Common use of Requester and Approved User Responsibilities Clause in Contracts

Requester and Approved User Responsibilities. The Requester agrees that the Approved User has reviewed and understands the principles for responsible research use and data management of the genomic datasets as defined in the NIH Security Best Practices for Controlled-Access Data Subject to the GDS Policy. The Requester and Approved User further acknowledge that they are responsible for ensuring that all uses of the data are consistent with national, tribal, and state laws and regulations, as appropriate, as well as relevant Requester policies and procedures for managing sensitive genomic and phenotypic data. The Requester certifies that the Approved User is in good standing (i.e., no known sanctions) with the Requester, relevant funding agencies, and regulatory agencies and is eligible to conduct independent research (i.e., is not a postdoctoral fellow, student, or trainee). The Requester and any Approved User may use the dataset(s) only in accordance with the parameters described on the dbGaP website for the appropriate research use, as well as any limitations on such use, of the dataset(s) and as described in the DAR and as required by law. The Approved User agrees to submit either a Project Renewal or Project Close-out request prior to the expiration date of the one-year data access period. The Approved User also agrees to submit an annual progress update or a final progress report prior to the one-year anniversary of the DAR, as described under Article 9 (Research Use Reporting) below. Failure to submit a Project Renewal or to complete the Project Close-out process, including confirmation of data destruction by the Requester through its Institutional Signing Official, may result in termination of all current data access and/or suspension of the Approved User and all associated personnel and Requester Collaborators from submitting new DARs for a period to be determined by NIH. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. An Approved User who has access to personal identifying information for research participants in the original study at the Requester or through their Requester Collaborators may be required to have IRB approval. By approving and submitting the attached DAR, the Requester through its Institutional Signing Official provides assurance that relevant institutional policies and national, tribal, and state laws and regulations, as applicable, have been followed, including IRB approval if required. The Institutional Signing Official also assures through the approval of the DAR that other institutional departments with relevant authorities (e.g., those overseeing human subjects research, information technology, or technology transfer) have reviewed the relevant sections of the NIH GDS Policy and the associated procedures and will uphold the principles defined. Requester acknowledges that NIH anticipates that controlled-access datasets subject to the GDS Policy will be updated with additional information. Unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of these datasets.

Requester and Approved User Responsibilities. The Requester (e.g., Lead Investigator) agrees through the submission of the WIHS Concept Sheet that the Approved User has Investigators named in the WIHS Concept Sheet have reviewed and understands understand the principles for responsible research use and data management handling of the genomic datasets as defined in WIHS Genomics Data Use Contract, the NIH WIHS Genomics Data Code of Conduct, and the WIHS Data Security Best Practices for Controlled-Access Data Subject to the GDS PolicyRequirements. The Requester (e.g., Lead Investigator) and Approved User Users (e.g., co-Investigators, trainees, Contractors) further acknowledge that they are responsible for ensuring that all uses of the data are consistent with nationalfederal, tribalstate, and state local laws and regulations, as appropriate, as well as regulations and any relevant Requester policies and procedures for managing sensitive genomic and phenotypic datainstitutional policies. The Requester certifies that the Approved User is all investigators are in good standing (i.e., no known sanctions) with the Requesterinstitution, relevant funding agencies, and regulatory agencies and is eligible to conduct independent research (i.e., is not a postdoctoral fellow, student, or trainee). The Requester and any all Approved User Users may use the dataset(s) only in accordance with the parameters described on in the dbGaP website approved WIHS Concept Sheet for the appropriate research use, as well as any limitations on such the use, of the dataset(s) and as described in the DAR approved WIHS Concept Sheet and as required by law. The Approved User Through submission of the WIHS Concept Sheet, the Lead Investigator agrees to submit either a Project Renewal project renewal or Project Closeclose-out request prior to the expiration date of the one1-year data access period. The Approved User Lead Investigator also agrees to submit an annual progress update or a final progress report prior to at the one1-year anniversary of the DARapproved WIHS Concept Sheet, as described under Article 9 (Research Use Reporting) Reporting below. Failure to submit a Project Renewal renewal or to complete the Project Closeclose-out process, including confirmation of data destruction by the Requester through its Institutional Signing OfficialWIHS PI/Contact, may result in termination of all current data access and/or suspension of the Approved User Lead Investigator and all associated key personnel and Requester Collaborators collaborators from submitting new DARs WIHS Concept Sheets for a period to be determined by NIH. Repeated violations or unresponsiveness to WIHS and/or NIH requests may result in further compliance measures affecting the Requester. An Approved User Users who has may have access to personal identifying information for research participants in the original study at the Requester their institution or through their Requester Collaborators collaborators may be required to have IRB approval. By approving and submitting the attached DARWIHS Concept Sheet, the Requester through its Institutional Signing Official WIHS PI/Contact provides assurance that relevant institutional policies and nationalapplicable federal, tribalstate, and state local laws and regulations, as applicable, regulations (if any) have been followed, including IRB approval if required. The Institutional Signing Official WIHS PI/Contact also assures through the approval of the DAR WIHS Concept Sheet that other institutional departments with relevant authorities (e.g., those overseeing human subjects research, information technology, or technology transfer) have reviewed the relevant sections of the NIH GDS Policy WIHS Genomics Data Use Contract, the WIHS Genomics Data Code of Conduct, and the WIHS Data Security Best Practices Requirements and the associated procedures and will uphold are in agreement with the principles defined. Requester acknowledges that In some cases, NIH anticipates that controlled-access the WIHS Genomics Database datasets subject to the GDS Policy will be updated with additional information. Unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of these datasets.

