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Political analysis can enrich our understanding of the interface between health and society. Here, a theoretical framework called 'the biomarket' is proposed, one that describes the interaction between life, power and the market, and the progressive institutionalisation of this dynamic by state actors. This framework expands upon 'biopower', a social concept developed by Michel Foucault. The role of the biomarket is illustrated by analysis of a range of cases, namely the relationships between global health and the pharmaceutical and tobacco industries. The potential adverse consequences of the biomarket are demonstrated, revealing how in some instances, important social measures of welfare are discarded for the sake of economic efficiency and profit. The authors conclude that the biomarket may serve to deepen our understanding of the authority and control exerted by corporations over life, positing that the biomarket must be further regulated for sustainable advances in global health.

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. This review is an update using more stringent methodology and also investigating sponsorship of device studies., 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: We searched MEDLINE (1948 to September 2010), EMBASE (1980 to September 2010), the Cochrane Methodology Register (Issue 4, 2010) and Web of Science (August 2011). 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 identified potentially relevant papers, and a decision about final inclusion was made by all authors. 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)., Main Results: Forty-eight papers were included. Industry sponsored studies more often had favorable efficacy results, risk ratio (RR): 1.24 (95% confidence interval (CI): 1.14 to 1.35), harms results RR: 1.87 (95% CI: 1.54 to 2.27) and conclusions RR: 1.31 (95% CI: 1.20 to 1.44) compared with non-industry sponsored studies. Ten papers reported on sponsorship and effect size, but could not be pooled due to differences in their reporting of data. The results were heterogeneous; five papers found larger effect sizes in industry sponsored studies compared with non-industry sponsored studies and five papers did not find a difference in effect size. Only two papers (including 120 device studies) reported separate data for devices and we did not find a difference between drug and device studies on the association between sponsorship and conclusions (test for interaction, P = 0.23). Comparing industry and non-industry sponsored studies, we did not find a difference in risk of bias from sequence generation, allocation concealment and follow-up. However, industry sponsored studies more often had low risk of bias from blinding, RR: 1.32 (95% CI: 1.05 to 1.65), 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: 0.84 (95% CI: 0.70 to 1.01)., Authors' Conclusions: Sponsorship of drug and device studies by the manufacturing company leads to more favorable 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.

This article describes the challenge of sustaining a balanced agenda for drug use research in the USA to advance understanding of the nature and extent of drug use and drug use disorders in a population; the processes and mechanisms that underlie onset, continuing, and stopping drug dependence; how to effectively prevent the onset of and early drug use as well as the social and health consequences of such use; and how to treat and maintain those with drug use disorders. This review concludes with recommendations to achieve sustained stability of funding for and to promote the progress of epidemiologic, prevention, and treatment policy research.

United Stated federal regulations allow participation of children in greater than minimal risk research with no potential for direct benefit under narrowly defined circumstances. This type of research is controversial, as it runs contrary to the best interest standard, on which we base most decisions made on behalf of children. I argue that such research is ethically defensible if a fully informed, scrupulous, and virtuous parent would choose to enroll his or her child in the study. Further, I defend the current regulations, which allow local Institutional Review Boards to approve more than minimal risk, nontherapeutic research when the research involves children with the medical condition being studied, but requires federal review for similarly risky studies that involve healthy children. Because families of children with medical diseases tend to be more familiar with the health care system and with medical procedures, they are more able to make informed decisions about the burdens of research participation. Further, parents of children with medical conditions have a morally significant interest in advancing medical knowledge about their child's condition. It is appropriate to take this interest into account when evaluating the ethical status of a research study., (© 2012 American Society of Law, Medicine & Ethics, Inc.)

Physicians and patients rely on medical journals as trusted sources of medical information. Unfortunately, conflicts of interest (this article primarily considers financial conflicts of interest) may undermine the credibility of the medical literature. Improved policies and practices at journals should address the conflicts of interest of authors, reviewers, editors, and journals. Medical journals should manage and eliminate conflicts, not just improve the disclosure of financial relationships., (© 2012 American Society of Law, Medicine & Ethics, Inc.)

