Genetics / attempt to regulate genetic research to deal with legal and moral problems
Tamara Traubman
The main recommendations for genetic research
* Ethical rules will be formulated for the management of genetic research
* The authority will supervise the research among large populations
* The general public must be informed about the conduct of DNA research
* Companies that conduct research will return part of the profit to the community
* Group consent of testimony in relation to sensitive studies
* The data will be published with maximum sensitivity to prevent stigma
About two years ago, an Israeli genomics company began research that was unprecedented in its scope: as part of the research, the company collects DNA samples from thousands of patients in order to establish a private DNA database and discover new genes for diseases. The establishment of the private database "caught" the Ministry of Health unprepared - so there has not yet been a public discussion on the issue and the ethical rules for conducting this type of research have not yet been formulated. According to members of the committee that oversees genetic experiments on humans on behalf of the Ministry of Health - the "Supreme Helsinki Committee" (the Israeli body that approves or rejects genetic research on humans) - an in-depth and principled discussion took place only after the company had already been approved to begin collecting the samples.
"There was a tremendous conflict," says Prof. Bracha Reger, a member of the Helsinki High Commission and a scientist at Ben Gurion University. According to her, the research has the potential to advance science and medicine, but nevertheless it raises new moral questions: Who does the genetic information actually belong to? Is the genetic profile of a particular ethnic group a commercial resource or a resource that belongs to the community, and is a private company even entitled to own it?
The establishment of DNA databases and the carrying out of genetic studies among large ethnic groups in the population are now being discussed in two reports that try to deal with the rapid development of research; the reports will be published soon. One report was compiled by the Bioethics Advisory Committee of the National Academy of Sciences, headed by Prof. Michel Rebel from the Weizmann Institute; the second report was compiled by the Bureau of Ethics of the Medical Association, headed by Prof. Avinam Raks from Hadassah Hospital. Many of the recommendations in the reports are the same. These recommend establishing a statutory national authority, which will oversee commercial and public DNA databases of populations in Israel, and a national DNA database, which will be managed by the authority.
Rebel, winner of the Israel Prize for Medicine, and Rakes say that the need for such permission stems from the new nature of genetic research in large and defined populations, which creates new moral and legal issues. In addition to this, according to them, it is likely that with the development of technologies for deciphering and analyzing DNA, the desire to establish additional repositories will also increase. "The report was written to regulate the research and in recognition of its potential," says Professor Rebel.
The members of the Rebel Committee propose to name the new authority "The Authority for Collections of Samples and Genetic Information of Populations in Israel". According to both proposals, the Authority will formulate ethical rules for conducting research among ethnic groups and large population groups. Prof. Rechs emphasizes that the authority will also supervise the research itself. "The big problem today is that once the research is approved, there is no follow-up on what was actually done with it and if it exceeds the approval given to it or not," he says. However, Rebel and Rakes are skeptical about the establishment of the public H-NA Bank. "In an economic reality that is going down, I am satisfied if this happens in the coming years," says Prof. Rebel.
However, the proposal is already controversial and involves ethical problems. The members of the academy committee themselves write in the report: "Producing a genetic profile of a group that can be defined according to its ethnic or national origins, could lead to the risk of stigmatizing all the members of the group. Worse, this could lead to discrimination in a variety of forms - moral, physical or economic." According to Prof. Hagit Maser-Yeron, the chief scientist of the Ministry of Science, alongside the possibility that the establishment of such a database will promote the development of new drugs and diagnostic methods, "there are many risks and costs". She mentions, for example, the question of protecting the privacy of the people whose samples will be in the database Universities register patents after discovering a new gene, could a national DNA database, which is supposed to be built with public funds, also be used to generate personal financial profit?
In order to allow the subjects who contributed DNA to the database to benefit from the results of the research, the committee of the Medical Association recommends that a person participate in the experiment through his doctor, while maintaining medical confidentiality regarding the results of the research that concern him personally. "But what if the person does not want to know that he carries a serious mutation, which will cause him a serious illness at a young age," asks Prof. Asa Kosher, an ethicist from Tel Aviv University and one of the members of the academy committee. "The people in the database did not choose in advance to know about their genetic traits, says Kosher, "The dilemma here will be the doctor's and we will have to develop new tools that will allow us to distinguish between those who want to know and those who don't."
But genetic information is also characterized by the fact that it has meaning not only for the person tested in the research, but also for the group to which he belongs, says Verdit Ravitzky, who is writing a doctoral thesis in ethics and genetics at Bar Ilan University. This question exists in genetic tests that detect mutations that cause increased susceptibility to disease and can also indicate the possibility that a similar mutation also exists in the test's family members and children. However, collecting information about ethnic groups in Israeli society (such as Ashkenazim, Ethiopians) raises a new question. "The information," Ravitzki says, "may have consequences - positive or negative - that directly affect the members of the entire community, whose members did not give their consent to the research."
According to Ravitzky, a typical expression for this was given by Rabbi Moshe Tendler, in an interview he gave to American radio in which the genetic research conducted on the group to which he belongs was released. "Why do you focus on Ashkenazi Jews only and create the impression in the world that we carry 'bad genes'"? He asked, "People don't know my name but I am already identified as a member of the Ashkenazi Jewish community who carries bad genes. (The investigators) had no right to do this to me."
Prof. Rex says that the report's recommendations try to provide an answer to this problem and recommend that in the case of "special" ethnic groups, such as the Ethiopian or Druze communities, to seek consent for conducting the research not only from the participants themselves, but also from the community leaders.
According to Prof. Kosher, today it is customary to see the community from which the DNA was taken as having "status" in the use that will be made of the information. "This is actually the genome of the community," he says. The recommendations of the two committees suggest that companies donate back to the community from their profits.