Requester and Approved User Responsibilities. The Requester agrees through the submission of the DAR that the Approved User PI named has reviewed and understands the principles for responsible research use and data management of the genomic RADxSM datasets as defined in the NIH Security Best Practices for Controlled-Access Data Subject to the GDS PolicyRADxSM Data. The Requester and Approved User Users further acknowledge that they are responsible for ensuring that all uses of the data are consistent with national, tribal, and state laws and regulations, as appropriate, as well as relevant Requester institutional policies and procedures for managing sensitive genomic and phenotypic data. The Requester certifies that the Approved User PI is in good standing (i.e., no known sanctions) with the Requesterinstitution, relevant funding agencies, and regulatory agencies and is eligible to conduct independent research (i.e., is not a postdoctoral fellow, student, or trainee). The Requester and any Approved User Users may use the dataset(s) only in accordance with the parameters described on the dbGaP website study page and in the Addendum to this Agreement for the appropriate research use, as well as any limitations on such use, of the dataset(s) and ), as described in the DAR DAR, and as required by law. Through the submission of this DAR, the Requester and Approved Users acknowledge receiving and reviewing a copy of the Addendum which includes Data Use Limitation(s) for each dataset requested. The Requester and Approved User agrees Users agree to comply with the terms listed in the Addendum. Through submission of the DAR, the PI and Requester agree to submit either a Project Renewal or Project Close-out request prior to the expiration date of the one-one (1) year data access period. The Approved User PI also agrees to submit an annual progress update or a final progress report Progress Update prior to the one-one (1) year anniversary anniversary(**) of the DARproject, as described under Article 9 (Research Use ReportingReporting (Term 10) below. Failure to submit a Project Renewal or to complete By approving and submitting the Project Close-out processattached DAR, the Institutional Signing Official provides assurance that relevant institutional policies and applicable local, state, tribal, and federal laws and regulations, as applicable, have been followed, including confirmation of data destruction by the Requester through its Institutional Signing OfficialIRB approval, if required. Approved Users may result in termination of all current data access and/or suspension of the Approved User and all associated personnel and Requester Collaborators from submitting new DARs for a period be required to be determined by NIH. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. An Approved User who has have IRB approval if they have access to personal identifying information for research participants in the original study at the Requester their institution, or through their Requester Collaborators may be required to have IRB approval. By approving and submitting the attached DAR, the Requester through its Institutional Signing Official provides assurance that relevant institutional policies and national, tribal, and state laws and regulations, as applicable, have been followed, including IRB approval if requiredcollaborators. The Institutional Signing Official also assures assures, through the approval of the DAR DAR, that other institutional departments with relevant authorities (e.g., those overseeing human subjects research, information technology, or technology transfer) have reviewed the relevant sections of the NIH GDS Policy and the associated procedures and will uphold agree to the principles definedand terms of this agreement. The Requester acknowledges that NIH anticipates that controlled-access the RADxSM datasets subject to the GDS Policy will may be updated with to exclude or include additional information. Unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of these datasets.

