June 2012

On 31 May 2012, Jacqui Gath was asked to give a short talk about informed consent to a group of research nurses, researchers, and others involved in taking consent from patients before taking part in clinical trials.

The talk was a daunting prospect – I tend to lose control of the Powerpoint – but got one together and asked the lead presenter, Emily Calton, if I could stay for the day. I’m very glad I did! Here is my report.

Behind The Scenes of Patient Care – No 1 – Informed Consent for Clinical Trials

Training and educating is a very important aspect of patient care, and something not always understood or appreciated by us, the patients. We know there are regulations, rules and guidelines, but how do they affect us, and how are they delivered to those people taking care of our health needs?

Take clinical trials, by which medicine advances and patient outcomes continually improve. Clinical trials of course cover many aspects of research: from expensive new cancer drugs to better bandages, from new ways of counselling people to give up smoking to safer anaesthetics. To take part in any trial, participants must freely consent to take part, with full knowledge of the pros and cons, and possible side- or late-effects. There must be no pressure or coercion on the participant, who must be able to leave a trial at any time, without any compromise to continuing care.

From the health care professional’s point of view, taking informed consent for a patient to take part in clinical trials is a challenge, in that it must be done both sensitively, and with an eye on the legal background and those rules and regulations that govern today’s scientific research.

How do health care professionals learn about the legal and moral background tp consent?

On 31 May, having been asked to deliver the patient’s view of clinical trials, and what we look for in trials, I attended the Pan Yorkshire Informed Consent Workshop held by Emily Calton, South Yorkshire CLRN Senior Research Sister and GCP Facilitator, hoping to learn more. The delegates were research nurses, researchers, and others involved in taking consent from people wishing to take part in medical research.

Before attending, I canvassed the members of Independent Cancer Patients Voice, and the NTCRN Consumer Research Panel, for their views, and wrote them into a short talk, about 5 minutes long.

The first topic of the day was the earliest background to the rules governing the taking of consent, and this of course, was the Nuremberg War Crimes Trials, in which doctors who had used prisoners for cruel experimentation in WW2 were judged to be guilty of terrible crimes against humanity. This gave rise to the Nuremberg Code on human experimentation, drawn up in 1948.

This was followed by the Declaration of Helsinki in 1964, which expanded the Nuremberg code and enshrined in law new principles such as the freedom to not take part, and the ability to withdraw consent at any time. This was followed by setting out the principles and details of informed consent (ICH E6), and other directives from the EU, and the NIHR.

During this topic, there was quiet but insistent mention of the moral aspects, of ‘the banality of evil’ where ordinary people can be found able to do dreadful things, and that the results of research performed in this way are not used out of respect for the victims of such treatment.

The social background was discussed, the eugenics movement of the 30s and 40s, the Tuskegee experiment, and right up to the modern day, the unethical proposal that immigrants be x-rayed to discover their true age.

In short, powerful laws protect the patient and the public from exploitation and harm, but the public and researchers must continue to be vigilant lest powerful interests compromise that protection.

The second topic covered the many current rules and regulations governing tissue donation, Research Ethics Committees, data protection, use of information, the use of ionising radiation and radio-active substances, and the regulation of medicines and medical devices, among others. Some of the regulatory posts such as the Caldicott Guardian and Data Controller, are named individuals within an organisation, who are personally responsible for compliance with the law. From a practical viewpoint, anonymised data does not come within the Data Protection Act, and so it may be used with impunity on an unsecured laptop!

There must however, be room for exceptions to be made, and the law must be flexible should there be a national emergency. Section 251 of the NHS Act 2006 allows the duty of confidentiality to be set aside in particular circumstances, such as an epidemic, where the threat to society is deemed of greater importance than personal liberty. The Cancer Registry is another example of exemption.

After a short break, the group moved on to look at Genetics, which is governed by the Human Tissue Act 2004, the use of bodily materials and what exactly constitutes a relevant material, exemptions, what consent is required, and tissue banks. Researchers must understand the preciousness of what they are holding, and realise that the laws and rules in other countries are often not as rigorous as those here in the UK. Delegates were told always to obtain consent, whether or not it is required. Mention was made of Henrietta Lacks (died 1951), whose immortal cancer cells have been used in tissue culture and research for over 60 years. Henrietta was not asked for consent to this, and received no benefit, despite companies selling those cells making a large profit of billions of dollars.

The group then worked through several consent scenarios which highlighted the difficulties sometimes posed by the personal circumstances of the participant.

This was followed by a session looking at the individual responsibilities of Chief Investigators, NHS organisations, sponsors, funding bodies, and again we worked through several scenarios. Here we learned that consent can be delegated, and that the research done must comply with that laid out in the patient information sheet (PIS). Mission creep is not allowed!

During the 5th Session, entitled PPI, Alan Thompson (visiting professor at Cranfield University) gave his personal view of clinical trials, and I delivered my own talk which was based on the views of colleagues in the two patient groups previously mentioned. Both talks seemed well received, and we both touched on the same concern, namely the language used in the PIS.

The afternoon was devoted to the actual consent process, and the rules governing vulnerable groups such as prisoners, people with mental health problems, unresponsive patients, and children. Again, we worked through several scenarios, and looked for the faults in example consent forms. Here we learned that there is no such thing as a 24 hour time limit between talking about the possibility of entering a trial and signing the consent form. The time must be sufficient, that is all that is required.

During the breaks, I chatted with several delegates eliciting their views on various topics. During the sessions, and during the informal chats, the care and protection of the patient was seen to be of prime importance. Mention was made again and again of thought for the patient, and the care that must be taken. The word ‘compassion’ came up more than once. ‘Think first about doing good’, and while ‘the Professional Code of Conduct is the first concern, care for people is the first priority’.

As a member of the public and sometimes patient, I am very pleased that the hideous reasons for these laws and rules are fully explored, because it wasn’t expected, and memory dims with time despite relevance. It is evident that these delegates are conscientious people dedicated to the safety of their research participants, and that they make all efforts to ensure that medical research is carried out in a manner that protects the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of participants.

Jacqui Gath
June 2012

Further reading:

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The Nuremberg code
WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
The Tuskegee experiment
X-rays for immigrants