Leukodystrophy Biospecimen Resource Access Committee (LD-BRAC)

Leukodystrophy Biosample Access

Investigators interested in obtaining Leukodystrophy biospecimens should submit their application through the NINDS biosample online submission webform, which also details the application requirements. Requests are reviewed by the Leukodystrophy Biospecimen Resource Access Committee (LD-BRAC), an external scientific review panel, to ensure that these biosamples are appropriately disseminated for research on Leukodystrophy. Potential uses include, but are not limited to biomarker discovery, assay development and optimization, replication studies, metabolomic and/or genomic studies of Leukodystrophy. 

Step 1: Determine Sample Availability

Biospecimens and associated data are available from the following Leukodystrophy cohorts:

• Global Leukodystrophy Initiative Clinical Trials Network (GLIA-CTN): a longitudinal observational study with biospecimens from a multi-site cohort of individuals with Leukodystrophy and unaffected controls.   
• Additional biospecimen resources (not reviewed within the Leukodystrophy BRAC)
  • Myelin Disorders Bioregistry Project at the Children’s Hospital of Philadelphia Leukodystrophy Center: a sample repository from a cohort of individuals with Leukodystrophy.

Clinical data associated with Leukodystrophy biospecimens are available through the GLIA-CTN’s Rare Disease Clinical Research Network Natural History Studies.

It is recommended that investigators visit the NINDS Biomarkers Repository BioSEND website to learn more about

• 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.

The NINDS BioSEND repository is managed by Dr. Tatiana Foroud, along with her Program Manager, Ms. Claire Wegel. 

Contact BioSEND to obtain sample availability information.  

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):

1. Biosketch
2. Research Strategy(pdf, 40 KB) (pdf, 40 KB) - (4-page limit)
3. Biosample template(pdf, 197 KB)

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 (i.e., Research Strategy and Table Summary) and provide information about funding support for the study.

Step 3: Leukodystrophy BRAC Reviews Application

The LD-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 regarding the outcome of the review (i.e., approve, approve upon revisions, or deny), usually within a week after the review meeting.  Summary statements are released 2-3 weeks after review.  For applications that were ‘approve upon revisions’, investigators will be notified about concerns that need to be addressed before the application can move forward.  Please note that the Leukodystrophy BRAC does not provide funding. 

If sample access is approved by the Leukodystrophy BRAC, the two possible outcomes are:

1. 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 Rebecca Price, Ph.D.
2. 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.

To facilitate scientific rigor and reproducibility, samples for approved applications are shipped blinded (each aliquot is labeled with a Sample ID). The BioSEND team will work with investigators during the onboarding call to create box designs to facilitate blinded analyses. Investigators must return their assay analyses into an appropriate NIH repository prior to being unblinded by BioSEND.

Application Submission Dates

Please note that your application will be shared with Program Staff from NINDS as well as BioSEND at Indiana University. The Leukodystrophy BRAC subscribes to the ethical requirements as described within the Confidentiality Agreement(pdf, 98 KB).

Contacts

Questions about the review process should be directed to Rebecca Price, Ph.D.