RA&RM of Living Modified Mosquitoes

The issue of “informed consent” has arisen in the context of the release of transgenic insects, particularly vectors of human disease such as mosquitoes. Because this phrase has been repeated several times in this context (though never justified that I am aware of), it has gained some currency as a consideration. I will argue that the consideration is untenable and should be dismissed as an issue.

“Informed consent” refers to “… a legal condition whereby a person can be said to have given consent based upon a clear appreciation and understanding of the facts, implications and future consequences of an action.” This alone appears to be relevant to any action performed that might affect an individual, but in fact the usual meaning is in the context of a medical procedure performed on an individual that might affect their health or one in which an individual is granting or waiving certain legal rights to another entity.

Does the release of transgenic mosquitoes necessitate informed consent? Or more generally, do activities that might affect human health necessitate that individuals give informed consent? Clearly they do not. Chlorination of water supplies does not require informed consent. Spraying of insecticides on public lands does not require informed consent, even though they could drift into individual residences. These activities usually (but not always) require general assent of the populace via representative governments, not individual informed consent.

Nor does the fear or possibility that releases might cause harm to individuals mean that they require individual informed consent. Anticipated transgenic mosquito releases (almost all of which consist of males) are not medical procedures. They do not require the individuals who might be exposed to grant legal rights to another entity if that entity e.g. a national government already has that authority.

It is the responsibility of the relevant governments, operating with the consent of the governed, to implement general measures to promote public health. It is also the responsibility of the government to exercise due diligence to ensure that the public is not exposed to unacceptable risks.

The governed do obviously have the right to elect and lobby their governments, participate in the decision making process regarding releases, and to even protest loudly if they desire. But informed consent terminology and processes are irrelevant and should be eliminated from this discussion.

My own comments echo those of Dr Benedict.

I am no expert, but the phrase "informed consent" seems inappropriate in this context, as it carries with it all the connotations of individual-based consent (e.g., a patient needing to give consent for an operation to be performed on him/her). I do not believe the phrase is used in public health contexts. Legislation in many places allows public health workers to spray insecticides against the wishes of the property owner.  Water fluoridation programmes similarly are not based on individual-by-individual consent. (In many countries these decisions are made by elected officials and/or their proxies).

Currently the document states that:

'Local residents that may be affected by the intended release must register their "informed consent" prior to the release.  "Informed consent" means that they have been provided with relevant details of the research protocol, they agree to participate, their health must be monitored throughout the course of the experiment, they must be able to withdraw from the experiment at will, and ultimately they must be apprised of the results of the work.'

This statement could be read to mean that a single resident within the boundaries of an area-wide mosquito control programme could halt the programme. If that is the intended meaning, then I strongly disagree -- other public health measures do not operate in this way. And quite right: why should a single individual be able to deny preventative health measures desired by a thousand or a million others?

If that is not the intended meaning, then the wording should be clarified to exclude it. "Community consent" may be a preferable phrase. One would still want a definition (with examples such as those cited above) somewhere in the document.


Austin Burt
Professor of Evolutionary Genetics
Imperial College London

I am not sure that "informed consent" is the correct terminology in this situation, but in any case I consider this aspect outside the scope of the mandate of risk assessment considerations.

If information to the community will be included, I believe that not only the potential risks should be included but also the potential benefits.

About all the mandate about the preparation of a guidance document I consider that the online discussion on this subject it will be not enough, because there is not enough information yet to decide if the anex III will be enough guidence for this kind of organisms. I suggest to have workshops with the aim to detect the gaps in scientiphic information needed to have an environmental risk assessment and after this workshops with the participation of  entomologist, epidemiologist and risk assessment experts, to decide if it is needed a guidance document and what must it contain. This workshop (s) could be prepared in coordination with other international agencies like OECD, FAO, ICGEB,etc.