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, and it helps create visual summaries of consent forms, mapped to key underlying text, for use in software or print.
Visual summaries can assist informedness. Traditional consent forms are complex legal documents, written in formal language, and can obscure key study concepts they are supposed to convey. Clinicians and health workers must attempt to explain them in short time windows to study participants who often lack context for comprehension, and in many cases the forms are not even read. Using a mixture of icons and text labels can convey the essential concepts of a study in a more intuitive manner and help both sides of the consent conversation closer to the goal of informed choices.
The toolkit was launched with five active studies at Sage Bionetworks, Stanford University, Mt Sinai School of Medicine, and Massachusetts General Hospital. More than 25 studies overall now use consent approaches developed in the toolkit, which currently supports minimal-risk studies that collect sensor data, survey data, and data collected via the Apple Health application. We are developing for 2016 release new design elements to support collection and donation of data from electronic health records and genomic analysis.
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. However, this does not eliminate the underlying consent contract – it simply creates a “more informing” companion document for the formal legal document.
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 contains four kinds of assets:
- “Icons and Animations” – 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 language relevant to filing mobile study clinical protocols.
- Implementation support – step by step instructions on how to use the toolkit, a sample piece of workflow software, FAQs, and more.
PCC allows designers to embed essential consent concepts into a tiered, hierarchical information “stack” that uses iconography and simple language, paired with a quiz-based assessment of comprehension post-consent before data collection begins. The goal of the approach is to help those running studies to convert a static consent document into processes that extract the most important concepts of an e-research study, and make those concepts easier to understand and remember than rendering large quantities of text on a small screen.
The first “tier” of the information stack is icon-dominant with text labels to assist information retention. The screen is divided into elements indicating progress through the consent process, with the primary element devoted to a visual indication of the essential clinical study concept. Concepts for the final RK consents include: study activities, phone sensor data, data processing and use, data protection, potential benefits, risks to privacy, withdrawal, and more. It is essential for study designers to stop and consider: what are the concepts that participants must know to make an informed choice? Those concepts then must be presented at the top “tier” of the consent process.
The second “tier” is text-dominant. This is where clear language about the concept is expressed, providing more detail for those who wish. In future releases we plan to expand the text-dominant tier to include hyperlinks, multimedia, and other, more interactive ways to communicate essential clinical concepts to participants.
The third tier is the actual consent document, which we make available on the study website and inside the app itself in multiple places. We pair the PCC interface with an assessment test on both of our studies (Parkinsons and breast cancer survivors) so that people do not enroll in the study without a baseline of comprehension of key concepts. Click here for a slide deck containing our complete consent interface from the Parkinson mPower app, which reflects a fundamentally shared experience across all five apps at the visual tier. Each app of course has completely different text in their second tier of “learn more” screens, and different formal consent documents.
The PCC toolkit would not have been possible without the support of the EDM Forum.