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Research Ethics and the New Gene-editing Technology0

 

Nik Zeps, Consultant, AHRECS

Keywords: Ethical Review, International Guidelines, Gene editing technologies,

It has now been over six months since He Jiankuiand his team used the CRISPR/CAS9 gene editing technique to introduce a gene alteration in twin girls (STAT). The revelation that he had performed this audacious experiment shocked the world and left people asking how he had been permitted to do it. Dr He Jiankui is not a medical doctor but is qualified in biophysics and was one of the pioneers of the new gene editing technology in China having worked in the United States for five years where he undertook post-doctoral studies.

The report that accompanied the announcement of the birth of the twin girls outlined how He and his colleagues had sought out couples where the father was HIV-positive but the mother was not. The purpose of their work was to alter a gene known to confer resistance to HIV infection, CCR5, so that the children would be naturally resistant to possible infection. The public response worldwide was one of outrage and fierce opposition from all quarters. His fellow scientists and doctors denounced his actions as immoral and unethical and he was fired by the Southern University of Science and Technology in Shenzhen, China.

Chinese authorities immediately placed a prohibition on any such activities and research (human embryonic gene editing that leads to the birth of babies) and claims were made that he and his team had acted against the law. The People’s Republic of China does have guidelines that forbid any research that involves human reproductive cloning; however, they do permit therapeutic cloning using embryonic stem cells where the aim is to cure or prevent illness. This is similar to the United Kingdom and several other European countries, but this is not legal in Australia. The key question here is whether such research is restricted to generating embryo stem cell lines or whether it permits the creation of embryos that can be implanted and grown to a full-term delivery.

There remain many unanswered questions from this case. He claims that he had ethics approval but the responsible committee denies they had any involvement. Clearly the clinic that recruited the potential parents (several signed up) also knew of the work and endorsed it. All of those working on the project presumably knew what the aim of their work was and yet still conducted it willingly. It is also important to note here that in this highly controversial case the world does not have any independent confirmation that any gene editing actually happened or that the twin girls have the CCR5 alteration. However, prominent scientists who were present at the announcement appear to believe the claims and some of the details in the report itself appear to reflect the reality of his claim.

In response to international outrage, a group of prominent scientists have called for an international moratorium. This would be similar to the 1975 Asilomar conference on recombinant gene technology. In 2015 UNESCO called for a moratorium on genome editing of the human germline at least until the ‘safety and effectiveness of procedures remain unproven’. Both calls envision the possibility that prohibitions may be lifted if the evidence for safety and effectiveness can be met in contrast to those that wish for a permanent outright ban. The general prohibition on research involving human embryos, such as is the case in Australia, prevents anyone doing research that might demonstrate that such work is safe and effective though, effectively shutting the door. In the United States there is only a prohibition for federal funding of such research so private enterprise could easily step in. Moratoria are notoriously difficult to monitor or enforce and the lure of making money or gaining fame from the research may prove to be too powerful. He might reflect that he has achieved notoriety rather than fame as a hero but reports generally paint him as ambitious and naïve, conveniently ignoring the guidelines or ethical issues rather than being actually evil in intent. After all, the intention was to augment human capacity, even though that has led to claims of ‘taking a step down the road’ of human eugenics by prominent bioethicists such as Arthur Caplan.

One of the key messages coming out of the debate is that self-regulation by scientists remains open to abuse. On the other hand, scientists argue that attempts to limit their work with increased scrutiny may be disproportionate and have a negative effect on research that may ultimately lead to improvements in human health. This is the ‘rotten apple’ argument and to some extent it is fair to be sympathetic toward it as there are good examples of how increased regulation does not necessarily improve patient or community safety. However, there is more to this debate than just regulation of laboratory activities and the issues related to what it is to be human and the consequences of manipulation that extends into augmentation or spurious characteristic selection such as eye colour or enhanced sport performance are real.

The World Health Organisation (WHO) has called for international guidelines https://www.who.int/ethics/topics/human-genome-editing/en/to be developed and deployed by members states, forming a working party to develop these in December 2018. However, these would only be guidelines that would then have to be adopted by member countries. Importantly, the WHO panel does not envisage a permanent prohibition of embryo gene editing but stated in a media release that ‘The Committee will explore how best to promote transparent and trustworthy practices and how to ensure appropriate assessments are performed prior to any relevant work being undertaken.’ This clearly indicates that the intention is to regulate rather than prohibit future work in this area.

In many respects this is not a new ethical issue as the technology to alter the human genome has been around for many years, just not so cheap and potentially efficient. In addition, there are other applications of CRISPR that do not involve use in embryos or require a hereditary component. Somatic cell treatments for diseases such as muscular dystrophy and Beta Thalassemia have the potential to alleviate human suffering and are distinct from embryonic gene editing. It is probable that restrictions on these activities could also occur unless legislation and guidelines are careful to avoid capturing areas that are unintended. One could argue that these treatments which are aimed at people after birth should be treated in the same way as other biological therapies.

