DATA ACCESS & USE POLICY

GAIN Project Datasets (genotype data as well as genotype-phenotype datasets along with pre-computed analyses of them) will be made available through the GAIN Database as soon as both the phenotype and exposure data submitted by Contributing Study Investigators (Submitted Data) and the GAIN genotype data have passed appropriate data quality standards and have been approved by the GAIN Steering Committee.

Data will be made available at no cost to approved users through a Controlled Access Pathway:

The genotype data generated for each sample, plus coded phenotype and exposure data (Submitted Data) will be deposited in a controlled access section of the GAIN Database, which will be located within dbGaP, an NIH database for genotype- phenotype datasets maintained by the NCBI.  Only data that the GAIN Steering Committee agrees can be entered into the database without undue threat to the privacy and confidentiality of the original research participants will be included. Simple, unadjusted genotype-phenotype associations will be calculated and posted in the GAIN Database, along with a listing of all variants known to be in strong linkage disequilibrium (based on HapMap) with variants showing significant association with a phenotype or trait included within the Submitted Data. Other analyses, such as annotated information on genes and genomic features in identified regions of interest may be provided as well. GAIN intends that access to these datasets (GAIN Project Datasets) will be provided to Approved Users who, along with their institutions, have agreed to the requirements and terms of access within the Data Use Certification document. Further, GAIN intends that access to GAIN Project Datasets will be granted with the understanding that the data will be used in accord with the parameters described on the GAIN website for the appropriate research uses, and any limitations on such use, of a given dataset. Contributing Study Investigators, or any of their collaborators, who retain identifiers to the individual DNA samples used to generate GAIN genotype data will be responsible for compliance with any applicable federal, state, and local laws (e.g., 45 CFR Part 46) and any relevant institutional policies for their future research use of that particular GAIN Project Dataset during the application review process. All Approved Users and their institutions will be required to acknowledge responsibility for ensuring that all uses of the data are consistent with federal, state, and local laws and any relevant institutional policies. Additionally, Approved Users and their institutions will be listed within the GAIN Database as having approved access to particular GAIN Project datasets.

All Approved Users will certify through the Data Use Certification process that they will not distribute individual data contained within a GAIN Project Dataset in any form to any third parties, other than their own research staff who have agreed to the terms of the Data Use Certification. Approved Users who are not Contributing Study Investigators shall also certify that they will not attempt to identify the individual participants included within any GAIN Project Dataset. For collaborative projects, any independent collaborating investigator involved in the use of the GAIN data is required to submit a separate Data Use Certification. If, and only if, existing consent within GAIN-selected studies is deemed adequate by the responsible institution for open public access to genetic information, the genotype data generated for each sample and summary information, such as allele and genotype frequencies, may be deposited in the public section of the GAIN Database within dbGaP, with no individual identifying information and no connection to individual phenotype data. Descriptive information of the phenotype data, such as the variables measured and protocols used to collect the data and samples, but not the phenotype dataset itself, would also be made available in this way.

GAIN Partners, Contributing Study Investigators, and Genotype Contractors will not be provided advance research access to Submitted Data or GAIN Project Datasets. The terms and conditions governing data access for research use of GAIN Project Datasets for GAIN Partners, Contributing Study Investigators, and Genotype Contractors will be identical to those for any other member of the scientific community seeking to become an Approved User. All Submitted Samples provided to Genotype Contractors by Contributing Study Investigators for GAIN use will be returned or destroyed following the completion of the specified genotyping services according to the procedures set by the contributing study site.