Wednesday, 3 October 2012

The ethics of ethics

Is ethics about doing good or about avoiding doing harm?

Last week, I was chatting with a Danish colleague, who is running user studies in several European countries as part of the MONARCA project. They are developing and testing novel technologies for the detection and management of bipolar disorder. Apparently, it took 15 months to obtain ethical clearance to conduct studies in one country. 15 months!

Processes were faster in other countries, but still measured in months rather than weeks. In the UK, our experience is that the time taken to get approval to conduct user studies, even of established technologies, is highly variable, and unpredictable. But always measured in months rather than days or weeks. So it is impossible to plan a research project in detail before ethical clearance and R&D approval have been obtained. But this is a high-effort process, so you don't want to embark on it until you're sure the study will be going ahead.

The challenge of getting ethical clearance can be a real disincentive to proposing research projects on healthcare technologies. Why embark on projects in healthcare when you can do equally interesting projects in other areas that don't put such barriers in the way?

There have been some very welcome improvements over the past couple of years, with more streamlined processes for audit studies and proportionate review. But the focus is still on avoiding harm regardless of potential benefits. “VIP” is a useful mnemonic for the main concerns:

  • Vulnerability: particular care needs to be taken when recruiting participants from groups that might be regarded as vulnerable, such as children, the elderly, or people with a particular condition (illness, addiction, etc.)
  • Informed consent: participants should be informed of the purpose of the study, and of their right to withdraw at any time.
  • Privacy and confidentiality should be respected.
However, our work with clinicians and patients has really brought home to me that ethics goes beyond VIP. It should be about doing good, not just avoiding doing harm. But "doing good" might be in the long term: understanding current design and user experiences to guide the design of future technologies. And that doesn't directly address the need to engage positively with research participants. What motivates an individual clinician, patient or carer to engage with research on the design and use of medical technologies? There should be some positive benefit to participants.

For some, it will be about the "common good": about being prepared to invest time and expertise for long-term benefits. For others, there's an indirect pay-back in terms of having expertise and experience recognised and valued, or of being listened to, or having a chance to reflect on their condition, or their use of technology. There are probably many other complex motivations for participating in research. As researchers, we need to better understand those motivations, and respect them and work with them.

Why do clinician and patients engage in research on healthcare technologies? Because the perceive value – whether personal or societal – outweighs the perceived costs. Why do researchers engage in research on healthcare technologies? Ditto. The costs to all parties need to be proportionate to the benefits. So the ethics processes need to be proportionate, to encourage essential research. And as researchers we need to be mindful of the benefits, as well as the costs, to participants in research.

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