Request for Information (RFI): Policy Comments on data sharing for the National Database for Autism Research (NDAR)

Notice Number: NOT-MH-06-107

Key Dates
Release Date: April 7, 2006

Issued by
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

Background
The National Database for Autism Research (NDAR) is a resource that will allow autism data to be shared among researchers and groups that are seeking to cure autism (http://ndar.nih.gov/).

The number of people diagnosed with autism has increased, and so has the need for finding its causes and cures. Autism researchers have been making great strides in the last 10 years in identifying and treating autism. Early treatment shows promising results in controlling its symptoms. Although research and treatment projects and programs have proliferated, it is often difficult to share data across programs and across approaches. By giving researchers access to more data than they can collect on their own and making their own data collection more efficiently utilized, the time to discovery can be reduced. The National Database for Autism Research will allow researchers to share their data in a collaborative environment that gives them access to data from studies others have undertaken.

The NIH has a data sharing policy in place that supports the concept of timely release and sharing of anonymized data from NIH funded studies (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). The NIH is seeking input from the community that will contribute to and inform NDAR regarding approaches to specific governance and policy issues.   The NDAR needs to develop policies regarding data sharing, such as what data should be shared and what the timelines should be for various levels of release.  Input from the potential NDAR users and contributors is sought for the following questions:

A. Timelines for sharing  data:

  1. What is the best approach for determining data sharing timelines? [NOTE:  “Data publication date” is not an acceptable approach because of variability and inconsistencies in time to acceptance and publication across journals.]
  2. Should timelines for data sharing be based on data collection dates, data “lock” dates (when all data have been cleaned and finalized), final subject visit date, or other criteria?  
  3. What timelines would you consider appropriate for data sharing from:
      1. Phenomenologic/observational studies
      2. Clinical trials
      3. Epidemiological investigations
      4. Longitudinal investigations - Specifically, when should data be shared in a study that lasts many years and has several stages before the final endpoint is reached?
  4. When is it appropriate to share data from baseline evaluations?  Would the timing depend on whether the data came from specific populations or from the measures collected?
  5. Should there be different policies for data that are unique to specific studies (e.g., site-specific measures, animal data, physiological recordings, molecular studies, etc.) than for data collected as common measures using standardized tests?  If so, how should the policies differ?

B. Access to the database

  1. What is the optimum approach for providing data access?
  2. Should there be different levels of access to the database, with different approval processes?  If yes, what categories of data access are desirable, and what controls should be in place at each level?
  3. Should certification of users be required? 
  4. Once access is granted to the database, what tools and assistance in analysis might be helpful to facilitate data sharing?

Responses
Please send responses to NDAR@mail.nih.gov no later than May 15, 2006.

Inquiries

Specific questions about this Notice may be directed to:

NDAR Program Office
National Institute of Mental Health
6001 Executive Boulevard, Suite 6200, MSC 9617
Bethesda, MD 20892-9617
Email: NDAR@mail.nih.gov


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