Samples from both PREDICT-HD and 2CARE can be accessed via the BioSEND HD Specimen catalogs for each study. All requests must be reviewed and approved by the HD Biospecimen Review Access Committee (HD-BRAC). A visual representation of the distribution process can be found on the right hand side of the page.
To guide your biosample selection you will need access to the PREDICT-HD clinical dataset and cohort information which is available through dbGaP. To access this data, please complete a data access request for dbGaP to view the PREDICT-HD clinical dataset or 2CARE clinical dataset information which will guide your biosample selection. If you’re interested in reviewing sample inventory and requesting samples, please complete the data access request as soon as possible, as the approval process may take time.
Once your dbGaP access is approved, BioSEND will provide access to the appropriate catalog after completion of the HD Data Use Agreement
BioSEND will provide access to the PREDICT-HD and/or 2CARE catalog to query for biosamples based on associated clinical data in dbGaP.
HD-BRAC Application Process
To request access to specific Biosamples, please provide the following information for review by the HD-BRAC. Submit a single PDF file via email it to NINDS-HD-BRAC@ninds.nih.gov.
- Biosketch (or Biosketches): for all investigators involved in the proposed studies
- Research Strategy: (4-page limit)
- Rationale: Briefly describe the studies proposed and the rationale for the proposed analyses.
Background: Provide the relevant background to justify the request. Be sure to include:
- Importance of the project, including the significance of both the study question and of the specific project.
- Justification for requesting these specific samples, and why other sources of similar samples are not appropriate. This section should explain how the proposed use relates to the design and outcomes of the study that produced the requested samples. The question being posed by the investigator must be appropriate to the source of the biospecimens, how they were collected, prepared, analyzed and stored; their age; and the phenotypic and other accompanying data.
- Relevant preliminary data demonstrating the applicant’s experience with the assay or technique that will be used with the requested samples.
- Sample Information:If you will be combining the results from the proposed study with those obtained from other samples, be sure to explain how the requested samples will fit in with your overall study design (e.g. from which study and stage of the study the specimens are requested, whether random samples or specific selection of those with subjects with or without specified clinical events and laboratory or imaging findings are sought, etc.).Include a clear justification for the amount of sample being requested. In all cases, applicants should only request the minimum volume needed for the study.
- Hypothesis: There should be at least one important hypothesis that can be tested using the proposed methods and non-renewable samples provided by the repository, or a strong justification for carrying out discovery research.
- Methodology: Describe how the requested samples will be used, including a description of the specific procedures by which the samples will be tested and analyzed and the quality control and robustness of the assay. Is this a discovery, optimization or replication study?
- Power and effect size: Describe the power of the project and the anticipated size of a detectable effect.
- Data analysis: Provide a detailed plan for data analysis. Include a brief summary of the team’s expertise and experience and evidence that they can handle the analysis proposed.
- Sample management: Explicitly address how the samples will be held, managed, and processed. For example, who will have the main responsibility for storing and testing the samples?
- Plans for the next phase: Describe plans for follow up studies and, if relevant, further biomarker or assay development. If collaborations have been established for follow up, include these letters of collaboration.
- Project Support
- Do you currently have NIH funding to support this research project (Y/N)?
- If Yes, please state NIH Funding Institution (i.e. NINDS) and Grant Number
- If No, briefly describe the source of funding to support your proposed project.
- If you do not have any funding, please explain your plan to apply for funding.
- Do you require a letter of support for this application (Y/N)? Due Date?
- Summary of Samples of interest (table format) In a table (example), briefly outline the number, type, and amount of biospecimens/tissue requested, including subject type (e.g. HD, control, any specific clinical parameters), visit number (if applicable), volume of sample required, and the cohort or biorepository through which the biosamples are currently available. In addition, the applicant should determine if the samples required are available through the repository prior to submitting an application.
Application Submission Timeline
|Date Submitted||Reviewed By|
|April 13, 2019 - July 12, 2019||August 16, 2019|
|July 13, 2019 - September 13, 2019||October 18, 2019|
- Jonathan Sabbagh, PhD
- Health Program Specialist, Neurodegeneration
- National Institute of Neurological Disorders & Stroke
- 6001 Executive Boulevard, Room 2114B
- Rockville, MD 20852
- (301) 496-5680