Integrity Of Scientific Research Research Articles

Candor and Integrity in Science

In the pursuit of researches and in the reporting of their results, the individual scientist as well as the community of fellow professionals rely implicitly on the researcher embracing the habit of truthfulness, a main pillar of the ethos of science. Failure to adhere to the twin imperatives of candor and integrity will be adjudged intolerable and, by virtue of science’s self-policing mechanisms, rendered the exception to the rule. Yet both as philosophical concepts and in practice, candor and integrity are complex, difficult to define clearly, and difficult to convey easily to those entering on scientific careers. Therefore it is useful to present operational examples of two major scientists who exemplified devotion to candor and integrity in scientific research.

The Scientific Integrity of Applied Research

This paper reviews some of the threats to scientific independence in the Netherlands that have recently alerted the scientific community. The problems are not only apparent in research requested by the government or local authorities; they are also found in a variety of research fields. They are essentially related to the increasing dearth of research funding in the universities. In Europe in general, and the Netherlands in particular, there are no large, independent research foundations which exist elsewhere, so research funding generally depends on funding by government, local authorities or industry. The problem has long been underappreciated and no effective action has been taken. However, more recently and as a consequence of media reports, a number of drastic measures are being taken. This paper deals first with the nature of the threats to the integrity of scientific research, and then reviews the type of actions that have been, and could be taken.

On the Origin of Great Ideas: Science in the Age of Big Pharma

On the Origin of Great Ideas:Science in the Age of Big Pharma Leemon McHenry (bio) The vision most people used to have of medical research is that professors gain funding from universities or government agencies, go to the lab for careful observation and experiment, and after some years publish their hard-won results in scholarly, peer-reviewed medical journals. This is probably a simplified story that never played out quite as envisioned. As a result of commercial interests in the outcome of medical research, we are now even further from it. Pharmaceutical companies' marketing departments have developed a novel strategy. The old vision allowed costly failures when reality did not cooperate with the company's plans for its new molecular entities. With the rising price of bringing a new drug to the market, a method that guaranteed success was needed. Instead of fitting the conclusion to the evidence, the industry's strategy now is to "defend the molecules": Select the data that promote the drugs, file away the results that are unfavorable, and then buy just the right academic credentials to sign on to ghostwritten articles produced by the marketing department staff or by public relations agencies employed by the company. Publish these articles in the most respected [End Page 17] medical journals. Complete the circle of evidence by citing the published ghostwritten journal articles in "Dear Doctor" letters and other promotional materials, as if they were independent verification of the effectiveness and safety of the drugs. To some extent, academic medicine has long involved ghostwriting. Scientific writers have often written up the results of studies. But while this practice deprives the authors of the credit they rightly deserve, it does not threaten to undermine the scientific integrity of medical research. What is relatively new on the scene is industry-sponsored ghostwriting. Drug promotional materials masquerade as legitimate scientific research, and competition between the pharmaceutical companies for the market share is fought out using "key opinion leaders" who are paid to sign on to the ghostwritten articles. What follows is an account of one such case. The documents that build the case were filed into the public record by GlaxoSmithKline's lawyers on June 23, 2004 (docket numbers 290 and 291) in the In re Paxil Products Liability Litigation MDL 1574. They were then used in an ABC Primetime program on antidepressants that aired on December 9, 2004.1 The author is a research consultant for Baum-Hedlund, the Los Angeles-based law firm that filed the suit on behalf of individuals suffering from withdrawal symptoms upon discontinuing Paxil, which is one of the antidepressants known as selective serotonin reuptake inhibitors (SSRIs). As it turns out, the differences in efficacy among the SSRIs are minimal, so their side effects profiles can make all the difference in how doctors prescribe them. In the mid-1990s, Eli Lilly, which manufactures Prozac (another of the SSRIs), began attacking Paxil, manufactured by GlaxoSmithKline—at that time, SmithKline Beecham—on just these grounds. In 1996-97, Lilly sponsored conferences and journal supplements focusing attention on the side effects caused by Paxil.2 Paxil has a short "half-life"—the time after taking a drug at which half of the dose remains in the body—and therefore a short wash-out period when compared to Prozac. Paxil's half-life is twenty-one to twenty-four hours; Prozac's four to sixteen days. Because of the short half-life, a patient who abruptly ceases therapy with Paxil tends to have more severe withdrawal symptoms. Lilly's strategy was to play up the problems associated with Paxil's short half-life. One key paper sponsored by Lilly was Jerrold F. Rosenbaum and John Zajecka's "Clinical Management of Antidepressant Discontinuation," presented at a closed symposium titled "SSRI Discontinuation Events" and later published in a supplement of the Journal of Clinical Psychiatry. 3 In this short paper, Rosenbaum and Zajecka stressed the importance of gradually tapering all SSRIs except fluoxetine (Prozac). They also suggested substituting fluoxetine in cases where symptoms of "discontinuation"—as they now called withdrawal—persevere even when the SSRI is tapered slowly.4 Both citations for this claim refer to cases of paroxetine withdrawal...

