Independent Scientific Advice Research Articles

Fostering scientific integrity and research ethics in a science-for-policy research organisation

The Joint Research Centre (JRC) is the European Commission’s in-house science and knowledge service, employing a substantial staff of scientists devoted to conducting research to provide independent scientific advice for EU policy. Focussed on various research areas aligned with EU priorities, the JRC excels in delivering scientific evidence for policymaking and has published numerous science-for-policy reports and scientific articles. Drawing on a scientific integrity statement, surveys among JRC’s research staff, and thematic discussions with JRC’s research leaders, the JRC has developed a comprehensive Scientific Integrity and Research Ethics (SIRE) framework, including instruments, procedures, and guidelines to ensure high standards and independence in its research. Key components of the SIRE framework include a Scientific Integrity Officer, an Editorial Review Board, a Research Ethics Board, and guidelines for responsible conduct of research. This article provides an overview of the JRC’s SIRE framework and how it was developed, emphasising the importance of maintaining independence, integrity, and ethics in scientific research that supports EU policy. The article also discusses potential gaps in the framework and where additional efforts may be needed, comparing with the recent U.S. National Science and Technology Council report on Protecting the Integrity of Government Science.

‘Following the science’: the role of an independent advisory structure in the COVID-19 pandemic response and beyond

Background As the COVID-19 pandemic spread in 2020, many governments across the globe put structures in place to access rapid independent scientific evidence. The South African Minister of Health established an advisory committee in March 2020 to provide high-level strategic advice. This technical guidance, developed as topic-specific ‘advisories’, was expected to be context-specific and based on the best available evidence, locally and internationally. The authors developing the advisories could draw on systems-wide, multidisciplinary experience. Approach This chapter provides a reflective experience of the process of preparing advisories, the development of rapid evidence syntheses and their use in decision-making, the outputs and the lessons learned from that process, and the structural and operational changes over the course of the pandemic. As South Africa has moved out of the acute phase of the pandemic, the lessons learned must be embraced and best practices adopted to inform future pandemic preparedness. Advisories needed to use the best available evidence rather than wait for the best possible evidence. Some advisories were therefore revised multiple times, as new evidence emerged. Advisories were submitted to the Minister of Health for consideration prior to public release. However, in some cases, delays in such release led to confusion as to the scientific basis of policy decisions. The confidentiality of the committee debates also needed to be balanced against the need for engagement with the public. In order to promote accountability and build public trust, from March 2022 all advisories were published on a dedicated website within seven days of receipt by the Minister. The public were thus informed of the scientific basis of the advice, providing important context for subsequent executive decisions. Consistent feedback to the committee from decision-makers was also important, as their advice was only one of many inputs considered by a complex array of government bodies, across different departments. Conclusions The world faces a significant risk of further pandemics and other public health emergencies and is engaged in high-level negotiations on strengthening global capacity to respond. Whether that involves a global pandemic accord, strengthened International Health Regulations, or a strengthened global approach to medical countermeasures, rapid, credible, independent and country-specific scientific advice will remain essential. The lessons learned during COVID-19 should not be lost. Submitted on behalf of the Ministerial Advisory Committee on COVID-19.

Building an Engaged Himalayan Sustainability Science

The Himalayan region is facing a new crisis under climate change, rapid economic transformation, and escalating geopolitical tensions. A large body of Himalayan sciences has endeavored to understand this challenge but has failed to engage meaningfully with the local people and policymakers. I argue for a new engaged Himalayan sustainability science that not only understands and interprets the emerging challenges but also strengthens societal capability.

The role of validated analytical methods in JECFA drug assessments and evaluation for recommending MRLs.

