DISCUSSION
cancer, confusion, fatigue, breast cancer
CANCER, MINOR, LENS, BREAST CANCER
In our study, participants could reflect on their previous project‐specific consent when discussing under what conditions they would be willing to broaden their consent. Since this was not solely a hypothetical exercise, it was evident that their receptiveness to broadened consent was largely rooted in their underlying altruism for participating in the original PRISMA study, to improve screening practices and outcomes for women diagnosed with breast cancer. Our participants viewed sharing of their data and biomaterial as a conduit for advancing breast cancer research as well as medical research in general. Given the widespread use of digital monitoring technologies in their everyday lives, they experienced a normalization of data sharing, which they felt extended into scientific research. Yet, participants countered that data sharing should not come at the expense of privacy, as evidenced by most of their requested information needs relating to data protection. Perceived integrity was critical for our participants; integrity was more often attributed to noncommercial than commercial parties. They displayed a marked mistrust towards the pharmaceutical industry. Our participants emphasised that their ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de‐identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be reported to them. Notably, participants diagnosed with breast cancer voiced similar opinions regarding data sharing to those who had not.In general, our participants took a broad stance on re‐using their data and biomaterial. Whereas their original PRISMA consent referred to breast cancer research, our participants were not only open to the reuse of their data for other types of cancer research but also other (non‐cancer) medical‐related research, given that their procedural preferences and information needs were met. However, broad consent is not typically viewed through this lens. Ethicists and legal experts concur that broad consent does not imply complete unrestricted use of data and should, at minimum, be confined to research domains (for example, broadening breast cancer research to cancer research in general). The European Data Protection Board recently clarified this point in the context of the GDPR, stating that although Recital 33 GDPR may permit broad consent, the requirements stated in Article 5 GDPR (‘Principles relating to processing of personal data’) must still be observed.In contrast to their openness regarding research outside the scope of breast cancer, our participants exhibited reservations regarding data sharing. Participants adamantly rejected using their data for nonmedical research; they felt that data sharing should only occur in the medical domain. They preferred medical commercial parties, namely pharmaceutical industries, to collaborate with academic institutions since they viewed the latter as more trustworthy. Thus, our participants did not entirely reject sharing their data and biomaterial with external parties but instead took a conditional stance (e.g., medical research only, cooperation with an academic partner).Our participants' wariness towards medical commercial partners is not an isolated observation. Mistrust of commercial parties,It was clear that the COVID‐19 pandemic, a highly publicised showcase of industry in action, patently influenced our FG discussions regarding data sharing with pharmaceutical companies. For some, the pandemic provided a concrete example of industry profiteering, thus underscoring the need for restricted data sharing. Whereas for others, it exemplified the pivotal role industry serves in global health, which is better achieved through data sharing. In overarching terms, the experience of the pandemic appeared to modestly improve the industry's favorability amongst our participants, yet not enough to abolish their pervasive underlying scepticism.Optimal data security and privacy were marked concerns for our participants. Similar to their views on pharmaceutical research, our participants did not outrightly reject data sharing due to privacy concerns. They understood that data sharing could drive scientific research and innovation, but they placed a strong emphasis on the integrity of research teams and institutions. Data should only be shared with reputable parties prioritising privacy and data security and ideally linked with academic research. Although our participants displayed a high level of trust in their own national infrastructure for preserving privacy, there were clearly doubts regarding how international researchers would maintain their data. Mechanisms for data sharing and maintenance vary, with some more vulnerable to security risks than others. Cloud computing and virtualisation, however, are rapidly becoming the norm in the health sector.Nonetheless, it is questionable whether this form of data sharing is enough to assuage the fears expressed by our participants. Whereas cloud providers may be located locally, their data centres and server farms may be located worldwide. These information and commuications technology (ICT) concepts can be difficult to convey in information leaflets and potentially result in magnified fears over cyber security violations and confusion about where their data are maintained. Previous research in garnering confidence in digital data sharing in the healthcare sector can guide the development of suitable materials.In regard to privacy, we observed an important conceptual issue relevant to participant communication. Participants often used the terms anonymous and de‐identified interchangeably. However, the difference between these terms is more than a semantic nuance; both options confer specific advantages and disadvantages. True anonymity would inhibit many of the participants' desired choices in the consent process. Participants should further be aware that not all data falls under privacy legislation. For example, Recital 26 GDPR stipulates that the legislation only covers de‐identified data (i.e., no identifiable information but can be traced back to the original participant via a code) not anonymous data (i.e., untraceable to the original participant).Our participants were interested in knowing both primary and unsolicited findings. Unsolicited findings, also referred to as incidental, co‐incidental or accidental findings, are unrelated to the primary research question but may be medically informative for a participant and/or family members. Reporting of unsolicited findings is carried out according to local policies and although broad guidelines have been designed, ultimately, local institutions may differ in opinion for medical actionability and may not always disclose results.We observed numerous similarities between our participants' information needs and previous broad consent templates drafted without qualitative participant input.Yet, despite these findings, many challenges with dynamic consent persist. Consent fatigue is a noted concern that may lead to an increased number of study withdrawals.A hybrid consent process, however, would only address one challenge in dynamic consent. If not already integrated into the standard ICT process flow within an institution, implementing and maintaining a dynamic consent portal is a major undertaking that may not be achievable in all settings. Moreover, maintaining a biobanking facility is a challenging endeavour in its own right, as it must adapt to evolving legal‐ethical requirements, preservation techniques and quality controls. Many biobank facilities are comprised of a small core team with limited capacity to take on extra administrative duties. Even a relatively minor activity, such as ensuring up‐to‐date participant contact details for dynamic consent, would pose a substantial burden for many biobanks. Thus, such an endeavour must be weighed against the utility.Although our study participants have expressed interest in dynamic consent, in practice, its uptake may be limited.There were two main limitations in our study. Our response rate was low; however, our final sample size is comparable with other qualitative researchand data saturation was achieved within the FGs. Second, although participants were recruited from several screening centres across the Netherlands, our results might not represent all women eligible for breast cancer screening. Reassuringly, however, the information needs requested by our participants bared strong semblance to needs reported from other qualitative studies, thus strengthening our observations.