Better Research Through Community-Centered Data Governance

“There’s solid evidence that when you have a deep level of ongoing engagement like the flok community has, you inform better research with better clinical outcomes.”  - Mary Gray, Senior Principal Researcher, Microsoft

In the fall of 2023, as flok began to build the framework for our Research Platform, I heard two rare disease leaders make striking statements:  

• One said that people with rare diseases will give up “almost anything” in exchange for progress in the treatment of their conditions. 
• And another – a rare disease parent and epidemiologist – pointed out that in rare disease, almost no one is truly anonymous: there are so few with some conditions that knowing the gender, age, and geographic location of an individual with a particular rare condition is enough to identify them. 

These two statements have stayed with me as we developed our patient-led research approach.  flok's leadership believes that our community shouldn’t have to “give up” anything – we may choose to share our experiences, our data, our blood, sweat, and tears – but we must also share in the progress that results from it. And we must protect the privacy of our community throughout this process.  

The flok team has spent the last two years working with community members, leading researchers, ethicists, and legal experts on a revolutionary approach to research consent – one that places our community at the center.  

Community-Led Discovery 

Mary Gray, Senior Principal Researcher at Microsoft Research and member of flok’s Data Governance and Ethics Committee, is a key partner in this effort. Her recent work heading Microsoft Research’s Project Resolve focuses on empowering community-based organizations like flok to control their data and develop guardrails around consent and data-sharing. 

flok’s work is gaining recognition: we received a $100,000 in-kind grant from Microsoft’s AI For Good Lab. This ongoing partnership supports the flok app’s infrastructure, prioritizing our community as partners in exploratory research. Mary explains, “The work flok is doing creates an opportunity to reset our relationship with biomedical research to include the source of expertise – you, the community – as participants, and not just data points.” 

Meg Doerr, Director of Applied Ethical, Legal, and Social Implication Research at Sage Bionetworks and member of flok’s Data Governance and Ethics Committee, has been instrumental in designing a consent process that engages the flok community as active contributors to research. She explains, “Your daily care can reveal exponentially more about your condition and what potential treatments might be out there than a few data points collected at the doctor’s office.” Meg highlights that flok’s approach empowers our community to shape the research agenda — defining the questions we want answered and the problems we want solved. 

In addition to expert input, we held focus groups to hear from those directly impacted by rare metabolic conditions – patients, caregivers, and clinicians. From this process we developed the following Data Governance Principles. These guiding principles ensure our research collaborations use data to benefit the flok community, exceed legal and ethical standards, honor individual choice, and maintain transparency.   

flok’s Data Governance Principles  

1. Community Benefit: flok’s goal is that all use of data provides value back to the community and reflects the interests and needs of those represented by the data, including through improvements to the flok app and research initiatives. We prioritize community engagement and empowerment to ensure this goal is reached. Our commitment involves ongoing dialogue with community members, a participatory approach in decision-making about data use, and requiring flok and its research partners to be responsible stewards of data and any derived insights. 
2. Stewardship: flok takes responsibility for the data we receive and is accountable to the community. This means we uphold ethical and legal standards of data management and will answer to the community for our data-related actions. flok has clear data governance principles for the privacy and security of data and its use; we require partners to adhere to these principles. 
3. Individual Choice: flok acknowledges the importance of obtaining informed consent from individuals or their guardians that is freely given before collecting, using, or sharing their data for research purposes. For example, you will always have an explicit choice as to whether your data can be used for research. You will also have the opportunity to change your choice at any point for data collected going forward. Opting out of data sharing for research purposes will have no impact on your rights within the community or ability to use the flok app.
4. Transparency: flok commits to an open approach regarding our data practices, ensuring that everyone can easily access information about the methods of collection, purposes for which data is collected, and how data is used. We will provide clear, straightforward, and publicly accessible policies outlining our data management practices, and we will regularly report on our data use and the impact it has on the communities we serve. 

Join the Conversation 

We’d love to hear from you! If you have questions or feedback about flok’s data governance approach, please contact me at [email protected].    

We look forward to hearing your thoughts and continuing to work together to build a new future in metabolic care and research.