NIAID BEI Resources – Deposited Material / Data Sharing and Release Policy
BEI Resources complies with and adopts the NIAID-DMID Data Sharing and Release Guidelines as its policy for acceptance, handling and release of deposited material to the BEI Resources catalog, release of associated depositor data for deposited material, and availability of authentication and quality control data for the deposited material produced.
Depositors and users of BEI Resources materials should be aware of the following caveats with regard to availability and release of deposited material and associated data.
Expectations on Production and Release of Deposited Materials into the BEI Resources Catalog
BEI Resources maintains a constant queue of materials for production in the BEI Resources catalog, and materials will be processed as received or otherwise prioritized by NIAID. Depending on the category and resources available to BEI Resources, production of accepted and fully documented deposited materials may be delayed for prolonged periods when the production queue is extensive. Depositors may request an estimate of time required for release of approved materials to the BEI Resources catalog at any time prior to or following material transfer, but BEI Resources cannot guarantee the estimated time span quoted, due in part to the unpredictable nature, condition, viability or other performance of newly received deposit materials, the BEI Resources material production queue or NIAID prioritization of incoming deposited material requiring allocation of resources to other projects.
Unsolicited materials received by BEI Resources that have not been accepted and approved for deposit by BEI Resources and NIAID, and unsolicited or solicited materials for which fully completed Deposit form paperwork and institutional authorization have not been received, will not be processed and produced by BEI Resources, nor released to the BEI Resources catalog, until all approvals and required paperwork are received.
Deposit forms lacking required depositor, culture or reagent information, missing critical information required for processing or handling the culture or reagent (including but not limited to biosafety information, special protocols for growing, producing or characterizing the culture or reagent) will result in delays in production or release of the deposited material. Forms may be returned to the depositor for amendment or more information may be requested even if prior notification of acceptance of the material and deposit information was received.
BEI Resources maintains a stringent authentication and quality control program that includes purity (free of adventitious pathogens or contaminants) and mycoplasma testing for many cultures received. Cultures and reagents failing to authenticate by genotype or phenotype, where applicable, against depositor supplied data, publicly available genomics/proteomics or other metadata, or BEI Resources standards, controls or data, will not be released to the catalog, or will only be released with disclaimer or notification of the observed deviation.
Depositors will be notified of deposited cultures or reagents that are non-viable, contaminated with mycoplasma or other adventitious pathogens, or fail to authenticate or perform as expected based on depositor supplied information, published research information, comparison to database sequences, type or reference strain, reagent, controls or other supporting information or supporting assay results at BEI Resources disposal. Depositors may receive requests for replacement of the deposited material, notification or validation of BEI Resources findings and requests for technical assistance or further supporting information when relevant. BEI Resources may treat cultures or reagents for contaminating organisms (e.g. Mycoplasma spp.) or otherwise purify reagents to meet release criteria standards for purity and sterility of the cultures or reagents.
Depositor supplied data may be released to the BEI Resources website in support of the culture or reagent, usually within the accession record / reagent information page, associated product sheet, certificate of analysis, safety data sheet or other documentation. Depositors supplying data not intended for public release must make it clear to BEI Resources at the time of provision that the information is not to be released with the reagent to the BEI Resources catalog, and may be asked to justify the withholding of the depositor information if the information is required for production or use of the reagent.
BEI Resources may withhold certain culture or reagent information and details on use of materials regulated at BSL2 and higher, including select agents, from public view on its website accession records, product sheets and Certificates of Analysis (COA). Access to these reference materials requires an approved registration with BEI Resources at the appropriate safety level and access to web documentation, when available, will be granted with an approved BEI Resources Registered User Login and Password.
Confidentiality of depositor supplied material and culture/reagent data; deposited material research
BEI Resources is tasked with authentication, quality control and regulatory review of deposited materials prior to their accessioning and release to the BEI Resources catalog. To the extent necessary to meet the production, characterization, preservation and accessioning requirements of the deposited materials, BEI Resources may conduct research necessary to produce, document and accession the deposited materials into the BEI Resources catalog. Depositors are asked to supply information required to meet these needs, and information that is to be withheld from public release should be identified by depositors at the time of material and data transfer to BEI Resources.
NIAID can require that some reagents be acquired, produced and distributed to the research community with little to no authentication. In this case, BEI Resources will only include depositor or supplier provided data regarding reagents or cultures with a disclaimer the material has not been fully authenticated or quality controlled by BEI Resources.
BEI Resources and contractor staff handle deposited materials under best practices for repository management under the MID-BRR contract. BEI Resources recognizes and acknowledges depositor intellectual property rights and expectations of the scientific community for timely release of deposited materials that have been approved by NIAID. BEI Resources and contractor staff will not conduct research on deposited materials prior to release to the BEI Resources catalog, when not required for the production, authentication, quality control, and accessioning of the deposited material, unless done in collaboration with the depositor or at the guidance of NIAID. Any research not directly related to the activities described above requires explicit notification and approval from, or formal agreement to collaborate with, the depositor and /or depositor’s institution.
BEI Resources and contractor staff will not intentionally delay the release of any accepted and approved material deposited with BEI Resources to the BEI Resources catalog for the purposes of research not directly related to authentication, quality control, permit or safety concerns or accessioning of the deposited material. Any delay for release of deposited material due to research purposes not directly required for material production, authentication, quality control, regulatory review or accession and documentation requires notification and consent of the depositor and / or NIAID.
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