Human Genetic Data an international declaration soonHuman genetic data should soon have its own standard-setting instrument: an international declaration setting out the ethical principles that should govern their collection, processing, storage and use. A draft declaration is being examined by UNESCO’s General Conference, which is meeting in Paris for its 32nd session until October 17.
Collected from biological samples (blood, tissue, saliva, sperm, etc.), human genetic data are playing an increasingly important role in our lives. They are allowing scientists to identify, in advance, the diseases that threaten us, and they hold the promise of new cures. Genetic data banks, furthermore, are multiplying and growing all over the world. And certain countries – Iceland, Estonia, Latvia and Tonga–are undertaking a genetic census of their population. Such data are also providing answers to certain questions - concerning paternity, for instance, or the identity of law-breakers – posed by judges or police.
Genetic data tell us much, and promise to tell us more and more. Yet, like many other aspects of the genetic revolution underway, they are also a source of concern. Do they not risk opening the door to genetic discrimination, and lend themselves to uses contrary to human rights and basic freedoms?
In this rapidly evolving domain, the need for ethical guidelines is now obvious. UNESCO – which had previously developed the Universal Declaration on the Human Genome and Human Rights, adopted in 1997 – began an examination of human genetic data issues in 1993 through its International Bioethics Committee (IBC). Two IBC reports have already dealt with the subject: “Confidentiality and Genetic Data” (June 2000) and “Human Genetic Data: Preliminary Study by the IBC on its Collection, Processing, Storage and Use” (May 2002).
It was also the IBC that worked for several months, as a whole or through a drafting group specially formed for the purpose, to elaborate the text that is being presented to the General Conference. A series of consultations was held, including public hearings with associations and institutions representing indigenous people, the handicapped and doctors, as well as the private sector. Experts representing 57 of UNESCO’s Member States then studied the instrument during a meeting of a committee of governmental experts last June.
The text proposed to the General Conference opens with general provisions. The objective is clearly stated – to ensure the respect of human dignity and human rights, and fundamental freedoms - especially freedom of thought and expression, and including freedom of research. The draft continues: “Each individual has a characteristic genetic makeup. Nevertheless, a person’s identity should not be reduced to genetic characteristics, since it involves complex educational, environmental and personal factors and emotional, social, spiritual and cultural bonds with others and implies a dimension of freedom.” The specific nature of genetic data and the purposes for which they should be collected, treated, used and stored are also defined. Concerning procedures, the text, which insists on the protection of human rights, concludes with an article devoted to non-discrimination: “Every effort should be made to ensure that human genetic data and human proteomic data are not used for purposes that discriminate in a way that is intended to infringe, or has the effect of infringing human rights, fundamental freedoms or human dignity of an individual or for purposes that lead to the stigmatization of an individual, a family, or a group or communities.”
At the collection stage, the project raises the problem of consent, which should be prior, free, informed and express. Limitations are possible but they must be consistent with the international law on human rights. Other problems such as withdrawal of consent, the right to decide to be informed or not of research results, and the need for genetic counseling are all outlined in the context of collection.
At the processing stage, the major problem is confidentiality. Should the samples or data about them be linked or not to an identifiable person? If yes, how will confidentiality be respected? On the one hand, certain data need to be identified or identifiable (for police records and also genetic testing); on the other, everything must be done to guarantee maximum confidentiality. The draft establishes the principle that “human genetic data, human proteomic data and biological samples linked to an identifiable person should not be disclosed or made accessible to third parties, in particular, employers, insurance companies, educational institutions and the family, except for an important public interest reason in cases restrictively provided for by domestic law that is consistent with the international law of human rights, or where the prior, free, informed and express consent of the person concerned has been obtained provided that such consent is in accordance with domestic law and the international law of human rights.”
At the use stage, the major question concerns purposes. The text sets out the problem of changing the purpose or the medical or scientific research objective. In the case of genetic research on lung tissue taken from victims of a century-old flu epidemic, for instance, who can authorize such use, not foreseen at the time and obviously without consent? The draft also raises the idea of sharing benefits.
At the storage stage, we again encounter difficult questions. What kind of management of human genetic data can guarantee appropriate protection of human rights and fundamental freedoms? What do we keep and what do we destroy, particularly when dealing with data gathered in the course of a criminal investigation or court case?
The problems raised by human genetic data are complex. Situations also vary widely from one country to another, both in terms of technology and of legislation. In some cases, there is no legislation in this area. In others, it exists as “indirect” legislation, such as laws governing computer data, which include genetic data because they are usually processed as such. In other cases, there is recent legislation covering a specific aspect, such as the establishment and management of a national data bank.
To some, the variety of situations and their complexity represent an additional argument in favour of setting international standards. But the task of the General Conference will be difficult. The fact that UNESCO has chosen to draft a declaration (an instrument which is not legally binding) rather than a convention should, however, facilitate consensus and allow the text, if it is adopted, to be better adapted to a constantly evolving context.
(*) IBC reports are available at www.unesco.org/ibc/
The draft text of the declaration is on the website: http://unescdoc.unesco.org/images/0013/001312/131204e.pdf#page=27
Photo © UNESCO/Niamh Burke