ALS-FTD Biospecimen Access

Amytrophic Lateral Sclerosis/Frontotemporal Dementia Biosample Access

Investigators interested in obtaining biospecimens from Amytrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD) should submit their application through the NINDS biosample online submission webform, which also details the application requirements. Requests are reviewed by the Amyotrophic Lateral Sclerosis/Frontotemporal Dementia Biospecimen Resource Access Committee (ALS/FTD-BRAC), an external scientific review panel, to ensure that these biosamples are appropriately disseminated for biomarker discovery, assay optimization and replication studies.

Step 1: Determine Sample Availability

Biospecimens and associated data are available from the following ALS/FTD cohorts:

• Amyotrophic Lateral Sclerosis
  • Access for ALL in ALS (ALL ALS): a longitudinal natural history study and biomarker collection study for ALS.
    • PREVENT ALL ALS: includes first degree relatives of patients with ALS or FTD without current symptoms of ALS
    • ACCESS ALL ALS: includes patients with an ALS diagnosis or patients with no known family history of ALS or FTD
• Frontotemporal Dementia
  • Examination of the Earliest Symptoms and Biomarkers of FTLD: a longitudinal natural history study of microtubule-associated protein tau (MAPT) carriers

ALS clinical data associated with the BioSEND samples are available through the ALS Knowledge Portal. 

It is recommended that investigators visit the NINDS Biorepository 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.

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. Table Summary of Samples of Interest(pdf, 161 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.

Step 3: ALS/FTD 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 ALS/FTD BRAC does not provide funding. 

If sample access is approved by the ALS/FTD 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

Applications for biospecimen access will be received on a rolling basis and reviewed according to the following cycle

Please note that your application will be shared with Program Staff from NINDS as well as BioSEND at Indiana University.  The ALS/FTD-BRAC subscribes to the ethical requirements, as described within the Conflict of Interest document(pdf, 143 KB) and Confidentiality Agreement(pdf, 109 KB).

BRAC Membership

View the complete  ALS/FTD BRAC roster(pdf, 97 KB)

Contacts

Questions regarding the review process should be directed to the ALS/FTD-BRAC Coordinator, Rebecca Price, Ph.D.