Posted on 09/06/2006 11:00:27 PM PDT by 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.
pinging to both my lists tonight
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Draft Guidance for Institutional Review Boards, Clinical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.
If it sounds either too good or too bad to be true it probably isn't.
This post needs Theremin music.
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??
Skeptically, is this real?
Since the policy is not new, has it been done to patients already without consent?
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?)
I was wmbarassed at how many people at FR bought the "test pesticides on retarded kids" crap a couple of years ago.
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?
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
bullseye.
You did good. that's how I see it.
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.
Thanks - nice to see that fancy book larnin' paying off. ;^)
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.