Policies of the BCBC
Data and Reagent Sharing
Scientists participating in the Beta Cell Biology Consortium (BCBC) have agreed to freely share transgenic animals, reagents (antibodies and other), data, and expertise prior to publication. The BCBC is committed to fostering the careers of junior investigators, so that everyone associated with the BCBC benefits scientifically and in terms of career development. Moreover, whenever possible, it is expected that there will be cooperation between groups performing similar studies so as to minimize the duplication of research effort. Outlined below are the specific policies and guidelines regarding data and reagent sharing between BCBC-funded participants, and between the BCBC and the research community.
Sharing Among BCBC Members
The BCBC requires the sharing of all new mouse strains, reagents and data with other BCBC-funded participants prior to the initial peer-reviewed publication describing development of the resource, reagent or data. Sharing with other BCBC members prior to publication will be considered a collaboration, and will require 1) the written consent of the originating investigator, 2) agreement by the collaborating investigator to co-authorship status with the originator on the initial publication utilizing the new resource, and 3) a statement that there will be no transfer of the new resource to a third party without the written permission from the originator. The BCBC is committed to ensuring free and unencumbered sharing of information and resources within the consortium. Individuals found to be in breach of BCBC sharing policies may be subject to sanctions, including possible termination of their U19/U01 award by the NIDDK.
Ownership of ES Cell Lines, Mice, and Renewable Resources. One year after the creation of a new resource (ES cell clone, mouse strain, antibody, modified cell line, DNA construct, viral vector, protocol, or any other new reagent) or following the characterization and initial peer-reviewed publication announcing its development, whichever comes first, the resource will be freely distributed to investigators at academic institutions who want to make use of the resource for non-commercial research. ‘Freely distributed” is defined as unencumbered distribution patterned after practices of NIH-sponsored repositories, where distribution is carried out without regard to the requestor’s identity or experimental designs.
Distribution. The BCBC core facility or BCBC investigator responsible for generating the resource will be responsible for distribution to investigators prior to its submission to a central repository. The Executive Committee of the BCBC reserves the right to transfer mice generated with BCBC funds directly to an NIH supported mouse repository, such as the MMRRC (www.mmrrc.org) for the purpose of immediate cryopreservation. The Executive Committee of the BCBC also reserves the right to transfer specific renewable resources such as DNA constructs, monoclonal antibodies, genetically modified cell lines, and viruses for the purpose of facilitating distribution within the BCBC and to the scientific community at large.
Information about new resources developed by the BCBC will be posted on the BCBC website as soon as they become available. Additionally, all mice developed through the BCBC will be posted at the International Mouse Strain Resource (IMSR).
Sharing Between the BCBC and the Research Community
Sharing of Mice
Release and Licensing. Following the characterization and initial peer-reviewed publication announcing development of the modified mouse strain, mice will be freely distributed to investigators at academic institutions wanting mice for non-commercial research. We define “freely distributed” as an unencumbered distribution patterned after practices of NIH-sponsored repositories, where distribution is carried out without regard to the requestor’s identity or experimental designs. Individual requests for shipment of mice generated by this program to AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accredited institutions will be honored. The recipient investigators will provide written assurance and evidence that the animals will be used solely in accord with their local IACUC review; that animals will not be further distributed by the recipient without consent of the BCBC investigator who generated the mouse strain; and that animals will not be used for commercial purposes.
Distribution Plan. All modified mouse strains that are generated by BCBC funding will be deposited at an NIH supported mouse repository, such as the MMRRC (www.mmrrc.org). NIH supported repositories cryopreserve embryos or sperm and distribute the frozen embryos or mice to biomedical researchers.
Mouse Nomemclature and Husbandry. BCBC investigators will use standard nomenclature and receive approval from the Mouse Genome Informatic (MGI) nomenclature committee. To facilitate sharing and distribution of the transgenic/knockout mice and associated resources developed by the BCBC, mice will be maintained in a specific pathogen free facility. This facility will maintain the mice free of specific micro-organisms and pathogens (e.g. pinworms, mouse hepatitis virus (MHV), Sendai virus, mycoplasma, mites, etc.). Should the transgenic/knockout mice become infected with any of these micro-organisms, requestors will be made aware of the contamination within the line and mice will be re-derived through embryo transfer prior to shipment.
Sharing of Reagents and Intellectual Property Issues. Other research tools generated through BCBC funding, including renewable resources such as DNA constructs, monoclonal antibodies, genetically modified cell lines, etc., will be freely distributed upon request to qualified academic investigators for use in non-commercial research. BCBC investigators will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the “Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Grants and Contracts” issued in December, 1999. Specifically, material transfers would be made using the Simple Letter Agreement and without reach-through requirements. Should any intellectual property arise which requires a patent, we would ensure that the technology remains widely available to the research community in accordance with the NIH Principles and Guidelines document.
