POLICIES

GAIN policies are designed to facilitate the discovery of genetic variants related to health and disease in a manner that respects the research participants whose data and materials have been contributed to GAIN to generate the genotype-phenotype datasets. GAIN policies also are intended to encourage the development of new prognostic, diagnostic, preventive, and therapeutic products while safeguarding the important and unique contributions made by the scientists who collected the biological samples and associated phenotype data over many years (the Contributing Study Investigators).

The Foundation for the National Institutes of Health (FNIH) and its private and public sector partners in GAIN are committed to creating a resource founded on the principle of no cost, rapid, and complete release of GAIN Project Datasets for use by investigators throughout the global scientific community who, along with their institutions, certify their agreement with GAIN policies (Approved Users). All participants in GAIN (Contributing Study Investigators, their Institutions, GAIN Partners, and Approved Users) are expected to promote the policies on data access, publication, and intellectual property. Specific terms and requirements for study participation in GAIN can be found in the GAIN Applicant Policy Agreement. Specific terms and conditions for access to and use of the GAIN Project Datasets by Approved Users, can be found in the GAIN Data Use Certification document.

The FNIH Board of Directors, in consultation with the GAIN Steering Committee, make all final decisions concerning revision of GAIN policies. All GAIN policies are subject to change by the FNIH Board of Directors or the GAIN Steering Committee as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within GAIN operating procedures. Access to the GAIN Database, managed by the National Center for Biotechnology Information (NCBI), National Library of Medicine, will be overseen by the National Institutes of Health in accordance with United States Government rules and policies. All changes to GAIN policies will be posted on the GAIN website.