GDS JHSPH IRB Certification Letter TEMPLATE (Revised January 2015)
DATE:
TO:
NIH Funding Institute or Center
RE:
JHSPH Study Title:
JHSPH IRB Study No.:
Principal Investigator:
FROM:
Janet A. DiPietro, Ph.D.
Associate Dean for Research
In the reasonable belief of the Johns Hopkins University, within the limits of the Johns Hopkins
University’s knowledge of the current and future uses and users of the data:
1) Institutional policies and applicable national, tribal, state, and local laws and regulations permit
the Principal Investigator, pursuant to the conditions specified in this letter, to submit to the NIH
dbGAP or other NIH-designated genomic data repository the data obtained in accordance with
the above-referenced research proposal, provided that the data are actually obtained in
accordance with said proposal, and
2) The Principal Investigator plans to submit the data to a controlled-access NIH-designated
genomic data repository, and
3) [Insert if applicable] The limitations on the use of data, as expressed in the consent form,
are as follows:___in addition to any others, permit use by, and disclosure to, only faculty
employed by an NIH grantee institution___]; and
4) The Principal Investigator will not knowingly disclose the identities of research participants to
the NIH dbGAP or other NIH-designated genomic data repository unless required to do so by a
competent legal or governmental authority; and
5) The Institutional Review Board for The Johns Hopkins University School of Public Health (IRB)
has concluded as follows:
a. 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;
b. 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;
Page 1 of 2
GDS JHSPH IRB Certification Letter TEMPLATE (Revised January 2015)
c. 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 NIH-designated 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];
d. 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;
e. The consent forms 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;
f. The IRB has considered the risks to individuals, their families, and any groups or
populations associated with the submission of the above-referenced data to the NIH
dbGAP or other NIH-designated genomic data repository; and
g. 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.
Please note that this certification applies only to data that will be, or has been, collected and analyzed
by the Principal Investigator at Johns Hopkins under the above-referenced study.
Sincerely,
Janet A. DiPietro, Ph.D.
Associate Dean for Research
cc:
PI
JHSPH Office of Research Administration
Page 2 of 2