Enroll-HD – Clinical Data and Biosample Access Policy
The overarching goal of the Enroll-HD platform is to accelerate the development of therapeutics that will benefit HD-affected individuals. As a cornerstone of that goal, the Enroll-HD website hosts various datasets/biosample collections and makes these available to any interested researcher from academia, government institutions, nonprofit organizations, and public and private companies. The aim is to ensure that as many researchers as possible worldwide can access the coded study data and renewable biosamples from Enroll-HD and other clinical HD studies in a rapid, transparent, straightforward manner, lowering barriers to entry into HD research while safeguarding the identity of research participants.
There is no merit review of project proposals related to requests for access to periodic datasets or renewable biosamples. Any researcher who wants to access coded clinical data or biosamples will create an Enroll-HD Clinical Data and Biosamples Access Account; checks will be made to verify that the applicant is indeed employed by the stated, recognized research organization.
Requests for non-renewable biosamples or specified datasets will be referred to the Scientific Review Committee (SRC) for merit review of the proposed research or prioritization according to available resources, respectively.
Researchers will be required to sign a clinical data use agreement and/or a biosamples use agreement, as applicable, either online or downloadable hard copy. Any future modifications to online agreements will be electronically agreed to by each data user on first login after any new terms are adopted.
Active communication regarding planned and ongoing data analyses is encouraged to provide opportunity for collaborative work. Researchers accessing datasets are required, as part of the application process, to submit a brief, broad outline (50-200 words) of their proposed research study; this is posted publicly on the Enroll-HD website along with the researcher’s contact details. Other researchers interested in a particular research project are encouraged to contact the dataset/biosample recipient directly to discuss areas of mutual interest with a view to potential collaboration.