Conflicts Of Interest In Research Research Articles

Transparency of Values in Science: Elliott and Resnik Respond

We thank Schwartz for his thoughtful comments, which provide an opportunity for us to clarify some of the points in our commentary, in which we called for greater transparency about the values that influence policy-relevant research (Elliott and Resnik 2014). His first concern is that even though we call for employing different standards of evidence in various social contexts, the evidence itself remains the same. We agree; in our commentary we were not claiming that the evidence itself changes but only that the form of evidence required for different decisions depends on the social context. Nevertheless, it is important to recognize that although the evidence itself does not change, it has to be interpreted and weighed, and many contemporary science policy disputes stem from disagreements about how to do so (Douglas 2012). Therefore, our view is that conflicts over public policies often stem from value judgments about both the nature of the evidence and standards of evidence. We agree with Schwartz about the solution: Transparency is essential. The more scientists acknowledge the assumptions and values that influence their interpretations of evidence and their decisions about how to weigh it, the better. Schwartz’s second point is that it is problematic for us to treat tort law and chemical regulations as equivalent contexts, in which weaker standards of evidence can appropriately inform policy. We agree that different standards of evidence may be appropriate in the two contexts. However, we caution against equating the standards of evidence expected in tort law with those expected in more traditional scientific contexts. The tort system requires only a preponderance of evidence (> 50% likelihood) to win a case; this is much weaker evidence than scientists typically demand when presenting or publishing results, and confusion about these differing standards has led to significant legal controversies (Cranor 2006). Schwartz’s third point is that other conflicts of interest, such as “ideological ties to advocacy organizations,” are important to disclose in addition to financial ties to industry. We heartily agree; indeed, in our commentary (Elliott and Resnik 2014) we stated that “Disclosures of competing financial interests and nonfinancial interests (such as professional or political allegiances) also provide opportunities for more transparent discussions” (Elliott and Resnik 2014). One of the aims of our commentary was to encourage more careful thinking about how to promote transparency regarding a wide range of different factors that could influence scientists’ reasoning, including ideology. Nevertheless, there are at least two reasons that financial connections to industry groups should continue to receive careful attention: a) Advocacy organizations typically have much fewer resources than industry to generate policy-relevant research that serves their interests (Elliott 2011); and b) a large body of evidence indicates that industry funding has important effects on research outcomes, whereas there is less information about how ideological ties affect research (e.g., Lundh et al. 2012). Schwartz’s fourth concern is that it is important to think about risk–benefit relationships when applying science to public policy. This is a very good point, but it needs to be considered in conjunction with the fact that scientists’ values and assumptions may influence their assessments of the evidence. It would be ideal if scientists could provide perfectly unbiased risk assessments to policy makers, who could then evaluate the risks versus the benefits in order to make policy decisions. Unfortunately, this picture is unrealistic; scientists’ views about the benefits associated with new technologies likely have implicit influences on their risk assessments. For example, evidence from the literature on risk perception indicates that people’s perceptions of risk are influenced by a number of factors, including the voluntariness of the risks, the fairness of their distribution, their familiarity, and the perceived benefits associated with them (Fischhoff et al. 1981). Scientists are subject to these same influences, especially when they have limited data or are forced to weigh multiple forms of evidence (Cooke 1991). This provides further support for our central claim, namely, that scientists should explore ways to acknowledge the values that may influence them rather than denying the presence of these influences.

Researcher Perspectives on Conflicts of Interest: A Qualitative Analysis of Views from Academia.

The increasing interconnectedness of academic research and external industry has left research vulnerable to conflicts of interest. These conflicts have the potential to undermine the integrity of scientific research as well as to threaten public trust in scientific findings. The present effort sought to identify themes in the perspectives of faculty researchers regarding conflicts of interest. Think-aloud interview responses were qualitatively analyzed in an effort to provide insights with regard to appropriate ways to address the threat of conflicts of interest in research. Themes in participant responses included disclosure of conflicts of interest, self-removal from situations where conflict exists, accommodation of conflict, denial of the existence of conflict, and recognition of complexity of situations involving conflicts of interest. Moral disengagement operations are suggested to explain the appearance of each identified theme. In addition, suggestions for best practices regarding addressing conflicts of interest given these themes in faculty perspectives are provided.

