The author who wasn’t there? Fairness and attribution in publications following access to population biobanks

<div><p>We conducted a document analysis that explored publication ethics and authorship in the context of population biobanks from both a theoretical (e.g. normative documents) and practical (e.g. biobank-specific documentation) perspective. The aim was to provide an overview of the state of authorship attribution in population biobanks and attempt to fill the gap in discussions around the issue. Our findings demonstrate that the most common approach adopted in both the normative and biobank-specific documentation is acknowledgment. A co-authorship approach was second and highlighted concerns surrounding the fairness of imposing authorship of the scientific leadership as a condition to access data and biosamples, as well as the alignment with the International Committee of Medical Journal Editors’ criteria such as what is deemed a significant contribution and how to ensure accountability. Based on these findings, we propose a three-prong approach, that may be cumulative, to address the issue of authorship attribution in the context of population biobanks, namely 1) the biobank should be appropriately acknowledged; 2) an invitation for co-authorship should be made based on the spirit of collaboration and provided a substantial contribution has been made; and 3) a citation/referencing option should be available.</p></div

Document selection process.

<p>Document selection process.</p

Assessing the Acceptability of Individual Studies that use Deception: a Systematic Review of Normative Guidance Documents

Research participants are often deceived for methodological reasons. However, assessing the ethical acceptability of an individual study that uses deception is not straightforward. The academic literature is scattered on the subject and several aspects of the acceptability assessment are only scarcely addressed, which parallels reports of inconsistent ethics review. Therefore, we aimed to investigate where normative guidance documents agree and disagree about this assessment. A PRISMA-Ethics-guided systematic review of normative guidance documents that discuss deception of research participants was conducted. Our search strategy resulted in 55 documents that were subsequently analyzed through abductive thematic analysis. While guidance documents mention little about specific risks and opportunities of deception, our analysis describes a rich picture of the thresholds for acceptability of the risks and benefits of deception and their integration, the comparison with the risk-benefit analysis of alternative non-deceptive methods, and the bodies or people who are positioned to do the review. Our review reveals an agreement on the general process of assessing the acceptability of studies that use deception, although significant variability remains in the details and several topics are largely or completely unaddressed in guidance documents.</p

Sonden legen: Nasogastrale sonden

<p>Current practice on informing the patient about the possibility of (a) prenatal genetic diagnosis by chorionic villus sampling or amniocentesis and (b) pre-implantation genetic diagnosis (PGD) for ADPKD.</p

(Dis)agreement on ethical justification of prenatal diagnostics, termination of pregnancy and preimplantation genetic diagnostics (PGD) in pregnant women with ADPKD.

<p>Scoring ranged from 1 = strongly disagree to 6 = strongly agree. Dots, triangles and squares represent mean per group, lines the 95% confidence interval. **: <i>P</i><0.01, ***: <i>P</i><0.001, for difference between geneticists and combined nephrologist groups.</p

Responsibility of informing at-risk individuals about their genetic risk.

<p>Dot, triangles and square represent mean per group, lines ± 1 SD.</p

Demographic characteristics of respondents.

<p>Demographic characteristics of respondents.</p

(Dis)agreement on proposing clinical and genetic testing in at-risk minors and adults.

<p>Scoring ranged from 1 = strongly disagree to 6 = strongly agree. Dots, triangles and squares represent mean per group, lines the 95% confidence interval. **: <i>P</i><0.01, ***: <i>P</i><0.001, for difference between geneticists and combined nephrologist groups.</p