Common use of Submitting Investigator Clause in Contracts

Submitting Investigator. An investigator who submitted a genomic dataset to an NIH designated data repository (e.g., dbGaP). Study specific DUC addendum phs000007 : Framingham Cohort Public Posting of Genomic Summary Results - Not Allowed. NIH Data Access Committee (DAC) : National Heart, Lung, and Blood Institute DAC Important Contacts : xxxxxxxxxxxxxxxx@xxxxx.xxx.xxx; XXX@xxxx.xxx.xxx In the event of a data management incident, within 24 hours, please contact emails above. DATA USE LIMITATION FOR FHS: Use of the Framingham data deposited in dbGaP is restricted to research on: genotype-phenotype associations; molecular phenotype (e.g., gene expression; microRNA)-phenotype associations; and proteomics/metabolomics-phenotype associations. All other phenotype-only analyses are prohibited (note: investigators may request data for such phenotype-only analyses through NHLBI’s BioLINCC). Additionally, the Framingham data may not be used to: o Investigate individual pedigree structures or individual participant genotypes for the purpose of identifying individuals or families; or explore issues such as non-maternity or non-paternity. IC Specific Access Term : o Investigate topics that could be considered as stigmatizing an individual or group. o Assess outcomes that are not related to health or disease conditions (note: methodological research that will serve as a prelude to health or disease research is permitted). Data users are responsible for ensuring that all uses of the data are consistent with federal, state, and local laws and any relevant institutional policies, and that the data are always maintained in a secured fashion. Data users will be required to obtain IRB approval for their projects from their respective institutions (please note that only full or expedited approvals will be accepted). It is anticipated that, at least in some cases, the FHS data will be updated with additional information and will be so identified by an appropriate version number. Data use is limited by consent groups to the following two groups: a) Health/Medical/Biomedical and related Methods and b) Health/Medical/Biomedical and related Methods for Non-Profit Use Only. Acknowledgement Statement : link Name : Health/Medical/Biomedical (IRB, MDS) Consent Group # : 1 Abbreviation : HMB-IRB-MDS Use of this data is limited to health/medical/biomedical purposes, does not include the study of population origins or ancestry. Requestor must provide documentation of local IRB approval. Use of the data includes methods development research (e.g., development of software or algorithms). Data Use Limitation : Use of the Framingham data deposited in dbGaP is restricted to research on: genotypephenotype associations; molecular phenotype (e.g., gene expression; microRNA)-phenotype associations; and proteomics/metabolomics-phenotype associations. All other phenotype-only analyses are prohibited (note: investigators may request data for such phenotype-only analyses through NHLBI’s BioLINCC). Additionally, the Framingham data may not be used to: o Investigate individual pedigree structures or individual participant genotypes for the purpose of identifying individuals or families; or explore issues such as non-maternity or non-paternity. o Investigate topics that could be considered as stigmatizing an individual or group. o Assess outcomes that are not related to health or disease conditions (note: methodological research that will serve as a prelude to health or disease research is permitted). Please note that only full or expedited approvals will be accepted. Name : Health/Medical/Biomedical (IRB, NPU, MDS) Consent Group # : 2 Abbreviation : HMB-IRB-NPU-MDS Use of this data is limited to health/medical/biomedical purposes, does not include the study of population origins or ancestry. Requestor must provide documentation of local IRB approval. Use of the data is limited to not-for-profit organizations. Use of the data includes methods development research (e.g., development of software or algorithms). Use of the Framingham data deposited in dbGaP is restricted to research on: genotypephenotype associations; molecular phenotype (e.g., gene expression; microRNA)-phenotype associations; and proteomics/metabolomics-phenotype associations. All other phenotype-only analyses are prohibited (note: Data Use Limitation : investigators may request data for such phenotype-only analyses through NHLBI’s BioLINCC). Additionally, the Framingham data may not be used to: o Investigate individual pedigree structures or individual participant genotypes for the purpose of identifying individuals or families; or explore issues such as non-maternity or non-paternity. o Investigate topics that could be considered as stigmatizing an individual or group. o Assess outcomes that are not related to health or disease conditions (note: methodological research that will serve as a prelude to health or disease research is permitted).