31 research outputs found
A call for action: Improve reporting of research studies to increase the scientific basis for regulatory decision-making
Publisher's version (Ăștgefin grein)This is a call for action to scientific journals to introduce reporting requirements for toxicity and ecotoxicity studies. Such reporting requirements will support the use of peerâreviewed research studies in regulatory decisionâmaking. Moreover, this could improve the reliability and reproducibility of published studies in general and make better use of the resources spent in research.Nordic Council of Minister
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A proposed framework for the systematic review and integrated assessment (SYRINA) of endocrine disrupting chemicals
Background - The issue of endocrine disrupting chemicals (EDCs) is receiving wide attention from both the scientific and regulatory communities. Recent analyses of the EDC literature have been criticized for failing to use transparent and objective approaches to draw conclusions about the strength of evidence linking EDC exposures to adverse health or environmental outcomes. Systematic review methodologies are ideal for addressing this issue as they provide transparent and consistent approaches to study selection and evaluation. Objective methods are needed for integrating the multiple streams of evidence (epidemiology, wildlife, laboratory animal, in vitro, and in silico data) that are relevant in assessing EDCs.
Methods - We have developed a framework for the systematic review and integrated assessment (SYRINA) of EDC studies. The framework was designed for use with the International Program on Chemical Safety (IPCS) and World Health Organization (WHO) definition of an EDC, which requires appraisal of evidence regarding 1) association between exposure and an adverse effect, 2) association between exposure and endocrine disrupting activity, and 3) a plausible link between the adverse effect and the endocrine disrupting activity.
Results - Building from existing methodologies for evaluating and synthesizing evidence, the SYRINA framework includes seven steps: 1) Formulate the problem; 2) Develop the review protocol; 3) Identify relevant evidence; 4) Evaluate evidence from individual studies; 5) Summarize and evaluate each stream of evidence; 6) Integrate evidence across all streams; 7) Draw conclusions, make recommendations, and evaluate uncertainties. The proposed method is tailored to the IPCS/WHO definition of an EDC but offers flexibility for use in the context of other definitions of EDCs.
Conclusions - When using the SYRINA framework, the overall objective is to provide the evidence base needed to support decision making, including any action to avoid/minimise potential adverse effects of exposures. This framework allows for the evaluation and synthesis of evidence from multiple evidence streams. Finally, a decision regarding regulatory action is not only dependent on the strength of evidence, but also the consequences of action/inaction, e.g. limited or weak evidence may be sufficient to justify action if consequences are serious or irreversible.The workshops that supported the writing of this manuscript were funded by the Swedish Foundation for Strategic Environmental Research âMistraâ. LNV was funded by Award Number K22ES025811 from the National Institute of Environmental Health Sciences of the National Institutes of Health. TJW was funded by The Clarence Heller Foundation (A123547), the Passport Foundation, the Forsythia Foundation, the National Institute of Environmental Health Sciences (grants ES018135 and ESO22841), and U.S. EPA STAR grants (RD83467801 and RD83543301). JT was funded by the Academy of Finland and Sigrid Juselius. UH was funded by the Danish EPA. KAK was funded by the Canada Research Chairs program grant number 950â230607
The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies
Societies worldwide are investing considerable resources into the safe development and use of nanomaterials. Although each of these protective efforts is crucial for governing the risks of nanomaterials, they are insufficient in isolation. What is missing is a more integrative governance approach that goes beyond legislation. Development of this approach must b
On the issue of transparency and reproducibility in nanomedicine.
Following our call to join in the discussion over the suitability of implementing a reporting checklist for bio-nano papers, the community responds
Improving the transparency and predictability of environmental risk assessments of pharmaceuticals
The risk assessment process and the subsequent risk management measures need tobe constantly evaluated, updated and improved. This thesis contributes to that workby considering, and suggesting improvements, regarding aspects like userfriendliness,transparency, accuracy, consistency, data reporting, data selection anddata evaluation.The first paper in this thesis reports from an empirical investigation of themotivations, intentions and expectations underlying the development andimplementation of a voluntary industry owned environmental classification systemfor pharmaceuticals. The results show that the purpose of the classification systemis to provide information, no other risk reduction measures are aimed for.The second paper reports from an evaluation of the accuracy and the consistency ofthe environmental risk assessments conducted within the classification system. Theresults show that the guideline recommendations were not followed in several casesand consequently alternative risk ratios could be determined for six of the 36pharmaceutical substances selected for evaluation in this study. When additionaldata from the open scientific literature was included the risk ratio was altered formore than one-third of the risk assessments. Seven of the 36 substances wereassessed and classified by more than one risk assessor. In two of the seven cases,different producers classified the same substance into different classificationcategories.The third paper addresses the question whether non-standard ecotoxicity data couldbe used systematically in environmental risk assessments of pharmaceuticals. Fourdifferent evaluation methods were used to evaluate nine non-standard studies. Theevaluation result from the different methods varied at surprisingly high rate and theevaluation of the non-standard data concluded that the reliability of the data wasgenerally low.QC 2010092
From Science to Policy : Improving environmental risk assessment andmanagement of chemicals
A complex process like risk assessment and the subsequent risk management decision makingshould be regularly evaluated, in order to assess the need to improve its workings. In this thesisthree related matters are addressed: evaluation of environmental risk management strategies,evaluation of environmental risk assessments, and how ecotoxicity data from the open scientificliterature can be used in a systematic way in regulatory risk assessments. It has resulted in thefollowing: a publically available database with ecotoxicity data for pharmaceuticals (Paper I); anevaluation and review of the Swedish Environmental Classification and Information System forpharmaceuticals (Papers II and III); a comparison of current reliability evaluation methods and areliability evaluation of ecotoxicity data (Paper IV); and an improved reliability and relevancereporting and evaluation scheme (Paper V).There are three overall conclusions from this thesis:(1) Ecotoxicity data from the open scientific literature is not used to the extent it could be inregulatory risk assessment of chemicals. Major reasons for this are that regulators prefer standarddata and that research studies in the open scientific literature can be reported in a way that affectstheir reliability and the user-friendliness. To enable the use of available data more efficiently actionsmust be taken by researchers, editors, and regulators. A more structured reliability and relevanceevaluation is needed to reach the goal of transparent, robust and predictable risk assessments.(2) A risk assessment is the result of the selected data and the selected methods used in theprocess. Therefore a transparent procedure, with clear justifications of choices made, is necessaryto enable external review. The risk assessments conducted within the Swedish EnvironmentalClassification and Information System for pharmaceuticals vary in their transparency and choice ofmethod. This could come to affect the credibility of the system since risk assessments are notalways consistent and guidelines are not always followed.(3) The Swedish Environmental Classification and Information System for pharmaceuticalscontribute, in its current form, to data availability and transparency but not to risk reduction. Thesystem has contributed to the general discussion about pharmaceuticalsâ effect on the environmentand made data publicly available. However, to be an effective risk reduction tool this is not sufficient.QC 20121119MistraPharmaFormas - Evaluation of the Swedish Environmental Classification and Information System for Pharmaceutcals