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The ethics of patient consent in clinical research

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Interview with Dr Kieran Doran Senior Healthcare Ethics Lecturer, University College Cork

As Senior Healthcare Ethics Lecturer at University College Cork, a legal advisor to the Clinical Research Ethics Committee and a consulting solicitor specialising in health law, Dr Kieran Doran is well placed to discuss ethics in clinical research. For him the biggest issue at the moment is around patient consent; ‘making sure patients have all the relevant information to participate in trials’.

Participation in any form of clinical research is considered to be a voluntary decision, which means legally trial leaders must ‘give the patient every piece of information; outline to them every hazard and every level of risk of it occurring no matter how statistically negligible it is’.

However, the way in which this is interpreted can sometimes make gaining fully informed consent more difficult. Dr Doran often sees trial recruitment forms that follow the law to the letter rather than the spirit of it:

'I have seen patient information sheets that go on for 35 pages, or consent forms that go on for five or ten pages and the language used is of a highly technical nature. How can the patient understand the information, retain it and then communicate a decision based on 35 pages of highly technical text?’

The problem though is more nuanced than it may at first seem. When recruiting participants, trial leaders must of course still adhere to the legal and ethical framework, and at the same time, Dr Doran doesn’t want the industry to go too far the other way and over-simplify – ‘let’s not patronise the patient either’.

He takes the example of those suffering from cystic fibrosis where ‘patients can become quite sophisticated in their understanding of their condition and so often fully cognisant of what's going on.' In such situations, over-complication clearly becomes less of an issue as they want as much detail as possible.

Dr Doran admits it's a difficult balance to strike, but there are examples of those successfully trying to improve. In paediatric trials for example, where simplicity and understanding is more imperative than in almost any other research, ‘a lot of pharma companies have shown very good initiative by having flow charts and pictures which I think is a step in the right direction’.

For Dr Doran, the fact that those in charge of running trials are now starting to think about the issue more carefully is a step forwards: ‘We are moving in the right direction, but there is still a way to go.’

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