Explaining ‘ethics’ to some scientists is difficult at best and impossible in some cases. The term is sometimes used by those who should be concerned about the ethics of their research as a label or (to paraphrase and distort others) a flak jacket against moral objections to their work. In the case of the University of Bradford’s research tissue bank, the use of the term has reached a new low, turning into a counterproductive invocation of ethics that may dilute the meaning of the term and damage trust in biobanking.
In my experience as an ethics evaluator and advisor, the relationship between ethicists and wet scientists is still fraught with considerable difficulties. I am called on regularly to do off-site and on-site reviews of research projects, clinical trials, biobanks, etc. More often than not, I meet scientists who are either unclear what ‘ethics’ means (“probably just a fuzzy word for The Law, right?“), think they are clear what ‘ethics’ means (“it’s just the IRB that we need to get past, then we have our ethics finalised. Just like informed consent means consent in a form, right?“), those who simply do not care what it is (“it’s philosophy eejits trying to stop me from saving lives, right?“) and those who trivialise it (“I have consented [sic.] patients for 20 years. Anyone can do ethics, right?“).
I am working hard to improve this relationship by not seeing myself as a professional nay-sayer or lab-party-pooper. I give constructive feedback, I try to make things work, I recommend colleagues who can help ‘get it right’. In some cases, I (as a reviewer) even end up re-writing parts of grant proposals for research which seems to be socially desirable but would ordinarily fail the ethics review (some funding agencies, if pushed, will allow for this, especially in two-stage proposal processes).
I won’t go into why these categories of misunderstanding, or ignorance, still exist. The last few decades have seen scandals galore (think Bristol and Alder Hey and others who were not good at consent stuff and really bad at labelling their tissue samples). The last few years have also seen an increased drive towards formalising ethical aspects of biomedical research. Funders, government agencies, hospitals, universities and research institutions now pay a great deal of attention to ethical issues of the research they fund or host. Some do so in order to ensure that they don’t walk into a PR disaster, some do so because of a genuine wish to get things right. As far as biomedical research is concerned, it is relying – for the foreseeable future – on the active and free participation of patients and volunteers. So trying to get things right is likely to be a sound approach to doing this in a sustained fashion.
Many exotic approaches to addressing ethics in biomedical research can be explained by way of the types of misunderstanding I briefly outlined above. But some are simply inexplicable. A couple of months ago I was doing research on outreach and public engagement activities undertaken by biobanks. To this end, I was compiling a list of biobanks that had a reasonable web presence as a starting point for looking at a variety of information materials and patient information sheets, etc. One research biobank that very quickly caught my eye was the University of Bradford’s biobank spin off (hosted at the Institute of Cancer Therapeutic’s business incubator suite in Bradford). The reason I was mesmerised by this particular biobank (whose web presence – http://www.ethicaltissue.org – isn’t that reasonable to be honest, but much better than many others) was the name under which the biobank was presenting itself to the public: Ethical Tissue. My first thought was that if the tissue is ethical they should check if it was still alive and connected together to make up a person.
“Ethical” is not just in the name of the biobank – the website throws the term around liberally. Ethical Tissue has “ethical status” (which, presumably, means ethical approval for the purposes of the Human Tissue Act 2004, making this biobank into a one-stop-shop for the procurement of tissue samples for academic and industry research using human tissue: “Ethical approval status makes Ethical Tissue a leader amongst current sources of human tissue for research purposes” – no need to get an IRB to look at your research – Ethical Tissue can provide the raw material and the ethical approval, all in one fell swoop. The website also shouts “Highest Ethical Research Standards” (no exclamation mark, unfortunately) at the top of every page, so naturally I was keen to see their procedures and materials in order to bask in the glow of their ethical excellence.
The website, alas, gives very little information – in particular in relation to who their ethics experts might be. Surely, adhering to the Highest Ethical Research Standards, Ethical Tissue has a strong advisory board comprising regulatory experts and trained ethicists. No trace of any of this and precious little in terms of what heaps of connected ethical tissue are the people behind this enterprise. Just a liberal sprinkling of the words “ethical” and “ethics” on pretty much every page of the website. They are also remarkably vague about their business model but indicate that the tissue is sold at what Ethical Tissue considers to be cost price:
“All researchers seeking access to human tissue will be required to pay a cost recovery fee based on the cost of receiving, storing, processing and delivery of each donation. Cost recovery also includes maintaining the office that supports the administration of the supply of all human tissues and laboratory infrastructure essential to tissue handling and analysis.”
That seems reasonable (but then, I have been known to take the view that even profiteering from human tissue can in certain circumstances be reasonable).
The sample is also a gift from the patient to Ethical Tissue who can then do as they please with it. There is a right to withdraw your gift from the biobank, though the frequently asked question “[w]hat happens if I change my mind and want to withdraw my samples?” is answered with something like ‘write to us’, rather than what one would expect as best practice (or even Highest Ethical Research Standards!) nowadays – namely the outline of some sort of withdrawal cascade as pioneered by UK Biobank (though the downloadable patient information sheets (PDF) are more detailed, I should add).