Financial Conflicts of Interest in Research

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Police use of TASER devices in mental health emergencies: A review

The proliferation of TASER devices among police forces internationally has been accompanied by concerns about injuries and health effects, and about the use of TASER devices on vulnerable populations such as people with mental illness. TASER devices have generated a flood of research studies, although there remain unanswered questions about some of the key issues. This paper outlines the introduction of TASER devices to policing and their subsequent widespread adoption. The paper considers the role of police in mental health emergencies with a particular focus on use of TASER devices. Some factors contribute to the special vulnerability of people with mental illness to the effects of TASER devices. The paper also reviews research into use of TASER devices and raises issues about conflict of interest in research into TASER devices. We conclude that TASER devices look set to play a significant role in policing in the future. We make suggestions for a future research programme, and suggest guidelines for publication of papers in which there may be a conflict of interest.

Conflict of Interest in Research—The Clinician Scientist’s Perspective

Conflict of interest (COI) in research represents situations that pose risks of undue influence on scientific objectivity and judgment because of secondary interests. This is complex but is inherent to biomedical research. The role of a clinician scientist can be conflicted when scientific objectivity is perceived to compete with scientific success (publications, grants), partiality to patients (clinical trials), obligations to colleagues (allowing poor scholarship to pass), research sponsors (industry), and financial gains (patents, royalties). While there are many ways which COIs can occur in research, COI mitigations remain reliable. Collaborations between investigators and industry are valuable to the development of novel therapies and undue discouragement of these relationships may inadvertently harm the advancement of healthcare. As a result, proper management of COI is fundamental and crucial to the maintenance of long-term, mutually beneficial relationships between industry and academia. The nature of COI in research and methods of mitigation are discussed from the perspective of a clinician scientist.

2473 – EPA guidance papers and their impact in reducing the burden of mental disorders

The European Psychiatric Association (EPA) established the project “EPA Guidance” in order to improve the quality of mental healthcare in Europe by disseminating written information based on best evidence and expert consensus. To provide information on good clinical practice to national societies, health authorities and clinicians. The development of guidance for selected mental healthcare topics in order to improve the practice of psychiatry in Europe. Systematic literature searches and consensus processes. In order to improve the quality of mental healthcare and thereby reducing the burden of mental disorders, a first series of guidance documents on the quality of services structures, prevention and treatment of suicidal crises, prevention of mental disorders in general (illness prevention and health promotion), pharmacotherapy of depression, and how to deal with conflicts of interest in research and other professional activities, was published. The series of EPA guidance formulates recommendations and proposes strategies that may help to reduce the burden of mental disorders. The burden of mental disease is sought to be reduced by evidence-based, effective mental health prevention and promotion strategies as well as by optimizing the structures and processes of mental health services by the development of recommendations in the EPA guidance on the quality of mental health services. Many important clinical situations or problems beyond treatment that until now lacked proper guidance are addressed by the EPA guidance.

Physician-industry conflict of interest: public opinion regarding industry-sponsored research

Object The nature of physician-industry conflict of interest (COI) has become a source of considerable concern, but is often not discussed in the research setting. With reduced funding available from government and nonprofit sources, industry support has enthusiastically grown, but along with this comes the potential for COI that must be regulated. In this era of shared decision making in health care, society must have input into this regulation. The purpose of this study was to assess the opinions of a North American population sample on COI regarding industry-funded research and to analyze population subgroups for trends. Methods A survey was developed for face and content validity, underwent focus group evaluation for clarity and bias reduction, and was administered via the World Wide Web. Demographic and general survey results were summarized as a percentage for each answer, and subgroup analysis was done using logistic regression. Generalizability of the sample to the US population was also assessed. Results Of 541 surveys, 40 were excluded due to missing information, leaving 501 surveys for analysis. The sample population was composed of more females, was older, and was more educated than a representative cross-section of the American population. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies the most to head this effort. Respondents trust government officials and company representatives the least with respect to regulation of COI. Most respondents feel that industry-sponsored research can involve physicians and be both objective and beneficial to patients. Conclusions Most respondents in this study felt that surgeons should be involved in industry-sponsored research and that more research, regardless of funding source, will ultimately benefit patients. The majority of respondents distrust government or industry to regulate COI. The development of evidence-based treatment recommendations requires the inclusion of patient preference. The authors encourage regulatory bodies to follow suit and include society's perspective on regulation of COI in research.

