Organizational Structure and Approach. A. The LOT and Human Material LOT are attached to this Agreement as Appendix A and Appendix B respectively and are the means by which Material and/or Data shall be made available to External Investigators. The Parties agree the LOT and Human Material LOT shall be negotiated by the U24-CCS and signed by the External Recipient. The U24-CCS shall consult with PROVIDER (to the extent applicable) in the review and approval of the Human Material LOT.
B. The U24-CCS shall be responsible for systematically evaluating requests for sharing of Materials. The U24-CCS will determine whether the request is approved in full, approved contingent upon modification, or disapproved. Following approval by the U24-CCS, the applicable CONSORTIUM MEMBER shall be notified by the U24-CCS and shall use reasonable efforts to provide the Material and/or Data to the External Recipient in accordance with the applicable LOT or Human Material LOT. The addresses for notices are listed in Appendix C. The U24-CCS shall be solely responsible for ensuring compliance with U.S. laws, rules and regulations related to export control and shall conduct all compliance reviews of the External Recipient institution, of the External Recipient’s scientist and those under the control of the External Recipient’s scientist who will use the Material and/or Data, and of the proposed research with the Material and/or Data.
C. The U24-CCS shall store and maintain the accepted LOT or Human Material LOT.
D. The U24-CCS has responsibility for preparing, codifying, and overseeing implementation of the policies regarding release of Materials to External Recipients.
E. The guidelines described herein refer specifically to Materials and/or Data stored by CONSORTIUM MEMBER(S).
Organizational Structure and Approach. 2.1.1 The PERCH Biorepository Specimen and Access Committee has responsibility for systematically evaluating requests for sharing of Materials. The members of that committee will determine whether each request for Materials is approved in full, approved contingent upon modification, or disapproved.
2.1.2 The PERCH Biorepository Specimen and Access Committee consists of:
a. The PERCH Executive Committee (10 members);
b. A representative from the Foundation (1 member);
2.1.3 Decisions of the PERCH Biorepository Specimen and Access Committee will be made by majority vote of those committee members in attendance, provided that a quorum is reached. For the purposes of this Agreement, a quorum will be achieved with the Coordinating PI, at least one of the other Core team members of the EC and at least 4 site PI members of the EC.
2.1.4 The PERCH Executive Committee has responsibility for preparing, codifying, and overseeing implementation of the policies of the PERCH Biorepository Specimen and Access regarding release of Materials.
2.1.5 Release of Materials is contingent upon final approval from the site, including local ethics and (where applicable) scientific committee(s), and receipt of transport permits (where applicable).
2.1.6 The guidelines described herein refer all Materials collected as part of the PERCH project, including those stored at the PERCH site laboratories as well as in the Central Repository maintained at the Canterbury Health Laboratories (CHL), Christchurch, New Zealand.
2.1.7 The PERCH Specimen Repository includes study materials centrally located at CHL as well as study materials stored at the PERCH research sites. The central repository will contain the following Materials collected from enrolled cases and controls from each of the sites:
(a) Pathogens isolated from blood, nasopharyngeal, induced sputum, pleural fluid, and lung aspirate specimens, with the exception of Mycobacterium tuberculosis.
(b) Whole blood, sera, nasopharyngeal, induced sputum, and urine specimens.
(c) Additional material, such as extracted nucleic acid used in PCR assays. All study materials not shipped to CHL will be maintained locally at the PERCH research sites. Sites may also request samples to be returned from the central repository for local storage.
2.1.8 Study materials remaining at the sites, though not part of the PERCH Central Repository, will be governed by this Agreement in the same manner as those that are part of the Central Repository.
2.1.9 The ...
