User:ClemsonGal/National Database for Autism Research

The National Database for Autism Research (NDAR) is a secure research data repository promoting scientific data sharing and collaboration among autism spectrum disorder investigators. This project was launched in 2006 as a joint effort between five institutes and centers at the National Institutes of Health (NIH): the National Institute of Mental Health (NIMH), the National Institute of Child Health and Human Development (NICHD), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Environmental Health Sciences (NIEHS), and the Center for Information Technology (CIT). The goal of the project is to provide a shared common platform for autism research to accelerate scientific discovery. Data from over 35,000 research participants are available to qualified investigators through the NDAR portal. Summary information about the available data is available to everyone through the NDAR public website.

Background
In response to the heightened societal concern over autism spectrum disorders (ASD), the United States Congress passed the [Combating Autism Act (CAA) of 2006 (P.L. 109-416)]. Through this Act, Congress intended to rapidly increase and improve coordination of scientific discovery in ASD research. The CAA mandated the creation of the Interagency Autism Coordinating Committee (IACC), a federal government advisory panel charged with developing and annually updating a Strategic Plan for ASD Research. This plan provides a blueprint for autism research that is advisory to Congress, the Department of Health and Human Services, and other federal agencies on the needs and opportunities for autism research. The IACC Strategic Plan was designed to detail research opportunities centered on the six most pressing questions facing those affected by autism and links them to specific research efforts. In 2009, the plan was finalized and submitted to the Secretary of the Department of Health and Human Services; a seventh question was added to the plan in 2010.

NDAR was launched by the NIH with the goal of improving sample sizes and enabling researchers to share data for increased analyses. Question 7, Objective H of the 2010 and 2011 IACC Strategic Plans emphasizes the creation of mechanisms to specifically support the contribution of data into NDAR from 90 percent of newly initiated projects NIH-funded autism projects, and the linking of NDAR with other existing data resources by 2012.

NDAR Organization
Write about who manages the project
 * List any management changes
 * List specific people?
 * Write about IACC, NIT, DAC, etc.

Global Unique Subject Identifier (GUID)
The NDAR GUID is a subject identifier used to protect the confidentiality of a research subject. When submitting data, an investigator who has appropriate access to a subject’s personally identifiable information (PII) uses NDAR-provided software (available only to ASD researchers) to create a unique identifier for each subject in their study. Information from particular fields on the subject’s birth certificate is entered into the software, and one-way hash codes are generated based on this input. The software transmits the encrypted codes to NDAR. The GUID for a subject is the same regardless of when or where it is generated. If the same subject enrolls in another investigator’s project or provides a biological specimen for a repository, the same information from his/her birth certificate is entered into the software by the second investigator and the same GUID is generated.

Data are always submitted to NDAR in association with a GUID, and the data in NDAR are indexed by the GUIDs. In this way, data from a de-identified individual subject can be aggregated, tracked and linked across projects, time, databases, and biobanks, so when studying one aspect of patient's presentation, an investigator can relate it to other data from the same patient.

NDAR has the ability to generate pseudo-GUIDs for those subjects whose birth certificate data is not available. A pseudo-GUID can be promoted to a standard GUID if the appropriate information is acquired; it cannot be used to aggregate data between laboratories.

The GUID is the result of a collaboration between NDAR, the Simons Foundation, Prometheus Research, and a team of researchers from Columbia University. It has become the standard as a patient identifier for autism research and serves as a model for similar standards in other research areas.

NDAR Data Dictionary
NDAR has established a data dictionary with over 300 clinical, imaging, and genomic research definitions. The definitions were created in close collaboration with the ASD research community. The data definition tool allows researchers to define their own data structures. To submit data to NDAR, researchers are required to format their data in accord with an existing data definition or define new data definition which will be available for use by other researchers. As of May 2012, NDAR contains over 35,000 discrete data elements.

Researchers confirm that their data conforms to the existing definitions by using the data validation tool. The validation tool ensures that naming conventions are defined, GUIDS are properly registered, and the reported data are consistent with the value ranges defined in the dictionary. All data contributed and shared must pass validation before they are submitted.

Also write about:
 * How this concept came about
 * Who specifically edits the data dictionary
 * Why it is useful and unique to NDAR

Imaging Data Definition
May write about how imaging data definition came about in NDAR...

Genomics Data Definition
May write about how genomics data definition came about in NDAR...

Data Federation
Discuss how the concept of federation came about, why it is useful and how it works

The Autism Genetics Resource Exchange (AGRE)
The Autism Genetic Resource Exchange is a collaborative gene bank for the study of ASD and is supported by Autism Speaks. AGRE houses a collection of genomic and clinical data on over 1,300 well-characterized multiplex and simplex families made available to the greater scientific community.

The Autism Tissue Program (ATP)
The Autism Tissue Program is a post-mortem brain donation program supported by Autism Speaks with the goal of accelerating the pace of neurobiological research in autism. The ATP has obtained brain tissue from more than 170 individuals with autism, epilepsy, and from their family members and other normal controls across the lifespan (4-64).

The Interactive Autism Network (IAN)
The Interactive Autism Network is a project of the Kennedy Krieger Institute and funded by Autism Speaks, the Simons Foundation, and the NIMH. IAN consists of two interrelated components: IAN Community and IAN Research. IAN Community provides the public with family-friendly, evidence-based information about ASD and ASD Research. IAN Research is a database and research registry. Since 2007, IAN has engaged over 38,000 participants in its online research.

Other Federal Databases
May briefly describe other federation and available databases, i.e. Pediatric MRI data repository; need to link out