We follow the principles of Productivity (with Recognition of the investigator who develops a research idea and does the work to publish it), Transparency, Fairness, and Inclusiveness. The following policies regarding access to DIAN Obs data are intended to provide structure to the request process, respect for intellectual contributions, and standards regarding security/confidentiality.
Request process
All requests to access data must be submitted through the electronic data request form available on this website. The form includes several essential components for review:
Required Information
- Investigator Affiliation & Contact Information
- Full name, institutional affiliation, and contact details.
- Funding Support
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Approval (if applicable)
- NIH-style Biosketch
- Proposal/Abstract: Please provide a brief description of the project that should include the following key sections:
- Study Purpose/Goal
- A concise overview of your study, outlining its main objective and hypothesis.
- Study Aims
- List up to four specific aims of the study, with at least one aim clearly described.
- Background/Preliminary Data
- Provide data that demonstrates the feasibility of your study and supports your hypothesis. Avoid summarizing the background and include relevant figures and tables to reinforce your aims.
- Analytical Plan (include the following details)
- Methods: Detailed methodology for the proposed analysis.
- Inclusion/Exclusion Criteria: Criteria defining who will be included in the study and who will be excluded.
- Sample Size Justification: Explain how the sample size was determined and its adequacy for the study.
- Variables for Analysis: Be specific about the variables you are requesting and provide justification for their inclusion.
- Example: Requested data variables: clinical, demographic, imaging, and other relevant data.
- Study Purpose/Goal
Please ensure that your proposal is comprehensive and meets all of the specified requirements before submission. Investigators requesting data also will be required to sign a data user agreement (DUA) and an acknowledgment agreement, as specified below.
Applications for data use will be reviewed by the Principal Investigator (PI) and relevant DIAN Obs Core Leaders. The number and nature of all data requests will be tracked by the DIAN Obs Administration Core, and reports will be submitted to the National Institute on Aging (NIA).
The Biostatistics Core will prepare a data file containing only the requested data elements and will assign a participant identification number that maintains confidentiality. Investigators will not have access to participant identities, which are replaced by recoded identifiers.
Image data will be available to approved investigators in post-processed formats via the DIAN Central Archive (DCA), following the signing of the Data Use Agreement (DUA) by both institutions.
Terms & Obligations of Resource Usage
Acceptance of DIAN Obs data obligates the recipient to cite/reference the NIA grant (Dominantly Inherited Alzheimer Network, U19AG032438) and the Alzheimer’s Association (SG-20-690363-DIAN) in any presentation or publication that may result from this research. Publications should also acknowledge the funding agencies from the DIAN Obs self-funded sites including the following: the German Center for Neurodegenerative Diseases (DZNE), Raul Carrea Institute for Neurological Research (FLENI), Partial support by the Research and Development Grants for Dementia from Japan Agency for Medical Research and Development(AMED), the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), Korea Dementia Research Center (KDRC), funded by the Ministry of Health & Welfare and Ministry of Science and ICT, Republic of Korea RS-2024-00344521, and Spanish Institute of Health Carlos III (ISCIII).
Specific language should be included in each DIAN Obs publication detailing DIAN Obs as an author (please see the Publication Policy page). If fibroblasts (or iPSCs) are shared, any iPSCs generated from DIAN Obs fibroblasts must be shared back with DIAN Obs. We also request that any genetic data obtained on cell lines be shared with DIAN Obs for use by others. Additionally, we request that Dr. Celeste Karch be included as an author on any and all publications containing data produced from the iPSCs generated in her laboratory at Washington University.
Should publications result from the use of DIAN Obs resources now or in the future, the recipient agrees to notify the DIAN Obs Administration Core with details (reference or PubMedCentral ID#) and provide a copy of the publication so that DIAN Obs may report productivity derived from our resources to the funding agency, the National Institute on Aging (NIA). Such publications require compliance with NIH public access policies and DIAN Obs data sharing/publication policies.
Should funding result from this research now or in the future, please notify the DIAN Obs Executive Director with details (grant title, sponsor, number, dollar total, dates) so so that DIAN Obs may report productivity derived from our resources to NIA.
No sharing of data with a third party is allowed without permission of the DIAN Obs Steering Committee.
Any costs generated in sharing data or biospecimens will be paid by the recipient investigator.
Recipient of data/biospecimens will provide documentation of IRB approval valid for the analysis of DIAN Obs data/biospecimens (or acknowledgment from your IRB that receiving coded data/biospecimens without access to identifiers is not considered “research” requiring review).
De-identified DIAN Obs data will be made available to investigators to conduct analyses after approval by the PI and the relevant DIAN Obs Core Leader
Review process
The Scientific Director of DIAN Obs, or designee of DIAN Obs (i.e., Administration Core) will review the request and determine the relevant Cores that are required for the review of the proposal. Then the application will be sent to those Core Leaders and the Principal Investigator to review and approve or deny the request. When Core Leaders do not reach a consensus about the request or agree not to approve, further review by the Steering Committee may be necessary. To avoid overlapping effort, investigators are encouraged to use the search option on the DIAN Obs Investigator Resources page to see what other requests might be similar to theirs.
Criteria for review
Data requests will be reviewed based on the following criteria:
- Scientific merit and feasibility (e.g. availability of DIAN Obs resources to fulfill the request)
- Appropriateness of the investigator’s qualifications and resources to protect the data.
- Appropriateness to DIAN Obs goals/themes
Priority of access and review/approval process
To respect intellectual contributions of DIAN Obs investigators and collaborators, the following system has been adopted.
- DIAN Obs-affiliated requests: Data analyses to support manuscripts can be developed and proposed by anyone in DIAN Obs: Core Leaders, Site Leaders, other Steering Committee members, or any student, fellow, or investigator designated by a DIAN Obs Site Leader. All data requests will be reviewed by the relevant Core Leaders and the Principal Investigator of DIAN Obs. Upon approval, these requests will receive the most recent data freeze modules.
- External requests: For requests from those not affiliated with the DIAN Obs study, upon approval, access to the previous data freeze will be granted. Such projects/manuscripts will follow the “DIAN Obs-external request” review and approval process. Publications by investigators outside DIAN Obs would list the DIAN Obs Study Group in the acknowledgments with the required paragraph provided on the Publication Policy page under Required language to appear in acknowledgments of all publications using DIAN Obs resources.
Suggested timeline for resource requests
- Data requests: Allow 30-60 days for processing.
- Biospecimen requests: These requests are reviewed bi-annually with submission deadlines on February 15 and August 15. After a request is approved, allow 60-90 days from approval for processing.
- iPSC Requests: The review process for induced pluripotent stem cell (iPSC) lines follows the same timeline as the data request process.
- Biostatistics Core Interaction: Allow 30 days for the Core to provide the requested dataset.