DO NO HARM by Gregor Wolbring
Scientists often use decisionally incapacitated people for high-risk, non-benefit research purposes, despite the fact that this kind of research violates several national and international standards, including the Nuremburg Code, and the UN Declaration on Human Rights (Helsinki). This kind of research also contradicts the original meaning of BENIFICENCE "Do No Harm". There are at least three recent policy papers that condone high-risk, low-benefit research on decisionally incapacitated human subjects. The
first is the Maryland Report, produced by the Maryland Attorney General's working group on "Research Involving Decisionally Incapacitated Subjects." (1). This issue is also discussed in the UNESCO Declaration on Human Rights and the Human Genome (article 5e) (2); and the European Convention on Human Rights and Biomedicine (Articles 5, 16, 17) (3).
This article will discuss the Maryland report, which was made public in 1996 and greeted with little criticism. The final draft of this report, produced in 1998, CONDONED four categories of research
with human subjects: (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 increases over minimal risk; and (4) research involving NO direct medical benefit and more than a minor
increase over minimal risk.
How are POLICY MAKERS able to justify the use of decisionally incapcitated Human subjects in research activities that may cause harm? In the Maryland Report the "general provisions" section explains that: "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." The report goes on to suggest that, "researchers would 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." These sections seem to accept this type of human experimentation at the expense of the individual by claiming some sort of societal good.
Allowing high-risk, non-benefit research on non-competent people opens the door for serious abuse. For example, parents, as substitute decision-makers for their children, might be pressured into allowing the use of their children in such research. Another danger is that people who test positive for certain genetic conditions, such as Alzheimer's, might be pressured to sign an advance research directive and thereby consent to be used later in life for high-risk, non-benefit research.. Efforts like the Maryland Report do not provide sufficient safeguards. Within the bioethics community, there is already an established notion that people have a moral obligation to volunteer for experimental research (even high-risk, non-benefit research), which shows that the possibility of pressure as cited above is real.
Adil Shamoo, a member of the working group on "Research Involving Decisionally Incapacitated Subjects" put forward this dissent, "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 the 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 and declarations."
The Maryland Report has dangerous implications for people - both competent and decisionally incapacitated people - who undergo medical or genetic tests. It is important that we adhere to the ethical concepts and guidelines OUTLINED in the Nuremburg Code (4) and the HELSINKI Declaration of Human Rights (5) to prevent high-risk, non-benefit research on decisionally incapacitated human subjects.
!!!!Hot of the press The Maryland committee voted to kill the Decisionally Incapacitated Research Subject Protection Act for this
References 1-5 are found as links or in the section Important documents on my webpage