CRISPR babies raise an uncomfortable reality – abiding by scientific standards doesn’t guarantee ethical research

Uncertainty continues to swirl around scientist He Jiankui’s gene editing experiment in China. Using CRISPR technology, He modified a gene related to immune function in human embryos and transferred the embryos to their mother’s womb, producing twin girls.

Many questions about the ethical acceptability of the experiment have focused on ethical oversight and informed consent. These are important issues; compliance with established standards of practice is crucial for public trust in science.

But public debate about the experiment should not make the mistake of equating ethical oversight with ethical acceptability. Research that follows the rules is not necessarily good by definition. As He pushed ahead with human gene editing, how much he skirted the rules may not be his primary ethical failing.

He is taking heat from the scientific community. AP Photo/Kin Cheung

The ‘right’ way to conduct research

A statement signed by 122 Chinese scientists proclaimed He’s work “crazy” and in violation of ethical standards. Is that really the case?

Scientists undertake medical research to generate knowledge that may one day be used to improve human health. This work can help determine new strategies for prevention and early detection of disease, or develop new drugs and new technologies for treatment, for example. Without investigating them, no one knows which preventive measures, diagnostic tools, or treatments are most beneficial. They need to be rigorously tested.

Ethicists tend to focus most on studies that ask a lot of human subjects because these usually carry the most risks for volunteers. Picture a drug study with participants taking an experimental medication, keeping a daily diary of symptoms and side effects, meeting frequently with a physician and so on.

There’s a long history of abuse and misuse of human subjects in research, from medical workers withholding syphilis treatment from unsuspecting black men in Tuskegeee, Alabama so they could track the disease’s progress, to the deliberate infection of research participants with syphilis in Guatemala in the 1940s to more recently the role of conflicted investigators involved in psychiatric research at the University of Minnesota. In recognition of the potential for abuse, all research undertaken in the U.S. in institutions like universities that receive public research funds or by companies seeking FDA approval for a product is overseen by various ethical and regulatory committees.

A man included in a syphilis study has blood drawn by a doctor in Tuskegee, Alabama. National Archives via AP
The ethical acceptability of research is contingent on an institutional review board’s judgment that the procedure has the potential for benefit that counterbalances risk of harm. Institutional review boards are typically internal to research institutions but are meant to be independent of investigators. The board also works to ensure the process of informed consent is robust, such that participants are appropriately educated about the relevant risks of participation, are free from coercion to participate and are aware of their ability to decline to participate without penalty.

Funders of research will also conduct scientific peer review of a protocol to ensure the quality of the research design. Poorly designed research is ethically problematic since it wastes financial, human and other resources that could be allocated to better justified research.

Journal editors play an important gatekeeper role, as well. Studies conducted without appropriate ethical oversight may not be reviewed for publication in journals that abide by the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals adopted by the International Committee of Medical Journal Editors.

Concerns at any of these steps along the way can prevent health research from proceeding or from contributing to the scientific and medical literature.

Passing ethical review doesn’t mean it’s ethical

When He presented his work at a session of the Second International Summit on Genome Editing in Hong Kong, many people raised questions about the informed consent process. Important as they are, the queries also seemed to be groping for a smoking gun – some clear violation of existing standards – in order to declare what people already felt: that the research was unethical.

Having those standards and discovering a violation of them makes judgments of ethical responsibility feel straightforward and objective. A rule was broken, the research was unethical. Case closed. There are certainly questions about the adequacy of the processes He’s research went through. Were collaborators kept in the dark about its nature and aims? Was the experimental protocol and the informed consent process subjected to rigorous review by an independent oversight body? Was the consent process itself robust and not compromised by the interests of the researchers?

But by focusing heavily on these still-open questions, the scientific community risks implying that mere compliance with routines of oversight would have made it ethical. That approach fails to ask what is being overseen, what is being overlooked and whether that matters to how we judge the ethical acceptability of an experiment.