The Food and Drug Administration has issued draft guidance on the development and conduct of research in emergency settings in which informed consent cannot be obtained from the research subjects. The guidance � intended for institutional review boards, clinical investigators and sponsors -- describes the additional human subjects protections that are required in such cases. Public comments on the draft guidance are due Oct. 30. The FDA will hold a public hearing on the issue Oct. 11. For more information, please visit http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/
2006/pdf/E6-14262.pdf