Tony Long. Playing by the rules – and getting it wrong, Don't Forget the Bubbles, 2020. Available at:
Ethics is based in philosophy – the critical evaluation of arguments and assumptions – and therefore is the activity of philosophical reflection about norms and values; right and wrong; good and bad; what ought and ought not to be done. Bluffer’s Guide tip: ethics is Greek and moral is Latin. Talking about ethics and morals is like referring to renal kidneys or cardiac hearts.
Two main theories guide ethical behaviour. The most commonly espoused is that of deontology: a principles – or rules-based approach. This has nothing to do with gods (Latin “deus”). It is from the Greek “deon” for duty. Immanuel Kant (1724-1804)not-a-recent-reference defined the Categorical Imperative, a supreme over-riding principle that is never context-dependent, which rules humans absolutely, and which is felt even when defied. It’s like Pinocchio’s Jiminy Cricket. For Kant, the foundation of morality was duty. Acts should be considered good or bad of their own right, regardless of the outcome.
Following the rules
The Beauchamp and Childress schema of respect for autonomy, beneficence, non-maleficence and justice is often adopted. Patients should not smoke (no-one should): it’s hazardous to their health and 50% of smokers will die from a smoking-related illnessinsert-reference-of-your-choice. (This includes the fictitious lady who smoked only 19 a day.) Beneficence requires that we act in patients’ best interests and stop them smoking: confiscating cigarettes and frisking visitors for contraband. At the same time, non-maleficence requires us to prevent the effects of withdrawal that we enforce. If patients refuse to use them, we might have to sneak nicotine patches in under the dressings. Justice requires that we treat all patients equally, not spending too much time stopping the smoking because obese patients need to get on the treadmills and time must be allocated to preventing cake-smuggling. Then respect for autonomy requires that patients decide for themselves whether or not to smoke (or eat too much). There’s the rub.Hamlet, nd.
Rules-based approaches are difficult because the rules or principles conflict. Increasingly more conditions (formally known as “ifs and buts”) have to be introduced to make it work. Ifs and buts bring with judgements based on circumstances, so the rules are no longer universal and rigid. Judging what action to take based on guidance (rules that have to be interpreted) and on circumstances is more often known as a consequentialist stance. Discworld fans might recognise this as Commander Vimes’ “dealing with what is in front of you” approach:try “Night Watch” something that will be familiar to all senior clinicians.
Considering the outcome
An alternative, also not without its critics, justifies actions by expected outcomes. Jeremy Bentham (1748-1832) and John Stuart Mill (1806-1873) were the classic sources of consequentialist or utilitarian theory: that to act morally, we should try to bring about the best consequences. Sometimes, telling lies is right (“Is this spot really noticeable?”), and sometimes, judgement is needed to decide between opposing actions. In health care, possible outcomes are often not clear-cut. Complexity and differing viewpoints make judgements difficult.
Ethical decisions in research
Ethical decision-making in research is just as difficult. When to stop a trial because of side effects or because the results are obviously fabulous, whether we can deceive participants for the greater good, and how informed participants need to be can all be problematic. The opt-out article is a discussion of a decision made about informing potential participants and ensuring that they have given valid consent for data to be collected in a research study in paediatric urgent care departments.
Since the bureaucracy never retreats, the content of participant information sheets (PIS) continues to grow. Required items are added, but nothing is ever removed. A 20-page PIS is perfectly normal for a drug trial. Four pages will often be required even for an innocuous survey. GDPR regulations have added one or two pages of the densest and opaque text for those of standard (ie: low) reading age. You don’t read two pages of small print before signing a new mobile phone contract.No-you-don’t! There is evidence that participants don’t read PIS, either, so they are not informed before signing up. There is something odd, too, about requiring the person who is to be protected to sign the researcher’s consent form. The participant’s signature actually protects the researcher by evidencing that consent was sought.
In the study, we adopted opt-out consent in which brief information (one side of A4 in large print and low reading age) was provided, and parents or young people would sign only to indicate a refusal to participate. (This last sentence has a Gunning-Fog readability index of 21.5. Anything above 12 is hard for most people to read!)Years of experience in research with young people has taught us that they will not read more than a paragraph before making a decision, and they will decide immediately, refusing a cooling-off period.
Since that study, incorporation of GDPR into English law has led (in good faith and with appropriate professional concern) to the banning of opt-out consent in NHS research by the Health Research Authority and therefore by the National Institute for Health Research, applying the rule that “active consent” is compulsory. We argue that this is based on the false assumption that opt-out consent implies a lack of information and lack of a decision by participants. The brief information that we supplied had a better chance of being read than a standard PIS, so participants may have been better informed than usual. Parents made a decision for their child’s clinical data to be included and did so by not completing the contact details on the reverse of the form.
Applying a blanket rule like this can damage recruitment to very large studies, may lead to participation without effective information, and places a greater burden of time on participants which is not commensurate with the risks of participation. The law must be obeyed, but what if the law has been misinterpreted? What if the rule brings about worse outcomes? See what you think.