Rationale: Each UC Biomedical campus contains tens to hundreds of biorepositories. These operations collect human biological samples (tissues and fluids) and associated data for use in research. UC biobanks traditionally have established their own governance structure, which includes rules for accessing, storing and sharing samples/data, including informed consent practices. Governance, a complicated process, has myriad ethical implications including risk to individuals, identifiability, and data sharing.
To facilitate the development, conduct or analysis of clinical & translational research
Proposals on Regulatory
Rationale: There is currently an unacceptably long delay in the time required to obtain study approval by the UCSF Committee on Human Research (CHR). The CHR must review and approve all studies involving human subjects performed by UCSF faculty, staff, or students. Studies with more than minimal risk to participants, such as trials of diagnostic tests or treatments, require in-depth review by a faculty-led committee, a process referred to as Full Committee Review. Currently, the average time from submission to approval of these studies is 84 days.
Rationale: US law requires researchers to register clinical trials within 21 days of enrolling the first participant (since 27Sep2007) and to report clinical trial results in the ClinicalTrials.Gov (CT.gov) online system within 12 months of the last participant visit. Reporting results does not mean publishing in a peer reviewed journal, but rather entering information in CT.Gov’s standardized system. Noncompliance can result in the following for institutions and individual PIs: fines of u