The Joint Food and Agriculture Organization and World Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA) is one of three Codex committees tasked with applying risk analysis and relying on independent scientific advice provided by expert bodies organized by FAO/WHO when developing standards. While not officially part of the Codex Alimentarius Commission structure, JECFA provides independent scientific advice to the Commission and its specialist committees such as the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) in setting maximum residue limits (MRLs) for veterinary drugs. Codex methods of analysis (Types I, II, III, and IV) are defined in the Codex Procedural Manual as are criteria to be used for selecting methods of analysis. However, if a method is to be used under a single laboratory condition to support regulatory work, it must be validated according to an internationally recognized protocol and the use of the method must be embedded in a quality assurance system in compliance with ISO/IEC 17025:2005. This paper examines the attributes of the methods used to generate residue depletion data for drug registration and/or licensing and for supporting regulatory enforcement initiatives that experts consider to be useful and appropriate in their assessment of methods of analysis. Copyright © 2016 Her Majesty the Queen in Right of Canada. Drug Testing and Analysis © 2016 John Wiley & Sons, Ltd.

Science in politics: An interview with Dame Anne Glover, former Chief Scientific Advisor to the President of the European Commission.

EMBO Reports (2019) e48349 > EMBO reports (ER):You were the first and the last Chief Scientific Advisor to the European Commission. Why was the role later abolished? > Anne Glover (AG):It was the first time the EC had a scientific advisor and I was appointed by then President, Jose Manuel Barroso. A Chief Scientific Adviser (CSA) role was unusual, because most member states don't have CSA and some had difficulties initially to come to terms with or understand that role. Among the member states that were most unconvinced initially of the role of CSA were France and Germany, but they both became huge supporters. When President Barroso's term came to an end, I wrote to president‐elect Jean‐Claude Juncker to set out a number of options as to how he might go about getting independent scientific advice. At the end of the day, he decided on a more distributed form of advice. This has been transformed into a group of CSAs, and this more collegiate structure might fit better with the Commission and the EU. In the UK, we are used to having a CSA in government, but this is not the case in many countries in the EU, so maybe it is not the best model. > In order to have confidence in and trust scientific advisors, there needs to be transparency. > ER:What are the advantages and disadvantages of having a single CSA? > AG:The advantage is that you have an individual who is both visible and accountable. People can agree or disagree with the advice, but at least there is someone who is identifiable. In my case, accountability required that President Barroso was content with publishing the advice that I gave; otherwise, I could not be completely transparent about my role. I think that, in order to have confidence …

Surveillance and Epidemiology of Drug Resistant Infections Consortium (SEDRIC): Supporting the transition from strategy to action.

In recognition of the central importance of surveillance and epidemiology in the control of antimicrobial resistance and the need to strengthen surveillance at all levels, Wellcome has brought together a new international expert group SEDRIC (Surveillance and Epidemiology of Drug Resistant Infections Consortium). SEDRIC aims to advance and transform the ways of tracking, sharing and analysing rates of infection and drug resistance, burden of disease, information on antibiotic use, opportunities for preventative measures such as vaccines, and contamination of the environment. SEDRIC will strengthen the availability of information needed to monitor and track risks, including an evaluation of access to, and utility of data generated by pharma and research activities, and will support the translation of surveillance data into interventions, changes in policy and more effective practices. Ways of working will include the provision of independent scientific analysis, advocacy and expert advice to groups, such as the Wellcome Drug Resistant Infection Priority Programme. A priority for SEDRIC's first Working Group is to review mechanisms to strengthen the generation, collection, collation and dissemination of high quality data, together with the need for creativity in the use of existing data and proxy measures, and linking to existing in-country networking infrastructure. SEDRIC will also promote the translation of technological innovations into public health solutions.

Joint Research Centre, European Commission

The Joint Research Centre is the Commission's science and knowledge service. The JRC employs scientists to carry out research in order to provide independent scientific advice and support to EU policy.

