How to promote citizens' brain health? Insights from the Global Brain Health Survey on citizens' perceptions of brain health interventions

Brain health is about your mental well-being and the ability to remember, learn, plan and concentrate. The report is based on answers from 27,590 respondents from 81 countries who took part in the Global Brain Health Survey, which asked the public what they would need in order to help improve or maintain their brain health. The survey is the largest worldwide study to date about public perceptions of brain health. The report found that people want clear, evidence-based information about exactly which lifestyle changes can improve their brain health. People also say they would need professional support and regular monitoring or follow-up to track the effect of such changes. The report was written by Lifebrain consortium members at the University of Oslo and the Norwegian Institute of Public Health.publishedVersio

Towards a data sharing Code of Conduct for international genomic research

Data sharing is increasingly regarded as an ethical and scientific imperative that advances knowledge and thereby respects the contributions of the participants. Because of this and the ever-increasing amount of data access requests currently filed around the world, three groups have decided to develop data sharing principles specific to the context of collaborative international genomics research. These groups are: the international Public Population Project in Genomics (P3G), an international consortium of projects partaking in large-scale genetic epidemiological studies and biobanks; the European Network for Genetic and Genomic Epidemiology (ENGAGE), a research project aiming to translate data from large-scale epidemiological research initiatives into relevant clinical information; and the Centre for Health, Law and Emerging Technologies (HeLEX). We propose seven different principles and a preliminary international data sharing Code of Conduct for ongoing discussion

DataSHIELD:An Ethically Robust Solution to Multiple-Site Individual-Level Data Analysis

&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; DataSHIELD (Data Aggregation Through Anonymous Summary-statistics from Harmonised Individual levEL Databases) has been proposed to facilitate the co-analysis of individual-level data from multiple studies without physically sharing the data. In a previous paper, we investigated whether DataSHIELD could protect participant confidentiality in accordance with UK law. In this follow-up paper, we investigate whether DataSHIELD addresses a broader range of ethics-related data-sharing concerns. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Ethics-related data-sharing concerns of Institutional Review Boards, ethics experts, international research consortia and research participants were identified through a literature search and systematically examined at a multidisciplinary workshop to determine whether DataSHIELD proposes mechanisms which can address these concerns. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; DataSHIELD addresses several ethics-related data-sharing concerns related to privacy, confidentiality, and the protection of the research participant's rights while sharing data and after the data have been shared. The data remain entirely under the direct management of the study that collected them. Data processing commands are strictly supervised, and the data are queried in a protected environment. Issues related to the return of individual research results when data are shared are eliminated; the responsibility for return remains at the study of origin. &lt;b&gt;&lt;i&gt;Conclusion:&lt;/i&gt;&lt;/b&gt; DataSHIELD can provide an innovative and robust solution for addressing commonly encountered ethics-related data-sharing concerns.</jats:p

Recruiting and engaging adolescents in creating overweight and obesity prevention policies: The CO‐CREATE project

Special Issue: The CO‐CREATE Project: Co‐creating policy with youthThe CO-CREATE project aims to collaborate with adolescents across Europe in developing policy ideas that contribute to overweight and obesity prevention. In this paper, we present the theoretical basis and methodological approach to recruitment and engagement in the project. The principles of youth-led participatory action research were employed to design Youth Alliances in which adolescents and adults could collaborate. These Alliances should serve to promote and support adolescent participation and to develop policy ideas that would contribute to obesity prevention. Alliance members were recruited in two local geographical areas per country with a focus on reaching out to underrepresented youth. We started with fieldwork to assess locally relevant forms of inclusion and exclusion. The methodology entailed a handbook combining existing tools which could be used flexibly, a collaborative organization, and budgets for the alliances. Engagement started in local organizations, that is, schools and scouts, and with peers. Health- and overweight-related challenges were addressed in their immediate surroundings and supported the inclusion of experiential knowledge. Adolescents were then supported to address the wider obesogenic system when designing policy ideas. The CO-CREATE Alliances provide a concrete example of how to engage youth in public health, in a manner that strives to be participatory, transformative, and inquiry based.The “Confronting obesity: Co-creating policy with youth” (CO-CREATE) project has received funding from the European Union's Horizon 2020 research and innovation program under Grant 774210 (https://cordis.europa.eu/project/id/774210).info:eu-repo/semantics/publishedVersio

Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research

Source at https://doi.org/10.1371/journal.pone.0221496. Biobanks have evolved, and their governance procedures have undergone important transformations. Our paper examines this issue by focusing on the perspective of the professionals working in management or scientific roles in research-based biobanks, who have an important impact on shaping these transformations. In particular, it highlights that recent advances in molecular medicine and genomic research have raised a range of ethical, legal and societal implications (ELSI) related to biobank-based research, impacting directly on regulations and local practices of informed consent (IC), private-public partnerships (PPPs), and engagement of participants. In our study, we investigate the ways that these concerns influence biobanking practices and assess the level of satisfaction of the cross-national biobanking research communities with the ELSI related procedures that are currently in place. We conducted an online survey among biobankers and researchers to investigate secondary use of data, informing and/or re-contacting participants, sharing of data with third parties from industry, participant engagement, and collaboration with industrial partners. Findings highlight the need for a more inclusive and transparent biobanking practice where biobanks are seen in a more active role in providing information and communicating with participants; the need to improve the current IC procedures and the role of biobanks in sharing of samples and data with industry partners and different countries, and the need for practical, tangible and hands-on ethical and legal guidance

Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?

