This blog post expands on ideas from our recent publication: McWhirter, R. E., & Eckstein, L. (2018). Moving Forward on Consent Practices in Australia. Journal of Bioethical Inquiry, 1-15.
Recently I participated in a research study. With the research nurse sitting opposite me expectantly, I moved quickly to sign in the appropriate place.
Hang on a minute. I’m a researcher, and an HREC member. I’ve published papers on informed consent, for goodness’ sake. I know better than this. Dutifully, I went back to the information sheet to read it properly.
After a couple of lines, I got bored and started scanning for key phrases. What will they do with my data? Which HREC approved this? Am I signing myself into eternal servitude?
Oh, who am I kidding, I thought. I’ve already made my decision. So, I just signed it, the research nurse smiled, and we got on with it.
Research suggests that I am not alone in my reaction to consent forms. They are boring, sometimes bordering on impenetrable. HRECs blame researchers for not writing in plain English. Researchers blame HRECs for being too inflexible and demanding a ridiculously long list of things to be included in a rigid format. There’s probably some truth on both sides, as well as some misunderstanding. And so, we end up with long, boring and ultimately unhelpful consent documents.
This is not to suggest that everyone is doing consent badly. There are lots of examples of research groups working with communities – whose members are usually potentially vulnerable in some way – to develop consent materials or processes that actually meet the needs of participants. Sometimes the solutions are technological– involving multimedia tools to overcome literacy or language barriers – and sometimes structural – such as by undertaking consent over several visits, so that individuals can decline to participate either by saying no or by avoiding the researchers, which can be an important option in communities where this is considered a more culturally acceptable method for refusal.
So, consent doesn’t have to be boring.
But what of the other problem indicated by my experience above? I had already made up my mind to participate before I’d been given the information sheet. Those with experience in study recruitment will know that I’m not unusual in this respect either. Depending on how the recruitment is undertaken, first contact might be a phone call, an email or letter, or a face to face conversation. In most cases, there will be some kind of blurb that precedes a participant’s reading of the consent documents and this is largely what people are basing their decision on.
These initial contacts are difficult to standardize (and it’s not necessarily desirable to do so) and difficult for HRECs to review, especially if they are verbal. A lot depends upon the character of the person doing the recruiting (usually a research nurse or research assistant rather than a principal investigator).
For one study in remote Aboriginal communities that I was involved in, I undertook several months of community consultation prior to commencing recruitment. I worked with community members to develop the study design and consent materials, employed local research assistants, and was helped enormously by senior women from each community. The relationships we developed meant that the study better met the needs of the communities, was more ethically sound (complying with both the National Statement and Values and Ethics) and resulted in a wider range of benefits than would otherwise have arisen.
These relationships also created trust between us. And that no doubt had an effect on our recruitment. The women liked me and wanted to help me. I had the support of influential elders. And by the time we got to use our carefully designed audio books, with information recorded in multiple dialects and with culturally relevant illustrations, most participants had already heard about the study, either from the community meetings during the consultation phase or through word of mouth. Although I stressed that participation was voluntary, and they were welcome to say no, everyone I invited agreed to participate.
So, what was the point of informed consent here? Well, it’s still polite to ask. The process of consultation that preceded it was effectively a form of community consent. And although individual decisions were probably influenced by their relationship with me and other study team members, these participants arguably had a greater understanding of the study than many participants in studies using more traditional methods.
I’m not sure there is a perfect way to ‘do’ consent. But it helps to be aware that the process is wider than just the consent documents. Providing training and ongoing team-based reflection for recruiters would help to address concerns over the quality of the less formal elements of consent. And it would be useful for HRECs to recognize the value of community consultation and consumer engagement in the study design phase, and to be open to non-traditional approaches to undertaking consent, rather than focusing unduly on the precise wording of consent forms.
We can’t ‘protect’ participants from researchers through mandating lists of information to be conveyed through formal documents, but we can encourage a culture of ethical research that better addresses community interests by reflecting on what we’re actually doing when we ‘do’ consent.
Centre for Law and Genetics, Faculty of Law, University of Tasmania
This post may be cited as:
McWhirter R. (26 August 2018) How do we ‘do’ consent?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/how-do-we-do-consent
We invite debate on issues raised by items we publish. However, we will only publish debate about the issues that the items raise and expect that all contributors model ethical and respectful practice.