The Policies for the Disclosure of Funding and Conflict of Interest in Surgery Journals: A Cross-Sectional Survey.

BACKGROUND: Industry through its funding of research and through its relationships with study authors can influence the results of research. Most journals have policies for reporting funding and disclosing conflict of interest (COI) to mitigate the influence of industry on research. The objective of this study is to assess the policies of surgery journals for the reporting of funding and the disclosure of COI. METHODS: We described the prevalence and characteristics of funding and COI policies of journals indexed under "Surgery" in the Journal Citation Reports. We extracted data from publicly available information and through simulation of manuscript submission. RESULTS: Of the 186 eligible journals, 171 (92%) had policies for reporting of funding. None of the policies described procedures to deal with non-reporting or underreporting of funding. Of the 186 journals, 183 (99%) had a policy for disclosure of COI. All journals with a COI policy required disclosure of financial interest, while 96 (52%) required the disclosure of non-financial interests. Only 24 (13%) policies described how non-disclosure of COI affects the editorial process, and none described procedures to verify COI disclosure. Of the policies that required disclosing COI, 94 (51%) also required reporting the source of financial COI. CONCLUSIONS: Most journals have policies for reporting of funding and disclosure of financial COI. However, many do not have clear policies for disclosing non-financial COI. Major limitations in the policies include the lack of processes for the verification of disclosed interests and for dealing with underreporting of funding and of COI.

What Is Human Research For? Reflections on the Omission of Scientific Integrity from the Belmont Report.

The Belmont Report has provided a useful and virtually universal framework for protecting human subjects from research abuses. However, it provides little to no guidance on the substance of human research. In an environment where major decisions concerning health-care access, funding, and regulation hinge on human research, this omission leaves downstream users of human research virtually unprotected and with few tools or frameworks to protect against a variety of practices that compromise the social value of human research. This essay advocates for the addition of a fourth principle to the Belmont three: "scientific integrity." Such a principle would seek to train human research on important social objectives while maximizing the accessibility, credibility, and generalizability of findings.

Governance of health research funding institutions: an integrated conceptual framework and actionable functions of governance.

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.

Peer Review Practices for Evaluating Biomedical Research Grants: A Scientific Statement From the American Heart Association.

The biomedical research enterprise depends on the fair and objective peer review of research grants, leading to the distribution of resources through efficient and robust competitive methods. In the United States, federal funding agencies and foundations collectively distribute billions of dollars annually to support biomedical research. For the American Heart Association, a Peer Review Subcommittee is charged with establishing the highest standards for peer review. This scientific statement reviews the current literature on peer review practices, describes the current American Heart Association peer review process and those of other agencies, analyzes the strengths and weaknesses of American Heart Association peer review practices, and recommends best practices for the future.

Metrics and evaluation of scientific productivity: would it be useful to normalize the data taking in consideration the investments?

There has been in increasing interest in evaluating research production by means of "objective parameters" which should score the scientific impact of single articles and researchers' career. In contrast, the attention of the economic aspects of research production has been highly neglected. I suggest that introducing the assessment of the return of research investment would be useful for fair comparison among researchers and probably it would render more understandable to public opinion what are the criteria according to which research funds are distributed.

Responsible Gambling Research and Industry Funding Biases.

This brief report examines whether there are differences in aspects of different characteristics, including design/methodologies of responsible gambling (RG), between studies funded by industry as compared to other sources. To investigate this, the authors used those studies included in a recent meta-analysis focusing on the empirical basis of RG initiatives (Ladouceur et al. in Addict Res Theory 25:225-235, 2017). We examined eight associations between funding sources, and different design/methodological characteristics of these studies; type of strategy, inclusion of comparison groups, measurement scales and repeated measures, publication source, number of inclusion criteria met, secondary sources of funding, publication year. The results revealed no statistically significant difference between the funding source, and the index study characteristics. These results do not support claims that funding exerts influence on the design or methodologies of RG studies. However, the absence of statistically significant findings should not be used to assert the absence of a funding effect because there are many reasons for failing to find differences, or interpretation of findings. Unexpectedly, a third of the papers included in this study failed to disclose their funding sources. This finding highlights the need for more open and transparent disclosures.

Why Stating Hypotheses in Grant Applications Is Unnecessary.

