The Bioethics of IVD Devices and Informed Consent Issues

April 1, 2008

Recently, no area has contributed more and increasingly complex layers to the bioethics debate than research employing human genetic material. One such layer involves the use of patient samples for in vitro diagnostic (IVD) device studies and informed consent requirements, as evidenced by a recent document issued by the FDA, entitled “Guidance on Informed Consent for In Vitro Diagnostic Device Using Leftover Human Specimens that Are Not Individually Identifiable.” (Genetic Engineering & Biotechnology News)