PS3-16: Access and Collaboration with the Kaiser Permanente Research Program on Genes, Environment, and Health (RPGEH)

Background/AimsThe Kaiser Permanente Northern California (KPNC) Research Program on Genes, Environment, and Health (RPGEH) provides a research resource to support investigations of environmental and genetic factors in the development of a wide variety of conditions. While the resource is still evolving with new data collection, it consists of data from surveys and electronic medical records on over 400,000 adult members of KPNC; biospecimens collected and stored on ~200,000 of these individuals; and data from genome-wide and telomere-length assays on ~110,000 of those who have contributed biospecimens; and linkage of these members to environmental, area-level databases.MethodsThe RPGEH was developed in part with the understanding that it would be made available to the scientific community for appropriate studies. An Access and Collaborations Core has developed procedures for submission of applications for research studies, their review, and decisions on approval and support. Review of proposals by an Applications Review Committee follows a two-step process, with a pre-application to assess feasibility (e.g., adequate numbers of the phenotype: availability of appropriate data, given inclusion criteria) and a full application to assess appropriateness of the study in the RPGEH context. Scientific merit; alignment with RPGEH guiding principles, including ethical, legal, and social implications; consistency with informed consents; potential overlap with prior approvals; and collaboration with a researcher affiliated with the Division of Research are among the criteria for approval. As an alternative for select analyses, genomic and selected phenotypic data will be available in the NIH database of genotypes and phenotypes (dbGaP) for the substantial subset of RPGEH participants who have consented to dbGaP deposition.ResultsAs of October 31, 2012, the RPGEH has received 74 pre-applications and full applications for the use of its resources; only 6 pre-applications were not approved. In 2011-2012, 13 approved applications were funded by NIH and other agencies. Studies currently underway include genome-wide association studies of prostate cancer, bi-polar disorder, multiple sclerosis, and mammographic density.ConclusionsAccess to the unique and outstanding research resources of the RPGEH balances the mission of promoting research with the need to shepherd finite resources and safeguard member confidentiality.