Written consent and reproductive autonomy in the context of prenatal screening

Le test prénatal non invasif (TPNI) est une technique de dépistage prénatal qui ne présente pas de risque accru de fausse couche, peut être effectué plus tôt dans la grossesse et est plus précis que les technologies existantes. Cependant, ces avantages peuvent contribuer à l’érosion de l’autonomie reproductive. Entre 2013 et 2017, une étude intitulée PEGASE a été menée, validant les performances et l'utilité du TPNI, ainsi qu’analysant les implications économiques, éthiques, juridiques et sociales de la technologie. Le présent mémoire est basé sur les données d’une enquête auprès des professionnels de santé (N = 184). Ce mémoire aborde la relation entre les attitudes des professionnels de santé concernant a) le "consentement éclairé" et b) le "consentement écrit" dans le contexte du TPNI. Il remet en question le récit établi dans la littérature, que les professionnels qui croient que le consentement écrit pour le TPNI n'est pas important croient également que les procédures de consentement pour le TPNI «devraient devenir moins rigoureuses» (1). Les données montrent que ce sont les professionnels qui se soucient de l'autonomie qui doutent de l'importance du consentement écrit. Cela contredit le récit cité ci-dessus. Les opinions des professionnels sur le «consentement écrit» ne peuvent donc pas être utilisées pour inférer leurs opinions sur l’importance du «consentement éclairé». Il est recommandé d’enquêter les professionnels de la santé sur des considérations particulières liées à la pratique, telles que celles enquêtées dans cette étude, plutôt que d’interroger les répondants sur des concepts académiques tels le «consentement» ou l’«autonomie».Non-Invasive Prenatal Testing (NIPT) is a new generation of prenatal screening that poses no increased risk of miscarriage, can be performed earlier in the pregnancy, and is more accurate than previously existing technologies. These advantages, however, potentially contribute to eroding reproductive autonomy, already under threat from other screening methods. Between 2013 and 2017, a study titled PEGASUS was conducted, validating the performance and utility of NIPT, as well as studying the economic, ethical, legal and social implications of the technology. One of these activities was a series of surveys conducted throughout Canada in 2015-16. The present thesis is based on the data from the healthcare professionals’ survey (N=184). This thesis addresses the relationship between healthcare professionals’ beliefs regarding a) “informed consent” and b) “written consent” in the context of NIPT. It questions the established narrative in the bioethics literature, that professionals who believe written consent for NIPT is not important also believe consent procedures for NIPT “should become less rigorous” than those used for invasive prenatal testing (1). Data from the survey shows that it is precisely those professionals who care about reproductive autonomy considerations who doubt the importance of written consent for NIPT. This directly contradicts the narrative cited above. Professionals’ stated views on “written consent” thus cannot be used to infer their unstated views on the importance of “informed consent”. It is recommended to investigate particular practice-based considerations such as the ones in this study rather than querying survey respondents on scholarly concepts such as “consent” or “autonomy”

Responsible Conduct of Research in Research-Creation: Moving into Uncharted Terrain

Responsible conduct of research (RCR) is ubiquitous, and present in most areas of research. One area that has received little attention is Research-Creation (RC): • an emergent eld at the interface of academic research and creative activities • in Quebec, Canada, RC is de ned as “research activities or approaches that foster the creation or interpretation/ performance of literary or artistic works of all types” Researcher-Creators – who are at the same time researchers and practising artists, musicians, or designers – may be faced with very di erent issues or challenges from colleagues in the rest of academia. • How do researcher-creators reconcile their dual obligations to creation and to research? • Are the usual research ethics guidelines (e.g., TCPS2, ICH relevant and how do they apply? • How do the creative/artistic dimensions of research a ect evaluations by grant committees and REBs? To better understand how RCR issues are articulated in the very heterogeneous RC community, we combine here results from a literature review and an international survey on RCR in RC.FRQ Action concerté

Early-career researchers’ views on ethical dimensions of patient engagement in research

