Comment: Ethics Needed In Medical Research
( 2003-10-31 07:35) (China Daily)

The general public wouldn't have paid much attention to the revised Ministry of Public Health regulations on assisted
reproductive research and human sperm banks, were it not for the media hype on the controversial experiments in South
China's Guangzhou involving the technique of human egg nucleus transfer.

The three new administrative regulations, announced by the Ministry of Public Health on July 10, went into effect on
October 1. They defined, among other items, ethical principles in relation to the use of assisted reproductive
technology and human sperm bank management.

Following the Universal Declaration of the Human Genome and Human Rights, adopted unanimously by the general conference
of the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1997, the new regulation states
that "human cloning is forbidden.''

The regulation on the ethical principles on assisted reproductive technology specifically stipulates that "no medical
workers should use the techniques of human egg cell nucleus and human egg nucleus transfers for infertility treatment
before the problem of safety is resolved.''

However, the new regulations had received little media attention. Until the mid-October, when the results of the Sino-
US co-operative research project involving the use of human egg nucleus transfer at the Medical College of Dr Sun Yat-
sen University in Guangzhou were presented at a national reproductive research conference in the United States.

Medical professionals, followed by the general public, began to question the ethical and medical implications of the
experiments.

However, the incident and subsequent remarks from some researchers involved should serve as admonitions. The public
must remain vigilant against such medical malpractice and call for effective legislation, public caution and enhanced
social responsibility on the part of scientists.

Similar experiments in the name of science and international co-operation must be better supervised and managed, as
some of these moves may actually harm the well-being of the society, the environment, the ecology and the mankind.

In their interviews with the local media, the researchers involved seemed anything but repentant. They claimed they had
good intentions to help infertile women to have children of their own. They emphasized that the experiment they carried
out should in no way be linked to human cloning, despite the fact that the technique seems to be perilously close.

They even suggested that they'd only moved a little "faster,'' by doing the experiments in China that have already been
banned in many developed countries such as the United States. And they claimed only boldness and even a spirit of
adventure could lead to further scientific discoveries and make our lives even better.

Their responses to the media and medical criticism are a cause for concern. They seem to have forsaken their cardinal
responsibility as scientists who should place the general good of society above their mere research interests.
Traditional medical treatment is helping most people with infertility problems.

By international standards, any clinical medical experiments must be based on the following three criteria. The
procedure is assured of safety to human beings, proven viable in animal research and thoroughly considered for all of
its social and ethical implications.

Despite the researchers' argument, the now banned research project satisfied none of the above criteria. For one thing,
they cannot explain how much the microstructures of the human eggs are disrupted during the extraction and transfer of
the egg nucleus. The hazards that nuclear transfer could pose to children who may be born as a result remain unknown.

Even though the researchers claim they've done experiments on mice, experiments on lab animals alone cannot justify
going straight into actual human experiments.

True enough, as a result of boldness and adventure, sciences have made much headway over the past two centuries. Human
beings have been able to guard against many diseases and live longer. We've seen the land on earth altered almost
beyond recognition from 200 years ago.

But we must acknowledge that scientific advances have also been accompanied by environmental degradation, reductions in
biodiversity, global warming and new diseases. We will also encounter unforeseeable complications that now challenge
the continuing well-being of human society and the earth.

We must be aware that some scientists from developed countries make use of the ignorance and eagerness of their
colleagues in the developing countries to carry out experiments banned in their own nations.

That's why many conscientious scientists call for exercising caution. Research does not always produce a panacea for
all our physical and environmental problems.

That's why UNESCO member countries unanimously pledged in Universal Declaration of the Human Genome that "treatment or
diagnosis affecting an individual's genome shall be undertaken only after rigorous and prior assessment of the
potential risks and benefits pertaining thereto and in accordance with any other requirement of national law.''

And the declaration also states "assessment of the risks and benefits pertaining to research on the human genome to be
carried out and abuse to be prevented'' in the framework of international co-operation with developing countries.

In fact, although the 2001 Ministry of Public Health regulations did not specifically ban the human egg nucleus
transfer, the ministry did require the researchers to seek extensive consultations and consent from ethical boards and
the ministry.

But the researchers involved in the project have undertaken none of the consultations, even with the knowledge that the
same procedure was already banned in the United States.

However complete the new ministry regulations are, there are ways to get around them.

So the public, the scientific institutions and the legal departments must team up to work out specific ways to enforce
the new regulations. They should also make the researchers socially and ethically accountable for their conduct.

The scientific and medical world should dishonour those who disregard the well-being of the humanity and who forsake
their social and ethical obligations.

We human beings are enjoying what we have achieved, but are also suffering from the mistakes we've made.

We should not leave our posterity an environmentally, ecologically and socially degenerated earth because of the errors
we've made in the name of science.

SOURCE: China Daily
http://www1.chinadaily.com.cn/en/doc/2003-10/31/content_277136.htm

Reference:

Universal Declaration of the Human Genome and Human Rights 1997
http://www.cehat.org/humanrights/decl12.html

Pregnancy Created Using Egg Nucleus Of Infertile Woman
http://tinyurl.com/t9y1

Controversial fertility technique is successful
http://www.twincities.com/mld/pioneerpress/7006705.htm

Reproductive technology - Not cloning
http://www.economist.com/science/displayStory.cfm?story_id=2138009

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