A Patient-Centric Approach to Consent
This paper explores RARE-X’s patient-centric approach to developing flexible and easy-to-understand Consent Agreements and Data Sharing Agreements. This novel approach is another way RARE-X is lowering the barriers to participation for rare disease patients while protecting their privacy and allowing them to retain ownership of their own data.
RARE-X is committed to transforming rare disease by ensuring that patient communities, clinicians, researchers, and drug developers have access to the right data at the right time. At the heart of RARE-X’s approach is a belief that patients should own their data. In July 2021, RARE-X launched its first set of rare disease pilot programs on its data collection platform supported by data governance and consent that will ensure participants who spend the time to enter their data are able to share it with those stakeholders they choose.
RARE-X understood that to achieve this vision of enabling data sharing to accelerate research, improve the understanding of rare diseases, and speed diagnoses; it would need to take a novel approach. This approach included creating governance and a patient-centric consent process supported by technology designed for the future life of data. This includes leveraging existing technology platforms for the widespread sharing of data developed at the Broad Institute of MIT and Harvard that follows federated data-sharing principles and enables access to structured data in a semi-automated manner. The RARE-X platform strives for the data collection program to be supported through collaborations with technology providers with the strongest security and data oversight.
The organization has invested significant resources in developing its governance and consent. RARE-X Research and Data Governance Lead Vanessa Vogel-Farley and data governance expert Joy Pritts spearheaded an 18-month effort with the RARE-X governance and compliance, data standards, and patient engagement teams. An extensive network of scientific advisors, survey developers, attorneys, and rare disease patient communities generously shared their time and insights in helping RARE-X forge its approach to governance and consent.
By capitalizing on technology, RARE-X has taken an approach to governance and consent that is forward-looking and provides needed flexibility to ensure data lives beyond its initial and expected use, maximizing potential usage of this data to understand disease and develop therapies. These efforts also aim to avoid requiring participants to enter the same data repeatedly over time.