Abstract Background Increasing attention and efforts are being put towards engaging patients in health research, and some have even argued that patient engagement in research (PER) is an ethical imperative. Yet there is relatively little empirical data on ethical issues associated with PER. Methods A three-round Delphi survey was conducted with a panel of early-career researchers (ECRs) involved in PER. One of the objectives was to examine the ethical dimensions of PER as well as ECRs’ self-perceived level of preparedness to conduct PER ethically. The study was conducted among awardees of the Québec SPOR-SUPPORT Unit in Canada, who represent the next generation of researchers involved in PER. Many themes were addressed throughout the study, such as definition, values, patients’ roles, expected characteristics of patients, and anticipated challenges (including ethical issues). Open-ended questions were used, and all quantitative data were collected through statements using 7-point Likert scales. Results Between April and November 2016, 25 ECRs were invited to participate; 18 completed both the first and second rounds, and 16 completed the third round. Panelists consisted of nine women and seven men with various backgrounds (general practitioners and postgraduate students). The majority were between 25 and 44 years old. Panelists’ responses showed PER raises important ethical issues: 1) professionalization of patients involved in research (with risks of patients becoming less representative); 2) adequate remuneration of patients; 3) fair recognition of patients’ experiential knowledge; and 4) tokenism (engaging patients only for symbolic appeal). While the panelists felt moderately prepared to confront these ethical issues, they reported being uncomfortable applying for an ethics certificate for a PER project. Conclusion If PER is an ethical imperative, it is vital to establish clear ethical standards and to train and support the PER community to identify and resolve ethical issues. Despite their overall readiness to conduct PER, panelists did not feel adequately prepared to address many of these issues. It is not easy for ECRs to reconcile ethical desiderata and logistical imperatives. Additional research should focus on supporting the responsible conduct of PER, which, if not done, can undermine the credibility and feasibility of the entire PER enterprise

Mitochondrial/Nuclear Transfer: A Literature Review of the Ethical, Legal and Social Issues

Mitochondrial/nuclear transfer (M/NT) to avoid the transmission of serious mitochondrial disease raises complex and challenging ethical, legal and social issues (ELSI). In February 2015, the United Kingdom became the first country in the world to legalize M/NT, making the heated debate surrounding this technology even more relevant. This critical interpretive review identified 95 relevant papers discussing the ELSI of M/NT, including original research articles, government-commissioned reports, editorials, letters to editors and research news. The review presents and synthesizes the arguments present in the literature in relation to the most commonly raised themes: terminology; identity, relationships and parenthood; potential harm; reproductive autonomy; available alternatives; consent; impact on specific interest groups; resources; “slippery slope”; creation, use and destruction of human embryos; and beneficence. The review concludes by identifying those ELSI that are specific to M/NT and by calling for follow-up longitudinal clinical and psychosocial research in order to equip future ELSI debate with empirical evidence.Le transfert mitochondrial / nucléaire (M/NT) visant à éviter la transmission de maladies mitochondriales graves soulève des enjeux éthiques, juridiques et sociaux (ELS) complexes. En février 2015, le Royaume-Uni est devenu le premier pays au monde à légaliser le M/NT, rendant le débat houleux sur cette technologie encore plus pertinent. Cette revue d’interprétation critique identifie 95 articles pertinents sur les enjeux ELS du M/NT, y compris des articles de recherche originaux, des rapports gouvernementaux ou commandés par le gouvernement, des éditoriaux, des lettres aux éditeurs et des nouvelles de recherche. La revue présente et synthétise les arguments présents dans la littérature quant aux thèmes les plus fréquemment soulevés: terminologie; identité, relations et parentalité; dommage potentiel; autonomie reproductive; alternatives disponibles; consentement; impact sur des groupes d’intérêt spécifiques; ressources; « pente glissante »; création, utilisation et destruction des embryons humains; et bienfaisance. La revue conclut en identifiant les enjeux ELS spécifiques au M/NT et en appelant à une recherche de suivi longitudinale clinique et psychosociale afin d’alimenter le futur débat sur les enjeux ELS de preuves empiriques

