This application seeks to develop and implement exemplary, harmonized procedures for human biosample informed consenting practices and associated biorepository operations at five University of California (UC) medical campuses, all of whom have Clinical and Translational Science Awards (CTSA). The University of California Office of the President (UCOP) has committed to creating a regional research network involving the UC CTSAs at Davis, Irvine, UCLA, San Diego and San Francisco. Critical to the success of this network will be the availability of high quality biosamples and associated clinical data that are obtained and shared in a manner acceptable to the institutional review boards (IRBs) at all five campuses. This application focuses on harmonizing such processes in outpatient clinics, which see the majority of our 12 million covered patients.
We aim to establish an ethical, efficient, and sustainable system for obtaining, processing, and sharing biospecimens and data that can serve as a baseline for future studies and a model for similar programs around the United States. We further aim to ensure that these processes achieve broad stakeholder input and buy-in, including from researchers, clinicians, patients, communities, and institutional officials. We have three specific aims. (1) Engage UC stakeholders (institutional officials, clinicians, investigators, and California's patients and communities) to identify, develop, and refine feasible approaches for (a) obtaining informed consent from outpatients to donate their biosamples to UC biorepositories and (b) handling collection, processing, and sharing of biospecimens and associated clinical data. (2) Compare the performance, in practice, of three alternative procedures for obtaining informed consent for outpatient biorepository studies: standard consent versus Portable Legal Consent (PLC) versus Community Informed Systemwide Consent (CISC). (3) Based on results from Aims 1-2, develop and implement policies and procedures that will create an exemplary system for obtaining and sharing biospecimens and associated data throughout UC in a manner that respects our diverse patient base and uses highest quality informed consent practices.
Biorepositories represent a valuable scientific resource for studies of human disease and treatment even as they present new challenges for the protection of human subjects. The proposed study seeks to develop and implement best practices for human subjects protections for biorespository studies for the diverse communities served by the University of California.
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