Trial mobile version Guidances- combined files 6_27_14 - page 10

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INFORMED CONSENT
 FDA Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover
Human Specimens That are Not Individually Identifiable
This guidance created by the U.S. Food and Drug Administration (FDA) is for sponsors,
Institutional Review Boards (IRBs), clinical investigators and agency staff. It describes regulations
for the use of leftover human specimens from routine clinical care, as well as specimens from
repositories for research projects investigating In Vitro Diagnostic (IVD) Devices.
Also see the following related resource from Columbia University IRB for answers to the following
questions:
 What is an In Vitro Diagnostic (IVD) Device?
 What is an IVD study?
 What human subjects’ protections are applicable to these studies?
A presentation from the FDA’s Center for Devices and Radiological Health (CDRH): ‘In Vitro Diagnostic
(IVD) Devices: How they Differ From Other Devices and How the FDA Regulates Them’
 Glossaries of Lay Terms for Informed Consent Documents:
These glossaries from various sources provide alternative language for those writing or reviewing
consent forms for either children or adults, in health or medical research. They are useful
resources to both IRBs and investigators.
First Clinical Research Glossary for Informed Consent
Kids Health.org: Online dictionary of medical terms for children and adolescents
Loma Linda University: Glossary of Lay Terms Frequently Used in Consent Forms
Partners: Alternative Lay Language for Medical Terms in Consent Forms
Stanford University: Lay Language Glossary (of Medical Terms)