Scientific Advisory Committees Research Articles

Reconciling science and democracy: evidence-based policy as seen from the perspective of a role-based democratic theory

The question of whether policy can be informed by evidence and at the same time be democratically legitimate is contentious. The present article draws on the philosophy of democracy and role-based moral theory in order to inform a reconciliation of rigorous use of evidence with democratic legitimacy. The article argues that in order to realise the value of equality that underpins their offices, democratic officials have a special moral responsibility to utilise appropriate, high-quality evidence to identify the means by which to realise citizens’ democratically chosen aims, because utilising appropriate, high-quality evidence that addresses how to achieve citizens’ aims makes it more likely that their aims will be realised. Furthermore, the paper argues that when value judgments must be made in the employment of evidence for policy, these value judgments should ideally be made by elected representatives serving on scientific advisory committees.

A Study on Life Skills among Adolescents Attending Government Schools

ABSTRACT Background: Adolescence is a phase of transition marked by several biological, psychological, and social changes. A vast majority of students attend government schools in India. There seems to be a paucity of studies assessing the level of life skills. Materials and Methods: The present study aimed to assess life skills among adolescents attending government schools. Life skills of government school-going adolescents belonging to the age groups of 14 (n = 47), 15 (n = 51), and 16 (n = 22) years were assessed cross-sectionally through the Life Skills Assessment Scale. Voluntary assent of the participants and written informed consent from the school and the guardians were obtained. Collected data were analyzed using the software (Statistical Package for the Social Sciences SPSS, 25.0 version) using the statistical methods of mean, standard deviation, frequency, and percentage. To see the variation in life skills across the sociodemographic factors, independent sample t-tests (religion, residence, types of family, and socioeconomic status) and ANOVA (age levels, birth order, mother’s education, and father’s education) were used. Effect sizes were computed as partial eta-squared. The level of significance was kept at 0.05, and post hoc Bonferroni corrections were made for multiple comparisons. The study had the approval of Scientific Advisory and Institute Ethics Committees. Results: Students aged 14 years were significantly lower in life skills compared to the other two groups. Parental education also had a significant effect on life skills development. Children belonging to lower socioeconomic group were poorer in life skills compared to middle socioeconomic status. Conclusion: Findings highlight the need for the inclusion of life skills-based curriculum in government schools.

LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial

IntroductionThere is uncertainty about the advantages and disadvantages of laparoscopic hysterectomy compared with abdominal hysterectomy, particularly the relative rate of complications of the two procedures. While uptake of laparoscopic hysterectomy...

A new typology for comparing scientific advisory committees. Evidence from the Italian response to the COVID‐19 pandemic

AbstractThe study of scientific advisory committees (SACs) is a recurrent topic of research in public policy and public administration. Scholars are increasingly interested in analyzing the scientization of policy advice as well as the role played by knowledge‐based policymaking processes. Despite recent developments in the field, SACs studies continue to face an analytical and empirical gap due to the lack of parsimonious conceptualizations of the characteristics that enable them to be both theoretically relevant and effective in driving comparative analysis. To fill this research gap, this article proposes a novel typology of SACs based on a specific conceptualization of the motivations of policymakers that allows the selection of two classificatory criteria: the origin of the members and the degree to which their expertise is homogeneous. The theoretical relevance of this typology is illustrated by applying it to the SACs established in the Italian regions to address the COVID‐19 pandemic. The article highlights the relevance of the typology to the theory underlying the empirical analysis. In doing so, it provides relevant insights into the composition and nature of SACs that is useful not only for the academic debate on evidence‐based policymaking but also for both practitioners and decision‐makers.

Network analysis of scientific advisory committee integration in climate change policy: A comparison of Germany and Japan

According to the literature on Environmental Policy Integration (EPI), decisionmaking in complex domains of environmental policy—of which climate change is a prime example—tend to fragment and silo into individual dimensions of a problem. Scientific Advisory Committees (SACs) have been widely used to promote more integrated decisionmaking. SACs are intended to integrate the varied, and often fragmented, dimensions of policy problems, and this integration is widely believed to enable more effective use of science in climate change policy. This paper empirically evaluates the degree of integration achieved through SACs in two national climate policy contexts: Germany and Japan. Network analysis is used to examine the myriad scientific advisory committees focused on climate change policy in these nations (N = 218), and quantify the degree of vertical integration (integration among different sectors) and horizontal integration (integration among different governmental bodies). Results show greater vertical integration among German SACs than Japanese SACs, and similar levels of horizontal integration between the two nations despite having very different structures. Such efforts to empirically connect the conceptual discussion of integration in EPI with empirical observations of integration in actual climate policy processes is an important step towards understanding the strategies that may be used to promote more integrated decisionmaking in climate change policy.

A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU.

