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GLOSSARY OF TERMS
1. GAIN:
The Genetic Association Information Network (“GAIN”) refers to the public-private partnership for whole
genome association studies coordinated and managed by
the Foundation of the National Institutes of Health
(FNIH). The major aim of GAIN is to carry out genome
wide association studies of existing studies using
previously collected DNA samples from individuals
affected by common diseases of public health importance
along with control samples collected from unaffected
individuals. Study selection will be based on a
competitive peer-review process. All data generated
through GAIN will be made available to the scientific
community rapidly and at no cost to users.
2. GAIN Partners:
GAIN consists of a number of individual member entities
(“GAIN Partners”).
It is anticipated that organizations from the following
sectors will participate over the life of the
partnership: the FNIH, specific Institutes within the
National Institutes of Health (NIH); pharmaceutical or
biotech corporations, patient advocacy organizations,
private foundations, and concerned individuals. A
current list of GAIN Partners can be found at
GAIN Partnerships.
3. GAIN Steering
Committee: The group of individuals
responsible for the scientific design and programmatic
oversight of GAIN. Current membership of the GAIN SC is
shown at
GAIN Steering Committee .
4. Contributing Study
Investigators: The research and clinical
investigators who submit data and/or DNA to GAIN.
5. GAIN Project:
A study selected for GAIN participation through the peer
review process.
6. Lead Principal
Investigator (PI): The individual who
assumes primary responsibility for the GAIN project,
including the application, data and sample submission
and analyses processes.
7. Major Co-investigator:
Any investigator who, in the Lead Principal
Investigator’s opinion, has or will contribute
substantially to the project. For the purpose of studies
submitting data and samples for GAIN genotyping, Major
Co-investigators must include the responsible
investigator at any study site that collected data and
samples.
8. Submitted Samples:
The DNA samples collected by Contributing Study
Investigators, through previous or on-going studies,
which are submitted to GAIN for genotyping.
9. Submitted Data:
The existing phenotype and exposure information
collected from study participants (both control and
affected individuals) and submitted to the central GAIN
Database by Contributing Study Investigators for use in
GAIN. The Contributing Study Investigators are
responsible for removing certain identifying information
from the Submitted Data.
10. GAIN Database:
The data resource managed for GAIN by the National
Center for Biotechnology Information that includes
descriptive information about participating studies and
GAIN Projects, the GAIN Project Datasets, and provides
the user interface for the GAIN Project-specific
datasets.
11. GAIN Project
Dataset: GAIN-supported genotype data
and the relevant phenotype and exposure data (Submitted
Data) for each GAIN Project.
12. Approved Users:
Research investigators who have submitted a request to
access one or more GAIN Project Datasets through the
completion of a
Data Use Certification document. The Data Use
Certification requires signatures from the requesting
investigator and his/her Institutional Business
Official. Submission of the Data Use Certification
indicates that the signers represent and warrant their
qualifications for access to and use of GAIN Project
Dataset(s) and certify their agreement to the GAIN
principles, policies and procedures for the use of GAIN
Project Dataset(s) as articulated in that document.
13. Institutional
Business Official: A member of the
Contributing Study Investigator’s home organization with
the authority to commit the organization to the terms of
the application.. Similarly, it also refers to a member
of the Approved User’s home organization with the
authority to certify their organization’s agreement to
the terms delineated in the Data Use Certification.
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