Scientific judgment and the limits of conflict-of-interest policies

This article argues that the three major elements of typical university conflict-of-interest (COI) policies (i.e., disclosure, management, and elimination of conflicts via divestiture or recusal) are likely to be insufficient for screening out many worrisome influences of financial COIs. Current psychological research challenges the effectiveness of disclosure, management plans are unlikely to address the wide range of ways that financial COIs can influence scientific judgment, and it is often impractical to eliminate conflicts. Identifying the limits of these policies highlights the importance of considering alternative strategies, such as encouraging more independently funded esearch, in order to maintain the integrity of science.     

The frequency of Mislabelled chemicals from commercial suppliers

This essay provides an analysis of conflicts of interest (COIs) that arise in university relationships with private industry and articulates the concept of an "institutional" COI. It compares personal and institutional COIs in order to shed some light on the difficulties universities face in managing their own COIs. The essay discusses some proposed strategies for responding to institutional COIs, such as developing independent boards to monitor and oversee the university's COIs, building firewalls between various parts of the university to prevent financial interests from affecting university functions, creating independent research institutes, and prohibiting some types of university investments.     

Conflict of interest and the university

This essay provides an analysis of conflicts of interest (COIs) that arise in university relationships with private industry and articulates the concept of an "institutional" COI. It compares personal and institutional COIs in order to shed some light on the difficulties universities face in managing their own COIs. The essay discusses some proposed strategies for responding to institutional COIs, such as developing independent boards to monitor and oversee the university's COIs, building firewalls between various parts of the university to prevent financial interests from affecting university functions, creating independent research institutes, and prohibiting some types of university investments.     

Supervisor–Student Relations: Examining the Spectrum of Conflicts of Interest in Bioscience Laboratories

Much attention has been given to financial conflicts of interest (COIs) in bioscience research. Yet to date, surprisingly little attention has focused on other COIs that arise in supervisor--student relations. We examine a spectrum of related situations, ranging from standard graduate supervision through to dual relationships sometimes found in research with commercial potential. We illustrate some of the less-obvious factors that can bias supervisory judgment, and situate financial COI along a spectrum of forces that are deserving of recognition. We conclude by providing two sets of recommendations: one for individual supervisors, and the other for institutions and policy-makers.     

Conflicts of interest in vaccine safety research

Conflicts of interest (COIs) cloud vaccine safety research. Sponsors of research have competing interests that may impede the objective study of vaccine side effects. Vaccine manufacturers, health officials, and medical journals may have financial and bureaucratic reasons for not wanting to acknowledge the risks of vaccines. Conversely, some advocacy groups may have legislative and financial reasons to sponsor research that finds risks in vaccines. Using the vaccine-autism debate as an illustration, this article details the conflicts of interest each of these groups faces, outlines the current state of vaccine safety research, and suggests remedies to address COIs. Minimizing COIs in vaccine safety research could reduce research bias and restore greater trust in the vaccine program.     

Disclosing Conflicts of Interest to Research Subjects: An Ethical and Legal Analysis

In this article, I examine the ethical and legal issues related to disclosure of conflicts of interest to research subjects, and discuss some empirical studies related to the topic. I argue that researchers have an ethical obligation to disclose conflicts of interest to research subjects, provided that they take steps to help subjects understand information about conflicts of interest and how to interpret it. Researchers also may have a legal duty to disclose conflicts of interests to subjects, depending on the facts of the case and the court's interpretation of the law. To reinforce and clarify the legal obligation to disclose conflicts of interest, the federal regulations should be amended to include disclosure of conflicts of interest as one of the informed consent requirements. Institutional review boards play a key role in helping researchers to disclose conflicts of interests to subjects in an appropriate manner. Institutional review boards should approve the disclosure language in informed consent documents, and they should require researchers to disclose financial interests to research subjects, if they have any, as a condition of approval.     

