Research subjects in clinical trials must be informed of certain financial arrangements or prior misconduct of clinical investigators, the FDA has announced.
The disclosures are part of a series of mostly routine changes to the Bioresearch Monitoring Information System that tracks clinical investigators’ compliance with FDA regulations. The agency published a notice of changes Jan. 9 in the Federal Register. The changes in disclosures to research subjects include:
* “Providing for disclosure to a research subject of information from a research misconduct proceeding that may have implications for that subject’s rights, safety or welfare, or participation in a research study,” and
* “Providing for disclosure to the public of information related to a clinical investigator’s financial arrangement with or interests in a study sponsor, to the extent disclosure is not an unwarranted invasion of personal privacy or is not otherwise protected from disclosure under FDA’s regulations or applicable statutes.”
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