Rationale. Consent forms for clinical trials have expanded and now often range from 25 – 30 pages, in spite of the fact that studies have documented the inability of most research participants to retain this amount of information.
Rationale
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