30Jan2015
JHSPH IRB Review Form
NIH Genomic Data Sharing Policy
Principal Investigator:
Grant No.:
Grant Title:
Review date:
IRB No:
The proposal to submit genome-wide association studies, genome sequence, single
nucleotide polymorphisms arrays, transcriptonic, metagenetic, epigenomic and/or gene
expression data from JHSPH IRB No. ___________ to the NIH-designated genomic data
repository <<insert repository name>> to ensure broad and responsible sharing of
genomic research data generated from NIH-funded research perform GWAS has been
reviewed, and the following determinations made:
The data submission is consistent with applicable national, tribal, and state laws
and regulation as well as JHSPH institutional policies.
Risks, if any, of identification or stigmatization of individuals, their families,
groups, or populations that might result from placing the data in the NIH
repository are minimized to the extent possible.
The Principal Investigator plans to de-identify the data according to the
standards set forth in 45 CFR 46.102(f), as those standards have been
interpreted by the federal Office of Civil Rights as of the date of this certification,
and will remove all of the HIPAA identifiers enumerated in 45 CFR 164.514(b)(2),
provided, however, that DNA sequence information will not be removed.
If relevant, Johns Hopkins does not certify that the whole genome or whole
exome sequence data are de-identified, but permits these data to be submitted
to NIH under a waiver of HIPAA authorization granted to the Principal
Investigator because the IRB believes that the dbGAP or other NIH-designated
genomic data repository data access policies and procedures are adequate
protections for the identifiers
Provided that the data are collected in accordance with a consent form
approved by the IRB for this purpose and describing the dbGAP or other NIHdesignated genomic data repository, the submission of data to the data
repository and subsequent sharing for research purposes are not inconsistent
with the informed consent of study participants from whom the data were
obtained [or from whom data will be obtained];
Provided that the investigator follows the data collection plan and standards
described in the above-referenced research proposal, the investigator’s plan for
de-identifying datasets will be consistent with any standards articulated in that
proposal
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The consent forms approved by, or to be approved by, the Johns Hopkins
University School of Public Health IRB for the above-referenced studies at Johns
Hopkins will not preclude Johns Hopkins from submitting de-identified data to
the NIH dbGAP or other NIH-designated genomic data repository unless data
submission to an NIH-designated data repository is not appropriate and falls
under the Exceptions provision in the NIH Final Genomic Data Sharing Policy
The genotype and phenotype data collected by the investigator directly from
participants will be obtained in a manner consistent with the requirements of 45
CFR Part 46 as of the date of this certification.
Comments (if applicable):
_______________________________________
Print Reviewer Name
Signature of Reviewer:
Date:
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