Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk‐based Mammascreening study

Abstract

Introduction Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk‐based MAmmascreening study (PRISMA). The original PRISMA informed consent was project‐specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants' needs for broadened consent to preserve informed decision‐making while maximising the potential re‐use of data. Methods Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach. Findings Twenty‐three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants' 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 disclosed. Conclusion Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision‐making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research. Patient and Public Contribution Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes.

From opt-out to opt-in consent for secondary use of medical data and residual biomaterial: An evaluation using the RE-AIM framework

“…Patient concerns over data security and privacy may have potentially impacted the frequency of refusals or non-response [ 11 ]. Patients generally understand that secondary use promotes scientific research and innovation, but pervasive fears of misuse can hinder their receptiveness to data reuse [ 11 ].…”

“…Patient concerns over data security and privacy may have potentially impacted the frequency of refusals or non-response [ 11 ]. Patients generally understand that secondary use promotes scientific research and innovation, but pervasive fears of misuse can hinder their receptiveness to data reuse [ 11 ]. In this context, it may be useful to inform patients how cloud computing and virtualization have allowed for the development of digital research environments.…”

“…In this context, it may be useful to inform patients how cloud computing and virtualization have allowed for the development of digital research environments. These settings create secure and auditable virtual workspaces and do not require data transfers between local hard drives [ 11 , 26 , 27 ]. Better understanding of digital security may have further improved response.…”

“…When opt-in consent became the standard policy in this hospital, response was very high (>90%), with minimal refusals. Yet, cancer patients have been historically more receptive to secondary use of data [ 7 , 11 ]. To determine if such findings would translate to a general patient population, Radboudumc was chosen as one of the first feasibility test sites given its status as a university medical center serving a diverse patient case-mix.…”

“…Still, it is important to emphasize that most patients are generally receptive to secondary use of their data and residual biomaterial as long as they are informed [7][8][9]. Dutch patients are no exception [10,11].…”