research · Food and Drug Administration · Rule · Published 2011-01-04 · Effective 2011-03-07 · 76 FR 256
Document
Document number
2010-33193
Federal Register citation
76 FR 256
CFR reference
21 CFR 50
Type
Rule
Action
Final rule.
Category
research
Sub-agency
Food and Drug Administration
Publication date
2011-01-04
Effective date
2011-03-07
HHS docket
Docket No. FDA-2009-N-0592
Abstract
The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/ NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.