Abstract
It is standard practice now for the NHS to only provide insurance cover for negligent harm resulting from research, not non-negligent harm. Indeed, formally they are not allowed to provide further cover for research that they sponsor.
There are, however, reasons to think that this is ethically dubious, as harms can result to research participants through non-negligent actions – for example, as a predictable, if regretted, potential side effect of the drug being tested. So how can this be justified? It is true that any healthcare needs that are incurred by those who suffer non-negligent harm are provided for free from the NHS. So perhaps further insurance is unnecessary?
However, of course new healthcare needs are not the only potential harms caused by non-negligent harms in research – there is potential loss of income if they suffer a serious and ongoing injury, and there are other possible psychological or ongoing harms. So, this rule against the purchase of further insurance exposes research participants – those who are taking risks so we can gain new scientific knowledge which will often not be directly beneficial to them – to what appear to be potential unmitigated costs.
It seems clear to me that non-negligent harm cover should also be provided for by researchers for research participants, especially those enrolled in clinical trials. This seems a minimal ethical requirement.
This then raises the question about what we as members of research ethics committees might do about it. Clearly one option is to express concern in editorials like this, or more directly. Should we go further? NHS research ethics committees could, for example, reject any applications for research that they felt do not provide adequate insurance cover for research participants.
I struggle to think they are obliged to do so, but it would certainly be within their rights to do so, and it would put pressure on this system to change.
In this issue
This issue focuses on power, culture and minority research ethics. We have three articles which speak to these issues for and in different contexts and perspectives.
Firstly, in ‘Resolving ethical challenges when researching with minority and vulnerable populations: LGBTIQ victims of violence, harassment and bullying’, James A Roffee and Andrea Waling describe their research journey through navigating ethics approval and appropriate ethical research with these vulnerable groups. They argue we have to be careful not to ‘revictimize’ the subjects of violence and discrimination by ‘protecting’ them from research, and instead empower them during the conduct of ethically sound research.
Secondly, in ‘Evolving power dynamics in an unconventional, powerless ethics committee’. Martin Tolich and Jay Marlowe flip this question around in this article following a previous article where they described the New Zealand Ethics Committee as an intentionally powerless ethics committee. Now power has been thrust upon this committee, and the authors describe how the committee aims to stay true to its principles despite this imposition of regulatory power.
Finally, in ‘Are research ethics guidelines culturally competent?’ Ben Gray, Jo Hilder, Lindsay Macdonald, Rachel Tester, Anthony Dowell and Maria Stubbe describe how indigenous research ethics systems tend to put more emphasis on interdependence and trust rather than informed consent. They argue that where there is unequal power between researcher and research participants, focusing on interdependence and trust is more likely to surface power relations and lead to ethically safe and appropriate research. They conclude by reflecting on the lessons non-indigenous research ethics systems could learn from their counterparts.