Life Sciences for the 21st Century. Ehud Keinan, Israel Schechter, and Michael Sela, eds. Weinheim, Germany: Wiley-VCH, 2003, 355 pp., $45.00, hardcover. ISBN 3-527-30588-2.

A companion volume to Chemistry for the 21st Century , this book opens with a discussion of how the branches of science arose as schisms within European universities. Today, however, academic institutions promote the integration of scientific disciplines and related research. In this volume, the authors seek to present a sampling of scientific domains within biology, with the aim of exposing readers to new ideas and topics “well beyond their own scientific disciplines”. The 16 chapters range from detailed descriptions of biochemical mechanisms to philosophical discussions of the application of scientific methods to agriculture and ecology. Chapter 1, for example, covers the functioning of ribosomes to make proteins. As a student of the mechanism of translation, I was amazed at how much has been learned in the past decade. The whole ribosome has been crystallized to show its tertiary structure with 2.4-A resolution. The smaller subunit, 30S in prokaryotes, has been found to be more flexible but less stable than the larger, 50S, …

Integrating Values in Risk Analysis of Biomedical Research: The Case for Regulatory and Law Reform

This paper offers a critical appraisal of the regulatory approach towards risk assessments of new biomedical technologies, with a particular emphasis on gene transfer and stem cell research. While the therapeutic and commercial potential of this research is well publicized, the normative and methodological problems pertaining to the assessment of its potential risks to research participants have received less attention. We build on previous analyses of risk assessment as a value-laden, political exercise in regulatory science. Parties to a risk debate can bring different value-frameworks to the process of biomedical research review. We see the potential for a conflict of interest if risk assessments are formulated exclusively by the parties who propose the research, which is currently often the case. They might be more prone to taking risks for the sake of possible benefits and much less risk cautious than the research participants who assume the risks. We argue for a review process which aims to balance the interests of those proposing risk by providing a mandate for the critical interests of those who might assume it. In the paper, we classify two general types of risk that have been highlighted by gene transfer and stem cell research: risks to persons and risks to social values. We then consider three risks which we believe the law should address. These are risks of physical or psychological harm to participants, risks to the objectivity and scientific integrity of research that are posed by conflicts of interest; and briefly, risks to other social values, e.g., public trust in the ethical conduct of research. These are very different areas of risk, but we argue that there is merit in addressing them jointly. In areas where there are problems with the understanding and transmission of risk information to subjects, there is greater concern about impact of conflicts of interest and more reason to develop a fully independent review of risks. We sketch some principles and guidelines for institutional reforms that could inspire the further development of a regulatory or legislative model for the oversight of research with human participants.

Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct

Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct

American Society of Clinical Oncology policy statement: oversight of clinical research.

American Society of Clinical Oncology policy statement: oversight of clinical research.

Scientific societies and research integrity: what are they doing and how well are they doing it?

Scientific societies can play an important role in promoting ethical research practices among their members, and over the past two decades several studies have addressed how societies perform this role. This survey continues this research by examining current efforts by scientific societies to promote research integrity among their members. The data indicate that although many of the societies are working to promote research integrity through ethics codes and activities, they lack rigorous assessment methods to determine the effectiveness of their efforts.

Challenges in studying the effects of scientific societies on research integrity.

Beyond impressionistic observations, little is known about the role and influence of scientific societies on research conduct. Acknowledging that the influence of scientific societies is not easily disentangled from other factors that shape norms and practices, this article addresses how best to study the promotion of research integrity generally as well as the role and impact of scientific societies as part of that process. In setting forth the parameters of a research agenda, the article addresses four issues: (1) how to conceptualize research on scientific societies and research integrity; (2) challenges and complexities in undertaking basic research; (3) strategies for undertaking basic research that is attentive to individual, situational, organizational, and environmental levels of analysis; and (4) the need for evaluation research as integral to programmatic change and to assessment of the impact of activities by scientific societies.

Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct

Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct

Planning, Design, and Management of Hazardous Waste Disposal by Environmental Systems Engineering Approach

In the past century, the natural environment has provided for our development needs in support of rapid industrialization and urbanization. As the world’s population grows over time, human beings have progressively made greater demands on the environment through an increase in technology capacity, energy demand, international trade, and social complexity. To explore the ultimate limitation of nature, an analysis of the environment in terms of the physical, chemical, and biological processes, and the relationship of these processes as well as the interactions between them and human society is essential. While certain facets of the various processes may be overlooked in the analysis, the seamless integration of them after respective analysis can be even more complicated and difficult to model. The fragmented analytical effort by accounting for individual components separately is no longer acceptable in decision analysis. Recent challenges in decision making require development of a radically different approach for assessing management options by using various tools and methodologies that can be broadly applied for conducting integrated assessments in conjunction with the embedded complexities of interest. Such integration of scientific research into policy formulation requires covering not only pertinent quantitative costbenefit data but also relevant risk information and social response. While state-of-the-science models characterizing the transport of contaminants in different environmental compartments are indeed necessary to rigorously understand the long-term dynamics of pollutant behavior, they may be of limited value in immediate policy planning and regulatory studies. Hazardous, toxic, and radioactive waste management frequently involves tremendous managerial efforts in dealing with social, economic, environmental, and ecological impacts when making disposal options safe, cost-effective, risk-informed, and consensus-oriented. Irrespective of the adopted methodologies, policy formulation with respect to planning, design, and management of waste disposal requires several critical decisions that eventually direct the path, progress, and success of such endeavors. However, a number of important conceptual ideas in the area of systems science and systems engineering have emerged when we consider the interactions between living systems and the nonliving environment in making critical decisions with respect to waste disposal. The system-based approach enables us to investigate the complex interactions fundamental to the coevolution of engineered and natural systems. Recent advances in environmental systems engineering lean toward making effective the search for the sustainable development strategy, via integrative efforts, that could intimately link domain knowledge with the envisioned system-based approach as the availability and scarcity of environmental resources become critical. Nevertheless, capturing the social, economic, ecological, and environmental objectives into a

Politicizing Science: The Case of the Bush Administration's Influence on the Lead Advisory Panel at the Centers for Disease Control

Since the 1970s, the CDC has depended upon independent scientists and policy consultants, who are experts in the field to gather information and provide advice to the CDC regarding policy initiatives for a variety of toxic materials. One of the most important safeguards of the scientific integrity of governmental policy and research has been the 258 scientific advisory committees to the various branches of the CDC that presently help policymakers decide on the appropriate means of addressing serious scientific issues. These advisory committees, while not possessing the actual power to reshape policy, are important in their role as the font of expert opinion available to various CDC chiefs. During the past two years, the Bush administration has sought to short-circuit the traditional manner in which appointments to the committees have been made and to substitute a process that by and large has reflected its own well-known anti-regulatory and anti-environmental agenda. In this paper we will look at this process, focusing on one important committee that has been responsible for protecting the nation's children from the devastating effects of lead on their neurological well-being.

Wellcome moves against scientific misconduct

By recently proposing its draft Guidelines on Good Practice in Biomedical Research, the Wellcome Trust took a clear stand for integrity in British scientific research. As from October 2002, to qualify for Wellcome grants, institutions are expected to have in place their own published standards of good research practice and formal written procedures for the investigation of scientific misconduct allegations. Although produced for Trust-funded researchers, the guidelines could well be of general application to other biomedical researchers. After years of watching US-borne scientific Watergate affairs from the sideline, the Trust's initiative has finally spurred a wider debate over scientific frauds, and the measures needed to circumvent the problem, in the UK. Robert Terry, senior policy analyst at the Trust, told The Guardian, ‘The main intention of these guidelines is to encourage best practice but, on rare occasion, where a serious scientific misconduct has been proved, we would be prepared to take action’ (The Guardian, August 24, 2001). The guidelines have generally been received as a step in the right direction for British science, although some in the USA fear the draft might cause controversy by broadening the definition of misconduct beyond the US government's standard [Science (2001) 293, 1411]. AR

Ethical guidelines for medical research on workers.

Federal regulations protecting research subjects make special provisions for individuals who are subject to coercion or undue influence. Because they are subject to coercion and undue influence, workers should be considered vulnerable subjects of research. A series of ethical guidelines are proposed for medical research on workers that seek to safeguard the rights of workers and maintain the scientific integrity of research. In general, the guidelines emphasize that participation must be voluntary and knowing, that the confidentiality of medical information must be protected, and that the benefits of the research to the participants must be maximized while the risks are minimized.

A national survey of policies on disclosure of conflicts of interest in biomedical research.

Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent)--5 medical schools and 10 other research institutions--reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity.

Scientific misconduct and research integrity for the bench scientist.

