What could this be? looks like? What could anyone change today, right now, without getting ready for a fight with lawyers over contract wording? Start with the artifacts – the physical things patients take home (or the digital things mailed to them). A typical consent process might yield two: a copy of the consent form itself, usually with a contact for questions, and (perhaps) a short brochure about the study. For a patient, this can feel like a dead end, with no real road to deeper involvement.
Consent forms can instead act as an invitation: a cover sheet detailing the community’s committees, meetings, and events, and how to get a patient involved. This doesn’t have to be a metaphorical invitation: QR codes, links, and literal calendar invites 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 perfectly into the transaction framework: we want the patient to read the form, think about what they’ve read (but not for too long), and pass the quiz.
But the relational framework suggests there’s more to it. It is not really clear whether conducting a quiz really shows that a patient understands the contents of a consent form, and in particular the terms embedded within the form: privacy, de-identification, etc. That may not seem so important, but without a common understanding of terms, patients and researchers may have different expectations about how data is handled and protected. Perhaps most importantly, communities need to make room for patients to learn about data concepts so patients can meaningfully participate in community governance.
Rather than just proving short-term retention, interactive consent forms can be set up to drive long-term patient learning. Perhaps a consent form comes with a data privacy field guide, or explains past examples of decisions the community has made about data. Or perhaps it allows patients to make their own decisions about data, or to predict how a community would respond to a hypothetical governance scenario.
And what if a patient wants to be less involved, or wants to leave altogether? Whether you leave a job, a service or a community, exit is an important tool for accountability and a way to protect yourself from further harm. But true exit can be difficult in the age of big data, where even patients or communities who refuse to participate in a study can be compromised by the results, such as biased diagnosis and treatment algorithms. This puts an end to the basic agreement of consent: that research participants accept additional risk in exchange for their participation.
As the line between community building and research initiatives blurs, as peer support groups go online or are built into research platforms, consent processes will also need to consider people who do not contribute data, but who still participate in the community, whether through support groups, community consultation, or even simply as a relative of an involved patient. This could mean building better bridges to the communities and patient groups affected by, but independent of, a research project. A dataset is not an island; a data community shouldn’t be either.
Of course there there’s more to do. Institutions still consider historical racism, research exploitation and abuse of trust. Distrust in healthcare can overflow distrust in research. Solving this takes work, not word art. Building trusted research relationships requires more than just better consent processes: it requires ongoing commitment from researchers and their institutions.
Still, more thoughtful approaches to consent can help shift the research framework from something that happens with patients into something that patients co-own. And it can also benefit communities. Participating communities may face pipeline problems and struggle to replace involved patients, board members, or counselors when they inevitably move forward. Investing in participation and capacity building creates a larger pool of people who may be willing to eventually take on more involved roles.
A consent form doesn’t have to look like the dozens of legal forms and disclaimers we ignore every day. And it shouldn’t. Reframing consent can help build bridges between patients and researchers and facilitate the long-term relationships needed to achieve better health outcomes for all.