Richard Ashcroft recently criticised UNESCO's proposed Universal Declaration on Bioethics and Human Rights (see Nothing to declare: UNESCO on ethics, human rights). I too have concerns about the proposal, based on years of experience managing research programs.

The inequity of the global distribution of biological benefits and risks from science and technology is probably the overriding issue that the UNESCO declaration should have addressed, but it does so very poorly. 

Most scientific research is financed by developed countries and controlled by their researchers, whereas clinical trials are often done in developing nations.

While people in poor nations face the risks associated with such research, they can seldom afford to use the benefits derived from that research. More generally, global research and development fails to adequately address the needs of developing nations, and global institutions fail to disseminate research results and technologies adequately to poor nations.

The declaration "addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings". But there are ethical issues that involve the risks and benefits to humans involved in engineering, and in both social and physical sciences research. Should these too not be addressed in a universal declaration on bioethics? What about ethical issues related to technologies applied to animals and other biological organisms?

The declaration also seems silent on biosafety. There are many concerns, from the containment of pathogenic organisms, to protection against radiation hazards, to proper handling of hazardous chemicals, which are especially relevant for developing nations. Governments regulating to protect researchers, research participants and the general public from such hazards would benefit from guidance on the relevant bioethical issues. For example, do members of the general public — who cannot provide informed consent to the risks they may face — require greater levels of protection from biohazards created by research than the actual participants?

The declaration does not refer specifically to the potential hazards to animals under research. Different standards are applied to different classes of laboratory animals, such as primates, rats, larger mammals such as dogs and cats, fish, and birds. Still other standards apply to livestock, captive wild animals, and wild animals in nature.

Research can also create hazards to animals outside the laboratory, through the release of dangerous organisms into livestock or wild animal populations. Should not a universal bioethics declaration clarify the ethical responsibility to prevent such events?

Botanical and agricultural research can create economically important risks to the environment. How are governments to regulate, and what are the ethical issues involved in such regulation? While the research would, in theory, be included under the proposed declaration, as 'life sciences', the current version does not identify the principles that might best be applied.

A considerable international effort has gone into the regulation of biotechnology. Such regulation is based on the special needs created by biotechnological research to deal with uncertainty. There are different approaches applied in regulation of biomedical biotechnology, agricultural biotechnology, and industrial biotechnology. The Universal Declaration is silent on the ethical basis of regulation of biotechnology.

Nor does it mention bioethical issues in the patenting of genes or issues of intellectual property rights concerning animals or plants.

I agree with Ashcroft that "the declaration is disappointingly vague and lacking in force is in its section about the environment and future generations". Research projects have been responsible for the release of many highly destructive organisms, and researchers have a responsibility to consider environmental consequences as they report their results and recommend policies. Regulation of such risks is an important task for governments, and one that would benefit from a well-developed universal declaration on biosafety.

One might hope that the General Conference of UNESCO will reject the proposed declaration, and send it back to the secretariat for revision.