US Government to Authorize Nazi-Like Human Experiments

http://www.profamilylawcenter.com/ ^ | 9 6 06 | Richard D. Ackerman

[freepatriot32]

The FDA is presently considering guidelines that would allow scientists to conduct "emergency research" on patients without any informed consent. PFLC is launching a direct challenge to these proposed regulations which would allow Nazi-like experimentation on human beings.

Do you remember from history what the Nazi party and Joseph Mengele did to human subjects during WWII? These reprobates conducted dangerous medical experiments on innocent people without consent. Many people died as a result of the Nazis' human experiments and many others suffered a lifetime of post-experimental trauma and injury. This is not to mention the deprivation of basic human dignity that is occasioned by unconsented experimentation on human beings. Your government is proposing to do the same thing in 2006 !!!

The Pro-Family Law Center has just discovered that the United States Food & Drug Administration (FDA) is considering new rules that would allow scientists and doctors to conduct "emergency research" on unconscious or other incapacitated patients. This "emergency research" could be conducted without any informed consent from the patient or their designated representative. The proposed regulations known as "Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent for Emergency Research" are set for public hearing on October 30, 2006. Most American citizens have no idea that this hearing is to take place. Moreover, most wouldn't know what to do about it.

However, PFLC is simply not willing to put up with the idea that the U.S. government can order that any human being be experimented on without valid consent. Our lead counsel and PFLC president, Rich Ackerman, has fought for the privacy rights of patients, informed consent rights, and other pro-life causes for over a decade.

PFLC considers this newest battle to be one of the most important of our times. If a human being can be experimented on with absolutely no consent, we have lost all sense of human dignity. While our Nation long ago lost much of its respect for preborn children, we attempted to hold on to the principles of informed consent and human dignity for adults. These new regulations would chip away at the remaining respect that our Nation has for human life.

[freepatriot32]

pinging to both my lists tonight

[freepatriot32]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0331]


Draft Guidance for Institutional Review Boards, Clinical
Investigators, and Sponsors; Exception from Informed Consent
Requirements for Emergency Research

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

---

SUMMARY: 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

[[Page 51199]]

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.

DATES: Submit written or electronic comments on the draft guidance by
October 30, 2006. General comments on agency guidance documents are
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy (HF-11), Office of the Commissioner,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your requests. Submit phone requests to 800-835-4709 or 301-
827-1800. Submit written comments on the draft guidance to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY

INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Carolyn Hommel, Good Clinical Practice
Program (HF-34), Food and Drug Administration, 5600 Fishers Lane
Rockville, MD 20857, 301-827-3340.

SUPPLEMENTARY INFORMATION:

I. Background

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 was developed to assist IRBs, clinical
investigators, and sponsors in the development and conduct of emergency
research, that is, research in emergency settings when an exception
from the informed consent requirements is requested under FDA's
emergency research regulation. Further, the draft guidance describes
the additional specific human subject protection requirements for
emergency research, such as community consultation and public
disclosure activities, the need for the concurrence of a licensed
physician, use of data monitoring committees, use of independent IRBs,
and the documentation of efforts to contact a subject's legally
authorized representative or family member regarding the subject's
participation in the study.
In addition to the draft guidance, FDA is holding a public hearing
on emergency research conducted without informed consent under FDA
regulations. The public hearing is designed to solicit the views of
individuals and groups affected by challenges encountered in the
conduct of emergency research in the absence of informed consent,
including patient advocacy groups, individuals who have participated in
clinical trials, IRB members, sponsors, clinical investigators, medical
societies, ethicists, and other interested parties. FDA will consider
comments and suggestions received at the hearing together with any
comments received on the draft guidance to determine whether the
current framework is adequate for the ethical conduct of emergency
research, or whether modifications would be appropriate.
Under the regulations in 21 CFR 50.24, and the conforming
amendments contained in 21 CFR parts 56, 312, 314, 601, 812, and 814,
an exception may be requested from the requirement to obtain informed
consent from each subject, or the subject's legally authorized
representative, prior to enrollment in a clinical investigation. The
narrow exception applies to emergency research for which, among other
things, the following conditions exist: (1) An investigational new drug
application (IND) or investigational device exemption application (IDE)
is required; (2) that involves human subjects who have a life-
threatening medical condition (for which available treatments are
unproven or unsatisfactory); (3) that involves subjects who because of
their medical condition (e.g., unconsciousness) cannot give informed
consent; and (4) where, to be effective, the intervention must be
administered before informed consent from the subjects' legally
authorized representative is feasible. Studies involving an exception
from the general requirement of informed consent may proceed only after
a sponsor has received prior written permission from FDA, and the IRB
has found and documented that specific conditions have been met.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
exception from informed consent requirements for emergency research. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 56 (21 CFR part 56) have been
approved under OMB control number 0910-0130, the collections of
information in part 312 (21 CFR part 312) have been approved under OMB
control number 0910-0014, and the collections of information in part
812 (21 CFR part 812) have been approved under OMB control number 0910-
0078. Modifications to these approved information collection
requirements are underway or will be made at the time that each
information collection is renewed. The agency believes that this is
appropriate because this guidance has only a minor impact on these
existing collections of information.

III. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the document at
either
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm
or
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.

Dated: August 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14262 Filed 8-25-06; 8:45 am]

BILLING CODE 4160-01-S

[Mike Darancette]

If it sounds either too good or too bad to be true it probably isn't.

[Capn TrVth]

This post needs Theremin music.

[Nathan Zachary]

Gee, I wonder what political party this author supports....

He shouldn't worry. there is no mention of a lamp shade factory being built behind the research facility that will make lamp shades from the skin of these medical reseach center prisoners. They don't have a ward filled with twins do they??

[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

[Jedi Master Pikachu]

Skeptically, is this real?

[Nathan Zachary]

To me it reads that if, as a last ditch effort to save a life, experimental treatments may be used without going through the usual process, which would take to long and result in the persons death anyways.

I don't see any "Joseph Mengele" intent here. The wording and guidelines haven't even been discussed, tabled, finalized yet, so how can anyone read "Joseph Mengele" intent into this?

[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?)

[Mr. Silverback]

I was wmbarassed at how many people at FR bought the "test pesticides on retarded kids" crap a couple of years ago.

[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?

[spinestein]

This is the important part and I don't see anything that warrants likening it to Nazi experiments. Total overreaction.


[FDA will consider comments and suggestions received at the hearing together with any comments received on the draft guidance to determine whether the current framework is adequate for the ethical conduct of emergency research, or whether modifications would be appropriate.Under the regulations in 21 CFR 50.24, and the conforming amendments contained in 21 CFR parts 56, 312, 314, 601, 812,and 814,an exception may be requested from the requirement to obtain informedconsent from each subject, or the subject's legally authorizedrepresentative, prior to enrollment in a clinical investigation. The narrow exception applies to emergency research for which, among other things, the following conditions exist: (1) An investigational new drug application (IND) or investigational device exemption application (IDE) is required; (2) that involves human subjects who have a life- threatening medical condition (for which available treatments are unproven or unsatisfactory); (3) that involves subjects who because of their medical condition (e.g., unconsciousness) cannot give informed consent; and (4) where, to be effective, the intervention must be administered before informed consent from the subjects' legally authorized representative is feasible. Studies involving an exception from the general requirement of informed consent may proceed only after a sponsor has received prior written permission from FDA, and the IRB has found and documented that specific conditions have been met.]

[Spktyr]

Exactly - all this says is that if you're carried in unconscious and dying, normal treatments wouldn't work, and the only option that could possibly save you from death is experimental, they don't have to wait to get consent. And this is *only* in cases where the *only* alternative to the experimental technique or gear is **death**. So basically, you, the patient, have nothing to lose (because you're going to die otherwise, because conventional treatments won't help) and everything to gain (you may have to have AA batteries on you the rest of your life, but hey, you're still alive.)

As for actual examples of this technique saving people, here you go. It takes place in Israel, where such guidelines are already in place; check out the bottom sidebar: http://www.newscientist.com/article/mg18925435.800-saved-by-sand-poured-into-the-wounds.html

[spinestein]

bullseye.

[Nathan Zachary]

You did good. that's how I see it.

[Spktyr]

I'm sure it has, long before the FDA came about. Here's an example; penicillin was originally used in the civilian sector on people dying from bacteriologial infections for which there was no treatment. Most of those patients were unconscious or delirious.

[Slings and Arrows]

Thanks - nice to see that fancy book larnin' paying off. ;^)