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 resources are intended to provide structure to the request process, respect for intellectual contributions, and standards regarding security/confidentiality.
Biospecimen sharing
A major goal of the DIAN Obs project is the creation of a participant registry, database and biospecimen repository to support research toward discovering antecedent biomarkers and therapeutic targets for Alzheimer disease (AD). DIAN Obs reviews and processes requests from qualified investigators seeking access to biospecimens collected from DIAN Obs research participants and banked for this purpose in the DIAN Obs Biomarker, Genetics (including at the National Cell Repository for Alzheimer Disease [NCRAD]), and Neuropathology Cores. These biospecimens include cerebrospinal fluid, plasma, serum, cell lines, DNA, fibroblasts and brain tissue; please see “Data and Biospecimens Available for Sharing” on the DIAN website. Please see the Biomarker and Neuropathology Core procedures manuals for details of biospecimen collection.
Restrictions on access to DIAN Obs tissue
Tissue from DIAN Obs participants cannot be used for exploratory research. Investigators seeking access to this resource must first demonstrate the hypothesized effect in tissue from sporadic AD compared to cognitively normal controls, unless a mutation specific effect is hypothesized. Demonstration of the effect in animal or cell models is good, supporting evidence but does not replace the need to demonstrate the effect in sporadic AD tissue. Please note that tissue requests for specified number of samples are pending aliquot availability.
Authority
Whether banked in a in a DIAN Obs Core or NCRAD, or transferred to another laboratory, these biospecimens remain under the authority of the DIAN Obs Steering Committee. Investigators receiving DIAN Obs biospecimens acknowledge this authority and will only use the materials in accordance with the ways approved by the DIAN Obs Steering Committee. Third party sharing is not permitted without DIAN Obs approval. Unless approved for a longer period of time, all requests are “active” for a maximum of 18 months or until the number of approved samples has been provided, whichever comes first.
Requesting DIAN Obs samples
Investigators seeking access to DIAN Obs biospecimens are strongly encouraged to contact and discuss their request with the relevant DIAN Obs Core Leader in advance of submitting a request. Such questions should address biospecimen collection protocols, types of tissue available, etc. Please avoid questions that would require database inquiries (ie., how many samples have XX?) Specific questions regarding DIAN Obs biospecimens should be directed to the relevant Core Leader according to the biospecimen type:
- Plasma, serum, or cerebrospinal fluid (CSF)- Biomarker Core Leader, Dr. Laura Ibanez, ibanezl@wustl.edu
- Autopsied brain material-Neuropathology Core Leader, Dr. Richard Perrin, rperrin@wustl.edu
- DNA-Genetics Core Leader, Dr. Alison Goate, alison.goate@mssm.edu
- Cell lines and Fibroblasts – Dr. Celeste Karch, karchc@wustl.edu
Terms & Obligations of Resource Usage
Acceptance of DIAN Obs resources obligates the recipient to cite/reference the grant (Dominantly Inherited Alzheimer Network, U19AG032438) in any presentation or publication that may result from this research. Should publications result from the use of DIAN Obs resources now or in the future, the recipient agrees to notify the DIAN Obs Executive Director with details (reference or PubMedCentral ID#) and provide a copy of the publication so productivity derived from our resources can be reported 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 (link to Data sharing page). 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 productivity derived from our resources can be reported to NIA. No sharing of data with a third party is allowed without permission of the DIAN Obs Steering Committee.
Review process
The review process for DIAN Obs Biospecimens is different than for data-only requests. Requests for DIAN Obs biospecimens should detail the associated data elements to accompany the samples. After initial review, the request is assigned to two to three reviewers selected in consultation with the DIAN Obs PI, at least one of whom must be a DIAN Obs Steering Committee member. Biospecimen requests are disseminated to the DIAN Obs Steering Committee for voting. A simple majority is required for approval. Upon final approval from the Steering Committee, the request will be forwarded to the relevant Core to prepare and ship the samples, in consultation with the DIAN Obs Biostatistics Core. A Material Transfer Agreement also is needed and will be sent to the investigator following approval of the request. The criteria for review are:
- scientific merit and feasibility
- demonstration of preliminary data from sporadic AD
- appropriateness of the investigator’s qualifications for proposed methods
- relevance to DIAN Obs goals/themes
- burden on DIAN Obs biospecimen resources
- burden on DIAN Obs staff
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-affiliated request” review and approval process (see next section). Publications by investigators outside DIAN Obs would list the DIAN Obs Study Group in the acknowledgments with the required paragraph at the end of this document.
Suggested timeline for resource requests
- Allow 30-60 days for the review process (data only)
- Allow 60-90 days for tissue requests (require external review)
- Allow 30 days for interaction with the Biostatistics Core to provide dataset.
Disclaimer: Screening for infectious agents is NOT performed on samples provided by the DIAN Obs Cores at Washington University School of Medicine. The investigator must take appropriate precautions.