Surveillance and Epidemiology of Drug Resistant Infections Consortium (SEDRIC): Supporting the transition from strategy to action

In recognition of the central importance of surveillance and epidemiology in the control of antimicrobial resistance and the need to strengthen surveillance at all levels, Wellcome has brought together a new international expert group SEDRIC (Surveillance and Epidemiology of Drug Resistant Infections Consortium). SEDRIC aims to advance and transform the ways of tracking, sharing and analysing rates of infection and drug resistance, burden of disease, information on antibiotic use, opportunities for preventative measures such as vaccines, and contamination of the environment. SEDRIC will strengthen the availability of information needed to monitor and track risks, including an evaluation of access to, and utility of data generated by pharma and research activities, and will support the translation of surveillance data into interventions, changes in policy and more effective practices. Ways of working will include the provision of independent scientific analysis, advocacy and expert advice to groups, such as the Wellcome Drug Resistant Infection Priority Programme. A priority for SEDRIC’s first Working Group is to review mechanisms to strengthen the generation, collection, collation and dissemination of high quality data, together with the need for creativity in the use of existing data and proxy measures, and linking to existing in-country networking infrastructure. SEDRIC will also promote the translation of technological innovations into public health solutions.

The importance of data collection for timely and accurate risk assessment

The European Food Safety Authority (EFSA) is responsible for food safety risk assessments at EU level. It provides independent scientific advice on risks associated with the food chain to support EU risk management decisions. Since its establishment, EFSA has amassed a wealth of data to underpin its risk assessments, such as food consumption data, monitoring data and experimental data. Increasing transparency of its risk assessments is a core objective of EFSA. EFSA aims to enhance the quality and transparency of its outputs by giving insofar as possible access to data and methods underpinning its scientific outputs. This paper provides an overview of the role of EFSA, its core data collections and their regulatory framework, as well as data quality and standardisation aspects. Finally, the paper elaborates on EFSA’s 2020 strategy in relation to data, and describes EFSA scientific data warehouse and Knowledge Junction in this regard.

Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years

In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally.

The role of validated analytical methods in JECFA drug assessments and evaluation for recommending MRLs.

The Joint Food and Agriculture Organization and World Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA) is one of three Codex committees tasked with applying risk analysis and relying on independent scientific advice provided by expert bodies organized by FAO/WHO when developing standards. While not officially part of the Codex Alimentarius Commission structure, JECFA provides independent scientific advice to the Commission and its specialist committees such as the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) in setting maximum residue limits (MRLs) for veterinary drugs. Codex methods of analysis (Types I, II, III, and IV) are defined in the Codex Procedural Manual as are criteria to be used for selecting methods of analysis. However, if a method is to be used under a single laboratory condition to support regulatory work, it must be validated according to an internationally recognized protocol and the use of the method must be embedded in a quality assurance system in compliance with ISO/IEC 17025:2005. This paper examines the attributes of the methods used to generate residue depletion data for drug registration and/or licensing and for supporting regulatory enforcement initiatives that experts consider to be useful and appropriate in their assessment of methods of analysis. Copyright © 2016 Her Majesty the Queen in Right of Canada. Drug Testing and Analysis © 2016 John Wiley & Sons, Ltd.

Integrating surveillance of animal health, food pathogens and foodborne disease in the European Union

The European Food Safety Authority (EFSA) is the keystone of European Union (EU) risk assessment for food and feed safety. In collaboration with national authorities and in consultation with its stakeholders, EFSA provides independent scientific advice and information about existing and emerging risks. Assessing biological risks at the human-animal interface is becoming ever more challenging because this interface is in a permanent state of flux. In addition, questions about food safety cannot usually be categorised under one discipline; most of the time, they need to be addressed in a transdisciplinary way. Two scientific panels of EFSA, on biological hazards (BIOHAZ) and on animal health and welfare (AHAW), have, in many instances, jointly addressed such complex, multifaceted questions of risk. This paper reviews the integrated approach of the EU towards risk assessment, with a special focus on human health and the whole food chain, and on science-based interventions to lower the risk to consumers.

