By Dr Susan Donnelly, Post-Doctoral Researcher, ARCH
How effective is the informed consent process? As researchers we devote a great deal of time to honing methods of data collection and analysis but to what extent do we reflect on methods of consent? If patient-centred research is to be placed at the top of our agenda, surely we should start by critically reflecting on this early stage of the research process.
In a recent blog, my colleague Dr Laura Mackey pointed out some of the sticky challenges around patient recruitment. This has been on my mind – particularly the issues around informed consent and its effectiveness.
In 1980 in the New England Journal of Medicine, Cassileth et al. (1980) published findings from a study exploring reasons for the failure of cancer patients to recall major portions of information when consenting for chemotherapy, radiation therapy or surgery. They found ‘Only 60 per cent understood the purpose and nature of the procedure, and only 55 per cent correctly listed even one major risk or complication’ (1980: 896). They add ‘only 40 per cent of the patients had read the [consent] form “carefully” (1980: 896). The authors attributed this to the legalistic connotations of the forms which they argue led to a cursory reading of the material and inadequate recall.
So how can informed consent be…well…a little more informed? It strikes me that this is largely a question of communication. Before joining ARCH, I spent a number of years lecturing in colleges and universities where my daily tasks involved trying to take complex social theories and compress them into succinct, digestible bites for students to understand (not forgetting to do this in a fun and engaging way!).
When trying to explain abstract ideas, I often found the most effective way to do this was by using visuals to illustrate my point. I would spend hours sifting through Google images to find just the right picture to capture an idea.
Lately I have been thinking about how visuals – and specifically storyboarding – can be used to good effect in the research process, particularly to inform consent. Of course, I’m not the first. Jimison et al. (1998) explored the use of multimedia in the informed consent process. They showed that this approach was feasible, and deemed useful by patients who “felt the use of video made information more understandable” (Jimison, 1998: 245). They report that patients “felt using the system would be less stressful, because they would have a greater sense of control and could proceed at their own pace” (1998: 245).
So I decided to test this idea out. I made a first attempt to storyboard a multi-layered recruitment process for one of our latest studies, REACHES. This study takes place in a nursing home and involves seeking consent from older people (a vulnerable group) and in some cases their families / next of kin (i.e. consent by proxy). It is facilitated by a “gatekeeper” to the research site.
I started with the “Expression of Interest”. This is where a potential research subject who fits the inclusion/exclusion criteria is first approached to see if they would be interested in taking part. This is typically done by the researcher or the gatekeeper. In our study, we relied on a senior member of staff in the care home to assist with the recruitment process, so it was important that I was very clear on the steps involved in this process so that I could communicate this to her. It was also important to provide an estimate of time for each step so that we could anticipate how long this activity would take for us, the staff and the potential participants (and their families in the case of consent by proxy).
With pen and paper, I drew the following storyboard to show the steps involved.
- Step 1: The staff member approaches the Care Home resident to see if they are interested in taking part
- Step 2: If they express an interest, they are then brought to a room to meet the researchers
- Step 3: The researcher explains the study and what is involved
As this study incorporated the use of mobile and wearable technology, we felt it would be helpful to bring along some of the devices used in our study. This allowed potential participants to interact with the objects; to touch and feel them and to make them less strange.
I created a storyboard of the study to show potential participants each research activity and explain where and when each activity would take place. The storyboard also included a small photo of the researcher / research partner to help them to become familiar with the many new faces they would meet.
I devised a short (1 page) summary of our Participant Information Leaflets to distribute to residents and their families during the Expression of Interest sessions. This gave them a quick overview of the study. They were also provided with a longer version containing more detailed information.
I also illustrated the next step in the recruitment process – Step 4: Obtaining written consent.
This showed my return to the research site about three to five days following the expression of interest session. At this point, participants would have had an opportunity to read the materials, digest the information and think about whether they wanted to participate.
I found the exercise of illustrating the research process was helpful to me as researcher who was trying to get to grips with recruitment in a specific setting with multiple stakeholders. It enabled me to think the process through step-by-step and anticipate potential issues or challenges. When using this approach ‘in the field’ with participants, I felt that I was able to be very clear in informing them about our study. When the research began they demonstrated a familiarity with the devices and researchers involved. I also found this approach was particularly effective when informing family members in the case of consent by proxy.
This was a first outing in using visuals to support the consent process and I am keen to further refine the approach. It is important to reflect on the extent to which multimedia should be used to compliment the consent process while retaining protection for the researcher and researched. As Jimison et al. (1998) found while researchers and institutional review board member found the multimedia consent system to be valuable they ‘had concerns about how to review [it] for potential biases in presentation and about the legal issues associated with replacing the paper document’ (1998: 245). As we move towards eConsent and telemedicine, this has important implications for how we do research –particularly remote research where consent may be obtained online. There are surely ways to protect the integrity of the consent process while also making it more patient-centred and ultimately more informed.
Cassileth, B.R. Zupkis, R. V., Sutton-Smith, K and March, V (1980) ‘Informed Consent — Why Are Its Goals Imperfectly Realized?’ New England Journal of Medicine 302: 896-900.
Jimison, H. B., P. P. Sher, R. Appleyard and Y. LeVernois (1998). ‘The use of multimedia in the informed consent process’ Journal of American Medic Am Med Inform Assoc 5(3): 245-256.
You can contact Susan on firstname.lastname@example.org. Check out our website for more information about Susan’s research interests.
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