A Delphi Technology Foresight Study: Mapping Social Construction of Scientific Evidence on Metagenomics Tests for Water Safety

Access to clean water is a grand challenge in the 21st century. Water safety testing for pathogens currently depends on surrogate measures such as fecal indicator bacteria (e.g., E. coli). Metagenomics concerns high-throughput, culture-independent, unbiased shotgun sequencing of DNA from environmental samples that might transform water safety by detecting waterborne pathogens directly instead of their surrogates. Yet emerging innovations such as metagenomics are often fiercely contested. Innovations are subject to shaping/construction not only by technology but also social systems/values in which they are embedded, such as experts’ attitudes towards new scientific evidence. We conducted a classic three-round Delphi survey, comprised of 107 questions. A multidisciplinary expert panel (n = 24) representing the continuum of discovery scientists and policymakers evaluated the emergence of metagenomics tests. To the best of our knowledge, we report here the first Delphi foresight study of experts’ attitudes on (1) the top 10 priority evidentiary criteria for adoption of metagenomics tests for water safety, (2) the specific issues critical to governance of metagenomics innovation trajectory where there is consensus or dissensus among experts, (3) the anticipated time lapse from discovery to practice of metagenomics tests, and (4) the role and timing of public engagement in development of metagenomics tests. The ability of a test to distinguish between harmful and benign waterborne organisms, analytical/clinical sensitivity, and reproducibility were the top three evidentiary criteria for adoption of metagenomics. Experts agree that metagenomic testing will provide novel information but there is dissensus on whether metagenomics will replace the current water safety testing methods or impact the public health end points (e.g., reduction in boil water advisories). Interestingly, experts view the publics relevant in a “downstream capacity” for adoption of metagenomics rather than a co-productionist role at the “upstream” scientific design stage of metagenomics tests. In summary, these findings offer strategic foresight to govern metagenomics innovations symmetrically: by identifying areas where acceleration (e.g., consensus areas) and deceleration/reconsideration (e.g., dissensus areas) of the innovation trajectory might be warranted. Additionally, we show how scientific evidence is subject to potential social construction by experts’ value systems and the need for greater upstream public engagement on metagenomics innovations

Darton local plan Technical papers

Incl. mapsSIGLEAvailable from British Library Lending Division - LD:84/31205(Darton) / BLDSC - British Library Document Supply CentreGBUnited Kingdo

Radar chart for Delphi survey round 2 and round 3 responses.

<p>Distribution of the standard deviations for each of the 107 Delphi survey questions (from 1 to 107, in the clockwise direction) in round 2 (<i>blue line</i>) and round 3 (<i>red line</i>). Note that the distribution of the standard deviations across the 107 survey questions is dampened in round 3 (<i>red line</i>) as anticipated in Delphi surveys.</p

Six Thematic Categories Used to Generate and Structure the Delphi Survey.

<p>Six Thematic Categories Used to Generate and Structure the Delphi Survey.</p

RANK ORDER of the <i>Dependency</i> of Consensus Indices’ on the GROUP CONFORMITY INDEX in a Delphi Survey

<p>*The dependency value ranges from 0.000 to 1.000. A value of “0.000” shows complete independence of the Consensus Index from the Delphi survey characteristic examined (e.g., the Group Conformity Index) whereas a value of “1.000” shows complete dependence. The dependency value is the maximum numeric difference observed for each consensus index when the Group Conformity Index in a simulated Delphi survey varied from 0.0 to 1.0.</p><p>All Delphi consensus indices (the <i>left column</i>) typically take a value ranging from 0.000 to 1.000, except the Interquartile Range (IQR). For example, in the case of the Fleiss’ Kappa, a maximum difference of 0.504 can be anticipated when the Group Conformity Index varies from 0.0 to 1.0. For the IQR, the dependency data are normalized by dividing the difference observed in simulations by the maximum possible difference (9.000), i.e., the length of the Likert scale from 1 to 10 used in the simulations.</p><p>RANK ORDER of the <i>Dependency</i> of Consensus Indices’ on the GROUP CONFORMITY INDEX in a Delphi Survey</p