[email protected] t esting and deployment of gm mosquitoes: what is different? ethical...
TRANSCRIPT
Testing and deployment of GM mosquitoes: what is different?
Ethical Review Process
Instituto Conmemorativo GorgasVicente Bayard S. MD;MPH;MSc.
Médico Epidemiólogo
Cookson A, 2006 [email protected]
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, 2006 [email protected] 3
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 individual2) Private information that is identifiably from
that individual (US Federal Regulation 15 CFR 27.102(f))
Devine B, 2007 [email protected] 4
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
Aguilar,E.,2007 [email protected] 5
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
Coach, 2007 [email protected] 8
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., 2003. TDR/STR/SEB/ST/03.1 [email protected]
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