What is the problem with all of this? Apart from the fact that calling yourself “Ethical Tissue” might, some may argue, be suggesting that other research biobanks aren’t ethical. And apart from the whole thing being slightly reminiscent of the garish advertising of “Best Most Excellent Exotic Takeaway Restaurant Ever” that you never order from because, let’s face it, if something or someone feels the need to scream at you that they are excellent, they’re probably not. And apart from the fact that the term ‘ethical’ is used in context, style and frequency that suggest that no trained ethicist has ever laid eyes on this website. Intuitively, the whole thing seems to be oddly self-defeating: it actually seems to be ethically indefensible to approach patients and volunteers with an unsubstantiated claim to being extra ethical. No questions allowed! Ethical status granted! Fully licensed! If you’re going to give your tissue, you’d better do it with us, because we’re the ethical tissue people. Apart from all of that, it also seems – at first, second and third glance – to be simply wrong.
I wrote to Ethical Tissue to get some additional information and, unfortunately, didn’t receive a response. So I submitted an FOI request to the Human Tissue Authority, who responded competently, swiftly and comprehensively. “Highest Ethical Research Standards” is a claim that I would query every time I read it in a grant proposal – especially if the proposer fails to articulate what those standards might be and why they might be the highest. In the case of Ethical Tissue, the claim even falls foul of their own self-assessment when they applied for their license with the Human Tissue Authority. From the possible self-assessment answers “1 – Standard not met“, “2 – Standard partially met“, “3 – Standard almost met” and “4 – Standard fully met or exceeded“, you would expect Ethical Tissue staff to crookedly draw an extra tick box on the form. “5 – Highest Ethical Research Standards!” (I know, but the lack of an exclamation mark must simply be an oversight by their excitable PR people). Instead, they submitted the answer “3 – Standard almost met” throughout the entire self-assessment, from consent procedure all the way to the premises’ fitness for purpose. The byline “All Legal Standards Almost Met!” doesn’t have the same ring to it as “Highest Ethical Reseach Standards”.
To be fair, Ethical Tissue may have come some way down the road of high-ish ethical research standards since their original license application. The 2009 site inspection report for Ethical Tissue says as much – they are much closer to actually meeting all the standards. Apart from quality management and audit. And apart from staff qualifications. And record management. And disposal documentation. Standards for all of these are still only almost met. And the tracing system for bodies, body parts, tissues and cells (if any) only scores a 2: “standard partially met”. The report concludes that:-
“[t]he establishment does not currently have a robust and consistent approach to ensuring traceability of all relevant human samples stored” (para. 28, p.8) and imposes conditions that should be met in the future: “[a]t a minimum, this system will ensure that relevant human samples stored on site are labelled with a unique identifying number, information for each sample’s storage location (including room number, freezer number, and shelf number) is recorded on a an [sic.] excel spreadsheet that is routinely backed up and that detail of disposal (including date method [sic.] and reason) is recorded”.
It seems plausible to assume from the imposition of this condition that these parameters were previously not fulfilled. Van Velzen would have been proud. As far as advice goes, the report suggests that it would be a good idea if hand-written records are legible and stored in a secure location. The Human Tissue Authority made a proposal to vary Ethical Tissue’s license on 22 September 2009, adding the condition that the traceability of materials is ensured.
So, what does all of this mean? It seems clear that processes at Ethical Tissue haven’t been completely up to scratch, at least until September 2009. I don’t know what has happened since then and Ethical Tissue have so far not responded meaningfully to my repeated requests for comment. Sue Boyce, the Head of Ethical Tissue (insert your own joke here) did respond briefly in April (five months after my first e-mail and a week after a second mail) so say that the first mail had slipped out of the intertubes and never reached them. Their website, she writes, is out of date but correct. And she will respond to my list of questions within a week, which she did not.
Any responsible ethicist, if called upon to advise a biobank, would of course advise in the strongest terms against the misuse of the label “ethical” in the way that Ethical Tissue has used it. It would be a grossly inappropriate way to present yourself to patients and volunteers even if you really did adhere to the highest ethical research standards in the world. In Ethical Tissue’s case it seems clear from the evidence that they did not adhere to even the mainstream standards but still used the label – to sell themselves to their community, to ride on the wave of the new-found significance of “ethics” in biomedicine. There are too many people out there who do not understand what it means but still adorn themselves, their projects and their ideas with this label. Anyone can do ethics, right?
Update 7/6/13: Also see this totally impartial profile – “‘You own your body tissue,’ Susan says”; “‘This is the ultimate in re-cycling,’ Susan says. ‘It is very ethical. It gives you relevant results that are for the benefit of all.’” [College Ethics]