Two examples from our study into experiences of discharge from specialist palliative care

Our first example concerns the recommended minimum consideration time of 24 hours between the moment when someone is invited to take part in a study and the start of their participation, alongside obtaining consent.4 In our recent research study, we recruited people with life-limiting conditions to take part in semistructured interviews to describe their experiences of a recent discharge from specialist palliative care.5 However, after implementation of a minimum 24-hour wait time (which was sometimes necessarily longer e.g. weekends), approximately 40% of potential interested participants either deteriorated significantly, so as to no longer be able to take part (eg, decline in energy, increased pain etc), or died. As the study progressed, we reflected on the decisions and processes that had led us to exclude so many people.

For those unfamiliar with the NHS ethics processes in the UK, typically, a research study requires approval by the Health Research Authority (HRA), usually provided in conjunction with a Research Ethics Committee (REC), and sponsorship by a higher education institute, NHS trust, or another appropriate organisation. The HRA ethics application, often administered by the Integrated Research Application System (IRAS), asks questions to understand the aims and methods of the research, as well as requires the research team to weigh the risk against the benefit and highlight any foreseen ethical issues and how these will be addressed.6 In turn, the sponsoring organisations ensure the study complies with relevant laws and guidance, and the REC explores the balance between risks and benefits of conducting the research.

Despite the HRA’s latest guidance advocating for a ‘proportionate approach’7 to the time to consider participation, the IRAS form (used to submit UK NHS ethics applications) emphasises that participants should not be ‘rushed into decisions’ and refers to the common practice of allowing a minimum of 24 hours.8 Therefore, once we were aware of this common standard, we accepted it to ensure a smooth(er) process through the ethical review. But, as we went on to find out, this was not without significant consequences.

For our study findings, the application of the minimum 24-hour wait time denied some people the opportunity to tell their story and contribute to research that seeks to improve care and services, including for people in the last days and weeks of life. This was particularly important for our research, as evidence has shown that a person’s priorities and perspectives may change as they near the end of their life.9 If such changes and opinions are not documented, there is a loss of representation of the perspectives of those in their final days or hours. But there were also consequences for the participants. This is because participation in research studies at the end of life—when physical capacity, interpersonal connections and social worth can be conceptualised as declining10—has been experienced as empowering and helped reaffirm a sense of personhood, dignity, self-worth and autonomy.11 This can occur when participants feel that by taking part in a research study, they are being altruistic12 and still have something of value to give that could benefit others and society. We now know that there was greater scope to accommodate those participants who withdrew, while also ensuring compliance with HRA guidance on a proportionate approach to timeframes, particularly for low-risk research where ‘it may be reasonable to accept a decision taken at the time of approach’.6 7

Our second example concerns the question of when to interview bereaved carers, which is a common quandary in palliative care research.13 Drawing on examples of previous research on bereavement,14–16 our study on discharge from palliative care5 excluded carers who were within 6 months of bereavement, so as to avoid causing further distress. However, in practice, a few carers who were within the 6-month period informed us of their wish to take part. We had to decline their offers, but were left asking: had we been right to assume that all carers within 6 months of bereavement should be excluded from our study?

Participation in our project would have provided them with a platform to share stories about supporting someone close to them. Being excluded, therefore, took away an opportunity to be heard—via a mode of data collection that itself may be cathartic17—and for them to have their range of emotions valued. The 6-month wait time was a norm that we had unreflexively included in our protocol based on other studies in the field with which we were familiar. Indeed, as we reconsidered the risks to the participant, we found we had overlooked a study in 2003 by Casarett et al18 which reported that timing of approach to bereaved carers had no effect on response or relative’s distress. Moreover, our review of the literature reminded us of a position that was more common several decades ago, when people at the end of life were a priori labelled as ‘vulnerable’ and often excluded from research; a position that we now rightly see as paternalistic and restricting individual autonomy.19

This brought us to our final reflection—a question posed by both examples that we cannot answer but believe is important to ask: why did none of the checks and balances built into the hyperproceduralised20 ethics process in the UK—including our sponsor, the REC or the IRAS process—question our overprotective and exclusionary timeframes? This collective failure suggests to us that exclusionary norms seeking to ‘protect the vulnerable’ continue to affect decision-making at multiple levels of palliative and end-of-life care research in the UK.

What lessons have we learnt?

We suggest that how wait times are implemented is reconsidered for palliative and end-of-life care research, in particular that researchers and ethics committees carefully interrogate how the risk of inclusion in low-risk research is balanced against the greater danger of having their experiences and voice excluded. We believe that, in the case of non-invasive, observational and interview palliative research, the norm for the wait time should be 0–1 hours, so that participants can be surveyed or interviewed soon after they have provided their interest and informed consent, to prevent or reduce the likelihood of their exclusion through deterioration or death. Of course, any 0-hour wait time for research may need additional measures in place to avoid coercion4 and ensure participants receive information about participating in the study in multiple formats appropriate to their needs, for example, videos/audio explaining the study.

The nature of palliative care research requires researchers to be flexible and adaptable and prioritise the participant’s needs in their approaches to data collection. As a field, we now have decades of collective knowledge on conducting research with people at the end of life and those who care for them. We therefore seek to encourage researchers and ethics committees to draw on that literature when considering questions of who should participate in palliative care research and when. We hope this encourages us all to balance issues concerning harm reduction with what we know about both the individual benefits of sharing (potentially distressing) experiences and the social benefits of including and listening to people exactly when they find themselves at their most vulnerable.