Bioethics.net

Although the research use of identifiable health information is closely regulated, the use of deidentified health information and biological specimens is not subject to regulation under either the Common Rule or HIPAA Privacy Rule. The distinction between identifiable and deidentified information is not justified in light of the range of harms that can be caused by the nonconsensual use of deident...

On February 3, 2010, a Letter of Concern from Bioethicists, organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research...