The aim of this study was to assess the effect of expedited regulatory approval programs used by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), type of product (small molecule or biotechnology‐derived product) and consulting scientific advisory committees on the regulatory review time of the marketing authorization applications (MAAs) for new anticancer drugs. A dataset composed of 76 new anticancer drugs was constructed. The date of submission of the MAAs in the United States and the European Union were comparable. The typical review time of MAAs was 136 days shorter in the United States (201 days [median]) than in the European Union (337 days [median]). The type of product did not have a high impact on the review time. The review time of the MAAs for drugs undergoing priority review in the United States or accelerated assessment in the European Union at the stage of review of MAA was generally shorter than that for drugs following the standard regulatory pathway. The regulatory pathway using at least one expedited regulatory program at the stages of drug development, review of MAA, and approval of drug in the United States (172 days [median]), and that at the stages of review of MAA and approval of drug in the European Union (183 days [median]) enabled the shortest review time of MAAs. Referral to advisory committee meeting increased the review time of MAAs for drugs undergoing one or more expedited regulatory approval programs in the United States and the European Union close to that for drugs undergoing the standard regulatory approval pathway.

Learning lessons from the long, troubled history of stem cell therapy for future clinical success

<div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Rasko copy.jpg" data-image="1"></div><div class="author-det"> <b>John EJ Rasko</b> is an Australian pioneer in the application of adult stem cells and genetic therapy. Since 1999 he has directed the Department of Cell and Molecular Therapies at Royal Prince Alfred Hospital and the Gene and Stem Cell Therapy Program at the Centenary Institute, University of Sydney. John Rasko is a clinical hematologist, pathologist and scientist with an international reputation in gene and stem cell therapy, experimental hematology and molecular biology. In over 200 publications he has contributed to the understanding of stem cells and blood cell development, gene therapy technologies, cancer causation and treatment, human genetic diseases and molecular biology. He serves on Hospital, state and national bodies including Chair of GTTAC, Office of the Gene Technology Regulator – responsible for regulating all genetically-modified organisms in Australia – and immediate past Chair of the Advisory Committee on Biologicals, Therapeutic Goods Administration. Contributions to scientific organizations include co-founding (2000) and past-President (2003–5) of the Australasian Gene &amp; Cell Therapy Society; President (2018–20), President-Elect (2016–18) and Vice President (2008–12) of the International Society for Cell &amp; Gene Therapy; Scientific Advisory Committees and Board member for philanthropic foundations; and several Human Research Ethics Committees. He is a founding Fellow of the Australian Academy of Health and Medical Sciences. In 2018, the Board of the ABC honored him as the sixtieth Boyer Lecturer. He is the recipient of national (RCPA, RACP, ASBMB) and international awards in recognition of his commitment to excellence in medical research, including appointment as an Officer of the Order of Australia. </div></div></div>

COVID-19 and the Paradox of Scientific Advice

The scientific advisory committee is a neglected political institution whose importance became clear during the COVID-19 pandemic. What I call “the paradox of scientific advice” consists in that the two basic expectations from scientific advisory committees—neutrality and usefulness—are inherently in tension. To be useful, advisers must help governments set and attain their goals. Judgments about values and ends are necessary for useful advice, as are subjective judgments in the face of uncertainty and disagreement. This puts the committee in a double bind: if it tries to be more useful, it compromises the neutrality that is the source of its authority and legitimacy; if it tries to remain neutral, it sacrifices usefulness. I argue that this dilemma cannot be solved within the committee but that broader democratic scrutiny could mitigate its force. Advisory committees, in turn, should be structured to facilitate this scrutiny.

Recruitment, risks, rewards and regrets: Senior researcher reflections on working with alcohol industry social aspects organisations.

A growing body of literature suggests alcohol industry corporate social responsibility activity, including the creation of 'social aspects' organisations (SAO), may harm rather than improve public health. We aimed to explore established researcher experiences of working with SAOs, and the factors informing their decisions to do so. Qualitative interview study with senior alcohol researchers who had previous or ongoing connections to SAOs or their predecessors initiated when their careers were established (n= 16). Thematic analysis using NVivo software. Established researchers were recruited for their expertise by alcohol industry SAOs via employees who were previously academics or via academic colleagues with SAO connections. Motivated by the desire to improve public health and 'reach out' beyond academia, researchers were confident that they could maintain their independence when sharing their expertise with SAOs. Short-term connections included attendance at SAO-funded events and book chapter contributions. Sometimes, these led to long-term relationships with SAOs, or researchers were invited to long-term roles by a colleague. These included memberships of scientific advisory committees, board positions, or work as independent consultants. Most researchers reflected negatively on their experiences and had ended their associations, while some had positive experiences. Current and former researchers play key roles in initiating connections with SAOs, with industry-funded events and invitations to long-term roles by trusted colleagues, mechanisms used to facilitate the development of such relationships. Our study adds to existing evidence that SAO scientific activity does not contribute to public health goals, but does present industry with public relations opportunities.