This Viewpoint argues that a hypothesis-centric approach to writing grant applications is problematic and instead suggests that funding applications should be evaluated by their relevance and methodological quality rather than by qualitative assertions before the study is conducted.

Seeking a Better Paper Trail of Federal Research Funding.

This work discusses initiatives designed to capture the value of public investment that will result in an accurate, comprehensive, and transparent paper trail of public funding.

Congress of the United States, Ramazzini Institute and its affiliates, IARC: questions on scientific transparency.

SUMMARY: No abstract available.

Assessment of potential bias in research grant peer review in Canada.

BACKGROUND: Peer review is used to determine what research is funded and published, yet little is known about its effectiveness, and it is suspected that there may be biases. We investigated the variability of peer review and factors influencing ratings of grant applications. METHODS: We evaluated all grant applications submitted to the Canadian Institutes of Health Research between 2012 and 2014. The contribution of application, principal applicant and reviewer characteristics to overall application score was assessed after adjusting for the applicant's scientific productivity. RESULTS: Among 11 624 applications, 66.2% of principal applicants were male and 64.1% were in a basic science domain. We found a significant nonlinear association between scientific productivity and final application score that differed by applicant gender and scientific domain, with higher scores associated with past funding success and h-index and lower scores associated with female applicants and those in the applied sciences. Significantly lower application scores were also associated with applicants who were older, evaluated by female reviewers only (v. male reviewers only, -0.05 points, 95% confidence interval [CI] -0.08 to -0.02) or reviewers in scientific domains different from the applicant's (-0.07 points, 95% CI -0.11 to -0.03). Significantly higher application scores were also associated with reviewer agreement in application score (0.23 points, 95% CI 0.20 to 0.26), the existence of reviewer conflicts (0.09 points, 95% CI 0.07 to 0.11), larger budget requests (0.01 points per $100 000, 95% CI 0.007 to 0.02), and resubmissions (0.15 points, 95% CI 0.14 to 0.17). In addition, reviewers with high expertise were more likely than those with less expertise to provide higher scores to applicants with higher past success rates (0.18 points, 95% CI 0.08 to 0.28). INTERPRETATION: There is evidence of bias in peer review of operating grants that is of sufficient magnitude to change application scores from fundable to nonfundable. This should be addressed by training and policy changes in research funding.

Gender contributes to personal research funding success in The Netherlands.

We examined the application and review materials of three calls (n=2,823) of a prestigious grant for personal research funding in a national full population of early career scientists awarded by the Netherlands Organization for Scientific Research (NWO). Results showed evidence of gender bias in application evaluations and success rates, as well as in language use in instructions and evaluation sheets. Male applicants received significantly more competitive "quality of researcher" evaluations (but not "quality of proposal" evaluations) and had significantly higher application success rates than female applicants. Gender disparities were most prevalent in scientific disciplines with the highest number of applications and with equal gender distribution among the applicants (i.e., life sciences and social sciences). Moreover, content analyses of the instructional and evaluation materials revealed the use of gendered language favoring male applicants. Overall, our data reveal a 4% "loss" of women during the grant review procedure, and illustrate the perpetuation of the funding gap, which contributes to the underrepresentation of women in academia.

Considering Sex as a Biological Variable Will Be Valuable for Neuroscience Research.

The recently implemented National Institutes of Health policy requiring that grant applicants consider sex as a biological variable in the design of basic and preclinical animal research studies has prompted considerable discussion within the neuroscience community. Here, we present reasons to be optimistic that this new policy will be valuable for neuroscience, and we suggest some ways for neuroscientists to think about incorporating sex as a variable in their research.

Industry sponsorship and research outcome.

