[AdmSmith]

Have you really read the guidance?

The text above gives the impression that this is something new. But a google search for Exception from Informed Consent for Emergency Research gives about 2,530,000 hits.

These are old guidelines that will be updated.

here are the guidance http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0331-gdl0001.pdf

and the notice http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-14262.htm

[weegee]

Since the policy is not new, has it been done to patients already without consent?

[endthematrix]

Here's another:

http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc97-01.htm

"On October 2, 1996 (Federal Register, Vol. 61, pp. 51531-51533), the Secretary, HHS, announced, under Section 46.101(i), a waiver of the applicability of the 45 CFR Part 46 requirement for obtaining and documenting informed consent for a strictly limited class of research, involving research activities that may be carried out in human subjects who are in need of emergency therapy and for whom, because of the subjects' medical condition and the unavailability of legally authorized representatives of the subjects, no legally effective informed consent can be obtained. This waiver, which provides a third route through which IRBs may approve research in this class, takes effect November 1, 1996.


This waiver applies to the Basic HHS Policy for Protection of Human Research Subjects (Subpart A of 45 CFR Part 46) and to research involving children (Subpart D of 45 CFR Part 46). However, because of special regulatory limitations relating to research involving fetuses, pregnant women, and human in vitro fertilization (Subpart B of 45 CFR 46), and research involving prisoners (Subpart C of 45 CFR Part 46), this waiver is inapplicable to these categories of research."

(Regulatory limitations now a thing of the past?)

[Nathan Zachary]

Exactly. This is just an proposal to open debate and establish, introduce or update guidelines for the use of experimental treatments in a emergency situation where a patient is on the verge of death and no other option (except to let the patient die) is available.

I'd be more worried about what changes are made to the existing guidelines and are being voted on.

[Slings and Arrows]

If I'm reading this correctly, it says (summarized) "If you're unconscious or delerious AND at death's door AND no standard treatment exists that will save you, we don't need the consent of you or your guardian to try an experimental treatment on you if there's not time get that consent without you dying."

How did I do?