Disclosing conflicts of interest to research subjects: an ethical and legal analysis

In this article, I examine the ethical and legal issues related to disclosure of conflicts of interest to research subjects, and discuss some empirical studies related to the topic. I argue that researchers have an ethical obligation to disclose conflicts of interest to research subjects, provided that they take steps to help subjects understand information about conflicts of interest and how to interpret it. Researchers also may have a legal duty to disclose conflicts of interests to subjects, depending on the facts of the case and the court's interpretation of the law. To reinforce and clarify the legal obligation to disclose conflicts of interest, the federal regulations should be amended to include disclosure of conflicts of interest as one of the informed consent requirements. Institutional review boards play a key role in helping researchers to disclose conflicts of interest to subjects in an appropriate manner. Institutional review boards should approve the disclosure language in informed consent documents, and they should require researchers to disclose financial interests to research subjects, if they have any, as a condition of approval.     

Ten Steps to Developing a National Agenda to Address Financial Conflicts of Interest in Industry Sponsored Clinical Research

Financial liaisons between clinical researchers, research institutions, and industrial sponsors have gained momentum in recent years. In the process, it has been argued by many that trust in the research infrastructure is being eroded by the financial conflicts of interest that emerge from these arrangements. Yet, the financial resources of industry are needed to continue technology transfer from the bench to the bedside. Policy makers and government regulators are currently struggling to determine how to best manage financial conflicts of interest that emerge from these liaisons. Various organizations and governmental entities have proposed different strategies. This paper explores the limitations of existing measures and recommends that a unified national agenda is needed. We propose 10 steps to develop an agenda to address financial conflicts of interest in industry-sponsored clinical research.     

Ten steps to developing a national agenda to address financial conflicts of interest in industry sponsored clinical research

Financial liaisons between clinical researchers, research institutions, and industrial sponsors have gained momentum in recent years. In the process, it has been argued by many that trust in the research infrastructure is being eroded by the financial conflicts of interest that emerge from these arrangements. Yet, the financial resources of industry are needed to continue technology transfer from the bench to the bedside. Policy makers and government regulators are currently struggling to determine how to best manage financial conflicts of interest that emerge from these liaisons. Various organizations and government entities have proposed different strategies. This paper explores the limitations of existing measures and recommends that a unified national agenda is needed. We propose 10 steps to develop an agenda to address financial conflicts of interest in industry-sponsored clinical research.     

The therapeutic misconception,beneficence, and respect

In order to provide benefits to society, human medical trials must place subjects at risk of harm. This activity is thought to be justified in part by the consent of the subjects involved. But, studies have shown that most such consents are based on a therapeutic misconception (TM); the false belief of subjects that their researchers will act as their personal physicians (seeking their benefit and protecting them from harm), rather than placing them at risk of harm for the good of others. Toleration by researchers of the TM in their subjects is a form of “informational manipulation”; that renders consent procedures disrespectful to subject autonomy. Consent obtained from subjects who labor under a TM is neither voluntary nor informed; as long as they have not been disabused of the TM, the action they take in enrolling in a trial is not the one they intend nor is it autonomously chosen. Changes in consent procedures should be adopted to ensure that all subjects are aware inter alia that (a) the health interests of future patients (as well as the researchers’ and their sponsors’ financial interests) may be more important to researchers than the interest of a subject in his or her health, and (b) normal subjects neither understand nor believe this when told. Close attention to the response of prospective subjects to this information should allow for the exclusion of all but the truly altruistic. However, the result of conscientious implementation of such policies would likely be that human medical research could no longer be conducted on more than a minimal level.     

Sources of antagonism to ‘qualitative’ research

This paper considers why quantitative methods are believed to be more ‘scientific’, rigorous and ultimately valid than qualitative ones, and argues that the term ‘qualitative’ is applied variously to different aspects of research (style, design, epistemology) which are sufficiently independent of one another to make the quantity/quality distinction an artificial one. The author takes the position that its use arises not from methodological considerations but rather from other underlying relevances, purposes and interests, suggesting that criticisms of qualitative research ‘are ideological in the sense that they give support to existing institutions wherein some classes or groups try to exert control over others’, the group in this context being research sponsors. Typical criticisms of such research are analysed to expose the nature of the underlying ‘expressions of interest’.     