Independent Scientific Advice: Comparing Policies on Conflicts of Interest in the EU and the US

This article highlights the importance of unbiased scientific advice in the European Union legal system. It then analyses and compares the policies in force throughout the European Food Safety Authority, European Medicines Agency and European Commission’s Scientific Committees with that implemented by the US Food and Drugs Administration. The Author argues that, the framework adopted and implemented by the European Food Safety Authority seems to be the most complete and stringent among those taken into account in the article and advances some proposals aimed at further improving the policies regulating conflicts of interests.

A framework for scientific advice on health: EuSANH's principles and guidelines.

BackgroundSociety expects politicians to make sound decisions by bringing the best evidence to bear on the health problems in question. Performing this task requires access to independent sources of sound scientific advice. The European Science Advisory Network for Health (EuSANH) is a network of national science advisory bodies in Europe which are active in the field of health and provide independent scientific advice to their authorities. The EuSANH addressed this question in a European project.MethodsGuidelines and principles for producing sound advice have been formulated after international comparative evaluations and extensive discussions among participants of the EuSANH-ISA project with input from international experts.ResultsA framework for scientific advice on health has been produced.ConclusionsThis framework will ensure a uniform approach and thus opens possibilities for collaboration between science advisory bodies.

Risk assessment of biological hazards for consumer protection

EFSA's scientific Panel on Biological Hazards (BIOHAZ Panel) provides independent scientific advice on biological hazards in relation to food safety and food-borne diseases. This covers food-borne zoonoses, food microbiology, food hygiene, antimicrobial resistance (AMR), transmissible spongiform encephalopathies (BSE/TSEs) and associated waste management issues. Most of the activities of the BIOHAZ Panel focus on human health and the whole food chain and on science-based interventions to lower the risk to consumers. In the future, food-borne disease burden estimations are foreseen to become increasingly relevant. The risk assessments done by the BIOHAZ Panel are in line with the EU (European Union) strategy of one health, include a farm to fork approach and in many cases have a high multidisciplinary component. Whenever possible, the Panel applies this risk assessment framework developed by Codex Alimentarius as a basis for their work on food safety. The outcomes of some of the activities during the last three to four years are presented. From these examples of recent BIOHAZ opinions it can be seen that the work covers different approaches, ranging from quantitative risk assessments over structured qualitative risk assessment/risk ranking to opinions with short deadlines summarising existence knowledge from scientific literature. The approach taken depends on both the terms of reference (ToR) as received from the EC (European Commission), the available data and resources, and last but not least the time frame for the work following the risk managers’ needs.

Risk assessment of plant protection products

EFSA's Panel on Plant Protection Products and their Residues (PPR Panel) provides independent scientific advice in the field of risk assessment of plant protection products (PPPs, pesticides). Since its establishment in 2003 under Regulation (EC) No 178/2002, it has delivered a series of scientific outputs in support of evaluation of pesticide active substances, establishing scientific principles and guidance documents in the field of pesticide risk assessment and in support of decision making of European Union (EU) law makers. Next to a series of scientific opinions evaluating specific adverse effects of PPPs for human health (like for instance carcinogenicity) the Panel also delivered scientific opinions on general principles in the field of human health risk assessment (like reference value setting) and is, in particular over the last years, very much engaged in development of methodologies to meet new challenges in regulatory risk assessments such as assessment of toxicity of pesticide metabolites and potential cumulative effects of pesticides to human health. Fate, behaviour and transformation of pesticides after their application and consequent release to the environment are a major aspect of pesticide risk assessment. The PPR Panel has achieved major accomplishments by delivering guidance and scientific opinions on degradation in soil, exposure of soil organisms and assessment of environmental risks by use of pesticides in greenhouses or grown under cover. A series of scientific opinions have been delivered also in the field of environmental risk assessment of pesticides. Scientific output covered specific issues arising in the peer review of specific active substances, revision of data requirements, development of risk assessment methodologies and the development of guidance documents. A major milestone of the PPR Panel was the development of the methodological framework for deriving specific protection goals for environmental risk assessment of pesticides in view of the future dialogue between risk managers and risk assessors during the next steps of the revision of the ecotoxicology guidance documents.

