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NIH HIV Reagent Program – Deposited Material / Data Sharing and Release Policy
The NIH HIV Reagent Program 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 NIH HIV Reagent Program 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 the NIH HIV Reagent Program 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 NIH HIV Reagent Program Catalog
The NIH HIV Reagent Program maintains a constant queue of materials for production in the NIH HIV Reagent Program catalog, and materials will be processed as received or otherwise prioritized by NIAID. Depending on the category and resources available to the NIH HIV Reagent Program, 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 NIH HIV Reagent Program catalog at any time prior to or following material transfer, but the NIH HIV Reagent Program 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 NIH HIV Reagent Program material production queue or NIAID prioritization of incoming deposited material requiring allocation of resources to other projects.
Unsolicited materials received by the NIH HIV Reagent Program that have not been accepted and approved for deposit by the NIH HIV Reagent Program 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 the NIH HIV Reagent Program, nor released to the NIH HIV Reagent Program 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.
The NIH HIV Reagent Program 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 the NIH HIV Reagent Program 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 the NIH HIV Reagent Programs disposal. Depositors may receive requests for replacement of the deposited material, notification or validation of the NIH HIV Reagent Programs findings and requests for technical assistance or further supporting information when relevant. The NIH HIV Reagent Program 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 NIH HIV Reagent Programs 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 the NIH HIV Reagent Program at the time of provision that the information is not to be released with the reagent to the NIH HIV Reagent Program 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.
The NIH HIV Reagent Program may withhold certain culture or reagent information and details on use of materials regulated at BSL2 and higher 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 the NIH HIV Reagent Program at the appropriate safety level and access to web documentation, when available, will be granted with an approved NIH HIV Reagent Program Registered User Login and Password.
Confidentiality of depositor supplied material and culture/reagent data; deposited material research
The NIH HIV Reagent Program is tasked with authentication, quality control and regulatory review of deposited materials prior to their accessioning and release to the NIH HIV Reagent Program catalog. To the extent necessary to meet the production, characterization, preservation and accessioning requirements of the deposited materials, the NIH HIV Reagent Program may conduct research necessary to produce, document and accession the deposited materials into the NIH HIV Reagent Program 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 the NIH HIV Reagent Program.
NIAID can require that some reagents be acquired, produced and distributed to the research community with little to no authentication. In this case, the NIH HIV Reagent Program 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 the NIH HIV Reagent Program.
The NIH HIV Reagent Program 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. The NIH HIV Reagent Program and contractor staff will not conduct research on deposited materials prior to release to the NIH HIV Reagent Program 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.
The NIH HIV Reagent Program and contractor staff will not intentionally delay the release of any accepted and approved material deposited with the NIH HIV Reagent Program to the NIH HIV Reagent Program 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.