Sage Bionetworks developed and maintains the Participant-Centered Consent (PCC) toolkit. The toolkit is built for people who are designing clinical studies and who wish to make their informed consent user-centered, rather than document-centered. It contains the building blocks of a visual, interactive approach to informed consent. The PCC toolkit lets its users create visual summaries of consent forms, mapped to key underlying text, for use in software or print.
Here’s a slideshow of it in use for our Parkinson mPower project.
We used the toolkit to develop mobile-centric informed consent processes for our own clinical studies. You can use the PCC toolkit to transform a legal document into a visual process (either in software or in print) that engages participants and assists in informing them about research studies.
The PCC toolkit is openly licensed and can be adapted for any kind of informed consent interaction, including an offline, in-person experience. It was developed after a set of interviews with experts including ethicists and clinicians and mobile health experts, 2 workshops, a series of public presentations across the fall of 2014 (including a plenary session at PRIMR AER), and was released in January 2015 during the ELSI Issues in Citizen Science meeting at the NIH.
The toolkit comprises four core areas:
- “Nouns, Verbs, and Sentences” – icons and animations that visually represent elements of research studies that need to be understood by participants – think of it as a dictionary;
- Design assets for informed consent – Editable documents for our own implementations of informed consent on mobile devices, web layouts, workflows for enrolling participants, and more;
- Reference documents – Informed consent templates, and copies of our own IRB-approved clinical protocol filings;
- Implementation support – step by step instructions on how to use the toolkit, a sample piece of workflow softare, detailed FAQs, and more.
The PCC toolkit would not have been possible without the support of the EDM Forum.