Helene Nobile

First-in-human studies involving gene transfer or genome editing give rise to complex uncertainties. There is a broad acknowledgment that the current scientific guidelines should be supplemented with ethical guidance, particularly with regard to decisions about whether to initiate such trials. As a first step toward this goal, we present a three-tiered conceptual framework that operationalizes ethical principles to provide researchers with guidance on this decision. In the first “diagnostic” step, researchers are invited to identify the drivers of uncertainty in their study and to collaboratively reflect on the value judgments commonly taking place in the evidence assessment. Here, the principles of research validity and integrity are operationalized. The second “decisional” step outlines elements for the ethical deliberation about initiating a trial, formulated as benchmarking questions related to the principles of beneficence, nonmaleficence and their proportionality. The third “communicational” step offers guidance for communication about the study during planning, submission and, eventually, with potential participants, operationalizing the principles of honesty and respect for participants. This conceptual contribution is expected to stimulate further work on the relevance, practicality and adaptability of such an ethical framework in research settings characterized by complex uncertainty.

Background In bioethics, especially nursing ethics, systematic reviews are increasingly popular. The overall aim of a systematic review is to provide an overview of the published discussions on a specific topic. While a meta-review on systematic reviews on normative bioethical literature has already been performed, there is no equivalent for systematic reviews of empirical literature on ethical topics. Objective This meta-review aims to present the general trends and characteristics of systematic reviews of empirical bioethical literature and to evaluate their reporting quality. Research design Literature search was performed on PubMed and Google Scholar. Qualitative content analysis and quantitative approaches were used to evaluate the systematic reviews. Characteristics of systematic reviews were extracted and quantitatively analyzed. The reporting quality was measured using an adapted PRISMA checklist. Findings Seventy-six reviews were selected for analysis. Most reviews came from the field of nursing (next to bioethics and medicine). Selected systematic reviews investigated issues related to clinical ethics (50%), followed by research ethics (36%) and public health ethics or organizational ethics (14%). In all, 72% of the systematic reviews included authors’ ethical reflections on the findings and 59% provided ethical recommendations. Despite the heterogeneous reporting of the reviews, reviews using PRISMA tended to score better regarding reporting quality. Discussion The heterogeneity currently observed is due both to the interdisciplinary nature of nursing ethics and bioethics, and to the emerging nature of systematic review methods in these fields. These results confirm the findings of our previous review of systematic reviews on normative literature, thereby highlighting a recurring methodological gap in systematic reviews of bioethical literature. This also indicates the need to develop more robust methodological standards. Conclusion Through its extensive overview of the characteristics of systematic reviews of empirical literature on ethical topics, this meta-review is expected to inform further discussions on minimal standards and reporting guidelines.

As a cornerstone of public health, epidemiology has lately undergone substantial changes enabled by, among other factors, the use of biobank infrastructures. In biobank-related research, the return of results to participants constitutes an important and complex ethical question. In this study, we qualitatively investigated how individuals perceive the results returned following their participation in cohort studies with biobanks. In our semi-structured interviews with 31 participants of two such German studies, we observed that some participants overestimate the nature of the personal information they will receive from the study. Although this misestimation does not seem to jeopardize the validity of the consent provided at recruitment, it may still represent a threat for participants’ trust in research and thus their long-term commitment, crucial for such studies. We argue that such misestimation may have ethical consequences on the principles guiding the reflection on the return of results in biobank research, i.e. autonomy, beneficence, non-maleficence and reciprocity. We suggest that shifting from the idea of directly benefiting participants through the return of research results could help focusing on benefiting society as a whole, thereby increasing research trustworthiness of population-based studies using biobanks.