HEDGE Study FAQs
These FAQs provide additional detail about the Hypermobile Ehlers-Danlos Genetic Evaluation (HEDGE) study, including governance, oversight, data security, and study contributors. For an overview of the study and the latest updates, please visit ehlers-danlos.com/hedge/.
Study Oversight and Ethics
Who oversees the HEDGE study?
The HEDGE study has Institutional Review Board (IRB) oversight and approval through the Genetic Alliance. This ensures that the research follows strict ethical and safety standards.
- IRB Organization Number: IORG0003358
- IRB Number: IRB00003999
- Federal Wide Assurance Number: FWA00017292
- Protocol Number: EDS002
You can look up more information by entering “Genetic Alliance” in the NAME search field on the Office of Human Research Protections website.
Confidentiality and Data Security
Will my research data be kept confidential?
Yes. All data are de-identified before being analyzed. The EDS Global Registry is securely stored on the RedCap platform, which is compliant with international privacy and security standards, including the European General Data Protection Regulation (GDPR).
Participants provided written informed consent and were also offered a consent video presentation.
Will my DNA be sold?
Participants in the HEDGE study have consented to their blood samples being tested for whole genome sequencing. The results of these tests are private and confidential. The DNA is not sold to a third party. Sequencing data will be analyzed by researchers to look for the genetic causes of hEDS. Researchers viewing the data will not have access to identifying information
Where are samples stored?
Blood and DNA samples were processed at ReproCell (USA) and securely stored at the Genetic Alliance Precision for Medicine Biobank and Reprocell (USA).
Funding
Who funded HEDGE?
HEDGE is fully funded by two anonymous private donors, whose families have been impacted by hEDS. These donors have no commercial interest, ownership, or rights to any of the data from the study.
The study was initially made possible thanks to an extraordinary gift in 2018, followed by a generous matching donation in 2019.
Contributors and Governance
Who is involved in the HEDGE study?
HEDGE is a global collaboration led by The Ehlers-Danlos Society in partnership with:
- The Broad Institute of MIT and Harvard (whole-genome sequencing)
- University of Illinois and Carle Illinois College of Medicine (analysis team)
- Indiana University (co-investigator leadership)
- Members of the Hypermobility Biology Network, an international group of researchers, clinicians, and scientists
Committees and teams
The HEDGE study has multiple committees to guide and oversee its work, including:
- Enrollment team (screening and recruitment)
- Analysis team (genome sequencing and interpretation)
- Governance committee (protocol oversight and fund allocation)
- Publications committee (peer review and publication process)
A full list of contributors and committee members can be found here.
Participation
Is enrollment still open?
No, unfortunately enrollment in HEDGE is now closed. Anyone who wants to contribute to research can participate through the new Global Biobank and the DICE Registry, which were established based on the study.
Future Research
Will my data be used for future studies?
Yes, de-identified data and samples from HEDGE may be used in future approved studies to help advance research into hEDS and related conditions. Data generated from these analyses may also be shared with qualified researchers to support additional studies. If you have any questions, please refer to your consent form.
What happens next?
The HEDGE analysis teams are now:
- Completing rare variant analyses
- Linking genetic variants to symptom patterns (genotype–phenotype studies)
- Building biological models of connective tissue changes
- Preparing first publications, expected in December 2025
Contact
Who can I contact with questions about the study?
For questions about the HEDGE study, or if you are a participant, please contact: [email protected]
