Advance medical directives; revises Health Care Decisions Act to clarify process. (SB1142)

SB1142 Proposes to Violate the Nuremberg Code In One of its Provisions
SB1142: Advance medical directives; revises Health Care Decisions Act regarding.

An advance directive may authorize an agent to approve participation by the declarant in any health care study approved by an institutional review board pursuant to applicable federal regulations, or by a research review committee pursuant to Chapter 5.1 ( 32.1-123 et seq.) of Title 32.1 that (i) snipped OR

(ii) aims to increase scientific understanding of any condition that the declarant may have or otherwise to promote human well-being, even though it offers no prospect of direct benefit to the patient.

Directives for Human Experimentation

NUREMBERG CODE
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

http://www.wesleyjsmith.com/blog/2009/01/virginia-senate-bill-1142-paving-way.html

Virginia Senate Bill 1142: Paving the Way for Experimenting on the Incapacitated and Dying?
A correspondent--who is a disability rights activist--alerted me to SB 1142, a proposal in Virginia to overhaul its law concerning advance directives. There are several things in the bill that concern me, but she wrote worrying that it would open the door to experimenting on the incapacitated and the dying.

She is right--the bill authorizes signers of advance directives who become incapacitated to be experimented upon if the named surrogate decision maker consents--even if the experiments are not intended to provide them any help at all. From the bill:

Section: 54.12983.1. An advance directive may authorize an agent to approve participation by the declarant in any health care study approved by an institutional review board pursuant to applicable federal regulations, or by a research review committee pursuant to Chapter 5.1 (§ 32.1123 et seq.) of Title 32.1 that (i) offers the prospect of direct therapeutic benefit to the declarant, or (ii) aims to increase scientific understanding of any condition that the declarant may have or otherwise to promote human wellbeing, even though it offers no prospect of direct benefit to the patient.
Adding to the concern, if the patient is terminally ill, an advance directive may be established orally:
Further, any competent adult capable of making an informed decision who has been diagnosed by his attending physician as being in a terminal condition may make an oral advance directive to authorize the providing, withholding or withdrawing of lifeprolonging procedures or to appoint (i) directing the specific health care the declarant does or does not authorize in the event the declarant is incapable of making an informed decision, and (ii) appointing an agent to make health care decisions for the declarant under the circumstances stated in the advance directive if the declarant should be determined to be incapable of making an informed decision.
My correspondent notes that the form language permitting experimentation is the default setting--there isn't a check box to indicate yes or no in the suggested form. Unless the creator scratches the provision out, he or she is authorizing him or herself to be the subject human experimentation. Since some people will surely see the text as mere boilerplate or might not understand the import of the words, they might not know that they had consented to be experimented on while incapable or dying.

This provision explicitly violates the Nuremberg Code that requires subjects of human experimentation be capable of consenting to--and have complete understanding of--the experiment in which they participate. From the Code:
The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice,...and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
The Nuremberg Code isn't legally binding, but its precepts are proper guidelines to follow. The substitute decision making to allow experimentation aspect of this bill should be removed since by definition, a person for whom decisions are being made consistent with an advance directive is incapable of giving truly informed consent to participate. A nebulous general assent ahead of time of the kind allowed in the bill doesn't cut it.

Thanks very much to my correspondent for bringing this important matter to my attention.
Labels: Virginia SB 1142. Unethical Human Experimentation.

posted by Wesley J. Smith @ 4:33 PM 0 Comments

Virginia Senate Bill 1142: Paving the Way for Experimenting on the Incapacitated and Dying?
http://www.wesleyjsmith.com/blog/

Won't go and LIVE in Virginia (have in the past and LOVED the state) Also will pray that we never have an accident in Virginai. Inhuman and lacks compassion. Ranks right down there with Michael Vick. Shame on them for taking advantage!

The Senate Substitute (available on the General Assembly website--see button on right above) has just made this bil shockingly worse. Now two doctors can decide your treatment or withdrawal of treatment if you have no available or willing family member or power of attorney. Every Virgnian is at risk.

The House passed the Senate version today. Now it is up to Governor Kaine to protect us from this bill.

My bad. It's cross over today--I read the minutes incorrectly. We still have a chance to amend this bill. Don't give up!

SB 1142 was reported out by the House HWI committee with a substitution today but I haven't found the substitution yet.

Bill has passed both chambers with improvements to the research provison that make it clearer what a person is agreeing to when they sign an advanced directive and elimination of the 2 doctors clause allowing doctors to in essence act as POA's or guardians.

Scratch my last post, as of today the bill is in conference since the Senate rejected the House's Amendment. So not on the way to the Governor.