Re-thinking the ethics of dual-use research of concern on transmissible pathogens

Rapid acceleration in the science of genetic engineering of infectious diseases has outpaced legal and ethical frameworks for dealing with such research. Dual-use research of concern (DURC), which can be used for good or for harm, raises new questions about potential harm to human beings which have not traditionally been considered by medical research ethics committees, and may require us to revise and standardize ethical guidelines worldwide for the conduct of such research. The weighing of harm versus benefit of research as traditionally considered on an individual level needs to be considered on a population level for infectious diseases DURC, and on a global level due to the potential for transmissible infections to cause a pandemic, thus affecting people in places far from where the research was conducted. The harm of such research could result from either laboratory accidents or bioterrorism. As an example, engineered organisms such as influenza could result in an unnatural pandemic, affecting and harming people who were never informed of the research nor consented to it. The debate to date has been held among medical researchers and has been focused on the rights of researchers and scientific freedom. The community is also a stakeholder with rights, and DURC done in one country could cause harm to people in other countries who were never included in the debate. The first requirement is to inform and engage the public as a stakeholder in such research, and to make deliberations about DURC public and transparent. Secondly, governance structures and guidelines are not uniform internationally, and only some institutions and countries have specific DURC policies, none of which are enforceable. Consistent international guidelines and uniform, enforceable global governance models need to be developed for medical research ethics committees around potential population harm and benefit of DURC. Finally, researchers should be required to quantify potential population risks and benefits of DURC before it is approved. Models for quantifying risk–benefit equations could be drawn from health economics, with the onus on researchers to demonstrate that potential benefit outweighs potential harm. These would be positive steps towards protecting the interests and rights of all potentially affected populations in the case of transmissible infectious disease DURC. Past quantum changes in medical research governance such as mandatory registration of clinical trials show that major changes in research culture can be achieved. Current systems leave community stakeholders vulnerable to potential harms of infectious diseases DURC, and need to be addressed in a consistent and comprehensive manner internationally to ensure ethical obligations are met.