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ITAS – Assessing the impact of life science technologies

The Karlsruhe Institute for Technology Assessment and Systems Analysis (ITAS) is one of the largest and most renowned institutions in Germany involved in evaluating scientific and technological developments. The institute assesses the impacts and possible effects of new methods from a wide range of scientific fields - including the life sciences. It particularly focuses on controversial disciplines such as synthetic biology, genome editing and brain research.

The technology assessment research field deals with the impact and effects of new technologies on society and the environment. Scientists from a wide range of disciplines analyse the opportunities and risks of innovative developments, contribute to forming public opinion and provide policy and design options to policymakers.

The Institute for Technology Assessment and Systems Analysis (ITAS) in Karlsruhe is one of the largest traditional research institutes working on technology assessments in Germany. The ITAS has over one hundred scientific staff from a wide variety of disciplines working on the latest technological developments and advising, among others, the European Parliament and the German Bundestag through the Office for Technology Assessment at the German Bundestag (TAB). The life sciences are one of the ITAS’ major focus areas.

Representing the opinion of society as realistically as possible

Political scientist Christopher Coenen from the ITAS in Karlsruhe is investigating the opportunities and risks of new developments in the field of biotechnology. © KIT, photographer: Christin Bamberg

"Assessing life science methods not only involves academic research, but also setting up measures to promote dialogue," explains Christopher Coenen, researcher at the ITAS and expert in human enhancement and synthetic biology. "We glean options for political action from our findings, but I would like to emphasise that achieving public acceptance is not our main purpose. It is not our job to convince people of the benefit of certain technologies; we just look soberly at the associated opportunities and risks.”

At the start of each assessment, the researchers first need to understand the method that they are investigating and its current state of development. They identify and read literature on the topic, interview scientists and other relevant people. Sometimes, they even visit laboratories and look over scientists’ shoulders as they are working. “Participatory observations like these are relatively expensive,” says Coenen. Once all this is complete, the researchers will then specifically focus on analysing facts and different viewpoints, sometimes bringing these issues to public notice. “We usually have a relatively large budget that allows us to invite experts and social stakeholders as well as organise public events in which as many different social groups as possible are present to discuss various issues. For example, we have run discussions between biohackers – people who have a more critical view of biotechnology – greens and church representatives. The results of our projects are then presented to relevant decision-makers and the general public,” says Coenen.

No fundamental rejection of synthetic biology

ITAS building in Karlsruhe where an interdisciplinary team of life scientists, engineers and people with social sciences and arts degrees is working on the assessment of a broad range of innovative developments - including of life science technologies. © ITAS, photographer: Arnd Weber

This procedure was applied to Synenergene, a large-scale four-year project on synthetic biology. It involved international researchers and ran up until 2017. "As part of Synenergene, we organised around 150 events on three continents, both traditional-type events as well as more unusual formats such as theatre productions, film festivals and role-playing workshops," says Coenen. "Of course, we also ran many other public events to bring stakeholders from different fields together. At the German Evangelical Church Convention in Stuttgart in 2015, to name just one example, we organised panel discussions and evaluated questionnaires and comments.”

Roughly summarised, the Synenergene project has come to the following conclusions: there is no evidence of extreme opposition to synthetic biology. However, the researchers found that there was a significant lack of information as far as the public is concerned about developments in the field of synthetic biology. “Of course, some people are strongly opposed to synthetic biology. In general, however, the different standpoints – especially as far as green genetic engineering is concerned – have long been entrenched. There is a very influential sector of society that organises and funds the resistance to green genetic engineering. Surveys on the application of genetic engineering to plant breeding show that there is still enormous opposition to the technology in Germany. However, society as a whole is not opposed to green biotechnology, and the situation can be quite different in other countries. This is why we integrated into our project survey groups such as biohackers. Biohackers are generally very positive about synthetic biology.”

High acceptance of genetic engineering for medical applications

Coenen further highlighted that there are justified doubts about the neurosciences, but that different standpoints are not generally that rigid, and people are far more open to future developments in the field of brain research than to developments in the field of genetic engineering. In fact, many people regard brain research as a fascinating field of research. “In general, public acceptance of a particular technology increases enormously once it shows great potential for medical application,” says Coenen. “This even holds true for genetic engineering. When genetic engineering can be put to good use in human health, opposition to it seems to disappear.” Coenen went on to highlight that it cannot be assumed that it is possible to change people’s opinions by providing them with more information or hard facts, and that scientific debate should not be confused with democratic political discussion; value decisions, once made, are rarely questioned.

Biologist Dr. Harald König has worked as researcher at the ITAS for many years and is an expert in the assessment of future technologies in the life sciences. © private

Dr. Harald König is also well aware of this point. König is a biologist and researcher at the ITAS and an expert in the assessment of life science technologies. He comments: "There are many heavily value-laden issues where opinions are simply fixed. In synthetic biology, these are mainly bioeconomy-related topics such as the increasing use of biofuels. Some people fear that nature is becoming more and more commercialised.

König and some other TAB staff are currently involved in a project to assess the application of genome-editing methods for human therapy. The major focus of the project, which is expected to be completed in summer 2018, is the application of these methods in germline therapies. Gene-editing methods can be used to make specific genetic changes, for example "correcting" disease-causing genes directly in fertilised egg cells. This leads to the introduced changes appearing in all subsequent cells and generations. "This of course raises a whole series of ethical questions," says König. "These include, does the genome belong to humanity as a whole? Are we really allowed to do this? What about the consent of future generations? As far as the latter is concerned, some people are of the opinion that such germline interventions also affect human self-understanding and freedom."

Is the Embryo Protection Act under pressure?

The German Embryo Protection Act of 1990 generally prohibits germline interventions in Germany. "Back in 1990, germline interventions were considered too dangerous and too difficult to control," says König. "Nowadays, we can significantly reduce any risks. Gene-editing methods have tremendous potential to accurately control the introduction of genetic changes. Experiments suggest that unintentional genome modifications can in future be prevented. Some lawyers might therefore derive from Germany’s constitution an individual’s legal right to therapy. The legislative authorities might then come under the pressure to legitimise these forms of therapy and would have to weigh up both sides carefully.”

Genome editing enables the nucleic acids of a gene to be exchanged, much like letters or words with the copy-and-paste function on a computer keyboard. © ITAS, photographer: Natalie Matter-König, Harald König

In addition to researching and analysing the state of technology and the ways in which genome-editing technologies can be used, the experts are currently in the process of collecting expert reports from clinicians, legal scholars and ethicists as well as initiating discussions between Bundestag members and reviewers. The researchers are aiming to progress the monitoring project relatively quickly in order to do justice to the rapid advancement of genome-editing methods. “The objective of our analysis is to see whether the Embryo Protection Act or parts of it will actually come under pressure, where there is need for action and which options are available,” says König.

In addition, ITAS is planning a project on the convergence of artificial intelligence and modern genome research. "We want to analyse the potential of these technical capabilities in order to understand the relationship between genes and traits, and to work out what needs to be taken into account when, for example, patient genomes become part of large biobanks,” explains König. “It may soon become possible to predict a person’s appearance from his or her genome. But there are also other ways this information can be used, for example targeted genetic interventions for treating diseases such as diabetes and Alzheimer’s, or even the alteration of complex traits such as intelligence. Here, the questions arise as to whether therapy can be separated from prevention, and where the boundaries for genetic enhancement lie.”

Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/assessing-the-impact-of-life-science-technologies