Requester and Approved User Responsibilities. The Requester agrees through the submission of the DAR that the Approved User PI named in the DAR has reviewed and understands the principles for responsible research use and data management handling of the genomic datasets as defined in the NIH Security Best Practices for Controlled-Access GWAS Data Subject to the GDS PolicySharing Policy and as detailed in this Data Use Certification (DUC) agreement. The Requester and Approved User Users further acknowledge that they are responsible for ensuring that all uses of the data are consistent with nationalfederal, tribalstate, and state local laws and regulations, as appropriate, as well as regulations and any relevant Requester policies and procedures for managing sensitive genomic and phenotypic datainstitutional policies. The Requester certifies that the Approved User is in good standing (i.e., no known sanctions) with the Requesterinstitution, relevant funding agencies, and regulatory agencies and is eligible to conduct independent research (i.e., is not a postdoctoral fellow, student, or trainee). The Requester and any Approved User may use the dataset(s) only in accordance with the parameters described on the dbGaP website for the appropriate research use, as well as any limitations on such use, Through submission of the dataset(s) and as described in DAR, the DAR and as required by law. The Approved User PI agrees to submit either a Project Renewal project renewal or Project Closeclose-out request prior to the expiration date of the one1-year data access period. The Approved User PI also agrees to submit an annual progress update or a final progress report prior to at the one1-year anniversary of the DAR, as described under Article 9 (Research Use Reporting) Reporting below. Failure to submit a Project Renewal renewal or to complete the Project Closeclose-out process, including confirmation of data destruction by the Requester through its Institutional Signing Official, may result in termination of all current data access and/or suspension of the Approved User and all associated key personnel and Requester Collaborators collaborators from submitting new DARs for a period to be determined by NIH. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. An Approved User Users who has may have access to personal identifying information for research participants in the original study at the Requester their institution or through their Requester Collaborators collaborators may be required to have IRB approval. By approving and submitting the attached DAR, the Requester through its Institutional Signing Official provides assurance that relevant institutional policies and nationalapplicable federal, tribalstate, and state local laws and regulations, as applicable, regulations (if any) have been followed, including IRB approval if required. The Institutional Signing Official also assures through the approval of the DAR that other institutional departments with relevant authorities (e.g., those overseeing human subjects research, information technology, or technology transfer) have reviewed the relevant sections of the NIH GDS GWAS Data Sharing Policy and the associated procedures and will uphold are in agreement with the principles defined. Requester acknowledges that NIH anticipates that controlled-access TCGA datasets subject to the GDS Policy will be regularly updated with additional information. Unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of these datasets.

Requester and Approved User Responsibilities. The Requester agrees through the submission of the DAR that the Approved User PI named has reviewed and understands the principles for responsible research use and data management of the genomic datasets as defined in the NIH Security Best Practices for Controlled-Access Data Subject to the GDS Policy. The Requester and Approved User Users further acknowledge that they are responsible for ensuring that all uses of the data are consistent with national, tribal, and state laws and regulations, as appropriate, as well as relevant Requester institutional policies and procedures for managing sensitive genomic and phenotypic data. The Requester certifies that the Approved User PI is in good standing (i.e., no known sanctions) with the Requesterinstitution, relevant funding agencies, and regulatory agencies and is eligible to conduct independent research (i.e., is not a postdoctoral fellow, student, or trainee). The Requester and any all Approved User Users may use the dataset(s) only in accordance with the parameters described on the dbGaP NIAGADS website for the appropriate research use, as well as any limitations on such use, of the dataset(s) and as described in the DAR and as required by law. The Approved User Through submission of the DAR, the PI agrees to submit either a Project Renewal project renewal or Project Closeclose-out request prior to the expiration date of the one1-year data access period. The Approved User PI also agrees to submit an annual progress update or a final progress report prior to the one1-year anniversary of the DAR, as described under Article 9 (Research Use Reporting) Reporting below. Failure to submit a Project Renewal renewal or to complete the Project Closeclose-out process, including confirmation of data destruction by the Requester through its Institutional Signing Official, may result in termination of all current data access and/or suspension of the Approved User PI and all associated personnel and Requester Collaborators collaborators from submitting new DARs for a period to be determined by NIH. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. An Approved User who has access to personal identifying information for research participants in the original study at the Requester or through their Requester Collaborators may be required to have IRB approval. By approving and submitting the attached DAR, the Requester through its Institutional Signing Official provides assurance that relevant institutional policies and national, tribal, and state laws and regulations, as applicable, have been followed, including IRB approval if required. The Institutional Signing Official also assures through the approval of the DAR that other institutional departments with relevant authorities (e.g., those overseeing human subjects research, information technology, or technology transfer) have reviewed the relevant sections of the NIH GDS Policy and the associated procedures and will uphold the principles defined. Requester acknowledges that NIH anticipates that controlled-access datasets subject to the GDS Policy will be updated with additional information. Unless otherwise indicated, all statements herein are presumed to be true and applicable to the access and use of all versions of these datasets.