Biospecimen Request Terms and Instructions
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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 resources are intended to provide structure to the request process, respect for intellectual contributions, and standards regarding security/confidentiality.
A major goal of the DIAN 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 reviews and processes requests from qualified investigators seeking access to biospecimens collected from DIAN research participants and banked for this purpose in the DIAN 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 tissue
Tissue from DIAN 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.
Whether banked in a DIAN Core or NCRAD, or transferred to another laboratory, these biospecimens remain under the authority of the DIAN Steering Committee. Investigators receiving DIAN biospecimens acknowledge this authority and will only use the materials in accordance with the ways approved by the DIAN Steering Committee. Third party sharing is not permitted without DIAN 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 samples
Investigators seeking access to DIAN biospecimens are strongly encouraged to contact and discuss their request with the relevant DIAN 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 biospecimens should be directed to the relevant Core Leader according to the biospecimen type:
- Plasma, serum, or cerebrospinal fluid (CSF)-Biomarker Core Leader, Dr. Anne Fagan, email: firstname.lastname@example.org
- Autopsied brain material-Neuropathology Core Leader, Dr. Nigel Cairns, e-mail: email@example.com
- DNA-Genetics Core Leader, Dr. Alison Goate, firstname.lastname@example.org
- Cell lines and Fibroblasts – Dr. Celeste Karch, email@example.com
Terms & Obligations of Resource Usage
Acceptance of DIAN 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 resources now or in the future, the recipient agrees to notify the DIAN 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 data sharing/publication policies (link to Data sharing page).Should funding result from this research now or in the future, please notify the DIAN 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 Steering Committee.
The review process for DIAN Biospecimens is different than for data-only requests. Requests for DIAN 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 PI, at least one of whom must be a DIAN Steering Committee member. Biospecimen requests are disseminated to the DIAN 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 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 goals/themes
- burden on DIAN biospecimen resources
- burden on DIAN staff
Priority of access and review/approval process
To respect intellectual contributions of DIAN investigators and collaborators, the following system has been adopted.
- DIAN-affiliated requests: Data analyses to support manuscripts can be developed and proposed by anyone in DIAN: Core Leaders, Site Leaders, other Steering Committee members, or any student, fellow, or investigator designated by a DIAN Site Leader. All data requests will be reviewed by the relevant Core Leaders and the Principal Investigator of DIAN. Upon approval, these requests will receive the most recent data freeze modules.
- External requests: For requests from those not affiliated with the DIAN study, upon approval, access to the previous data freeze will be granted. Such projects/manuscripts will follow the “DIAN-affiliated request” review and approval process (see next section). Publications by investigators outside DIAN would list the DIAN 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 Cores at Washington University School of Medicine. The investigator must take appropriate precautions.