“I am delighted that the HFEA has approved Dr Niakan’s application. Dr Niakan’s proposed research is important for understanding how a healthy human embryo develops and will enhance our understanding of IVF success rates, by looking at the very earliest stage of human development – one to seven days.”
In line with HFEA regulations, any donated embryos will be used for research purposes only and cannot be used in treatment. These embryos will be donated by patients who have given their informed consent to the donation of embryos which are surplus to their IVF treatment.
The genome editing research now needs to gain ethical approval and, subject to that approval, the research programme will begin within the next few months.
Britain gives scientist go-ahead to genetically modify human embryos, reuters, Feb 1, 2016.
CRISPR Editing of Human Embryos Approved in the U.K., genengnews, Feb 1, 2016.
In a world first, UK scientists just got approval to edit human embryos, vox, February 1, 2016.
U.K. Approves First Studies of New Gene Editing Technique CRISPR on Human Embryos, time, Feb 1, 2016.
UK researcher gets go-ahead to create embryos using CRISPR, siliconrepublic, Feb 1, 2016.
Are we destined to repeat the DES experience with AZT use by pregnant women?
The purpose of this Article is to examine the tort liability experience with DES, compare it to the recent and ongoing trials of AZT in pregnant women, and extract lessons that can be used to mitigate against the likelihood of tort liability and to encourage the inclusion of women of childbearing age in clinical trials.
… “Although many factors may have contributed to the underrepresentation of women in clinical studies, the potential exposure of drug trial sponsors to tort liability frequently is cited as one of the primary reasons for excluding women from trials. The true source of legal anxiety in the recruitment of female research subjects arises, however, not from a concern for women’s safety, but from the fear of potential injuries to their offspring. Observations and reports of birth defects in children of women who had been treated with thalidomide or bendectin brought liability concerns to the forefront. When the courts held manufacturers liable for injuries caused to the offspring of women exposed to Diethylstilbestrol (DES), it became yet another reason for excluding pregnant women and women of childbearing age from clinical trials. “…
…”In the early 1950s, large controlled clinical trials of DES were conducted on pregnant women at the University of Chicago, which led to the cases of alleged research-related injury. Both cases were brought after the discovery of the carcinogenic potential of DES in offspring of women who had been given DES. In Mink v. University of Chicago, three women, on behalf of themselves and approximately one thousand women who had participated in the trials, alleged injury, as well as increased risk of injury, to their daughters. In Wetherill v. University of Chicago, the plaintiffs were two daughters who had contracted cancer that they attributed to the DES that was administered to their mothers while they were pregnant. In both Mink and Wetherill the plaintiffs claimed that the women taking DES never knew that they were participating in an experiment or that they were even taking DES.
Read the Full Paper,
DUKE JOURNAL OF GENDER LAW & POLICY, Volume 5:167, 1998.
In the hearing in Mink on whether the case brought by the mothers against the manufacturer and the institution conducting the research should be dismissed, the court held that the manufacturers had a duty to notify the women about the risks posed by DES at the time when the company became aware of them or should have become aware of them.63 The court permitted the battery allegations against the University of Chicago to stand, stating that nonemergency treatment performed without consent or knowledge raises a claim of battery. The case was settled with financial compensation to the plaintiffs and an agreement by the University of Chicago to provide medical services to women in the trials and to their offspring. In Wetherill, the court permitted the daughters to bring an action against the manufacturer and the University of Chicago. This case also settled, although the terms of the settlement were undisclosed.”…
Gene editing might also be used, in principle, to make genetic alterations in gametes or embryos, which will be carried by all of the cells of a resulting child and will be passed on to subsequent generations as part of the human gene pool. Examples that have been proposed range from avoidance of severe inherited diseases to ‘enhancement’ of human capabilities. Such modifications of human genomes might include the introduction of naturally occurring variants or totally novel genetic changes thought to be beneficial.
Germline editing poses many important issues, including:
the risks of inaccurate editing (such as off-target mutations) and incomplete editing of the cells of early-stage embryos (mosaicism);
the difficulty of predicting harmful effects that genetic changes may have under the wide range of circumstances experienced by the human population, including interactions with other genetic variants and with the environment;
the obligation to consider implications for both the individual and the future generations who will carry the genetic alterations;
the fact that, once introduced into the human population, genetic alterations would be difficult to remove and would not remain within any single community or country;
the possibility that permanent genetic ‘enhancements’ to subsets of the population could exacerbate social inequities or be used coercively;
and the moral and ethical considerations in purposefully altering human evolution using this technology.
It would be irresponsible to proceed with any clinical use of germline editing unless and until
the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives,
and there is broad societal consensus about the appropriateness of the proposed application.
Moreover, any clinical use should proceed only under appropriate regulatory oversight. At present, these criteria have not been met for any proposed clinical use: the safety issues have not yet been adequately explored; the cases of most compelling benefit are limited; and many nations have legislative or regulatory bans on germline modification. However, as scientific knowledge advances and societal views evolve, the clinical use of germline editing should be revisited on a regular basis.
Women-Centered Perspectives (Contemporary Issues in Biomedicine, Ethics, and Society)
Women most fully experience the consequences of human reproductive technologies. Men who convene to evaluate such technologies discuss “them”: the women who must accept, avoid, or even resist these technologies; the women who consume technologies they did not devise; the women who are the objects of policies made by men. So often the input of women is neither sought nor listened to. The privileged insights and perspectives that women bring to the consideration of technologies in human reproduction are the subject of these volumes, which constitute the revised and edited record of a Workshop on “Ethical Issues in Human Reproduction Technology: Analysis by Women” (EIRTAW), held in June, 1979, at Hampshire College in Amherst, Massachusetts. Some 80 members of the workshop, 90 percent of them women (from 24 states), represented diverse occupations and personal histories, different races and classes, varied political commitments. They included doctors, nurses, and scientists, lay midwives, consumer advocates, historians, and sociologists, lawyers, policy analysts, and ethicists. Each session, however, made plain that ethics is an everyday concern for women in general, as well as an academic profession for some.
The United Kingdom is on course to become the first country to allow in vitro fertilisation (IVF) to create babies using biological material from three people to prevent serious inherited disease, after MPs voted overwhelmingly in favour of the procedure, reports the BMJ.
The UK House of Commons voted by 382 to 128 to approve regulations allowing mitochondrial donation, after MPs were given a free vote of conscience on the issue.
House of Commons, Science and Technology Committee, 2013
Clinical trials are the experimental foundation on which modern medicine is built. Trials also make a significant contribution to the UK economy and can provide patients with an important means of accessing the most exciting and innovative new treatments, before they reach the market.
Here you can browse the House of Commons Science and Technology Committee report together with the Proceedings of the Committee.
” 3.9 – I hope that the Science and Technology Committee will agree with Jeremy Paxman that the current situation is indeed “nuts”—unethical, unscientiﬁc and uneconomic nuts. “ ” 3.10 – My efforts to prompt improvement in clinical trial transparency over most of the past 30 years have manifestly failed. However, it is becoming clear that Sense about Science’s recently launched public campaign (www.alltrials.net) and Ben Goldacre‘s bestselling book Bad Pharma may be “game changers”. For the ﬁrst time in over 30 years I feel that there is reason to hope for substantive progress. I think that those who continue not to take under-reporting of research seriously will ﬁnd themselves on the wrong side of history. I hope that the Committee will see to it that, after decades of inadequate action, something substantial will be done to deal with the current, indefensible situation. ”