Obtain Prior Informed Consent for GM mosquito release
The National Biosafety Board on 5 October 2010 approved the application submitted by the Institute for Medical Research (IMR) for approval for release of these GM Aedes aegypti mosquitoes.
One of the conditions of the approval, which has to be fulfilled before the start of the field releases, is that of public notification and consensus. The terms and conditions for the certificate of approval state that: “It is mandatory that the applicant through a public forum obtains prior consensus and approval for the inhabitants in the release sites regarding the proposed MRR [mark-release-recapture] field trial”.
CAP and SAM have already made clear our objection to the proposed field trials and the reasons why we have taken this stance. However, in view that the releases may still occur despite the objections of NGOs and the public, we would like to stress that the highest standards of prior informed consent must apply when it comes to obtaining the consensus and approval of the local communities in the release sites.
In the first place, any public forum conducted for the purpose of obtaining the consensus and approval of local inhabitants must be independent, open and balanced, presenting both the benefits and risks of the GM mosquitoes.
In our view, the public forum should not be conducted by IMR, although they may be called upon to provide technical or scientific inputs or to answer any specific questions on the trials. With all due respect to IMR, a public forum conducted by IMR would be seen as a clear conflict of interest, as IMR is the applicant for this field trial.
Secondly, the local inhabitants at the release sites must also be adequately notified and informed in advance about the public forum, and should be free to make their views known without fear of reprisals.
Thirdly, obtaining the consensus and approval of local inhabitants should be premised first on providing them transparent and comprehensive information about the proposed field releases. We would like to highlight paragraph 24 of the World Medical Association’s Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, in this respect (highlighted in bold for emphasis):
In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
We hope that IMR will apply the letter and spirit of the Helsinki Declaration in obtaining the consensus and approval of the local communities at the field release sites. Any less would be a breach of internationally recognized standards.
Fourthly, one issue that does not seem to be adequately disclosed is the involvement of the UK-based company Oxitec in the proposed research. It is not clear from the information provided to the public whether and how Oxitec is involved and what role it is playing. This, despite the known fact that the transgenic technology used in the GM mosquitoes is owned and patented by Oxitec. The public and the local communities should be adequately informed on this issue as well.
Finally, it is not too late for the government to call off the experiment and field release of the GM Aedes aegypti mosquitoes. Genetic engineering gives rise to unintended and unpredictable effects and the risks to public health and environment should not be underestimated. Thus we urge the Malaysian government to withdraw the approval and opt for safer solutions to control the spread of dengue fever.
Letter to the Editor, 14 December 2010