Dark Matters: An archive of research ethics mistakes

Stories discussed in Dark Matters could prove useful when teaching about research ethics

I discovered recently that the Discovery Science channel has an interesting little series called Dark Matters: Twisted but true. Started in 2011, to date there have been two series of the show. Typically each 45 minute episode looks at three separate examples of “strange science”. The standard format for each tale includes historical reenactment and soundbite interviews with experts from the field.

In truth the choice of incidents discussed is patchy; some aligning poorly with the definition of “science”, or “strange”, or both. The subtitle “Twisted but true” gives insight into the audience for whom the series may be targeted.  We also need to be slightly cautious about putting too much reliance on the validity of docudrama versions of events.

Having said that, however, there are plenty of examples here which could be used as introductions to some of the more notorious breaches of research ethics. For example, Season 2 Episode 2 (TRILT 02F8C452) discusses Louis Pasteur’s testing of an experimental rabies vaccine on Joseph Meister. Episode 2.6 (TRILT 02FB2D0F) includes recreation of the notorious Stanford prison experiment, and 2.7 (TRILT 02FD7B36) discusses the Tuskegee syphilis experiment in which poor sharecroppers with syphilis were deliberately kept untreated, even after the efficacy of penicillin for treating the illness had been demonstrated.

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Fat Family Tree

Here at BioethicsBytes we aim to recommend good clips from TV programmes that might be useful in discussing ethics associated with biology and biomedicine. We don’t usually have time to offer any warnings against watching particular programmes. One very disappointing recent pseudo-documentary was Channel 4’s offering Fat Family Tree (First broadcast 23rd May 2013, TRILT code: 03163CBC). We had been promised insight into “whether unlocking the secrets of families’ genes can help provide an answer to weight problems” with the participants taking “a unique DNA test to find out if the genes they have inherited could help explain their weight problems”.

Unfortunately, the reality was very superficial. Luckily for me, Linda Wijlaars over at the Progress Educational Trust’s BioNews has already written an excellent harsh-but-fair critique of the show.

Headline Bioethics: Change to organ donation law in Wales?

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Christopher Jones

Clip: Will Wales change organ donation law?

Date of story: 8^th November 2011

Summary of story: The Welsh government’s has published a White Paper Proposals for Legislation on Organ and Tissue Donation: A Welsh Government White Paper in which they outline their intention to change the law regarding organ donation. In keeping with the rest of the UK, Wales current has an “opt-in” system, in which a person has to actively indicate (e.g. by signing organ donor register) that they give consent for their organs to be used by the NHS. Under the proposed system of presumed consent, all adults resident in Wales will automatically be placed upon the register; if anyone wishes to withdraw their consent they must actively remove themselves from the list. Many countries already operate this “opt-out” system; including, in Europe, such countries as France, Spain, Austria, Belgium, Norway and Sweden. In the news coverage, Glyn Davies MP state his opposition to the proposal, highlighting concerns about both the efficacy of the new system, and whether adequate consideration will be given to ethical aspects of the change.

Discussion of ethical issues: One ethical argument against presumed consent suggests that it violates the patient’s right to make an informed decision, and so does not uphold respect for their autonomy (Gillon, 1994). The specific purpose of informed consent is to protect a patient’s right to autonomy, as made clear by both the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005) and the Declaration of Helsinki (World Medical Association, 2008). Enforcing presumed consent would remove the need for informed consent, and as such would be “a violation of an individual’s autonomy” (Kurosu, 2008).  Presumed consent, it is argued, forces patients either to become donors, or to state their wish to not become donors; in both instances the patient’s autonomy is violated, as  “compelling patients is unethical” (Kurosu, 2008). This deontological argument suggests a move to presume consent in Wales would be intrinsically unethical. Similarly, Kennedy et al. (1998) consider that a government body “assuming possession of our body parts” would be “a step too far”.

Headline Bioethics: Enviropig – significant advance or environmental ‘band-aid’?

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Rebecca Hyde

Clip: ‘Enviropigs’: genetically modified for food consumption

Date of Story: 4 January 2011

Summary of story: For the past decade, researchers at the University of Guelph, Canada, has been developing a line of Yorkshire pigs now known as Enviropig. In January 2011, a BBC reporter had the opportunity to see the pigs in a research facility while applications to approve the Enviropig for human consumption were being deliberated by the US Food and Drug Administration. The Enviropig has been genetically modified to contain genes from Escherichia coli and mice and bred over several generations to become more environmentally friendly by reducing the toxicity of their waste.

Discussion of ethical issues: Development of the Enviropig raises a number of ethical questions. Some of these relate to issues of animal rights, some relate to genetic modification of organism in general and foods in particular. Given the reasons behind the investment in the Enviropig research, there are also specific issues relating to environmental ethics, and this represents a good place to begin evaluation.

Intensive pig farming produces large amounts of manure which contains high levels of phosphate. Whilst some phosphate is vital to life, and is necessary for good plant growth, high concentrations can lead to disruption and poisoning of ecosystems. Runoff from pig farms can lead to eutrophication of nearby water ecosystems, which can potentially lead to the water becoming anoxic and unable to support life (University of Guelph, 2011). Enviropig has been genetically modified to produce phytase in its saliva. This enzyme is important for the breakdown of phytic acid, an indigestible form of phosphorus commonly found in cereal-based foodstuffs. Bacteria in the guts of cattle and other ruminants, but not pigs, normally provide this enzyme allowing this dietary phosphate to be released and used by the mammal.

