Huntington's Disease Biosample Access
Investigators interested in obtaining Huntington's Disease (HD) biospecimens should submit their application through the NINDS biosample online submission webform, which also details the application requirements. Requests are reviewed by the Huntington’s Disease Biospecimen Resource Access Committee (HD-BRAC), an external scientific review panel, to ensure that these biosamples are appropriately disseminated for HD biomarker discovery, assay optimization and replication studies.
Step 1: Determine Sample Availability
Biospecimens and associated data are available from the following HD cohorts:
- PREDICT-HD: a longitudinal observational study facilitating HD biomarker discovery and validation
- 2-CARE: clinical and biosample data from a completed double-blind, placebo-controlled clinical trial evaluating coenzyme Q10 for the treatment of Huntington’s Disease
Clinical data associated with the BioSEND samples are available through dbGaP. To view the PREDICT-HD clinical dataset and/or the 2CARE clinical dataset you must first open a dbGaP account. Please contact Dr. Ran Zhang (NINDS dbGaP liaison) for any questions related to clinical HD data in dbGAP, and follow these links for information on how to apply for a dbGaP account. Please complete the data access request as soon as possible, as the approval process may take time.
- Data and biospecimens available;
- Material Transfer Agreements and Data Use Agreements required for each collection;
- Any tissue processing or other fees associated with the biospecimens and tissue.
Step 2: Submit Online Application
All applications are submitted through an online webform. Within the webform, applicants are required to upload the following files (in pdf, gif, jpg, jpeg, or png file formats):
- Research Strategy(pdf, 39 KB) (pdf, 38 kb) - (4 page limit)
- Table Summary of Samples of Interest(pdf, 157 KB) (pdf, 153 kb) - (This should include information on sample availability)
The first page of the webform requires the investigator to fill in basic information (e.g name, institution, address) and to upload the biosketch. The second page of the webform requires the investigator to upload the application files (e.g. Research Strategy and Table Summary) and provide information about funding support for the study.
Applications for biospecimen access will be received on a rolling basis and reviewed according to the following cycle
|Date Submitted||Reviewed by|
|December 16, 2020 - February 12, 2021||March 26, 2021|
|February 13, 2021 - April 16, 2021||May 27, 2021|
|April 17, 2021 - July 16, 2021||August 26, 2021|
|July 17, 2021 - September 17, 2021||October 28, 2021|
|September 18, 2021- December 17, 2021||January 31, 2022|
Please note that your application will be shared with Program Staff from NINDS as well as BioSEND at Indiana University. The HD-BRAC subscribes to the ethical requirements, as described within the Conflict of Interest document(pdf, 280 KB) (pdf, 274 kb) and Confidentiality Agreement(pdf, 75 KB) (pdf, 73 kb).
Step 3: HD BRAC Reviews Application
The BRAC committee will assess the applications based on experimental rationale, feasibility/reproducibility of the assays, expertise of the investigator, availability of the institutional resources to support the study, and the statistical analysis of the number of samples required for the hypothesis testing. Investigators will be notified by email the outcome of the review (i.e. approve, approve upon revisions, or deny) within a week after the review meeting. Summary statements are released 2-3 weeks after review. For applications that were ‘approved upon revisions’, investigators will be notified about concerns that would need to be addressed before the application could move forward. Please note that the HD BRAC does not provide funding.
If sample access is approved by the HD BRAC, the two possible outcomes are:
- If the study has funding, the samples are distributed to the investigator following a virtual meeting to introduce the sample distribution process (“on-boarding”) and after fulfilment by the investigator of additional requirements specified by BioSEND (i.e. MTA, Data Use Agreement, data analysis and sharing plan). For questions, please contact Christine Swanson-Fischer, Ph.D.
- If the investigator has yet to obtain funding for the study, the BRAC will issue a letter to the applicant documenting provisional access to the samples requested. This letter can be used to support an application for funding opportunities from the NIH or other organizations. Conditional approvals will be valid for a period of up to 12 months.
Questions regarding the review process should be directed to the HD-BRAC Coordinator, Christine Swanson-Fischer, PhD.
View the current list of approved Biospecimen Requests(pdf, 90 KB) (pdf, 89 kb) through the HD BRAC.
View the complete HD BRAC roster(pdf, 72 KB) (pdf, 70 kb)