Prevalence of Industry Support and its Relationship to Research Integrity

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.     

Effect of monetary policy credibility on the fear of floating: Evidence from Brazil

Based on the argument that monetary policy credibility can reduce the fear of floating (FF), we analyze this hypothesis for Brazil. Since expectations play a key role under Inflation Targeting, we also analyze whether credibility can affect the expectations of financial markets about the FF of the Central Bank. The results show credibility can reduce the FF, and financial markets expect less intervention by the Central Bank when credibility is higher. Thus, policymakers must pay attention to the credibility of their policies, otherwise they may be misinterpreted regarding both the goals they pursue and how they conduct monetary policy.     

Preregistering qualitative research

The threat to reproducibility and awareness of current rates of research misbehavior sparked initiatives to better academic science. One initiative is preregistration of quantitative research. We investigate whether the preregistration format could also be used to boost the credibility of qualitative research. A crucial distinction underlying preregistration is that between prediction and postdiction. In qualitative research, data are used to decide which way interpretation should move forward, using data to generate hypotheses and new research questions. Qualitative research is thus a real-life example of postdiction research. Some may object to the idea of preregistering qualitative studies because qualitative research generally does not test hypotheses, and because qualitative research design is typically flexible and subjective. We rebut these objections, arguing that making hypotheses explicit is just one feature of preregistration, that flexibility can be tracked using preregistration, and that preregistration would provide a check on subjectivity. We then contextualize preregistrations alongside another initiative to enhance credibility in qualitative research: the confirmability audit. Besides, preregistering qualitative studies is practically useful to combating dissemination bias and could incentivize qualitative researchers to report constantly on their study's development. We conclude with suggested modifications to the Open Science Framework preregistration form to tailor it for qualitative studies.     

Misconduct versus Honest Error and Scientific Disagreement

Researchers sometimes mistakenly accuse their peers of misconduct. It is important to distinguish between misconduct and honest error or a difference of scientific opinion to prevent unnecessary and time-consuming misconduct proceedings, protect scientists from harm, and avoid deterring researchers from using novel methods or proposing controversial hypotheses. While it is obvious to many researchers that misconduct is different from a scientific disagreement or simply an inadvertent mistake in methods, analysis or misinterpretation of data, applying this distinction to real cases is sometimes not easy. Because the line between misconduct and honest error or a scientific dispute is often unclear, research organizations and institutions should distinguish between misconduct and honest error and scientific disagreement in their policies and practices. These distinctions should also be explained during educational sessions on the responsible conduct of research and in the mentoring process. When researchers wrongfully accuse their peers of misconduct, it is important to help them understand the distinction between misconduct and honest error and differences of scientific judgment or opinion, pinpoint the source of disagreement, and identify the relevant scientific norms. They can be encouraged to settle the dispute through collegial discussion and dialogue, rather than a misconduct allegation.     

Is failure to raise concerns about misconduct a breach of integrity? Researchers’ reflections on reporting misconduct

This article describes and discusses the views of researchers on the significance of raising concerns about scientific misconduct in their work environment and the reasons or circumstances that might deter them from doing so. In this exploratory qualitative research study, we conducted in-depth interviews with 33 researchers working in life sciences and medicine. They represent three seniority levels and five universities across Switzerland. A large majority of respondents in this research study argued that failure to raise concerns about scientific misconduct compromises research integrity. This is an encouraging result demonstrating that researchers try to adhere to high ethical standards. However, further interaction with respondents highlighted that this correct ethical assessment does not lead researchers to take the consequent action of raising concerns. The factors that discourage researchers from raising concerns need to be addressed at the level of research groups, institutions, and by setting a positive precedent which helps them to believe in the system’s ability to investigate concerns raised in a timely and professional manner. Training of researchers in research integrity related issues will have limited utility unless it is coupled with the creation of research culture where raising concerns is a standard practice of scientific and research activities.     