Background: Evaluation of the social and economic outcomes of health research funding is an area of intense interest and debate. Typically, approaches have sought to assess the impact of research funding by medical charities or regional government bodies. Independent research institutes have a similar need for accountability in investment decisions but have different objectives and funding, thus the existing approaches are not appropriate., Methods: An evaluation methodology using eight indicators was developed to assess research performance across three broad categories: knowledge creation; inputs to research; and commercial, clinical and public health outcomes. The evaluation approach was designed to provide a balanced assessment across laboratory, clinical and public health research., Results and Discussion: With a diverse research agenda supported by a large number of researchers, the Research Performance Evaluation process at the Murdoch Childrens Research Institute has, by necessity, been iterative and responsive to the needs of the Institute and its staff. Since its inception 5 years ago, data collection systems have been refined, the methodology has been adjusted to capture appropriate data, staff awareness and participation has increased, and issues regarding the methodology and scoring have been resolved., Conclusions: The Research Performance Evaluation methodology described here provides a fair and transparent means of disbursing internal funding. It is also a powerful tool for evaluating the Institute's progress towards achieving its strategic goals, and is therefore a key driver for research excellence.

A diverse array of stakeholders supports biomedical investigation, the major goal of which is to improve human health. For patients with dermatological disease, the Coalition of Skin Diseases (CSD) has for more than two decades provided a base from which public advocacy, education, fund-raising, and communication have flourished. Their efforts, combined with that of investigators and national funding agencies, have advanced scientific enterprise and, ultimately, human health.

Problem: Considerable progress in Asian American health research has occurred over the last two decades. However, greater and sustained federal support is needed for reducing health disparities in Asian American communities. PURPOSE OF THE ARTICLE: This paper reviews federal policies that support infrastructure to conduct minority health research and highlights one model for strengthening research capacity and infrastructure in Asian American communities., Key Points: Research center infrastructures can play a significant role in addressing pipeline/workforce challenges, fostering campus-community research collaborations, engaging communities in health, disseminating evidence-based strategies and health information, and policy development., Conclusion: Research centers provide the capacity needed for academic institutions and communities to work together synergistically in achieving the goal to reduce health disparities in the Asian American community. Policies that support the development of concentrated and targeted research for Asian Americans must continue so that these centers will reach their full potential.

Strong, evidence-based practice requires that objective, unbiased research be available to inform individual clinical decisions, systematic reviews, meta-analyses, and expert guideline recommendations. Industry has used seeding trials, publication planning, messaging, ghostwriting, and selective publication and reporting of trial outcomes to distort the medical literature and undermine clinical trial research by obscuring information relevant to patients and physicians. Policies that promote transparency in the clinical trial research process, through improved and expanded disclosure of investigator contributions and funding, comprehensive publicly available trial registration, and independent analysis of clinical trial data analysis may address these subversive practices by improving accountability among industry and investigators. Minimizing marketing's impact on clinical trial research and strengthening the science will protect medical literature's integrity and the public's health.

This article updates the ethical standards and methods for the conduct of high-quality animal and human biological rhythm research, which should be especially useful for new investigators of the rhythms of life. The editors of Chronobiology International adhere to and endorse the Code of Conduct and Best Practice Guidelines of the Committee On Publication Ethics (COPE), which encourages communication of such updates at regular intervals in the journal. The journal accepts papers representing original work, no part of which was previously submitted for publication elsewhere, except as brief abstracts, as well as in-depth reviews. The majority of research papers published in Chronobiology International entails animal and human investigations. The editors and readers of the journal expect authors of submitted manuscripts to have made an important contribution to the research of biological rhythms and related phenomena using ethical methods/procedures and unbiased, accurate, and honest reporting of findings. Authors of scientific papers are required to declare all potential conflicts of interest. The journal and its editors endorse compliance of investigators to the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, relating to the conduct of ethical research on laboratory and other animals, and the principles of the Declaration of Helsinki of the World Medical Association, relating to the conduct of ethical research on human beings. The peer review of manuscripts by Chronobiology International thus includes judgment as to whether or not the protocols and methods conform to ethical standards. Authors are expected to show mastery of the basic methods and procedures of biological rhythm research and proper statistical assessment of data, including the appropriate application of time series data analyses, as briefly reviewed in this article. The journal editors strive to consistently achieve high standards for the research of original and review papers reported in Chronobiology International, and current examples of expectations are presented herein.

Despite remarkable growth in the clinical neurology literature, there is little research on peer review and biomedical publication in neurology. Biomedical publication research encompasses every step of the research process, from the methodology to the publication of research findings. Some general medical journals have served as leaders in improving scientific publication. Many medical fields have taken it upon themselves to characterize journals and peer reviewers within their own fields. Not all of these data can be applied to the clinical neurology literature; research methodologies, article types, and the journals themselves are unique to every medical field. This article reviews current publication research in the neurology literature and concludes that, to sustain and improve upon the integrity of clinical neurology research, further study is needed of the journals and the peer review process in neurology. Otherwise, the value of clinical research findings and patient care guidelines will be diminished.