This paper describes the role of the Office of Research Integrity (ORI), a component of the Public Health Service (PHS), in defining scientific misconduct in research supported with PHS funds and in establishing standards for responding to allegations of misconduct. The principal methods by which ORI exercises its responsibilities in this area are defining what types of behaviors undertaken by research investigators constitute misconduct, overseeing institutional efforts to investigate and report misconduct, and recommending to the Assistant Secretary for Health (ASH) PHS administrative actions when misconduct is identified. ORI also takes affirmative steps to promote research integrity through education, training, and other initiatives. The role of the research institution in responding to misconduct and promoting research integrity is complementary and overlapping with ORI's efforts but, as the employer of research investigators and front-line manager of the research, the institution has a greater opportunity to promote the highest standards of integrity in the day-to-day conduct of research. Finally, legal precedent established through civil litigation has played an important role in defining the standards that apply in determining when a breach of research integrity has occurred.

Maintaining client safety and scientific integrity in research with battered women.

To increase awareness of considerations of privacy and safety as well as the potential for scientific misconduct in research with battered women and other groups especially vulnerable to these concerns. Research with such vulnerable populations demands consideration of privacy and safety of participants in order to limit any potentially negative consequences while also ensuring scientific integrity. Maintaining scientific integrity and protecting vulnerable groups are important but potentially contradictory. Battered women are the examples to illustrate instances of conflict in which protecting participants may undermine scientific integrity. Literature on scientific integrity and misconduct, battered women, and vulnerable populations, and socially sensitive topics from nursing, other biomedical and social sciences, and the U.S. Public Health Service, 1978-1998. Integrative literature review. Conducting research with battered women in an ethically responsible manner that maintains scientific integrity without compromising advocacy or safety is possible when scientists are aware of potential conflicts and methods to ensure integrity. Nurses frequently do research with vulnerable groups such as battered women. Being proactive can help promote scientific integrity, avoid scientific misconduct, and decrease negative outcomes.

Scientific misconduct and research integrity: federal definitions and approaches.

Scientific misconduct and research integrity: federal definitions and approaches.

Generating, sharing and using science to improve and integrate policy

This paper discusses some of the new challenges that the quest for sustainable development poses to scientific research and the interface between science and policy. One of the issues fundamental to both science and policy is that of integration. Integration of scientific research requires a systemic approach, an interdisciplinary research style, and the consideration not only of the relevant quantitative data but also the relevant qualitative information. Appropriate mechanisms for making science available to policy-makers must include team-based approaches; some successful models are identified. A number of factors that impinge on the likelihood of success of interdisciplinary research are identified. However, it is recognised that it will also be necessary to move beyond that towards true inter-paradigmatic dialogues. The fact that the high complexity of natural and societal systems implies a degree of irreducible uncertainty should not lead to policy paralysis. The precautionary principle gives prudent guidance, but it is not always possible to follow it. On the other hand, scientific uncertainty should not be interpreted as total ignorance and a licence for "anything goes" in the policy realm. Adaptive (active and passive) approaches are necessary for the management of complex systems. Adaptive approaches contrast with command-and-control approaches. In many cases, scientific research does not produce the kind of understanding usable by policy-makers. One way of dealing wth this is to involve policy-makers in the scientific enterprise. Innovative experiments on how to generate a dialogue between science and policy are needed. The paper ends with a simple checklist of things to do or take into account by groups dealing with science in support of policy.

Social epistemology and the ethics of research.

Throughout much of the 20th century, philosophers of science maintained a position known as the value-free ideal, which holds that non-epistemic (e.g., moral, social, political, or economic) values should not influence the evaluation and acceptance of scientific results. In the last few decades, many philosophers of science have rejected this position by arguing that non-epistemic values can and should play an important role in scientific judgment and decision-making in a variety of contexts, including the evaluation and acceptance of scientific results. Rejecting the value-free ideal creates some new and vexing problems, however. One of these is that relinquishing this philosophical doctrine may undermine the integrity of scientific research if practicing scientists decide to allow non-epistemic values to impact their judgment and decision-making. A number of prominent philosophers of science have sought to show how one can reject the value-free ideal without compromising the integrity of scientific research. In this paper, we examine and critique their views and offer our own proposal for protecting and promoting scientific integrity. We argue that the literature on research ethics and its focus on adherence to norms, rules, policies, and procedures that together promote the aims of science can provide a promising foundation for building an account of scientific integrity. These norms, rules, policies, and procedures provide a level of specificity that is lacking in most philosophical discussions of science and values, and they suggest an important set of tasks for those working in science and values—namely, assessing, justifying, and prioritizing them. Thus, we argue that bringing together the literature on research ethics with the literature on science and values will enrich both areas and generate a more sophisticated and detailed account of scientific integrity.