United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2006_register
executive
2010-09-22
article
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research
Notices
D09002ee1bde0c443
D09002ee1bde0c4af
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.'' This draft guidance, when finalized, is intended to assist Institutional Review Boards (IRBs), clinical investigators, and sponsors in the development and conduct of emergency research.The draft guidance also describes the additional specific human subject protection requirements for emergency research. Elsewhere in this issue of the Federal Register, FDA is announcing a public hearing on emergency research conducted without informed consent under FDA regulations.
71 FR 51198
https://www.govinfo.gov/app/details/FR-2006-08-29/E6-14262
E6-14262
fr29au06-48
4160-01-S
Docket No. 2006D-0331
https://www.govinfo.gov/app/details/FR-2006-08-29/E6-14262
https://www.govinfo.gov/content/pkg/FR-2006-08-29/html/E6-14262.htm
https://www.govinfo.gov/content/pkg/FR-2006-08-29/pdf/E6-14262.pdf
2 p.
51198
51199
71 FR 51198
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research; Federal Register Vol. 71, Issue
NOTICE
E6-14262
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2006-10-30
Docket No. 2006D-0331
4160-01-S
E6-14262
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.'' This draft guidance, when finalized, is intended to assist Institutional Review Boards (IRBs), clinical investigators, and sponsors in the development and conduct of emergency research.The draft guidance also describes the additional specific human subject protection requirements for emergency research. Elsewhere in this issue of the Federal Register, FDA is announcing a public hearing on emergency research conducted without informed consent under FDA regulations.
Submit written or electronic comments on the draft guidance by October 30, 2006. General comments on agency guidance documents are welcome at any time.
Carolyn Hommel, Good Clinical Practice Program (HF-34), Food and Drug Administration, 5600 Fishers Lane Rockville, MD 20857, 301-827-3340.
Reports and guidance documents; availability, etc.:
Exception from informed consent requirements for emergency research; guidance for institutional review boards, clinical investigators, and sponsors,
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
Federal Register
Vol. 71, no. 167
Office of the Federal Register, National Archives and Records Administration
2006-08-29
continuing
daily
deposited
born digital
337 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2006-08-29
P0b002ee180965019
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr29au06
https://www.govinfo.gov/app/details/FR-2006-08-29
https://www.govinfo.gov/content/pkg/FR-2006-08-29/pdf/FR-2006-08-29.pdf
https://www.govinfo.gov/content/pkg/FR-2006-08-29/xml/FR-2006-08-29.xml
fdlp
51095
51420
DGPO
2010-09-22
2023-05-03
FR-2006-08-29
machine generated
eng
FR
FR-2006-08-29
71
167