ࡱ> mplM Lbjbj!! D^KGiKGiV V 84LJ>*<`\J0=======$t@*C`=]z``zz=H>==69<ð^:m=>0>:CC8<Cy<zzzzzzz==zzzJ>zzzzCzzzzzzzzzV X :  Date: FORMTEXT      PI Name: FORMTEXT      IRB Number: FORMTEXT       1.Describe all data fields (genotype and phenotype) that will be submitted to the NIH-designated genomic data repository: FORMTEXT       2. What kind of genomic data will be submitted (specify if whole genome or whole exome sequencing data are included)? FORMTEXT       3.Describe any limitations on use of data (e.g., informed consent limits use of data or specimens to particular fields of research): FORMTEXT       4.Provide written confirmation that the PI will de-identify the data prior to submission: to ensure that the identities of participants cannot be readily ascertained (45 CFR 46.102(f) (human subjects regulations), and to strip the data of identifiers according to the HIPAA rule (45 CFR 164.514(b)(2) FORMTEXT       5.Describe the method(s) to be used to code data for transmission to the NIH: FORMTEXT       6.Describe how the code key(s) will be maintained by the PI: FORMTEXT       7.Provide written confirmation by the PI that the code keys will never be shared with the NIH: FORMTEXT      8.If consent has already been obtained, attach a copy of the consent form(s) used to obtain consent. If consent has not been obtained: Submit a copy of the proposed consent form, or Provide written confirmation that the consent form will contain Genomic Data Sharing language as provided in the JHSPH IRB consent form template. 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Genomic data includes: genome-wide association studies, genome sequence, single nucleotide polymorphisms arrays, transcriptonic, metagenetic, epigenomic, and gene expression data. Note: the JHSPH IRB will allow submission of individual-level data only to a controlled-access repository as defined by the NIH policy. For Planning Phase applications or other new PHIRST applications, upload this document in the  Miscellaneous Documents section. For Amendment Applications, submit with the Amendment Application and provide a copy of the grant. 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