Once you have identified the datasets and/or biosamples you require, please submit the following via email to accountsetup@enroll-hd.org:

• Data and biosamples request form
• Data Security Questionnaire (one per requesting organization)
• Technical and operational security measures (TOMs) of each requesting organization

When drafting a project description to request biosamples, please carefully consider and address the following points:

• Purpose: The purpose of the project must be clearly presented. The SRC must understand whether the samples you are requesting are appropriate to meet the aims of your research. For example, will the project look for significant changes between disease stages, or study biological variability over time?
• Novelty: What are the criteria for introducing new assays/methodologies, especially in a competitive space?
• Sample size: The sample size must be appropriately justified in the project description. If no data are available to perform a power calculation, this must be mentioned.
• SAP: A brief description of the statistical analysis plan must be provided.
• Assay validation: All applicants should first validate their single target assay(s) with non-HD biofluids to provide standard assay parameters (e.g., biological Coefficient of Variations for power calculation, etc.) for the specific biological matrix of interest, or have relevant publications to support their methodology and approach. This information should be included in the request application.
• Consideration of prior proteomics results: For projects aiming to study a specific protein, previous proteomics results should be considered. If the protein has failed to show HD associations in any of the current proteomic projects, then applicants should explain if the proposed protein-specific assay method is substantially different from those previously used, and whether there is a reason to believe that the assay may be more sensitive for measuring the protein in question.

All requests are reviewed for completeness and feasibility by the Enroll-HD Operations team (1 - 7 days). Requests for specified datasets and non-renewable biosamples also require review and approval by the Scientific Review Committee (SRC; 2 - 8 weeks). 

Once your request is approved, a Data and/or Biosample Use Agreement¹ will need to be signed and executed with your Institution before resources can be provided. On execution of the Use Agreement, biosamples will be shipped and/or datasets will be delivered electronically. Incurred fees² should be received during this process. 

¹Data Use Agreements: Execution of these agreements typically takes 4 weeks minimum. Please review these documents with your Institution early in the request process to make sure the terms of use as stated are acceptable, as they are largely non-negotiable. Biosample selection and preparation of specified datasets takes place in parallel to agreement preparation. On execution of the Use Agreement, biosamples will be shipped and/or datasets will be delivered electronically.  

²Fees: Clinical datasets are made available free of charge. There is a cost associated with biosample requests. Participant biosamples are not sold for profit. The cost associated with obtaining biosamples consists of: 1) a biosample fee, 2) a shipping fee, and 3) a handling fee. Biosample fees (i) are applied to partially offset the costs of collecting and storing the requested biosamples, and (ii) give people requesting biosamples a sense of the actual “cost” of their experiments. Shipping and handling fees are direct pass-throughs of project-specific costs and will be provided upon request.