T esting and deployment of GM mosquitoes: what is different? Ethical Review Process Instituto Conmemorativo Gorgas Vicente Bayard S. MD;MPH;MSc. Médico Epidemiólogo

Cookson A, Is a National and/or Institutional level Ethics Review needed for GMM testing and deployment? Sterile insect technique has been used without ethics review (agricultural objectives) Public health decisions have been taken for the public good, without individual consent (e.g. fluoridation of water, iodine in salt, choice of vaccination programme, etc) In addition to the biosafety process (for GM), however, we argue that the decision to use GMM may merit ethics review

Cookson A, Approval through an Ethics Review process is generally required for all research involving human subjects Human subjects are living individuals on which the researcher conducts a study to obtain: 1) Data through intervention or interaction with the individual 2) Private information that is identifiably from that individual (US Federal Regulation 15 CFR (f))

Devine B, Research involving human subjects – evolution of best practice Best practices have developed after past exploitation of vulnerable communities, such as: Prisoners in concentration camps (WW II) Infamous US study of African Americans infected with syphilis (control group denied access to penicillin) And others

Ethical principles Respect for the persons Human rights, self-determination, informed consent Privacy and confidentiality Potential benefit Proper estimate of risks and benefits Maximise individual benefits, reduce risks Justice Equitable distribution of risks and potential benefits Community access, equity, protect vulnerable groups

Unanticipated problems vs. Adverse events Unanticipated problems include things not considered Most adverse events are not unanticipated AdverseEvents Unanticipated Problems OHRP Guidance Topic III

When to report an adverse event? Coach, 2007

Coach, Institutional Review Board IRB To obtain the maximum protection of the participating subjects, the IRB should: Assure immediate reporting of any unanticipated events for participants and others Develop plans to deal with possible anticipated adverse events Assure adherence to international laws, regulations, and standards

Comply with safety and international standards before field trials Set up procedures/evaluation of risk, with some basis Environmental monitoring baselines Gene stability proven in laboratory before field trials Gene flow considered (especially in self-replicating cases) Social/scientific indicators are appropiate Epidemiologial, environmental and/or social studies for site selection Information openly exchanged Leaders, community, mass media Consent from communities involved More inclusive: The better

Macer D., TDR/STR/SEB/ST/03.1 Specific considerations proposed: Before GMM field release: Assess scientific and social issues Develop safety precautions Address potential risks Risk should be minimazed: Relevant lab experience Careful site selection Understanding of baseline vector population

Regulatory, Ethical, Cultural considerations These factors can often be more important than many scientific and technical criteria Few ethical objections to combating disease However, there is seldom 0% risk factor Need to evaluate potential benefit & risk perspective Most GM mosquito trials will have potential impact on human population. Participants need to be fully aware that they are involved in trials, and be given the opportunity to voluntary consent

Some research is so unobtrusive that individual consent may not be needed CIOMS/WHO Guidelines (2003) International ethical guidelines for biomedical research involving human subjects “where research is undertaken on a community basis …Individual consent may not be feasible and the ultimate decision to undertake research will rest with the public heath authority in consultation with research ethics committee”

Summary GM mosquito field release would normally need institutional ethics approval Human populations are involved Adequate information and dialogue must be provided for participation and approval by communities