Clean slate for EPA scientific advisory committees

After just a few weeks on the job, Michael Regan, administrator of the US Environmental Protection Agency, is shaking up membership on two influential scientific advisory committees. Regan announced March 31 that he is eliminating all members of the agency’s Science Advisory Board (SAB) and the Clean Air Scientific Advisory Committee (CASAC) and directing EPA staff to reconfigure the panels with a more balanced mix of expertise. The move comes after 4 years of the Trump administration’s dismantling various panels and excluding members who received grant money from the EPA in favor of members with ties to industry. “Resetting these two scientific advisory committees will ensure the agency receives the best possible scientific insight to support our work to protect human health and the environment,” Regan says in a statement. The EPA is encouraging members released from the committees to reapply if they are still interested in serving. It is

Clean slate for EPA scientific advisory committees

Clean slate for EPA scientific advisory committees

How Do Data Bolster Pandemic Preparedness and Response? How Do We Improve Data and Systems to Be Better Prepared?

How are data driving the response for the ongoing COVID-19 pandemic? How do data support preparedness toward epidemics and pandemics? How do data inform the potential severity and spread of an outbreak? Past infectious disease outbreaks have demonstrated several challenges associated with rapid aggregation, integration, and sharing of data to inform a response during an outbreak. The ongoing pandemic response has demonstrated the value of timely data collection and sharing and the usage of data for decision-making.

Can BCG be useful to mitigate the COVID-19 pandemic? A Canadian perspective.

There is ample evidence from in vitro, animal and human studies that the Bacillus Calmette-Guerin (BCG) vaccine epigenetically reprograms innate immunity to provide “off target” protection against pathogens other than mycobacteria. This process has been termed “trained immunity”. Although recent ecological studies suggested an association between BCG policies and the frequency or severity of COVID-19 in different countries, the interpretation of these results is challenging. For this reason, a case-control study aiming to test this hypothesis has been initiated in Quebec. Several phase III clinical trials are underway, including one in Canada, to assess the efficacy of BCG against SARS-CoV-2 infection (results expected in 2021). In the past, BCG has been widely used in Canada but current indications are restricted to high-risk individuals and communities experiencing TB outbreaks as well as for the treatment of bladder cancer. The potential implication of BCG as an interim measure to mitigate COVID-19 is the subject of widespread discussion in the scientific community and can be considered for the vulnerable population in Canada. To conclude, BCG vaccination should be placed on the agenda of research funding agencies, scientific advisory committees on immunization and federal/provincial/territorial public health authorities.

Safeguarding Science from Attack: Data and Trends from the Trump Administration and How to Strengthen the Role of Science-Based Decisionmaking

Background/Aim: Protecting the environment and public health often depends on the effective incorporation of science into the federal decisionmaking process. However, the Trump administration has undermined these safeguards such that environmental hazards like air pollution and harmful chemicals are increasingly affecting communities across the US. It is worth analyzing how science is being attacked by the Trump administration and how to strengthen the role of science in the decisionmaking process. Methods: We created a searchable public database to track and analyze attacks on science that have occurred since the inauguration of the Trump administration. A rigorous and systematic set of criteria were used to assess what constitutes an attack on science and how to categorize the attack. Results: Over one hundred attacks on science have been carried out by dozens of federal agencies that follow six trends: anti-science rules, censoring scientists, manipulating studies, making data inaccessible or halting its collection, politicizing funding, sidelining scientific advisory committees, and restricting conference attendance. Conclusions: Our analysis suggests that attacks on science follow a set of patterns that future presidential administrations can guard against. By analyzing data and trends associated with the Trump administration’s attacks on science, we offer specific policy recommendations to combat them, including restoring the role of scientific experts in policymaking, bolstering scientific integrity, improving public access to government research, strengthening conflicts of interest policies, restoring protections for government scientists, encouraging public engagement in the rulemaking process, and safeguarding fundamental processes of a healthy democracy.

In Defense of the Weight-of-Evidence Approach to Literature Review in the Integrated Science Assessment

In Defense of the Weight-of-Evidence Approach to Literature Review in the Integrated Science Assessment

4-month moxifloxacin containing regimens in the treatment of patients with sputum-positive pulmonary tuberculosis in South India - a randomised clinical trial.