It is likely that a general prohibition of embryo manipulation for reproductive cloning will remain in most countries and some may now move to more specifically outlaw therapeutic cloning using gene editing. Many jurisdictions have looked at guidelines that prohibit this but there is little harmonization of these thus far. There is a great deal of work underway in many countries now to examine the issues and to establish appropriate pathways for regulation. AHRECS will monitor these activities and report on them as they arise.

This post may be cited as:

Zeps, N. (26  May 2019) Research Ethics and the New Gene-editing Technology. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/research-ethics-and-the-new-gene-editing-technology

Requesting your input0

 

We’re preparing to work on a new version of the subscribers’ area, so we’d appreciate hearing your thoughts and ideas.

Some of you have told us you’d like to subscribe, but your institution’s accounting rules don’t allow for open ended online subscriptions.  Some subscribers have told us that it would be helpful if the listed items were better organised.

We agree, but the Patreon platform doesn’t provide the kind of flexibility to make these kinds of sensible changes.

So, we’re exploring the cost and logistics of creating a subscribers’ area we control. While we work out its details, the key changes will be:

  1. Institutions that wish to access the contents in the subscribers’ area will be sent a tax invoice for a 12-month subscription which would be paid by EFT or PayPal.
  2. The area will be structured in two sections (Human Research Ethics and Research Integrity) each with five subsections:
    1. Commentaries
    2. Professional development material
    3. Images
    4. Audio files
    5. Video files
  3. There will be tools to link to related items, profile items and search the library.

Subscribers to the existing Patreon service can move to the new service at the same level for the remainder of whatever time they have remaining, at no extra cost.

Because we suspect some users of the Patreon service may prefer to stay there, we plan to continue posting items to both Patreon and the new service.

Is the new service something you’d recommend your institution subscribe to?  Before we spend the money to build it, we’re hoping to hear at least 15 institutions are interested in-principle.  Please send an email to patron@ahrecs.com.

Travelling Consultants and Professional Development Roadshows0

 

Prof. Mark Israel plans to be in CANBERRA (2-3 April), SYDNEY (8-10 May), UK and Belgium (27 May-8 June), MELBOURNE (13 June) and Perth (22-26 April, 1-5 July) should any universities, health services or research organisations wish to meet to discuss their research ethics or research integrity needs with an AHRECS Senior Consultant.

Prof. Colin Thomson plans to be in CANBERRA (8-10 April), BRISBANE (30 April – 1 May).

Mark and Colin are also available to run professional development workshops for HRECs, academic or professional staff, in research ethics and research integrity including the changes to the National Statement and the new Australian Code.

AHRECS has other consultants based in those cities or who travel through regularly should these dates not be convenient. Of course, we also remain available by videoconference at other times.

Send an email to enquiries@ahrecs.com if you would like any further information.

Interest in ‘self-plagiarism’1

 

Mark Israel

Mark Israel’s article in Research Ethics Monthly on ‘Self-plagiarism?’ has been receiving a little interest outside Australia and New Zealand. It was reposted by the LSE Impact of Social Sciences Blog, and listed by Retraction Watch. Given that it offered guidance on the ethics of republishing in another language, it was nice to hear that the five pieces of advice had been translated into Mandarin by Zheng-Rong Gan for use at National Cheng Kung University in Taiwan (reproduced below with her permission).

  • Assess whether your reasons are ethically defensible; 評估這麼做的理由在倫理上是否站得住腳
  • Seek the agreement of those involved in your first publication – co-authors, editors and publishers; in some cases, publishers will want a specific form of acknowledgement; 尋求出現在第一次出版相關文章/文字者的同意,其中可能包含共同作者、編輯、出版商(有時會要求有特定的認可方式)
  • Seek the agreement of those involved in the new publication that will be reproducing material – any co-authors, editors and publishers; 尋求此次新出版相關文章/文字者的同意,其中可能包含共同作者、編輯、出版商等
  • Clearly acknowledge in the new publication that you are drawing on the earlier publication and do so with the agreement of the various parties, 在新出版品中清楚註記出處,且註記方式能被原出版者及新出版者所認可
  • Where it would be misleading not to do so, also note the relationship between publications in your CV and any job or grant applications在您的學術履歷、研究經費或升等之類文件,務必清楚註記這些前後出版品的關係,以避免被誤解或重複計算發表篇數等

There were a few responses to the LSE Blog. One respondent pointed out the concept of ‘self-plagiarism’ is self-contradictory as one cannot plagiarise one’s own work. Mark Israel agrees with this respondent, notes that the term is in wide use and recognises that its use should be challenged. The same respondent pointed to the Ingelfinger Rule which has been adopted by journals who refuse to publish articles that have already been published elsewhere. The Rule has been modified and challenged over time, most recently in relation to the use of preprint servers (see Resnik, 2018).

Contributor
Mark Israel, Senior Consultant AHRECS | Profile | mark.israel@ahrecs.com

This post may be cited as:
Israel, M. (27 March 2019) Interest in ‘self-plagiarism’. Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/interest-in-self-plagiarism

 

 

 

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