Volume 20, Issue 5, June 2020, Page 24-25.

Recent attempts to develop and apply digital ethics principles to address the challenges of the digital transformation leave organisations with an operationalisation gap. To successfully implement such guidance, they must find ways to translate high-level ethics frameworks into practical methods and tools that match their specific workflows and needs. Here, we describe the development of a standardised risk assessment tool, the Principle-at-Risk Analysis (PaRA), as a means to close this operationalisation gap for a key level of the ethics infrastructure at (...) many organisations – the work of an interdisciplinary ethics panel. The PaRA tool serves to guide and harmonise the work of the Digital Ethics Advisory Panel at the multinational science and technology company Merck KGaA in alignment with the principles outlined in the company’s Code of Digital Ethics. We examine how such a tool can be used as part of a multifaceted approach to operationalise high-level principles at an organisational level and provide general requirements for its implementation. We showcase its application in an example case dealing with the comprehensibility of consent forms in a data-sharing context at Syntropy, a collaborative technology platform for clinical research. (shrink)

Volume 20, Issue 5, June 2020, Page 36-37.

Friesen et al. (2023) describe barriers to research in patient populations that have been historically labeled as vulnerable and, as a result, are under-represented in research due to the Instituti...

Volume 20, Issue 5, June 2020, Page 28-30.

Volume 20, Issue 5, June 2020, Page 38-40.

Volume 20, Issue 5, June 2020, Page 1-3.

Volume 20, Issue 5, June 2020, Page 22-23.

The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)

BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and (...) health-related data for observational research.MethodsWe conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues.ResultsSudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives.ConclusionsSudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well. (shrink)

Millum and Bromwich provide a thorough and thoughtful analysis of what is required for sufficient informed consent, offering distinct conceptualizations of the ethical requirements of disclo...

Volume 20, Issue 5, June 2020, Page 31-33.

I welcome the efforts described by Neal Dickert and his colleagues in “Partnering with Patients to Bridge Gaps in Consent for Acute Care Research” (Dickert et al. 2020). I am a long-time supporter...

Volume 20, Issue 8, August 2020, Page W12-W13.

Volume 20, Issue 5, June 2020, Page 40-42.

Volume 20, Issue 5, June 2020, Page 26-28.

Volume 20, Issue 5, June 2020, Page 18-20.

Volume 20, Issue 8, August 2020, Page 49-50.