Managing Conflict of Interest in Research: Some Suggestions for Investigators

Conflict of interest situations threaten to compromise objectivity and tempt researchers to act wrongly. Allowing oneself to drift into such situations without appropriate preparation is negligence which is, itself, a sort of wrongdoing. Since conflict of interest is unlikely to be eliminated or tamed by the professional---and institutional---level safeguards currently under discussion, individual researchers must make their own preparations. We offer individuals ten strategies for managing their own conflicts of interest.

How Can the Evidence from Global Large-scale Clinical Trials for Cardiovascular Diseases be Improved?

BackgroundClinical investigations are important for obtaining evidence to improve medical treatment. Large-scale clinical trials with thousands of participants are particularly important for this purpose in cardiovascular diseases. Conducting large-scale clinical trials entails high research costs. This study sought to investigate global trends in large-scale clinical trials in cardiovascular diseases.FindingsWe searched for trials using clinicaltrials.gov (URL: http://www.clinicaltrials.gov/) using the key words 'cardio' and 'event' in all fields on 10 April, 2010. We then selected trials with 300 or more participants examining cardiovascular diseases. The search revealed 344 trials that met our criteria. Of 344 trials, 71% were randomized controlled trials, 15% involved more than 10,000 participants, and 59% were funded by industry. In RCTs whose results were disclosed, 55% of industry-funded trials and 25% of non-industry funded trials reported statistically significant superiority over control (p = 0.012, 2-sided Fisher's exact test).ConclusionsOur findings highlighted concerns regarding potential bias related to funding sources, and that researchers should be aware of the importance of trial information disclosures and conflicts of interest. We should keep considering management and training regarding information disclosures and conflicts of interest for researchers. This could lead to better clinical evidence and further improvements in the development of medical treatment worldwide.

Conflicts of interest in research on antipsychotic treatment of pediatric bipolar disorder, temper dysregulation disorder, and attenuated psychotic symptoms syndrome: Exploring the unholy alliance between big pharma and psychiatry

AbstractWe acknowledge those individuals who assisted us in our investigation by providing consultation and feedback on key issues of concern. Thank you in particular to Richard Bargdill, Victor Barbetti, Lisa Cosgrove, Daniel Burston, and Sharna Olfman.

Conflicts of Interest in Research—Towards a Greater Transparency

Recently, substantial undisclosed financial Conflicts of Interest (COI) by researchers at academic medical centers have been discovered and reported in US Senate investigations, prompting large research institutions to take a close look at policies and procedures associated with the reporting and with the management of researcher COI. This article defines COI, reviews the background, describes the problems that arise, and offers solutions.

Ethical perspectives on relations between industry and neuropsychiatric medicine

Conflicts of interest may influence medical research. In particular, the study on psychotropic treatment of ageing subjects suffering from neurological disorders and comorbid neuropsychiatric phenomena may be hypothetically considered economically non-advantageous, or even of negative impact on drug reputation, because of the high probability of non-response or side effects. Thus, studies on this issue may be disregarded from industry.We aimed to verify whether the global commitment of medical research reflects the actual relevance of depression in the world ageing population, associated or not with neurological conditions.Here, we: 1) have reviewed the literature on this issue, 2) have examined world published data concerning population by age, burden of disease and frequency of depressive disorders and antidepressant therapies, and 3) have reviewed the frequency of published papers on depression and its treatment associated with three neurological conditions.The overall rate of papers about depressive disorders in ageing people reflects adequately the world population and the prevalence of depression in the elderly. However, the rate of papers concerning medical experimentation for antidepressant treatment in Alzheimer's disease, Parkinson's disease and stroke is quite inadequate with respect to the rate of depressive disorders associated to these conditions.Thus, innovative medical experimentation must be encouraged, also in areas apparently of dubious economical advantage but of undoubted clinical relevance and the adoption of strategies to limit the detrimental effect of conflicts of interest in research must be enhanced.

