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Appendix D
eMERGE Consortium
Data Use Agreement
Data Use Agreement
For use by and among
Members of the Electronic Medical Records and Genomics Research
Network (eMERGE)
TERMS AND DEFINITIONS: The Electronic Medical Records and Genom -
ics (eMERGE) Network (https://www.mc.vanderbilt.edu/victr/dcc/projects/
acc/index.php/About) is a National Institutes of Health (NIH)-organized and
-funded consortium of U.S. medical research institutions (“eMERGE Net-
work”). The primary goal of the eMERGE Network is to develop, disseminate,
and apply approaches to research that combine DNA biorepositories with elec -
tronic medical record (EMR) systems for large-scale, high-throughput genetic
research. Member institutions participating in the consortium study the rela -
tionship between genetic variations and clinically relevant human traits, using
the technique of genome-wide association (GWAS) analysis. Such studies in -
volve testing hundreds of thousands of genetic variants called single nucleotide
polymorphisms throughout the genome in people with and without a condition
of interest. A fundamental question that eMERGE seeks to answer is whether
electronic medical record (EMR) systems can serve as resources for such com -
plex genomic analysis of disease susceptibility and therapeutic outcomes, across
diverse patient populations. In addition, the consortium includes a focus on
social and ethical issues such as privacy, confidentiality, and interactions with
the broader community. Detailed information on the eMERGE network can be
found at the eMERGE website (www.gwas.org).
115
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116 APPENDIX D
The following entities are eMERGE Network members (“eMERGE Network
Members” or “Members”): Group Health/University of Washington, Marsh -
field Clinic, Mayo Clinic, Northwestern University and Vanderbilt University
serve as the clinical sites (“Clinical Sites”); Vanderbilt University also serves as
the consortium’s coordinating center (“Coordinating Center”); Broad Institute
and Center for Inherited Disease Research both serve as genotyping facilities
(“Genotyping Facilities”); and the National Center for Biotechnology Infor-
mation (NCBI), NIH; and the National Human Genome Research Institute
(NHGRI), NIH (“Program Officials”) serve as scientific and programmatic
managers and technical advisors.
Researchers with a wide range of expertise in genomics, statistics, ethics,
informatics, and clinical medicine employed by an eMERGE Network Member
participate in the eMERGE network, including: Principal Investigators of the
eMERGE Clinical Sites, the Coordinating Center, the Genotyping Facilities,
and Program Officials from the National Center for Biotechnology Information
and the National Human Genome Research Institute.
Data Sharing Guiding Principles: All data sharing will adhere to 1) the
terms of consent agreed to by research participants; 2) applicable laws and
regulations, and; 3) the principle that individual sites within the network have
final authority regarding whether their site’s data will be used or shared, on a
per-project basis. These principles are intended to maximize sharing of GWAS
data generated by the eMERGE Members among and between other Members
as well as with the wider scientific community, and to do this without com -
promising data security or the confidentiality of information about individuals
whose data and/or samples are used for research.
Data Sharing Responsibilities: Principal Investigators of each eMERGE
Clinical Site may designate data to accomplish activities defined in eMERGE
sanctioned research studies (eMERGE data) to be shared as follows: (1) distri -
bution through dbGaP; (2) distribution within the eMERGE Network; and/
or (3) distribution to the eMERGE Coordinating Center. The eMERGE data
to be shared within eMERGE will be provided only to eMERGE Network
Members that have signed this Agreement. All eMERGE Network Members
and the eMERGE Coordinating Center may aggregate eMERGE data from all
Member sites and, with documented approval prior to each submission from
the contributing site(s), submit said eMERGE data to dbGaP and/or other
databases administered by the National Institutes of Health. Each eMERGE
Network Member may share its own data with external collaborators without
approval of the other Members. If eMERGE data received from any Member is
shared externally by another Member, prior approval from the Member provid-
ing the eMERGE data must be obtained and documented. Members sharing
eMERGE data externally must also ensure that each external eMERGE data
recipient agrees to the same restrictions and conditions applicable to Members
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117
APPENDIX D
and Member Representatives regarding the use and disclosure of the eMERGE
data as outlined in this Agreement or as may be required by law.
Statement of Confidentiality: By signing this Agreement, the authorized
official representing an eMERGE Network Member, certifies that s/he and
the Principal Investigators, fellows, students, and research staff (collectively,
“Network Member Representatives”) working on eMERGE-related projects
are aware of the confidential nature of data on research participants maintained
by the Member and of the necessity for maintaining that confidentiality.
The eMERGE Network Member agrees not to attempt to personally iden-
tify any eMERGE participant based on eMERGE data and agree not to attempt
to contact any eMERGE participant of a site other than their own. The Member
agrees not to transfer or disclose any confidential data or any information about
individual eMERGE participants, except as permitted by this Agreement or
as required by law, either during or after the conclusion of the affiliation with
eMERGE. The Member agrees to provide adequate security for the eMERGE
data, including but not limited to safeguards intended to prevent unauthor-
ized use or disclosure of such information. In addition each Member agrees
to report in writing to the other Members any use or disclosure of any portion
of the data of which it becomes aware that is not permitted by this Agreement
including disclosures that are required by law.
The eMERGE Network Member agrees to ensure that its Network Mem -
ber Representatives do not use, disclose or transfer any eMERGE data to
anyone who is not an eMERGE Network Member except as permitted by
this Agreement or as required by law. Further, the Member agrees to return
all eMERGE data to the eMERGE Coordinating Center or delete/destroy all
electronic eMERGE data upon termination of its affiliation with the eMERGE
Network and to notify the eMERGE Coordinating Center when it has done so.
Limitations of Data Use: The eMERGE Network Member agrees to en-
sure that Network Member Representatives will only use eMERGE data in a
manner that is consistent with any limitations that have been specified for in -
dividual studies by the disclosing Member and agreed to by the Steering Com -
mittee and shall ensure compliance with all applicable state and federal laws
and regulations governing the use of such data including the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), if applicable, including
any and all future amendments.
The eMERGE Network Member agrees to comply with all established
policies of eMERGE governing the acquisition, analysis, reporting, publication,
use and distribution of eMERGE data.
This Agreement supersedes and replaces all prior agreements made be -
tween eMERGE Network Members.
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118 APPENDIX D
Agreed to by:
eMERGE Institution Authorized Official name and title (print): ___________
Signature: _______________________________ Date: ________________
Read & Understood by:
Network Member Representative name & title (print): ___________________
Signature: ___________________________ Date: ________________
Member Representative’s Institution:
_________________________________________________
