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White Paper on Risk Governance: Toward an Integrative Framework

ABSTRACT: This document aims to guide the work of the International Risk Governance Council and its various bodies in devising comprehensive and transparent approaches to ‘govern’ a variety of globally relevant risks. Globally relevant risks include trans-boundary risks, i.e. those that originate in one country and affect other countries (such as air pollution), international risks, i.e. those that originate in many countries simultaneously and lead to global impacts (such as carbon dioxide emissions for climate change) and ubiquitous risks, i.e. those that occur in each country in similar forms and may necessitate a co-ordinated international response (such as car accidents or airline safety). To this end the document and the framework it describes provide a common analytic structure for investigating and supporting the treatment of risk issues by the relevant actors in society. In doing so, the focus is not restricted to how governmental or supranational authorities deal with risk but equal importance is given to the roles of the corporate sector, science, other stakeholders as well as civil society — and their interplay. The analytic structure will, it is hoped, facilitate terminological and conceptual clarity, consistency and transparency in the daily operations of IRGC and assure the feasibility of comparative approaches in the governance of risks across a broad range of hazardous events and activities. In particular, this document is meant to assist members of IRGC in their tasks to provide scientifically sound, economically feasible, legally and ethically justifiable and politically acceptable advice to IRGC's targeted audiences. It is also to support IRGC in its effort to combine the best available expertise in the respective field with practical guidance for both risk managers and stakeholders.

SUBMITTER: Renn O

PROVIDER: S-EPMC7120941 | biostudies-literature | 2008 Jan

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Clinical free-text data (eg, outpatient letters or nursing notes) represent a vast, untapped source of rich information that, if more accessible for research, would clarify and supplement information coded in structured data fields. Data usually need to be deidentified or anonymized before they can be reused for research, but there is a lack of established guidelines to govern effective deidentification and use of free-text information and avoid damaging data utility as a by-product. OBJECTIVE:This study aimed to develop recommendations for the creation of data governance standards to integrate with existing frameworks for personal data use, to enable free-text data to be used safely for research for patient and public benefit. METHODS:We outlined data protection legislation and regulations relating to the United Kingdom for context and conducted a rapid literature review and UK-based case studies to explore data governance models used in working with free-text data. We also engaged with stakeholders, including text-mining researchers and the general public, to explore perceived barriers and solutions in working with clinical free-text. RESULTS:We proposed a set of recommendations, including the need for authoritative guidance on data governance for the reuse of free-text data, to ensure public transparency in data flows and uses, to treat deidentified free-text data as potentially identifiable with use limited to accredited data safe havens, and to commit to a culture of continuous improvement to understand the relationships between the efficacy of deidentification and reidentification risks, so this can be communicated to all stakeholders. CONCLUSIONS:By drawing together the findings of a combination of activities, we present a position paper to contribute to the development of data governance standards for the reuse of clinical free-text data for secondary purposes. While working in accordance with existing data governance frameworks, there is a need for further work to take forward the recommendations we have proposed, with commitment and investment, to assure and expand the safe reuse of clinical free-text data for public benefit.

Project description:BACKGROUND:Health research has scientific, social and political impacts. To achieve such impacts, several institutions need to participate; however, health research funding institutions are seldom nominated in the literature as essential players. The attention they have received has so far focused mainly on their role in knowledge translation, informing policy-making and the need to organise health research systems. In this article, we will focus solely on the governance of national health research funding institutions. Our objectives are to identify the main functions of governance for such institutions and actionable governance functions. This research should be useful in several ways, including in highlighting, tracking and measuring the governance trends in a given funding institution, and to forestall low-level governance. METHODS:First, we reviewed existing frameworks in the grey literature, selecting seven relevant documents. Second, we developed an integrated framework for health research funding institution governance and management. Third, we extracted actionable information for governance by selecting a mix of North American, European and Asian institutions that had documentation available in English (e.g. annual report, legal status, strategy). RESULTS:The framework contains 13 functions - 5 dedicated to governance (intelligence acquisition, resourcing and instrumentation, relationships management, accountability and performance, and strategy formulation), 3 dedicated to management (priority-setting, financing and knowledge transfer), and 5 dedicated to transversal logics that apply to both governance and management (ethics, transparency, capacity reinforcement, monitoring and evaluation, and public engagement). CONCLUSIONS:Herein, we provide a conceptual contribution for scholars in the field of governance and health research as well as a practical contribution, with actionable functions for high-level managers in charge of the governance of health research funding institutions.

Project description:BackgroundGrowing interest in public involvement in health research has led to organisational and policy change. Additionally, an emerging body of policy-oriented scholarship has begun to identify the organisational and network arrangements that shape public involvement activity. Such developments suggest the need to clearly conceptualise and characterise public involvement in health research in terms of governance.MethodsWe drew on an established health research system framework to analyse governance functions related to public involvement, adapting scoping review methods to identify evidence from a corpus of journal papers and policy reports. We drew on the logics of aggregation and top down configuration, using a qualitative interpretive approach to combine and link findings from different studies into framework categories.ResultsWe identified a total of 32 scholarly papers and 13 policy reports (n = 45 included papers) with relevance to governance for public involvement. Included papers were broadly consonant in identifying the need for activity to specify and support public involvement across all four governance functions of stewardship, financing, creating and sustaining resources, and research production and use. However, different visions for public involvement, and the activity required to implement it and achieve impact, were particularly evident with respect to the stewardship function, which seeks to set overall directions for research while addressing the potentially competing demands of a system's many constituents.ConclusionsA governance perspective has considerable value for public involvement in health research systems, supporting efforts to coordinate and institutionalise the burgeoning public involvement enterprise. Furthermore, it highlights challenges for what is, ultimately, a highly political intervention, suggesting that diverse publics must be both involved within health research systems and enrolled as governors of them.

Project description:Emissions of plastic waste to the environment and the subsequent degradation into microplastic particles that have the potential to interact with biological organisms represent a concern for global society. Current understanding of the potential impacts on aquatic and terrestrial population stability and ecosystem structure and function associated with emissions of microplastic particles is limited and insufficient to fully assess environmental risks. Multistakeholder discussions can provide an important element in helping to identify and prioritize key knowledge gaps in assessing potential risks. In the present review, we summarize multistakeholder discussions from a 1-d International Council of Chemical Associations-sponsored symposium, which involved 39 scientists from 8 countries with representatives from academia, industry, and government. Participants were asked to consider the following: discuss the scientific merits and limitations of applying a proposed conceptual environmental risk assessment (ERA) framework for microplastic particles and identify and prioritize major research needs in applying ERA tools for microplastic particles. Multistakeholder consensus was obtained with respect to the interpretation of the current state of the science related to effects and exposure to microplastic particles, which implies that it is unlikely that the presence of microplastic in the environment currently represents a risk. However, the quality and quantity of existing data require substantial improvement before conclusions regarding the potential risks and impacts of microplastic particles can be fully assessed. Research that directly addresses the development and application of methods that strengthen the quality of data should thus be given the highest priority. Activities aimed at supporting the development of and access to standardized reference material were identified as a key research need. Environ Toxicol Chem 2019;38:2087-2100. © 2019 The Authors. Environmental Toxicology and Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.

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White Paper on Risk Governance: Toward an Integrative Framework

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