Conflict of interest in research on anthropogenic noise and marine mammals: Does funding bias conclusions?

Abstract The U.S. Navy, whose sonars kill marine mammals, provides approximately 50% of the funds for marine mammal research worldwide. We examined six reviews of research on the effects of anthropogenic sound on marine mammals, as well as the primary papers cited in the reviews. These reviews cite references showing noise has no effect on marine mammals at an increasing frequency as their funding moves from a conservation organization to independent to partial U.S. military sources. Primary papers are 2.3 times more likely to be cited in the reviews as concluding no effect of noise if the research was militarily-funded than if not. Thus, conflict of interest may have led to a misrepresentation of the effects of noise on marine mammals in both the primary and secondary literature, and thus misinform public policy decisions.

IOM Calls for Stronger Protections Against Conflicts of Interest in Research, Education, and Practice.

IOM Calls for Stronger Protections Against Conflicts of Interest in Research, Education, and Practice.

IOM Calls for Stronger Protections Against Conflicts of Interest in Research, Education, and Practice

IOM Calls for Stronger Protections Against Conflicts of Interest in Research, Education, and Practice

Evaluating conflicts of interest in research presented in CME venues

There is much in the literature regarding the potential for commercial bias in clinical research and in continuing medical education (CME), but no studies were found regarding the potential for bias in reporting original research in CME venues. This pilot study investigated the presence of perceived bias in oral and print content of research findings presented in certified CME activities. Research presentations at two national primary care CME activities, where authors had self-reported potential conflicts of interest, were peer reviewed and monitored for perceived commercial bias. Blinded and unblinded peer reviewers' and monitors' analyses of bias were compared to assess whether knowledge of potential conflicts of interest affected perceptions of bias. Knowledge of potential conflicts of interest appeared to increase awareness of potential commercial bias with regard to use of a single product in care and assurance that there was reasonable evidence to support the practice recommendation. A perception of the presenter's strong opinion regarding care did not appear to be influenced by knowledge of a potential conflict of interest. While limited, by study design, this research detected subjectivity and variability in perceiving commercial bias within research findings presented in CME venues. Further study of these questions is required to guide the resolution of conflicts of interest in research and CME.

Ethics and Stem Cell Therapeutics for Cardiovascular Disease

As research on stem cell therapeutics for the treatment of cardiovascular diseases in adults is being planned and conducted it is essential to address the ethical issues associated with it. The considerable attention that is currently focused on the ethical issues associated with stem cell research as well as the acute clinical situations sometimes encountered when treating cardiovascular disease, underscore the need for explicit attention to the ethical aspects of this research. In this article, I survey some of the key ethical considerations regarding research involving stem cell therapeutics for cardiovascular diseases including: (1) the standard ethical considerations for translational and clinical research and mechanisms of ethical oversight of them; (2) additional oversight related to stem cell research; (3) considerations for obtaining informed consent for this research and in selecting individual human subjects to participate in it; (4) concerns related to justice that may manifest themselves with respect to which research endeavors move forward and (5) conflicts of interest in research and their potential relationship to research integrity.

Managing conflicts of interest: a survival guide for biotechs

Conflicts of interest in research can affect a company's ability to move a product through the approval processor attract investment. Avoid the pitfalls by taking pro-active steps to manage these risks.

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

Medical schools tackle conflict of interest

As ties between industry and the medical community become more complex, the issue of conflict of interest in research and clinical decision-making has spilled over into the realm of medical schools. ![Figure][1]</img> Figure. Many medical students now examine the potential pitfalls of industry