Trauma- and injury-related research is recognised in Australia as a National Health Priority Area. Within the past 5 years (2005-2009) 926 trauma-related research publications with an Australian author can be retrieved from the Thomson-Reuters ISI Web of Science database. These publications are written with co-authors from 725 institutions world-wide and span 110 discipline areas from surgery to interdisciplinary social science. Each of these disciplines can represent an opportunity to bridge the gulf between research and health practice, but must be supported by major funding if this translational research is to continue. There are ways in which junior researchers and experience research teams can optimise their trauma-related research proposals to convince funding agencies of the continuing importance of the field and obtain the necessary funding., (Copyright (c) 2010 Elsevier Ltd. All rights reserved.)

Physician-scientists, in the eyes of the National Institutes of Health (NIH), are crucial to the biomedical research enterprise since the development of evidence-based practice based on cutting-edge research. At the same time, NIH has heightened the importance of research mentorship by permitting investigators to revise an application a single time. The current NIH approach, therefore, narrows the margin of error allowable in a proposal and requires that investigators fully develop research protocols for initial submission. The purpose of this manuscript, therefore, is to provide medical toxicologists with a proven research methodology that can be applied to substance abuse investigations. A secondary aim is to provide successful grant language that can be used in subsequent applications for research funding.

Background and Purpose: A new national system for funding research in universities and hospitals in Norway based on publication output is described., Methods: All scientific publications were counted and weighted according to the quality of the publication channel. Author addresses were credited. This led to a number of publication points for each institution/department., Results: The number of publication points for neurology had increased from 75.0 in 2005 to 98.3 in 2007. Publishing and the quality of publications were given more attention than before, and there was a stronger focus on facilitating research at the institutions. Research was regarded as not only an institutional but also as an individual responsibility., Conclusions: The principle of performance-based funding in addition to funding based on project applications has been well received, and it stimulates more and better research. Scientific publications represent a useful marker, whereas the way of counting author addresses and determining quality is still debated.

Multiple issues surrounding the publication of clinical trials and the conduct of clinical trials, especially those that are industry-sponsored, have raised doubts regarding the integrity of their results, and of the integrity of the medical profession. An appreciation of the historical and economic changes in the relationship between physicians and industry is crucial to the understanding of these issues. Increasingly, as healthcare professionals and centers in the Asia-Pacific region become involved in corporate-funded multi-center drug trials, these ethical issues similarly come into play. It is imperative for medical leaders to take actions ensuring rights of subjects participating in these clinical trials, and to ensure the integrity of physicians and authors of clinical trials from this region of the world.

RECENTLY ESTABLISHED POLICIES FOR ethical conduct of researchers have resulted in efforts to implement those policies through educational practices. While these policies and training efforts have good intentions, how do researchers respond? Little research has been conducted to understand how researchers react to ethics policies, and to ethics education requirements as a particularly salient part of the policies. This research explores variations in the responses of life scientists to policies originating in the U.K., E.U. and U.S., between 2000 and 2003. Semi-structured interviews with 30 life scientists in the U.K., Italy and the U.S. provide the basis for the findings. Across the interviews, scientists consistently reported dislike of the ways the ethics policies and ethics programs are implemented, but with variation by country. U.K. life scientists regarded the policies tied to Research Council (RC) funding with a skeptical attitude, expecting that policies would change with RC leadership. Italian life scientists often noted the lack of funding (and policies) at the national level, and appeared frustrated by what they viewed as overly complex policy requirements at the European level, where successful grantees employed outside consultants to complete the ethics sections of their applications. U.S. life scientists expressed distaste for the implementation of the National Institutes of Health (NIH) policy in web-based ethics training modules. This research suggests that introducing new shallow routines that are separate from daily research and educational practices in science may be worse than no ethics training at all, if it turns off young researchers to the discussion of ethical issues. Observing variation in scientists' discourse on ethics policies allows us to see how education following ethics policies might be more effective, and indicates that ethics policy formation more informed by empirical research is a desirable goal.

Most U.S. clinical trials are funded by industry. Opportunities exist for sponsors to influence research in ways that jeopardize research objectivity. The purpose of this study was to survey U.S. medical school faculty to assess financial arrangements between investigators and industry to learn about investigators' first hand knowledge of the effects of industry sponsorship on research. Here we show first-hand knowledge that compromises occurred in: research participants' well-being (9%), research initiatives (35%), publication of results (28%), interpretation of research data (25%), and scientific advancement (20%) because of industry support. Financial relationships with industry were prevalent and considered important to conducting respondents' research.