View PAIN Data Sharing Policies as pdf
The Pain and Interoception Imaging Network (PAIN) seeks to characterize brain signatures associated with chronic pain disorders, understand underlying mechanisms, and identify novel treatment targets.
PAIN data will be used for the purposes of research and analysis, and may be accessed by PAIN network authorized investigators with pre-approval from the PAIN Executive Committee (EC). Once fully populated, PAIN data are expected to be made widely available in the future to investigators affiliated with an educational or scientific institution.
Membership
Membership to the PAIN Archived Repository is open to any pain investigator who is willing to contribute data and upon completion and approval of their online application and acceptance of the data sharing agreement. Members may contribute structural, resting state or DTI scans that do not conform to the PAIN Standardized parameters along with minimal demographic data. PAIN aims to promote scientific collaborations between all participating members: all contributing investigators are encouraged to provide the study methods accompanying the datasets they bring to the PAIN Archived Repository. On the other hand, all investigators planning to analyze an archived data set are encouraged to interact with the investigators that contributed the data set. Membership to the PAIN Archived Repository grants the investigator the right to access all other datasets contained in the Archived Repository.
Membership to the PAIN Standardized Repository is open to any pain investigator willing to contribute structural, DTI and resting state brain scans (preferably all 3 imaging modalities) acquired according to PAIN standardized study protocols and the established basic set of metadata. The investigator agrees to contribute data from a minimum of 20 subjects per year. Membership requires completion and approval of an online application and acceptance of the data sharing agreement. Membership to the PAIN Standardized Repository grants the investigator the right to access all data contained in both the PAIN Standardized and Archived Repositories.
Membership to the PAIN Repository is non-transferable. If another Principal Investigator assumes the research project, a new data sharing agreement in which the new recipient is designated is necessary. If the recipient changes institutions and wishes to retain access to the PAIN Repository a new data sharing agreement with the new institution agreeing to the PAIN Repository policies is necessary.
Data Format and Storage
To facilitate integration among scanners and information systems, all data submitted to the PAIN Repository should be in DICOM format.
The PAIN Repository should not be used by members as the sole or primary place for storage of any of their datasets. Instead, contributing investigators should always maintain readily accessible copies of their own data in their respective sites.
Data Distribution
Access to PAIN Standardized Data is open only to contributing members of the PAIN Standardized Repository who have accepted a data sharing agreement and completed the online data request application, describing the proposed research by qualified users. Only complete applications and proposals with a clear research focus will receive approval by the PAIN Executive Committee (EC) and access to download PAIN data from the repository.
PAIN Archived Data are accessible to contributing members of the PAIN Repository and requires acceptance of the data sharing agreement and completion of an online data request application.
Data recipients agree not to disclose, use or otherwise grant access to data obtained from the PAIN Repository in any manner to entities or individuals other than their research staff, who will also adhere to the PAIN Repository policies, except as expressly permitted by the PAIN Repository data sharing policies or otherwise required by law.
PAIN data recipients agree to establish appropriate technical, physical and administrative safeguards for data protection and maintenance of confidentiality, as well as to prevent unauthorized access and use of the data.
PAIN data recipients agree not to attempt to identify or contact any subject whose data are owned by other investigators and included in the PAIN Repository.
In the event of an unauthorized use or disclosure of data obtained from the PAIN Repository not covered by this agreement, the PAIN data recipient agrees to report such use or disclosure within fifteen days of becoming aware of the event.
Publications
The PAIN Network will share research findings with the scientific community through scientific abstracts and publications.
Publications from PAIN Standardized Data
The publication policy for the repository will closely follow NIH consortia policy, with an emphasis on fostering collaboration, making the most efficient and productive use of repository data and providing fair and timely access to all members. The policy includes the following specific points:
- All analyses and publication plans using data from the Standardized PAIN repository must be approved by the EC prior to the start of such analyses.
- Members submit analysis proposals in writing to the EC using the data request form prior to downloading scanning and metadata. These proposals are checked for overlap with other ongoing or proposed analyses and are either approved or, in the cases of overlap, discussed with the parties involved to reach an equitable division of data or collaborative approach. The EC will act promptly on each proposal and is expected to give approval or a discussion within two weeks of receiving a proposal. Approved proposals will be posted on the PAIN blog for input from all members to assure full agreement of all members.
- Each proposal includes a timeline and if an analysis is not making adequate progress, it may lose priority and need to be resubmitted.
- Publications using PAIN Repository data should include “PAIN Repository” under contributing institutions, as well as the following acknowledgement:
“Research reported in this publication was supported by the National Institutes of Health (NIDA and NCCAM) under award number 1R01AT007137.”