BACKGROUND: Clinical research affecting how doctors practice medicine is increasingly sponsored by companies that make drugs and medical devices. Previous systematic reviews have found that pharmaceutical-industry sponsored studies are more often favorable to the sponsor's product compared with studies with other sources of sponsorship. A similar association between sponsorship and outcomes have been found for device studies, but the body of evidence is not as strong as for sponsorship of drug studies. This review is an update of a previous Cochrane review and includes empirical studies on the association between sponsorship and research outcome. OBJECTIVES: To investigate whether industry sponsored drug and device studies have more favorable outcomes and differ in risk of bias, compared with studies having other sources of sponsorship. SEARCH METHODS: In this update we searched MEDLINE (2010 to February 2015), Embase (2010 to February 2015), the Cochrane Methodology Register (2015, Issue 2) and Web of Science (June 2015). In addition, we searched reference lists of included papers, previous systematic reviews and author files. SELECTION CRITERIA: Cross-sectional studies, cohort studies, systematic reviews and meta-analyses that quantitatively compared primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. We had no language restrictions. DATA COLLECTION AND ANALYSIS: Two assessors screened abstracts and identified and included relevant papers. Two assessors extracted data, and we contacted authors of included papers for additional unpublished data. Outcomes included favorable results, favorable conclusions, effect size, risk of bias and whether the conclusions agreed with the study results. Two assessors assessed risk of bias of included papers. We calculated pooled risk ratios (RR) for dichotomous data (with 95% confidence intervals (CIs)). MAIN RESULTS: Twenty-seven new papers were included in this update and in total the review contains 75 included papers. Industry sponsored studies more often had favorable efficacy results, RR: 1.27 (95% CI: 1.17 to 1.37) (25 papers) (moderate quality evidence), similar harms results RR: 1.37 (95% CI: 0.64 to 2.93) (four papers) (very low quality evidence) and more often favorable conclusions RR: 1.34 (95% CI: 1.19 to 1.51) (29 papers) (low quality evidence) compared with non-industry sponsored studies. Nineteen papers reported on sponsorship and efficacy effect size, but could not be pooled due to differences in their reporting of data and the results were heterogeneous. We did not find a difference between drug and device studies in the association between sponsorship and conclusions (test for interaction, P = 0.98) (four papers). Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment, follow-up and selective outcome reporting. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.25 (95% CI: 1.05 to 1.50) (13 papers), compared with non-industry sponsored studies. In industry sponsored studies, there was less agreement between the results and the conclusions than in non-industry sponsored studies, RR: 0.83 (95% CI: 0.70 to 0.98) (six papers). AUTHORS' CONCLUSIONS: Sponsorship of drug and device studies by the manufacturing company leads to more favorable efficacy results and conclusions than sponsorship by other sources. Our analyses suggest the existence of an industry bias that cannot be explained by standard 'Risk of bias' assessments.

Industry Support of Medical Research: Important Opportunity or Treacherous Pitfall?

Pharmaceutical and device manufacturers fund more than half of the medical research in the U.S. Research funding by for-profit companies has increased over the past 20 years, while federal funding has declined. Research funding from for-profit medical companies is seen as tainted by many academicians because of potential biases and prior misbehavior by both investigators and companies. Yet NIH is encouraging partnerships between the public and private sectors to enhance scientific discovery. There are instances, such as methods for improving drug adherence and post-marketing drug surveillance, where the interests of academician researchers and industry could be aligned. We provide examples of ethically performed industry-funded research and a set of principles and benchmarks for ethically credible academic-industry partnerships that could allow academic researchers, for-profit companies, and the public to benefit.

The use of technology enhanced learning in health research capacity development: lessons from a cross country research partnership.

BACKGROUND: With the recognition of the need for research capacity strengthening for advancing health and development, this research capacity article explores the use of technology enhanced learning in the delivery of a collaborative postgraduate blended Master's degree in Malawi. Two research questions are addressed: (i) Can technology enhanced learning be used to develop health research capacity?, and: (ii) How can learning content be designed that is transferrable across different contexts? METHODS: An explanatory sequential mixed methods design was adopted for the evaluation of technology enhanced learning in the Masters programme. A number of online surveys were administered, student participation in online activities monitored and an independent evaluation of the programme conducted. RESULTS: Remote collaboration and engagement are paramount in the design of a blended learning programme and support was needed for selecting the most appropriate technical tools. Internet access proved problematic despite developing the content around low bandwidth availability and training was required for students and teachers/trainers on the tools used. Varying degrees of engagement with the tools used was recorded, and the support of a learning technologist was needed to navigate through challenges faced. CONCLUSION: Capacity can be built in health research through blended learning programmes. In relation to transferability, the support required institutionally for technology enhanced learning needs to be conceptualised differently from support for face-to-face teaching. Additionally, differences in pedagogical approaches and styles between institutions, as well as existing social norms and values around communication, need to be embedded in the content development if the material is to be used beyond the pilot resource-intensive phase of a project.