Data Sharing Policy

The NIH states “Data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data.”¹ This document outlines the policy for sharing data internally within the Autism Consortium, though members are encouraged to go beyond these minimum standards in sharing data whenever possible. A separate document will be developed that addresses data sharing with external research groups.

This document is organized as a set of questions and answers and is meant to supplement the Autism Consortium Statement of Intent.

Q: What data will be shared?

A: Any de-identified data generated through Autism Consortium (AC) funding will be shared with any member of the Consortium. These data will be referred to as “AC data” throughout this document. AC data include data generated both in human subjects’ research and in laboratory research. The Consortium is committed to best practices in data standardization and will develop efficient mechanisms for sharing and dissemination of Consortium data. The Consortium also encourages its members to share non-AC data, i.e., data generated with non-AC funding, to the extent feasible under non-AC funder, external collaborator and institutional constraints.

Q: Who will have access to shared data?
A: Any member of the Autism Consortium. Autism Consortium members are those who have agreed to the Autism Consortium commitment statement, and who, on an annual basis, update the Autism Consortium Wiki with any autism research activities being conducted within their laboratories. Autism Consortium members acquiring shared data are bound by the commitment statement concerning the use of the data and are responsible for monitoring the use of shared data by members of their laboratories. 

Q: How can a member of the Autism Consortium gain access to shared data?

A:  By completing a data request form on the Autism Consortium Wiki. The data request form will ask for a brief description of the proposed study and the type of AC data needed for the study. Depending on the nature of the data requested, access will either be immediate, or it will require approval at the next monthly meeting of the Autism Consortium Executive Committee. In all cases, requestors will need to agree to the “Terms and Conditions” for use of shared data.

Q: How will the rights of individual research subjects be protected?  

A: Each subject in the database will be associated with a unique identifier.  Data shared within the Consortium will be keyed to this unique identifier and will not reveal individual names and other identifying information, consistent with the HIPAA Privacy Rule[5]. AC researchers may request identifiable information only with consent of the research subjects and with Institutional Review Board approval of the study.

  

Q: How will institution-specific Institutional Review Board (IRB) regulations and restrictions are addressed?

A: The staff and research protocols at each institution will comply with the regulations and requirements set by the IRB of the institution. Should substantive revisions of IRB protocols and consent forms be required by an individual IRB, the research coordinators, Executive Director, and Business Advisory Board will work with the institution’s IRB to resolve issues.

Q: How will institution-specific intellectual property regulations and restrictions be addressed?

A: The Autism Consortium Business Advisory Board and Executive Director will work with each of the AC institutions to develop an approach that is consistent with the data sharing policy described in this document.
   

Q: What is the publication policy if shared AC data have been used in the reported research?

A: Authors are listed by name and authors should also list the Autism Consortium as one of their affiliations. Where individuals have contributed data but are not listed as authors by name, the “Autism Consortium” is listed as an additional author, e.g., “Smith A, Jones B, and the Autism Consortium”, and these other significant contributors should be listed by name in a footnote.