Since the discovery of the structure of DNA in 1953, scientists working on nucleic acids have been able to explain how genes determine all life processes by directing the synthesis of cell proteins.

In the decades since, scientists have been able to identify genes or deficiencies in particular genes linked to diseases and illnesses. Doctors have come up with processes to diagnose the diseases while pharmaceutical companies have created medicines or gene therapies to treat the diseases.

The most ambitious DNA-related effort has been the human genome project. As scientists now complete mapping the genome, they are also beginning to describe what each gene does and develop treatments or cures to debilitating or fatal hereditary illnesses caused by a defective, inoperative or missing gene or genes.

With this scientific promise comes ethical issues that challenge scientists and the public. Participants during last week's Forum on Bio-ethics, Bio-engineering and Bio-safety in Hangzhou, which was sponsored by UNESCO (the United Nations Educational, Scientific and Cultural Organization), engaged in heated debates on a number of issues related to ethical problems that have arisen in genetic research and bio-engineering.

Madam Han's case

A few months ago, about 350 doctors, ethicists and medical school students from China and Germany were presented with a list of questions in a survey conducted by the Centre for Applied Ethics under the Chinese Academy of Social Sciences.

The same questionnaire was again presented to more than 200 scientists, doctors, business people and legal experts last week during the UNESCO forum.

The survey starts by telling the story of Madam Han. Han, in her 60s, has suffered high blood pressure for a long time.

When she was advised by the doctor to use a new medicine, her body reacted to it. Her abdomen frequently ached and she began to have blood in urine.

A check-up found she also suffered from kidney disease called ADPKD, which is caused by a genetic deficiency.

A closer look into Han's family history suggests that her father may have died of the same disease 30 years ago, implying that Han's other family members might also have the same genetic deficiency.

Treatment of high blood pressure will aggravate this kidney disease.

The only cure now available for Han is a kidney transplant, which is not only expensive, but also has side effects.

Besides the concern about expenses for medical treatment, a series of questions concerning ethics are also raised:

Should the doctor require Madam Han to inform her family of her disease and the genetic problem?

Does the doctor have the right to inform Han's family of her disease against her will?

Or is the doctor obligated, ethically or legally, to inform them so that a genetic check-up can be conducted as soon as possible to ensure timely treatment for others?

Furthermore, can doctors use the specific genetic information Madame Han carries for genetic studies in the future?

The questionnaire is intended to study Chinese people's views on dealing with genetic information of private people discovered in the genetic diagnosis of certain disease, said researcher and survey conductor Wang Yanguang.

As genetic diagnosis of certain ailments becomes more accepted by doctors for its efficiency and accuracy, ethical issues such as these will arise and create such dilemmas.

In the US, too, these questions are vexing. Some situations concerning clinical gene therapy treatment and diagnosis and patients there have led to lawsuits. Patents won by researchers through their gene studies have been questioned.

The problems include:

Should cloning of human beings be allowed?

Can prenatal genetic diagnosis be used for the purpose of eugenics?

Can a gene be patented?

All these issues are not yet defined by Chinese law and were fiercely debated during last week's conference.

Yet the hottest debates during the conference centred on the issue of "informed consent."

Informed consent requires prior consent from prospective research participants be obtained to show they have full knowledge of the study before any research can occur.

This principle is the result of historical lessons in which unethical biological research was conducted on socially and politically vulnerable races and social groups, especially during World War II, when Nazi Germany and Japanese Fascists conducted biomedical tests on countless innocent victims and killed them.

The right to know

The rising concern about the rights of individuals and patients prompted many countries, the United States, Australia and India, to enact laws requiring doctors and researchers to inform individuals of their treatment or research.

As a principle widely accepted in international biological research, informed consent was introduced to China quite early but the practical procedures remain far from clear.

It inevitably leads to confusion and even malpractice in some research.

"Many Chinese researchers and ethicists have talked about informed consent and its requirements, but when it comes to practice, many problems and difficulties arose," said Xu Haigei, a researcher from the Nanjing Institute of Environmental Science. "A slip may sink the whole research."

This problem was highlighted by controversial research on the genetic causes of hypertension, nicotine addiction and osteoporosis conducted jointly by China and Harvard University-affiliated institutions. The work was first funded by an American drug manufacturer. The US National Institutes of Health (NIH) is now funding the studies, which have been approved by the Chinese Government.

In this effort, two molecular genetic laboratories have been set up in Hefei, capital of East China's Anhui Province, and Anqing, another city in Anhui.

Epidemiologist Xu Xiping, associate professor at Harvard, and his partners from the medical division of Peking University and Anhui Medical University, started the collaboration in the mid-1990s.

They have collected massive blood, mainly in Anhui, without informing the farmer-research participants of the goal of the research.

Media reports from the United States and China also indicated the farmers were never offered the free medical treatment promised by the researchers.

Moreover, the samples will be used without official approval to study other diseases not in the original scope of the research, including obesity and asthma.

Chen Changzhong, an associate professor with Anhui Medical University involved in the collaboration, refuted the accusations at the Hangzhou conference.

He insisted "100 per cent of consent" had been obtained from all participants by having the farmers fill out a consent form that explained the study.

Yet Gwendolyn Zahner, a psychiatric epidemiologist, played the role of whistle-blower two years ago when she filed a complaint. She insisted at the conference that informed consent involves more than procedural issues. "Informed consent is not just a form," she said in a keynote address. "It is a process."

That process requires that research subjects are fully informed, she said. It must also include informing the whole community of a whole range of issues related to genetic research.

"As far as I know, the rural community in Anqing is not aware of the Harvard research project," said Xiong Lei, a senior reporter with the Xinhua News Agency, who published an investigative report on the case in the March 28 issue of Outlook Weekly.

Zahner suggested an independent monitoring system be established throughout such a research effort to ensure that the participants' full knowledge of the research and their rights have been protected.

Despite agreement on the necessity of informed consent, many questions remain open.

Among the most puzzling is how to reconcile the fact that informed consent bans scientists from giving participants anything, or creating an "undue influence," for their willingness to volunteer.

That goes against the practice of paying research participants. Conference participants debated whether compensation is undue influence, but no resolution was reached.

From China Daily