- Each investigator is required to submit a draft of the manuscript to the EC before submittal for publication for review for proper acknowledgement to the PAIN Repository, and to ensure the material conforms to the original approved hypotheses and scope and does not overlap with other approved manuscript proposals using the same data.
- Authors should inform the PAIN EC of any publications utilizing PAIN Repository data, and provide the URL/ PubMed link to published work, if permitted by the journal.
Publications from PAIN Archived Data
- Members must complete and submit the data request form.
- Publications using PAIN Archived Repository data should include “PAIN Repository” under contributing institutions, as well as the following acknowledgement:
“Research reported in this publication was supported by the National Institutes of Health (NIDA and NCCAM) under award number 1R01AT007137.”
- Each investigator is required to submit a draft of the manuscript to the Publications Committee before submittal for publication for review for proper acknowledgement to the PAIN Repository, and to ensure the material conforms to the original approved hypotheses and scope and does not overlap with other approved manuscript proposals using the same data.
- Authors should inform the PAIN EC of any publications, inventions, and abstracts utilizing PAIN Repository data, and provide the URL/ PubMed link to published work.
Confidentiality and Subject Protection
All datasets uploaded to the PAIN Repository require approval from their local IRB or equivalent institutional review board for collection and for coded* sharing such as the transfer to the repository. Interested contributors should request a determination from their IRB if the data sharing itself falls under the definition of “human subjects research.” The PAIN staff can assist in the removal of personal identifiers from the data if needed.
*Data are separated from personal identifiers through the use of a code. The code key will be held by the contributor only, and the PAIN Repository will never retain this linking file or have access to the code. PAIN data do not contain any personal identifiers.
The PAIN Repository contains coded data, meaning all descriptive information that would link a set of data with the identity of a subject has been removed. Data acquired following the PAIN Repository protocols for standardized data may contain neuroimaging, clinical and behavioral data, (and in the future biological samples), and includes demographics and primary diagnosis. To protect human subject confidentiality, personal information such as names, addresses, SSN, telephone numbers or other elements which could potentially be used to identify study participants will be removed prior to the transfer of data to the PAIN Repository.
Some biological information that is stored along with scanning data (such as genetic data) may in rare cases have the potential for subject identification and this needs to be reflected in the IRB approval for that data. Investigators must ensure that the contents of the datasets they provide to the PAIN Repository do not violate confidentiality agreements made with research subjects.
Investigators contributing data to the PAIN Repository agree not to disclose codes or identifiers which could potentially allow the identification of subjects to the PAIN Repository staff, PAIN Repository members or data recipients.
Communications with the PAIN Repository staff should preferably be carried on using secure and/or encrypted email.
Quality Control
All data submitted to the PAIN Repository will be initially quarantined until assessed for valid image files, correct formats and inclusion of relevant metadata.
All PAIN Standardized data will undergo comprehensive quality control prior to be made available in the repository. Results of the quality control process will be provided to data owners within xxx…. days of uploading the data, including pass/fail assessments. PAIN Archived Repository data will undergo automated quality control prior to be made available.
The exclusion criteria for imaging data include, but it is not limited to: excessive movement, scanner malfunction, artifacts, and incomplete brain coverage. The PAIN Repository reserves the right to exclude datasets, metadata and subjects due to failing the quality control process and/or at the discretion of the PAIN EC.
Termination
User accounts that remain inactive for 12 consecutive months may be closed at the discretion of the PAIN Repository.
Either the PAIN Repository or the PAIN collaborator may terminate membership to the PAIN Repository and the data sharing agreement without cause by providing 30 days written notice to the other party. Upon the principal investigator’s written request, data he/she owns and uploaded to the PAIN Repository will no longer be made available to other repository members from that point in time forward. However, data previously downloaded from the PAIN Repository by other members will not be recalled.
Disclaimer
Although every attempt is made to provide accurate database contents, data are submitted by diverse parties and occasional discrepancies may occur. In that event, reasonable measures will be applied to promptly correct errors. However, the PAIN Repository makes no warranty or representation, either implied or expressed, with respect to the accuracy of any data deposited in the PAIN Repository, nor it warrants results which may be obtained by using the data for any purpose.
The PAIN Repository will not be held liable for any direct, indirect, special, incidental or consequential damages arising out of the use and/or the inability to use the PAIN Repository website or any dataset contained in the repository. This includes but is not limited to the loss of data or loss of profit, even if the PAIN Repository was advised of the possibilities of such damages.
The PAIN Repository policies and procedures are subject to change by the PAIN EC at any time without notice.