The document outlines the key elements of the NIH Genomic Data Sharing (GDS) Policy, which became effective on January 25, 2015. The policy applies to both human and non-human genomic data generated through NIH-funded research and requires investigators and institutions to prepare and submit comprehensive genomic data sharing plans with their funding applications. Central to the policy are measures ensuring the de-identification and confidentiality of human genomic data, adherence to federal regulations such as HIPAA, and the encouragement to obtain Certificates of Confidentiality for added data protection. The GDS Policy stipulates that all large-scale human genomic data collected after the effective date must be consented for both future research and broad sharing, even if the data is de-identified. For data collected before the effective date, or from deceased individuals, the policy recommends consideration of participant and family interests and suggests seeking consent or surrogate permission where feasible.
Additionally, the document details the responsibilities of approved users of NIH genomic databases such as dbGaP, emphasizing strict codes of conduct regarding participant anonymity and non-distribution of data to unauthorized parties. Guidance from the Office for Human Research Protections (OHRP) clarifies when coded data is considered non-identifiable and thus not subject to human subjects research regulations, provided certain conditions are met. The policy underscores the importance of informed consent for the use of future genomic data, and requires justification when utilizing post-policy specimens lacking requisite consent. Collectively, these measures aim to balance the advancement of genomic research with the protection of participant privacy and ethical standards.