Background: There is growing consensus that individual genetic research results that are scientifically robust, analytically valid, and clinically actionable should be offered to research participants. However, the general practice in European research projects is that results are usually not provided to research participants for many reasons. This article reports on the views of European experts and scholars who are members of the European COST Action CHIP ME IS1303 (Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives) regarding challenges to the feedback of individual genetic results to research participants in Europe and potential strategies to address these challenges. Materials and Methods: A consultation of the COST Action members was conducted through an email survey and a workshop. The results from the consultation were analyzed following a conventional content analysis approach. Results: Legal frameworks, professional guidelines, and financial, organizational, and human resources to support the feedback of results are largely missing in Europe. Necessary steps to facilitate the feedback process include clarifying legal requirements to the feedback of results, developing harmonized European best practices, promoting interdisciplinary and cross-institutional collaboration, designing educational programs and cost-efficient IT-based platforms, involving research ethics committees, and documenting the health benefits and risks of the feedback process. Conclusions: Coordinated efforts at pan-European level are needed to enable equitable, scientifically sound, and socially robust feedback of results to research participants

A practical checklist for return of results from genomic research in the European context

An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws

Return of individual research results from genomic research: A systematic review of stakeholder perspectives.

Funder: Franca FundFunder: Canada Research Chair in Law and MedicineFunder: Canada Institute of Health ResearchFunder: Genome QuebecFunder: Genome CanadaFunder: Can-SHARE ConnectFunder: CIHRDespite the plethora of empirical studies conducted to date, debate continues about whether and to what extent results should be returned to participants of genomic research. We aimed to systematically review the empirical literature exploring stakeholders' perspectives on return of individual research results (IRR) from genomic research. We examined preferences for receiving or willingness to return IRR, and experiences with either receiving or returning them. The systematic searches were conducted across five major databases in August 2018 and repeated in April 2020, and included studies reporting findings from primary research regardless of method (quantitative, qualitative, mixed). Articles that related to the clinical setting were excluded. Our search identified 221 articles that met our search criteria. This included 118 quantitative, 69 qualitative and 34 mixed methods studies. These articles included a total number of 118,874 stakeholders with research participants (85,270/72%) and members of the general public (40,967/35%) being the largest groups represented. The articles spanned at least 22 different countries with most (144/65%) being from the USA. Most (76%) discussed clinical research projects, rather than biobanks. More than half (58%) gauged views that were hypothetical. We found overwhelming evidence of high interest in return of IRR from potential and actual genomic research participants. There is also a general willingness to provide such results by researchers and health professionals, although they tend to adopt a more cautious stance. While all results are desired to some degree, those that have the potential to change clinical management are generally prioritized by all stakeholders. Professional stakeholders appear more willing to return results that are reliable and clinically relevant than those that are less reliable and lack clinical relevance. The lack of evidence for significant enduring psychological harm and the clear benefits to some research participants suggest that researchers should be returning actionable IRRs to participants

Healthy minds 0-100 years: Optimising the use of European brain imaging cohorts ("Lifebrain").

The main objective of "Lifebrain" is to identify the determinants of brain, cognitive and mental (BCM) health at different stages of life. By integrating, harmonising and enriching major European neuroimaging studies across the life span, we will merge fine-grained BCM health measures of more than 5000 individuals. Longitudinal brain imaging, genetic and health data are available for a major part, as well as cognitive and mental health measures for the broader cohorts, exceeding 27,000 examinations in total. By linking these data to other databases and biobanks, including birth registries, national and regional archives, and by enriching them with a new online data collection and novel measures, we will address the risk factors and protective factors of BCM health. We will identify pathways through which risk and protective factors work and their moderators. Exploiting existing European infrastructures and initiatives, we hope to make major conceptual, methodological and analytical contributions towards large integrative cohorts and their efficient exploitation. We will thus provide novel information on BCM health maintenance, as well as the onset and course of BCM disorders. This will lay a foundation for earlier diagnosis of brain disorders, aberrant development and decline of BCM health, and translate into future preventive and therapeutic strategies. Aiming to improve clinical practice and public health we will work with stakeholders and health authorities, and thus provide the evidence base for prevention and intervention.This research is funded by the EU Horizon 2020 Grant: ‘Healthy minds 0–100 years: Optimising the use of European brain imaging cohorts (“Lifebrain”)’. Grant agreement number: 732592. Call: Societal challenges: Health, demographic change and well-bein