During a bioresearch monitoring inspection on December 12, 2024, the Food and Drug Administration issued 13 citations to Julia C. Carnevale, M.D., based in San Francisco, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘The informed consent document did not contain a description of the procedures to be followed and identification of any procedures which were experimental.’
- ‘The informed consent document did not contain an explanation of the purposes of the research, and the expected duration of the subject’s participation.’
- ‘The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject.’
- ‘There was no statement in the informed consent document that described the extent, if any, to which confidentiality of records identifying the subject would be maintained.’
- ‘For research involving more than minimal risk, the informed consent document lacked an explanation as to whether any compensation and medical treatments were available if injury occurred, and, if so, of what they consisted and where further information might be obtained.’
- ‘The informed consent document did not contain a statement that the subject might discontinue participation at any time without penalty or loss of benefits to which the subject was otherwise entitled.’
- ‘The informed consent document does not include the required statement: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”‘
- ‘The IRB did not approve a written summary of what was to be said to the subject or the subject’s legally authorized representative, in a situation where a short form written consent document was prepared.’
- ‘A short form informed consent document did not state that the required elements of informed consent had been presented orally to the subject or the subject’s legally authorized representative.’
- ‘An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.’
- ‘Failure to report non-serious adverse events to the sponsor in accordance with the study protocol timetable for reporting.’
- ‘Failure to report serious adverse events to the sponsor.’
- ‘Not all changes in research activity were approved by an Institutional Review Board prior to implementation.’
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