Headline Bioethics: Too NICE to Push? Ethical issues surrounding a woman’s decision for elective caesarean section

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Matthew Taylor

Clip: Women can choose caesarean birth

Date of story: 23^rd November 2011

Summary of story: In November 2011, The National Institute of Health and Clinical Excellence (NICE) updated its clinical guidance to health care professionals regarding caesarean sections. This update helps ensure “every mum-to-be in England and Wales can request [a caesarean birth].” The story examines the case of Leigh East, who had concerns over a vaginal birth due to a pre-existing back injury. She was initially refused a caesarean section (CS), but was allowed the treatment after her own research persuaded her midwife to allow it. East said, “There was a great deal of pressure initially to not plan a caesarean”.

The report continues by covering how women who have had a traumatic experience with natural childbirth in the past should be treated. This includes offering counselling and, ultimately, the option for a caesarean birth if the woman is not reassured. Jenny Clery, Head of Midwifery at Whittington Hospital, said “you shouldn’t force anything on anybody, i.e. go into labour and we’ll see what happens.” The report finishes by stating the new guidelines are there to help women make an inform decision regarding mode of birth (BBC, 2011a).

Discussion of ethical issues: There are many ethical issues surrounding a woman’s choice regarding the mechanism of delivery for her unborn child. Doctors are faced with decisions requiring them to take each case individually, taking a consequentialist approach to each mode of birth, whilst also considering patient autonomy. The Changing Childbirth report (Expert Maternity Group & Cumberlege J., 1993) makes it an explicit right for a woman to be involved in decisions regarding all aspects of her pregnancy and childbirth.

Headline Bioethics: Cut out by the NHS

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Arnold Gangaidzo

Clip: NHS obesity surgery court bid lost

Date of story: 27^th July 2011

Summary of story: In July 2011 Tom Condliff, a 22-stone man lost his Court of Appeal case for a life-saving gastric bypass operation which had a detrimental impact on his family life and mental well-being (BBC, 2011a). The North Staffordshire primary care trust (PCT) refused to fund the procedure arguing that he failed to fulfil their IFR (individual funding response) policy and his body mass index (BMI) of 43 was below their threshold. He claimed the main reason he gained weight stemmed from drugs that he took for long term diabetes and the procedure was the best solution in order to prolong his life. In August 2011, subsequent to the events in this story, the PCT reviewed his case again and decided to fund his procedure as they now saw his case as an exceptional circumstance (BBC, 2011b). After having the operation, Condliff was reported to have lost six stone (Doward, 2012).

Discussion of ethical issues: The ‘four principles’ of autonomy, beneficence, non-maleficence and justice are widely recognised as the cornerstones of biomedical ethics. In this case, the principle of justice is brought into question. Chadwick (2008) says ‘justice in allocation’ is a bioethical issue since resources can be unfairly distributed and people can be discriminated against. Article 2 of The European Convention on Human Rights (ECHR, 1950) state “everyone’s right to life shall be protected by law…” but also notes that this must not be interpreted in a way as to put an impossible burden upon the authorities (Foster, 2007). Tom Condliff, a man seeking a gastric bypass, had to battle against his PCT to have them fund the operation. He argued that it was a breach of his rights under Article 8 of the ECHR (right to a family life) for the PCT to restrict their decision to clinical factors, and Article 6 (right to a fair trial) for not giving him sufficient details regarding their reasoning (Alexander Thomas Condliff v North Staffordshire Primary Care Trust, 2011). The Court found against Mr Condliff (though, as noted above, the PCT eventually relented).

Headline Bioethics: GM chickens offer solution to bird flu problem?

[A printable version of this Headline Bioethics Commentary is available via this link]

Author: Rachel Bell

BBC News Clip: Chickens that cannot spread bird flu developed

Date of story: 13^th January 2011

Summary of story:   Scientists from the Universities of Edinburgh and Cambridge have created genetically modified chickens that are unable to transmit the H5N1 “bird flu” virus between individuals. This effect was generated by inserting genetic information coding for a ‘decoy’ RNA hairpin molecule that acts as an inhibitor for the RNA polymerase enzyme required for replication of the flu virus (Lyall et al, 2011). It has been suggested that this approach may offer a means to reduce the extent to which bird populations act as a reservoir for flu and other diseases.

Discussion of ethical issues:  This story presents ethical tension on two levels; the possible benefits and complications for the chickens themselves, but also the implications for the human population. Laws relating to the use of Genetically Modified Organisms (GMOs) vary in different parts of the world. In the UK, the law covering the creation and use of GMOs is set out by the Health and Safety Executive. This requires any experimentation to undergo strict risk assessment, notification of the authorities regarding any GM activity, and total clarity and public availability of information gathered by the research (HSE, 2011). In this case, Sang and her team at the Roslin Institute, Edinburgh have complied with these regulations and the necessary details are included in the final paper (Lyall et al, 2011).