Shortening tuberculosis (TB) treatment duration is a research priority. We tested the efficacy and safety of 3- and 4-month regimens containing moxifloxacin in a randomised clinical trial in pulmonary TB (PTB) patients in South India. New, sputum-positive, adult, HIV-negative, non-diabetic PTB patients were randomised to 3- or 4-month moxifloxacin regimens [moxifloxacin (M), isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E)] or to a control regimen (2H3 R3 Z3 E3 /4R3 H3 ) [C]. The 4 test regimens were 3R7 H7 Z7 E7 M7 [M3], 2R7 H7 Z7 E7 M7 /2R7 H7 M7 [M4], 2R7 H7 Z7 E7 M7 /2R3 H3 M3 [M4-I] or 2R7 H7 Z7 E7 M7 /2R3 H3 E3 M3 [M4-IE]. Treatment was directly observed. Clinical and bacteriological assessments were done monthly during treatment and for 24months post-treatment. The primary end point was TB recurrence post-treatment. Of 1371 patients, randomised, modified intention-to-treat (ITT) analysis was done in 1329 and per-protocol (PP) analysis in 1223 patients. Regimen M3 was terminated due to high TB recurrence rates. 'Favourable' response at end of treatment was 96-100% in the moxifloxacin regimensand 93% in the control regimen. Among these, the TB recurrence occurred in 4.1% in the M4 regimen and in 4.5% in the control regimen and demonstrated equivalence within a 5% margin (95% CI -3.68, 4.55). Similar findings were observed in modified ITT analysis. The TB recurrence rates in the M4-I and M4-IE regimens did not show equivalence with the control regimen. Sixteen (1.4%) of 1087 patients in the moxifloxacin regimens required treatment modification. The 4-month daily moxifloxacin regimen [M4] was found to be equivalent and as safe as the 6-month thrice-weekly control regimen.

Disability and socio-occupational functioning in persons with schizophrenia

Background: Schizophrenia is a chronic mental illness which severely affects the functioning of individuals in their daily life. Functional disability in chronic illness is one of the major concerns for mental health professionals. The study aims to assess the disability of persons with schizophrenia and its relationship with age of onset, total duration of illness, and socio-occupational functioning. Methods and materials: The present study is a descriptive cross-sectional study. Sixty persons with schizophrenia were selected using simple random sampling from the outpatient department (OPD). Written informed consent was taken from the participants who fulfilled the inclusion and exclusion criteria. Clarifications were made regarding the basic purpose of the study before administration of tools. The study was undertaken with the permission of the Scientific Advisory and Institute Ethics committees. Sociodemographic datasheet, the revised Kuppuswamy scale, the Brief Psychiatric Rating Scale (BPRS), the Indian Disability Evaluation and Assessment Scale (IDEAS), and the Social Occupational Functioning Scale (SOFS) were administered. Collected data were analysed using the software (Statistical Package for the Social Sciences [SPSS] 25.0) using the statistical methods of mean, standard deviation, frequency, percentage, and Pearson correlation. Results: The findings showed that most of the respondents (71.7%) were having moderate level of disability and moderate impairment (40%) in socio-occupational functioning. The global score of disability has a significant positive correlation with total duration of illness (r=0.255, p<0.05) and negative correlation with age of onset of illness (r=-0.075), and there is significant positive correlation (r=0.829, p<0.01) between socio-occupational functioning and global disability. Conclusion: Disability has an impact on socio-occupational functioning in persons with schizophrenia. A higher level of disability can lead to higher level of impairment.

US EPA lacks data to support chemical evaluations

The US Environmental Protection Agency’s scientific advisory committees are struggling. While one committee is wrestling with a lack of expertise when considering health risks of air pollution (see...

Long-term impact of giving antibiotics before skin incision versus after cord clamping on children born by caesarean section: protocol for a longitudinal study based on UK electronic health records

IntroductionIn the UK, about a quarter of women give birth by caesarean section (CS) and are offered prophylactic broad-spectrum antibiotics to reduce the risk of maternal postpartum infection. In 2011,...

Towards a Systematic Understanding of How to Institutionally Design Scientific Advisory Committees: A Conceptual Framework and Introduction to a Special Journal Issue.

Scientifically‐derived insights are often held as requirements for defensible policy choices. Scientific advisory committees (SACs) figure prominently in this landscape, often with the promise of bringing scientific evidence to decision‐makers. Yet, there is sparse and scattered knowledge about what institutional features influence the operations and effectiveness of SACs, how these design choices influence subsequent decision‐making, and the lessons learned from their application. The consequences of these knowledge gaps are that SACs may not be functioning as effectively as possible. The articles in this special journal issue of Global Challenges bring together insights from experts across several disciplines, all of whom are committed to improving SACs' effectiveness worldwide. The aim of the special issue is to inform future SAC design in order to help maximize the application of high‐quality scientific research for the decisions of policymakers, practitioners, and the public alike. In addition to providing an overview of the special issue and a summary of each article within it, this introductory essay presents a definition of SACs and a conceptual framework for how different institutional features and contextual factors affect three proximal determinants of SACs' effectiveness, namely the quality of advice offered, the relevance of that advice, and its legitimacy.