In such circumstances there are times consent can be sufficiently informed but not fully informed. It may be that given the circumstances, more information would be given after the emergency; some sort of explanation would be necessary. If there is a decision to not get informed consent, this has to be justified.
The panel spoke about obtaining consent when testing patients for viral infections. The experts said that to test a person with capacity, without their consent, is not ethical. It was discussed that in the past consent may have been considered to be implied, but this became unreasonable in the 1980’s. The change in practice overtime was discussed; limited information may have been given to patients prior to the 1970’s, but over the 1980’s preterm counselling became a standard for HIV testing and other viruses. The panel confirmed that once a diagnosis was known by a doctor, a patient should be made the offer to have these results disclosed to them, and make an autonomous decision to decide if they would like the results of the test.
The storage of patient samples, such as blood samples, without patient knowledge and consent was also discussed. The experts said there may be some circumstances where samples beginning retained and used may be unproblematic, such as for legal reasons or for quality assurance. Retention for reasons such as for research purposes without consent would be unethical. It was also suggested it may depend on the patients expectations when the sample was taken, if a sample was given for cancer testing, one might expect it to be retested if there were future developments.
The panel then discussed how ethics are considered in research. They referred to the value of research to society, and highlighted that the principles of reasonable risk and informed consent apply to research. In clinical research, it should be ensured risks are minimised and are proportionate to the benefit. Ethically, for consent, people need to know what the alternatives are. They should know the risks and benefits of participation in comparison to if they were not to participate. The experts highlighted the importance of voluntariness in research and issues which could arise due to relationships with clinicians such as coercion. Voluntariness may not be completely free or uncoerced when someone is unwell, in desperate need, or there is a power imbalance. For voluntariness, there needs to be an opportunity to withdraw and the best interest of the patient should be paramount.
These points were further discussed with regard to the Declaration of Helsinki and the BMA Ethics Handbook from 1980. It was noted that patients have a right to withdraw from trials and this will have no effect on future care. Furthermore, there must be confidence in the new intervention, but society takes precedence over the interest of the participant in research. For example, it may be in patients’ interest for a trial to end earlier, but in interest to society to obtain better odds, and extend the trial. Discussion was had on research on children, and the differences with capacity and ability to consent. They noted there is an importance to ensure a child’s open future.
The panel then laid out the function and development of Ethics Committees. The function is to subject research protocol to independent scrutiny. Better guidance for Ethics Committees arose in the 1990’s and increasingly there has been guidance on how they should act.
Further discussion was had on information about a patient that can be in the public domain without consent. The BMJ requires the patient to consent even if all identifying details have been removed. In the past this was not the norm, case histories were published without consent. It was said that ethically, patients should be informed on the outcome of research and when it is published. There was an interesting discussion as to the ethics of confidentiality in respect of administrative staff who might live locally to a patient.
The training of doctors in medical ethics was discussed. In the 1970’s it would have been more of a focus on etiquette, and in the 1980’s ethics would have likely been focused on for postgraduate study. The late 1990’s were said to be the time it became a core part of medical schools, it is now a continual strand in medical education. The experts said ethics is still seen as a peripheral issue, penetration has always been minimal in the profession.
Individual responsibility for decisions was discussed. In a team decision, ultimately, someone has to be responsible. The panel considered the question of who takes responsibility in situations such as a haemophilia patient referred to a heptologist, the haemotologist or heptologist? The experts said this could be a systemic issue, but one person should take responsibility. It was said that the patient should know and be made aware who is responsible for their treatment. When the issue was raised of guarding against clinicians sugarcoating and downplaying risks when obtaining consent, the panel said this is not informed consent, the risks must be framed appropriately.
When it was raised that there remains a problem of doctors still not placing patients first, the panel said that most doctors do place patients first. The panel said that doctors are operating in a system that isn’t fit for purpose. It needs to be revived and moved into the 21st century. They highlighted the problems in organisation, systemic issues, funding and the radical underinvestment in the NHS.
At the end of the hearing, Sir Brian thanked the experts for the valuable understanding they have given into how ethical principles can be applied. Sir Brian ended the hearing by clarifying changes to the Inquiry timetable. He stated that some clinicians of Haemophilia Centres will not be giving oral evidence. With some there are health issues. Sir Brian emphasised that if it is desirable to have evidence from a witness, the Inquiry will ensure they have it.