Malaysian researchers talk about the influence of culture on research misconduct in higher learning institutions

Based on a previous survey by the Office of Research Integrity (ORI) in the USA, a considerable number of foreign research scientists have been found guilty of research misconduct. However, it remains unclear as to whether or not cultural factors really contribute to research misconduct. This study is based on a series of interviews with Malaysian researchers from the local universities regarding their own professional experiences involving working with researchers or research students from different countries or of different nationalities. Most of the researchers interviewed agreed that cultures do shape individual character, which influences the way that such individuals conduct research, their decision-making, and their style of academic writing. Our findings also showed that working culture within the institution also influences research practices, as well as faculty mentorship of the younger generation of researchers. Given the fact such misconduct might be due to a lack of understanding of research or working cultures or practices within the institution, the impact on the scientific community and on society could be destructive. Therefore, it is suggested that the institution has an important role to play in orienting foreign researchers through training, mentoring, and discussion with regard to the “does” and “don’ts” related to research, and to provide them with an awareness of the importance of ethics when it comes to conducting research.     

Misconduct versus honest error and scientific disagreement

Researchers sometimes mistakenly accuse their peers of misconduct. It is important to distinguish between misconduct and honest error or a difference of scientific opinion to prevent unnecessary and time-consuming misconduct proceedings, protect scientists from harm, and avoid deterring researchers from using novel methods or proposing controversial hypotheses. While it is obvious to many researchers that misconduct is different from a scientific disagreement or simply an inadvertent mistake in methods, analysis or misinterpretation of data, applying this distinction to real cases is sometimes not easy. Because the line between misconduct and honest error or a scientific dispute is often unclear, research organizations and institutions should distinguish between misconduct and honest error and scientific disagreement in their policies and practices. These distinctions should also be explained during educational sessions on the responsible conduct of research and in the mentoring process. When researchers wrongfully accuse their peers of misconduct, it is important to help them understand the distinction between misconduct and honest error and differences of scientific judgment or opinion, pinpoint the source of disagreement, and identify the relevant scientific norms. They can be encouraged to settle the dispute through collegial discussion and dialogue, rather than a misconduct allegation.     

Balancing Scientific and Community Interests in Community-Based Participatory Research

Community-based participatory research is an approach to studying human populations that emphasizes extensive partnerships between researchers and community members. While there are many advantages of this approach, it also faces a number of conceptual and practical challenges, one of which is managing the conflict that sometimes arises between promoting scientific and community interests. This essay explores the potential conflict between scientific and community interests in several different stages of community-based participatory research, including research design, data interpretation, and publication, and makes some suggestions for practice and policy. To manage potential conflicts between scientific and community interests, investigators and community partners should enter into written agreements at the beginning of the study. In some cases, it may be necessary for a third party, such as a review committee from a supporting institution, the community, or a funding agency, to help investigators and community partners resolve disagreements. It may also be useful, in some situations, to publish a dissenting opinion when investigators and community partners cannot agree on how to interpret findings resulting from a study. These strategies may help address some of the challenges of implementing community-based participatory research.     

Comprehensive audits for use in evaluating scientific research

Calls for new arrangements to deal with problems involving the integrity of results reported from scientific research have generally taken the form of investigations into data quality and the research methods utilized. Alternatives to proposed government regulation of scientific research have included suggestions for using accounting type audits of the kind used for attesting to the representations of management in corporate financial reports. Here a different type of audit is suggested for the advantages it offers in dealing with the situations in science—which are much less structured and not restricted to situations like those to which financial accounting audits are directed. A broadening from “accounting”; to “accountability”; is thereby achieved. Experimentation with the use of such audits is suggested which can simultaneously help to improve scientific processes and accommodate the interests of the public in responding to the results of scientific research. A beginning is also suggested in the form of “GAO type”; (U.S. General Accounting Office) audits of research activities undertaken (or to be undertaken) at laboratories such as Los Alamos, Livermore and Sandia as they are being redirected from military to civilian type research. It is also suggested that GAO type audits be extended from audits of management activities to examination and evaluation of the validity and significance of the research that has been, or is to be, undertaken.