Politics and independent scientific advice in RFMO processes: A case study of crossing boundaries

Abstract Provision of independent scientific advice is central to the operation of regional fisheries management organizations (RFMOs) even though RFMOs are largely policy (and political) instruments. Political pressures and intervention in science and crossing of the boundaries between scientific and political processes, however, appear to be relatively common. A case study is presented to illustrate some ways in which this occurs. It involves a paper that was withdrawn from scientific meetings of two RFMOs as a result of largely political (rather than scientific) concerns. The details involved in this incident are important for understanding the ways in which political intervention in independent scientific process can and does occur. Moreover, unless one is directly involved in actions of this kind, it is impossible from the reports of RFMOs' scientific bodies to assess whether, and the extent to which, there has been political intervention in the scientific process. It is argued that the nature of the working arrangements in these scientific committees can engender deliberate or inadvertent crossing of the boundaries between scientific independence and the political processes of RFMOs, both of which are important components of RFMO operation. Further, there is very little documentation or assessment of the generic extent of such problems. No simple solutions or reforms exist for isolating scientific advice from political agenda in the processes of RFMOs but it is suggested that increased discussion of the problem along with better understanding and clarity of the role of science in the management process may lead to improved recognition of the importance of independent scientific analyses and advice.

Independent Scientific Advice: Comparing Policies on Conflicts of Interest in the EU and the US

This article highlights the importance of unbiased scientific advice in the European Union's legal system. It then analyses and compares the policies in force throughout the European Food Safety Authority, European Medicines Agency and European Commission's Scientific Committees with the one implemented by the US Food and Drugs Administration. The author argues that at the present time the framework adopted and implemented by the European Food Safety Authority seems to be the most complete and stringent amongst those taken into account in the article and he advances some proposals for further improvement of the policies regulating conflict of interest.

Science, Policy, and Species at Risk in Canada

The meaningful incorporation of independent scientific advice into effective public policy is a hurdle for any conservation legislation. Canada's Species at Risk Act (SARA; 2002) was designed to separate the science-based determination of a species' risk status from the decision to award it legal protection. However, thereafter, the input of independent science into policy has not been clearly identifiable. Audits of SARA have identified clear deficiencies in the protection and recovery of luted species; for example, of the 176 species legally protected in 2003, only one has a legal implementation plan for its recovery. We argue that clearly distinguishing science from policy at all relevant stages would improve the scientific integrity, transparency, accountability, and public acceptance of the legal listing and recovery implementation processes in SARA. Such delineation would also clarify exactly what trade-offs are being made between at-risk species recovery and competing policy objectives.

Food Safety Procedures and Food Law Principles in European Union

With a view to adopting a comprehensive, integrated "farm to table" approach, legislation must cover all aspects of the food production chain: primary production, processing, transport, distribution through to the sale or supply of food and feed. At all stages of this chain, the legal responsibility for ensuring the safety of foodstuffs rests with the operator and a similar system should apply to feed business operators.
 The White Paper on Food Safety emphasizes the need for a policy underpinned by a sound scientific basis and up-to-date legislation. The EU legislation is designed to restore consumer confidence in the wake of recent food-related crises, with all the interested parties having a part to play: the general public, non-governmental organizations, professional associations, trading partners and international trade organizations. 
 The European Food Safety Authority (EFSA) enhances the current scientific and technical support system and its main task is to provide assistance and independent scientific advice, and to create a network geared to close cooperation with similar bodies in the Member States.
 The recent food crises have shown that it is necessary to improve the procedures relating to food safety. For this reason, the scope of the rapid alert system was extended to cover animal feed and to identify measures to be taken in emergencies and for crisis management. A Standing Committee on the Food Chain and Animal Health is also being set up to replace the existing committees