We found strong support for layered consent. Firstly, consumers valued the sense of agency it provided, allowing control over the amount and type of information read during the consent process and thus, accounting for the wide variation in their information needs. Secondly, it supported the creation of more concise PICFs, which they believed were much more likely to be read and understood.
Consumers recognised that organisations (through their legal processes and governance policies) need to manage risk, but as illustrated in their quotes, consumers were critical that this took precedence over their values and preferences. In Australia, the National Statement requires trials to be grounded in four ethical principles—research merit and integrity, beneficence, justice and respect, and that researchers have ‘due regard for the welfare, beliefs, perceptions, customs and cultural heritage…of those involved in research’. Consumer preferences regarding PICF content are therefore paramount, but have rarely been included in this level of discussion. But although the SNAP PICF incorporates consumer views and preferences, it may still draw criticism, as it does not include content specified in Sect. 4.8.10 of the Good Clinical Practice (GCP) Guidelines [28]. However, GCP was specifically developed for trials submitting data to regulatory authorities for licensing of new or investigational drugs, and the Guideline itself states that compliance with its principles is more appropriate for other trial types. Moreover, full compliance is not a legal requirement in many regions, including Australia [29]. The SNAP trial (NCT05137119) is now approved (HREC/74098/MH-2021) and recruiting patients in Australia, New Zealand and Canada using a final PICF based on the PICF co-designed by our consumers (see Additional file 3), suggesting that ethics committees are also comfortable with layered consent.
Consumers supported a bulleted format for the PICF, consistent with studies that have elicited consumer and expert feedback [3, 10, 30]. Many felt that bullet points made the PICF easier to read and to locate the information most important to them. There was, however, less support for the diagrams, although this finding may have been due to the complexity of the information provided in the diagrams that were included.
Our findings highlight the importance of adequate knowledge of a patient’s disease condition when decisions about trial participation are made, suggesting that poor understanding of the health condition may hamper the ability to make well-informed decisions about trial participation, especially in acute conditions. This finding aligns with prior research suggesting that patient awareness of the health problem being studied is a precursor to successful trial recruitment [14, 31]. In large trials like SNAP with a dedicated website, there are opportunities to enhance understanding using multimedia learning resources [32]. Finally, consumers supported the inclusion of a ‘benefits’ statement in the PICF relevant to platform trials, as it was considered important for decision-making. They also supported a more balanced description of the trial’s risk–benefit ratio, so that risks are not overinflated.
The information provided to prospective participants for individual trials is context dependent. It is possible, therefore, that different conclusions would have arisen and in study populations with lower acuity medical conditions or in other settings (our consumers were drawing on their experience of being hospitalised or their experience having their children or relatives hospitalised). However, this study provides insights into the information a person needs when considering trial enrolment and in Australia in particular, the findings are likely to be applicable, as the key topics for discussion in the NHMRC PICF templates were included.
The study also reinforces the value of consumer involvement in the development of PICFs, not only to improve the information contained in the PICF, but also to reassure ethics committees that consumers consider layered consent to be a suitable approach. Moreover, many commentators in the US have concluded the reasonable person standard in the Common Rule should be operationalised for each trial with the help of consumers [23, 33].
A strength of this study is that it tested layered consent with consumers with experiential knowledge of the disease condition under study. Despite the absence of field notes, the use of focus groups and interviews was an effective way of drawing rich insights on complex issues like optimising trial consent, both from the perspective of patients and carers. We recognise, however, that the view of patients or carers considering trial participation and differ from our focus group participants. Our study has several other limitations. Only 24 consumers took part, in part because recruitment in the final focus group, which took place early in the pandemic, proved challenging. However, additional focus groups were discounted as our inductive thematic analysis indicated saturation had been reached. We also acknowledge that despite efforts to avoid framing effects when eliciting people’s responses, it is impossible to discount that their responses were impacted by the conversational frame. Finally, although efforts were made to ensure our cohort was diverse, few were from different cultural and ethnic populations and the sample was dominated by male participants and therefore did not fully represent the diversity of the Australian population.