Proposed genetic research moratorium raises ethical considerations, but unlikely to impact University projects

By Ian Dillingham, Statement Editor
Published March 22, 2015

Time to hit pause.

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Scientists at the forefront of biomedical research have requested a moratorium on the use of a contentious genetic technology to allow time for greater public discourse on its ethical considerations. The method, which uses a relatively novel system known as CRISPR-Cas9, could in the future allow researchers an unparalleled level of control in artificially altering the human genome.

Biologists from more than a dozen institutions nationwide are calling for the scientific community to promote “a framework of open discourse,” allowing discussions over ethics and policy the time needed to catch up with the current level of scientific understanding. The recommendations are outlined in a recently published article in the journal Science, following a similar article published in the journal Nature earlier this month. Both called for a voluntary moratorium on editing of germ cells — specialized cells involved in sexual reproduction.

While the University is home to several leading researchers of the CRISPR-Cas9 protein complex, it is unlikely that the moratorium — aimed at temporarily delaying the use of such technology in reproductive cells — would have any tangible impact on research being conducted on campus. Moreover, it remains unclear how such a moratorium would be enforced in any official capacity beyond the already stringent guidelines for human clinical research in the United States.

Still, ethical questions appear at the forefront of many advances in the field of human genetics. Following high-profile successes — genetic therapies have been researched for treatment of various blood diseases, metabolic disorders and cancers — the promise of groundbreaking cures entices those inside and outside the scientific community. But questions regarding science and research have come alongside ethical, religious, and political ones. Some fear the technology could be implemented for less benevolent purposes, such as artificially improving intelligence or cosmetic features.

Thomas M. Lanigan, an assistant research scientist in the University’s Department of Internal Medicine, has extensive knowledge of the CRISPR system. He said he supports the scientists’ efforts to promote responsible use of such technology.

“I think (CRISPR) has a possibility to revolutionize how we study science, how we study biology and how we study disease,” Lanigan said. “The potential is kind of amazing for science — both from a research perspective and a medical perspective.”

The possibility of editing human germ cell lines, however, is a “scary prospect,” Lanigan said. While the technique has great potential, he said it is important that scientists consider the social implications of such research.

“That’s a big step for humanity,” Lanigan said. “I think it scares a lot of people — and it should.”

The CRISPR system is not entirely unprecedented in biological research. Methods for altering and even repairing damaged genetic material have been researched and implemented in clinical practice since the early 1990s for a wide range of debilitating diseases.

At a fundamental level, the process is not too complicated. DNA — the organic molecule that carries genetic information — can be thought of as a long string of subunits called base pairs. These units are read and decoded by the cell to manufacture proteins, the building blocks for many cellular processes. When a DNA strand becomes mutated, the base pairs often fail to code for the correct protein. Such is the case in diseases such as cystic fibrosis.

Genetic therapy, however, offers the opportunity to repair the broken segments. Using process such as CRISPR, scientists can cut the DNA in areas on either side of the broken segment. Once the segment is removed, they can replace it with a functional version of the strand, allowing the cells to synthesize the necessary proteins.

For a long time, the problem for scientists was specificity. Until now, methods for breaking the DNA sequence have lacked the necessary accuracy to be implemented in human clinical therapies. While some methods might have been able to target the region of interest, it was difficult to ensure that other areas of the genome were not being altered as well. CRISPR holds the potential to offer a higher level of accuracy than many methods used in the past, though further development and research is needed before it reaches a level of accuracy that could be considered for human treatment.

Now, the conversation has turned to germ cells.

Previous genetic therapies focused on somatic cells — those not involved in reproduction. Manipulations made to these cells were considered less risky, given that they are naturally eliminated once a person dies. In germ cell lines, however, manipulations have the potential to be passed on for many generations. This concern led to the call for a voluntary moratorium and for more public input on the future implementation of such techniques.

Shobita Parthasarathy, an associate professor of Public Policy and an expert in biotechnology and ethics, said the United States has been less effective than other countries at developing a framework for science to gather public input on research with major social and ethical concerns.

“Generally, (the U.S.) approach to regulating science and technology — certainly in the last 30 to 40 years — has been that we’re so excited about the innovation that we just let it go,” Parthasarathy said. “We don’t have any real systematic regulatory framework for dealing with things like this.”

Parthasarathy said she is skeptical as to whether or not voluntary moratoriums will ensure public values are best represented in science. Moratoriums are heavily debated among scientists and only loosely defined, allowing each researcher to interpret as they see fit. The international climate of science — one that promotes intense competition among large institutions and research universities — does not lend itself to self-imposed restrictions among researchers.

Even if such research were regulated in the United States, Parthasarathy said rumors in the bioethics community “tend to focus on Chinese labs,” where clinical applications of genome alteration may be conducted under less scrupulous regulation.

In the United States, ethics committees or institutional review boards — panels of scientists who oversee and approve research being conducted at a particular institution — are currently tasked with addressing most ethical considerations of research.

“It still frames the debate from the scientific perspective and doesn’t really take into account what the public’s is or really even foster public conversation,” Parthasarathy said.

Barring the oversight of these committees, Parthasarthy said there is no reason such research might not be occurring at the University. She said the United States needs to rapidly develop a framework for public input and discussion as research pushes toward new ethical bounds.

“It calls into question how one distinguishes between acceptable and unacceptable research — where the line is between research and technology development and … who should be involved in that conversation,” Parthasarthy said. “These are profoundly ethical questions and social questions enabled by science … It is clear to me that scientists should not be the only ones answering those questions.”