Maryland Report on research on non consent able human subjects: A critique  

This article was triggered by the final report of the Maryland Attorney
General's Working group on "Research Involving Decisionally Incapacitated
Subjects". The surprising point with this working group was that it tabled
their first report in 1996 but the disability movement seemed not to have
heard of it or haven't found the issue of interest( the latter would
surprise me even more because the misuse of disabled people as guinea pigs
in research has been going on for a long time and is a major
disability/human/equality rights violation).  The conclusion of the report
is not surprising.  In essence, it condones research Involving Decisionally
Incapacitated Subjects. I will discuss that conclusion later, but first I
will consider how they justify that conclusion!

Under "General provisions," they state the following: " Research involving
decisionally incapacitated individuals may be essential under some
circumstances if science is to understand and ultimately combat diseases of
the brain, including  Alzheimer's Disease, severe psychiatric disorders,
severe trauma, stroke, other causes of decisional incapacity, and the
medical problems that are associated with these conditions and disorders."
They go on to suggest that "Researchers should seek to enroll decisionally
incapacitated individuals as research subjects only if the research is
expected to yield generalizable knowledge important to the understanding or
amelioration of the subjects' disorder or condition and related medical
problems, and the knowledge cannot be obtained without their participation."

This justification for involving people without their consent presents the
first major problem. Decisions to include individuals in research without
their consent is justified by what might benefit future generations and the
greater good of society (generalizable knowledge). Whether it has positive
or negative effects on the research subject is not considered. A second
problem is that the vast scope of conditions targeted which also means a
vast group of decisionally incapacitated individuals will be targeted. This
bill will touch many many people (just count the number of Alzheimer
people).
Now, let's have a look at which type of research is condoned in this
report. There are four categories
1)Research Involving Direct Medical Benefit
2)Research Involving NO direct medical benefit and minimal risk
3)Research Involving NO direct medical benefit and minor increase over
minimal risk
4)Research Involving NO direct medical benefit and more than a minor
increase over minimal risk

In essence there are two categories. The one where I take part in research
(1) which benefits me and one which does not benefit me.(2-4) As all are
dealing with decisionally incapacitated individuals it follows that 2-4 are
in violation of the Nuremberg Code and the UN Declaration on human rights
the  Declaration of Helsinki.

Now let's have a look at the safeguards for Category 4)

 Consent by research agent.
(a) A research agent may consent to a decisionally incapacitated
individual's participation  in research described in 20-638 if:
(1) a monitor confirms that:
(i) the research is unambiguously included in the individual's research
advance directive; and
(ii) the research agent understands the goals and risks of the research; and
(2) the research agent concludes, based on the research advance directive
and other  pertinent information, that the individual would consent to
participate in the research were the individual able to give informed
consent.
(b) A monitor shall witness the process by which an investigator provides
the research agent with the information required by an IRB for informed
consent.
20-640. Other consents prohibited.
No legally authorized representative other than a research agent may
consent to a decisionally  incapacitated individual's participation in
research described in 20-638.

Here the safeguards seems to be that you need to have signed a research
advance directive.
If that would be indeed required than you wouldn't have many people for
research as not many people have research advance directives. The report is
unclear as to what happens if you are non consent able like a child a
anacephalus baby any other person who becomes or is viewed as incompetent
without a directive. Does this report suggest they can't be used for
research? Or can a substitute decision-maker sign a research advance
directive if the other person was never competent?
Another problem is the factor of coercion. If I get tested for Alzheimer
and they find the marker Apo E4 and I start to develop Alzheimer how high
will be the pressure on me to do the responsible thing to volunteer for
research so that others will have the chance of a cure a treatment? Within
the bioethics community, the debate is there to establish that people have
the moral obligation to volunteer for experimental research. How high will
be the pressure on parents of non competent children or babies to let these
babies children be used for research purposes? To use non-competent
individuals is a way to gain some use from them as they are just a burden
to the system. If there are not enough competent
consent able volunteers to be found than society does not feel it needs
this research and it should not go than for the ones who can't say NO. This
report is in opposition to the principle of autonomy, self determination,
self preservation, benificiancy and equality rights.

Let's give now the word to Adil Shamoo who was a member of this working
group and put forward a

A DISSENTING STATEMENT
In brief, the proposed legislation does not address the major issues of the
protection of vulnerable uncomprehending human subjects from high risk
non-therapeutic experiments. In other words, those human beings will
continue to be used as guinea pigs for the benefit of future generations
and science. In our great country and in all civilized world, we have
rejected the supremacy of science or the advancement of society over the
interest of the individual human beings as enunciated by every code of
ethics anddeclarations. The following are the major flaws in this proposed
legislation:
(1) The legislation does not resolve the research protocol approval process
which is riddled with conflict of interest. The research institution
appoints 20-25 members of their employees called Institutional Review
Boards (IRB) to
decide on the propriety of recruiting human subject from the community.
Furthermore, the research institution also appoints the one and only member
from the community. The lone community member even if he/she
objects to the proposed protocol is overwhelmed by the large majority of
the researchers on the committee. The research institution has a direct
financial conflict of interest when deciding whether to approve or
disapprove a given research protocol.
(2) The same physician/investigator who proposes the research protocol is
in charge or has the major control of recruiting, informing, caring, and
interacting with patients. The physician/investigator is the one who
assesses the patient's capacity to sign informed consent. This approach
clearly does not resolve the past abuses of using ill-obtained
informed consent for the  past thirty years. Also, there is a conflict of
interest of the investigator acting as the care giver. The proposed
legislation pays a lip service to the appointment of medically responsible
physician with little authority over the final outcome.
(3) The proposed legislation had no deterrence to those who will violate
this proposed law on regular basis. There are no criminal or financial
penalties. In short, there is no accountability.
(4) The most important flaw in the proposed legislation in the lack of
independent oversight. The public's interest must be protected by
independent oversight from those institutions and individuals who gain
monetary as well as other benefits from their deeds using citizens that are
vulnerable, uncomprehending, and ill-informed.
 

To conclude this article, I would like to remind you that Maryland is not
alone. The UNESCO declaration on human rights and the human genome allows
the research on non consent able people even if it doesn't benefit them
(Article 5e).
And the European Convention on human rights and Biomedicine also allows for
such research (Article5,16,17). Interestingly because of the Article 5,16
and 17 Germany is not signing the convention as the public is rallying
against the use of people for  research not beneficial to them.

The article is only a little piece to start with. I hope that by the time
this article is out that there will be more informations accessible through
my webpage. On request,  I am willing to provide contact addresses to
people who work closely on the Maryland Report and the European Convention.
 

Dr. Gregor Wolbring
Dept. of Biochemistry and Molecular Biology
Faculty of Medicine
University of Calgary
3330 Hospital Drive NW
Calgary, T2N 4N1
Alberta, Canada
Phone 1403-220-5448
Fax   1-403-283-4740
e-mail gwolbrin@ucalgary.ca
web http://www.thalidomide.ca/gwolbring