McMaster philosopher leads the creation of principles to guide genetic modification

What if deliberate genetic modifications could prevent mosquitoes from transmitting devastating illnesses such as malaria, dengue fever and Zika, saving millions of lives?

What if the same modifications also turned out to have unanticipated harmful impacts?

These and other questions are at the heart of the debate over gene drive, the promising but controversial science of overriding natural selection by pushing preferred genetic traits through a population to create certain results, such as breeding out the capacity to transmit a virus, or breeding out the capacity to reproduce altogether.

The science is advancing quickly, and there is international concern about making sure it proceeds transparently, responsibly and beneficially.

McMaster philosopher Claudia Emerson, director of McMaster’s Institute on Ethics & Policy for Innovation, is the lead author of a major new paper in the journal Science that introduces a set of guiding principles for moving forward with such research. So far, 13 major funders of gene drive research have committed to adopting the principles.

Emerson and her fellow authors from the Bill & Melinda Gates Foundation, the Foundation for the National Institutes of Health in the US and the Wellcome Trust in the UK are hoping that others will commit to upholding the same guiding principles.

The principles are being established at a time when some opponents, including environmental and anti-GMO groups, are calling for such research to be banned outright.

The authors hope that broad uptake of the principles will help the public to understand that funders and investigators are committed working out the risks and benefits of gene drive before field-testing and deployment.

“One of the things we’ve learned is that as well as something might function in a laboratory environment, some level of uncertainty remains as to how it will function in the natural environment,” says Emerson from her office at LR Wilson Hall. “The benefits still seem to be greater than the risks, which is why we want to proceed with the research, but there are obviously groups who feel quite nervous about this and who are unconvinced by the data. They feel it’s crossing a boundary that shouldn’t be crossed.”

Emerson hopes the principles will show doubters that gene-drive funders and researchers understand public concerns, and assure the public that such research is conducted ethically and transparently.

“We need to keep going. We need to find out more. Banning the research would actually be a terrible idea,” Emerson says.

As funders continue to sign on to the common set of principles, she explains, it helps create a community of practice that adheres to the highest scientific and ethical standards.

“Scientific and technical advancement happen so quickly that the science seems to be ahead of the ethics, and sometimes the regulations,” Emerson says. “All of these things have serious ethical and societal implications. There is a need to think pre-emptively about the implications and to do something to stay one step ahead of the science, or at least in step with it.”

Here, from the Science paper, are the guiding principles for sponsors and supporters of gene drive research:

Advance quality science to promote the public good

The pursuit of gene drive research must be motivated by, and aim to promote, the public good and social value. Funded research shall embody the highest quality science and ethical integrity, consistent with the current best practice guidance set by the research community and relevant decision-making bodies.

Promote stewardship, safety, and good governance

Researchers and sponsors are stewards of science and the public trust. It is imperative that good governance is demonstrably shown in all phases of the research, and especially in relation to risk assessment and management. This requires compliance with applicable national and international biosafety and regulatory policies and standards. Research conducted with respect and humility for the broader ecosystem in which humans live, taking into account the potential immediate and longer-term effects through appropriate ecological risk assessment, is a hallmark of both good stewardship and good governance.

Demonstrate transparency and accountability

Knowledge sharing is not only essential for the advancement of science, but for transparency to foster public trust in emergent technologies. The timely reporting of results and broad sharing of data shall be the norm in gene drive research, consistent with the tradition of openness established in its parent communities of genetic and genomic science. Measures of transparency and accountability that contribute to building public trust and a cohesive community of practice will be supported.

Engage thoughtfully with affected communities, stakeholders, and publics

Meaningful engagement with communities, stakeholders, and publics is critical for ensuring the best quality science and building and sustaining public confidence in the research. Funded research shall include the resources needed to permit robust, inclusive, and culturally appropriate engagement to ensure that the perspectives of those most affected are taken into account.

Foster opportunities to strengthen capacity and education

Strengthening capacities in science, ethics, biosafety, and regulation is essential for enabling agile and steady progress in gene drive research globally. Opportunities to partner, educate, and train shall be supported throughout all phases of the research, from the early stages to deployment. Strengthening capabilities within countries for testing and deploying the technology is essential for informed decision-making.