What could this be looks like? What could anyone change today, right now, without having to arm themselves for a battle with lawyers over contract wording? Start with the artifacts – the physical things that patients take home (or the digital things that are sent to them via email). A typical consent process can yield two: a copy of the consent statement itself, usually with a contact person for questions, and (perhaps) a short brochure about the survey. For a patient, it can feel like a dead end with no real path to deeper engagement.
Consent forms could instead serve as an invitation: a cover sheet describing community committees, meetings, and events, and how a patient can be involved. This does not have to be a metaphorical invitation: QR codes, links and literal calendar invitations can make joining a community a one-step process.
We could also push the interactivity of a consent form beyond the quizzes that are popular in research today. Quizzes fit the transaction framework perfectly: We want the patient to read the form, think about what they have read (but not for too long), and pass the quiz.
But the relational framework suggests that there is more to do. It is not really clear whether a good quiz really shows that a patient understands the content of a consent form, and in particular terms embedded within the form: privacy, deidentification, etc. It may not seem like a big deal, but without a common understanding of concepts, patients and researchers may have different expectations of how data will be handled and protected. Perhaps most importantly, communities need to create space for patients to learn about data concepts so that patients can meaningfully participate in community governance.
Instead of just proving short-term retention, interactive consent forms can be created to kick-start long-term patient learning. Perhaps a statement of consent comes with a field guide to data protection or explains previous examples of decisions that the community has made about data. Or perhaps it allows patients to practice making data decisions themselves or to predict how a society would respond to a hypothetical governance scenario.
And what if a patient wants to be less involved or walk completely? Whether you are leaving a job, a service, or a community, exit is an important accountability tool and a way to protect yourself from further harm. But true exit can be difficult in an age of big data, where even patients or communities who refuse to participate in a study may be put at risk because of its output – such as biased algorithms for diagnosis and treatment. This repeals the basic agreement on consent: that research participants accept additional risk in exchange for their participation.
As the line is blurred between community building and research initiatives, as peer support groups move online or are embedded in research platforms, consent processes will also have to take into account people who do not contribute data but still participate in the community, whether through support groups, community counseling, or even just as a family member of an involved patient. This may mean that better bridges are built for the communities and patient groups that are affected by, but independent of, a research project. A dataset is not an island; a data community should not be either.
Of course there is more to do. Institutions still count on historical racism, research exploitation, and abuse of trust. Distrust of health care can spill over distrust of research. Correcting this requires work, not wordsmithing. Building credible research relationships requires more than just better consent processes: it requires a sustained commitment from researchers and their institutions.
Still, more thoughtful approaches to consent can help shift the framework of research from something that happens for patients to something over which patients take co-ownership. And it can also pay dividends for the communities. Participating communities may suffer from pipeline problems and struggle to replace committed patients, board members, or counselors as they inevitably move on. Investing in participation and capacity building creates a larger pool of people who may be willing to eventually take on more involved roles.
A statement of consent does not have to look like the dozens of legal forms and disclaimers we ignore every day. And it should not. Reframing consent can help build bridges between patients and researchers and facilitate the long-term relationships needed to promote better health outcomes for all.