2013 CTSI Annual Pilot Awards to Improve the Conduct of Research

To facilitate the development, conduct or analysis of clinical & translational research

Proposals on Regulatory

Governance of Extant UC Biorepositories

Submitted by Jennifer Hult on February 25, 2013 - 10:53am Last revised by Anonymous on March 1, 2014 - 9:30am.
Topics: 
Community Policies and Practices
Clinical Research
Regulatory
Proposal Status: 
Review Complete

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.

Decreasing Time for CHR Approval of Full Committee Review Applications

Submitted by Vanessa Jacoby on February 24, 2013 - 11:29pm Last revised by Anonymous on March 1, 2014 - 9:30am.
Topics: 
Clinical Research
Regulatory
Proposal Status: 
Awarded

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.

Tools and Infrastructure to Facilitate Compliance with ClinicalTrials.Gov Results Reporting

Submitted by Stuart Gansky on February 23, 2013 - 9:58am Last revised by Anonymous on March 1, 2014 - 9:30am.
Topics: 
Training
IT and Informatics
Clinical Research
Regulatory
Proposal Status: 
Awarded

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