The purpose of NDAR is to help accelerate progress in autism research by creating a secure, Web-enabled infrastructure that integrates heterogeneous datasets, providing unprecedented access to a high volume of research data relevant to ASD.
The NDAR research portal will provide investigators with a single point of access to multiple autism-relevant data sources (e.g., AGRE, IAN, NIMH Genomics Repository) in addition to the shared data stored in the NDAR Central Repository.
A Data Access Committee (DAC) has been established to oversee access to the data contained in the NDAR Central Repository. Investigators who wish to access shared data must complete a simplified SF-424 (R&R) and the NDAR Data Use Certification, which is reviewed and approved by the NDAR DAC.
For permission to query and access shared data stored in data sources that are federated with NDAR, an investigator will be expected to complete additional access agreements specific to these data sources and submit them through NDAR.
Please refer to SOP-04 Data Access Permission Request for the complete procedure.
In consultation with the research community, NDAR has established a two-tiered submission strategy to provide maximum benefit to investigators.
The NDAR Data-Sharing Checklist explains the process steps for submitting data to NDAR, which are:
NDAR expects all prospective studies to include a Global Unique Identifier (GUID) in the data submission. For retrospective studies, the NDAR team understands that the participant data needed to generate a GUID may not be available. Alternatively, the informed consents may be inadequate for an investigator to provide data accompanied by a valid GUID. To account for this, NDAR provides the capability to generate pseudo-GUIDs, which are random identifiers that, unlike GUIDs, are not derived from data associated with the research participant. Not having a valid GUID associated has limitations in NDAR. However, NDAR will accept data without a valid GUID for retrospective studies.
The NDAR team recognizes that there is a cost associated with contributing quality data to NDAR. Costs will vary based on the type of data contributed, the number of submissions performed, and the number of subjects enrolled.
For example, a five year research project containing 8 standard assessments contributed semi-annually and 10 custom assessments, imaging data, and genetic data contributed in year 5 of the grant for 100 enrolled subjects is estimated to require 60 hours of an investigator's time and 240 hours of a Data Manager's time over five years.
The NDAR team has developed a cost model for data submission for investigators who are preparing their research budgets. Contact us at ndar@mail.nih.gov to discuss the specific tasks associated with your research project and an appropriate estimate of labor hours.
The NDAR team is working with a number of autism-relevant data repositories that have agreed to federate and make their data available through NDAR:
The Pediatric MRI Data Repository will be the first in this series to be made available to ASD researchers, in the spring of 2010. At that time, investigators will be able to perform a single query in the NDAR portal to view results across multiple datasets.
NDAR's Ongoing Study capability allows investigators to work collaboratively on research studies in progress; sharing data, tools, and standards through the NDAR portal before they are shared with the rest of the ASD community.
To request this capability, an investigator is required to review the Ongoing Study Policy Addendum to the NDAR Policy and communicate with potential collaborators to develop an abstract for an ongoing study. Please refer to SOP-09 Request for Ongoing Study Approval for the complete procedure.
Datasets stored in the NDAR Central Repository are under strict security provisions, including but not limited to multiple firewalls, separate servers, and data encryption protocols. As a federal information system, NDAR follows the recommended security controls defined by the National Institutes of Standards 800-53r1 and related publications. NDAR undergoes an annual independent certification and assurance audit specific to the controls defined in 800-53r1 ensuring that the defined management, data recovery, procedural, and technical controls are followed.
NDAR has obtained a Certificate of Confidentiality for the data contained in NDAR, which helps to protect the privacy of human research participants. Investigators are encouraged to obtain their own Certificate of Confidentiality for data contained at their research site(s), or make data available to NDAR through data federation.
NDAR has developed specific policies, procedures, and tools to provide additional protections for data stored in the NDAR Central Repository and federated sites. These include:
Investigators must obtain appropriate informed consent from participants whose data will be shared with NDAR. Specific information must be added to consent forms. Sample language is available:
NDAR has developed a brochure that explains data-sharing in very clear language for parents. We encourage your intake coordinators to review it for use during enrollment.
This page was last updated: Nov 5, 2009
