Participant-Centered Consent (PCC) toolkit.
The goal of the PCC toolkit is to transform the concept of consent from a signature on a legal form to a process that educates, and to allow as many people as possible to engage in consented studies. The PCC toolkit is openly licensed and may be used in any context, by any user, for any purpose, as long as attribution is provided back to Sage Bionetworks.
The PCC toolkit contains a variety of resources for developing a consent process:
• PCC visual dictionary of icons and concept animations
• eConsent workflows
• Design documents and templates
The visual dictionary
Visual summaries can assist informedness. Traditional consent forms are complex legal documents, written in formal language, and which may obscure key study concepts. Using a mixture of icons and text labels may help convey the essential concepts of a study in a more intuitive manner to prospective participants, and may move the consent process closer to the goal of informed choices.
Download the Icons and Animations
Initial Study Activity Icons – Sage (*)
Initial Study Animations (*)
As Launched Animations and Icons (**)
(* attribution to Shannon Carter / Sage Bionetworks)
(** attribution to Apple)
Each link downloads a *.zip folder. Once you unzip each folder you will have a large directory of icons in each that you can use to begin representing clinical concepts.
Sage Bionetworks has developed a novel multi-media approach to addressing transparency and comprehension within electronic informed consent (eConsent) for app-mediated research studies. The eConsent has specific format and content features designed to maximize informedness, comprehension, and voluntariness. To learn about these features, visit the eConsent page or download our white paper.
Design documents and templates
The process of informing participants in a study is not a single form, webpage, or moment in time. We have developed example design documents and templates for reuse.
• Supporting Design Materials (study landing pages, enrollment workflow, wellness scales, and general study information graphics)
• Clinical Study Design Packages (the same materials, organized by study so you can see an entire packet)
For frequently asked questions about the PCC, please visit our FAQ. All Design Documents and Templates are copyright to Sage Bionetworks, and licensed to the public under the Creative Commons Attribution 4.0 license.
Disclaimer: The PCC toolkit is provided by the copyright holders and contributors “as is” and any express or implied warranties, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose are disclaimed. In no event shall the copyright holder or contributors be liable for any direct, indirect, incidental, special, exemplary, or consequential damages (including, but not limited to, procurement of substitute goods or services; loss of use, data, or profits; or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the use of this toolkit, even if advised against the possibility of such damage. direct, indirect, incidental, special, exemplary, or consequential damages (including, but not limited to, procurement of substitute goods or services; loss of use, data, or profits; or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the use of this toolkit, even if advised against the possibility of such damage.