FDA Expands Clinical Trial Disclosures

Research subjects in clinical trials must be informed of certain financial arrangements or prior misconduct of clinical investigators, the FDA has announced.


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.”

More for you

Loading data for hdm_tax_topic #better-outcomes...