David B Resnik

David B Resnik
National Institutes of Health | NIH · National Institute of Environmental Health Sciences (NIEHS)

PhD, JD

About

415
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7,888
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Publications

Publications (415)
Article
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In the last 20 years, there has been a sharp increase in the incidence of retractions of articles published in scientific journals, the majority of which are due to research misconduct. In some cases, researchers have revised and republished articles that were retracted due to misconduct, which raises some novel questions concerning authorship. Sup...
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To obtain some exploratory, qualitative data on ethical issues and values in managing a research laboratory, we conducted three focus groups with experienced investigators and laboratory managers. After validating the focus group transcripts for accuracy, two coders used deductive and inductive coding to develop themes from the text. Participants r...
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This letter responds to the article “The Social Risks of Science,” by Jonathan Herington and Scott Tanona, published in the November‐December 2020 issue of the Hastings Center Report.
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Every day we are exposed to thousands of chemicals (and other substances) through contact with the food we eat, the medications we take, the consumer products we use, the air we breathe, the water we drink, and the dust we touch. Most of these chemicals are naturally occurring, but many are man-made.
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Decision theory is the study of how people make rational choices, where rationality is defined as taking effective means to one’s goals and conforming to the rules of logic and axioms of probability theory (Resnik in Choices: An Introduction to Decision Theory. University of Minnesota Press, Minneapolis, MN, 1987; Peterson Introduction to Decision...
Chapter
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Every day we make decisions involving risks, benefits, and precautions. We engage in what I call precautionary reasoning in a variety of decision-making contexts, including lifestyle choices (e.g. smoking tobacco, riding motorcycles, eating excessively), financial decisions (e.g. investing money, loaning money, purchasing goods), health care choice...
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In the previous chapter, we explored decision-theoretic approaches to precautionary reasoning and found them wanting. While decision theory offers important insights into making individual and group choices involving risks and benefits, it does not provide use with adequate guidance for precautionary reasoning, because it lacks moral content. Decis...
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In the first four chapters of this book, I have taken the reader on a tour of decision theory and moral theory and examined, critiqued, and defended the precautionary principle (PP). In the first chapter, I made seven key points that form the basis of my approach to precautionary reasoning. In this chapter, I will develop my approach in more detail...
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In this chapter I will apply the PP to ethical and policy issues related to genetic engineering of microbes, plants, animals, and human beings. I will argue that the PP can provide some useful insights into these issues, due to the scientific and morally uncertainty surrounding the consequences of genetic engineering for public health, the environm...
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As I write this chapter, the entire world is reeling from the COVID-19 pandemic, one of the worst disease outbreaks in modern history. COVID-19 is a respiratory infection caused by the novel coronavirus SARS-CoV-2 (see Fig. 9.1). The pandemic is thought to have started in December 2019 in the wet markets of Wuhan, China, when a virus that normally...
Chapter
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I began this book with some general reflections on how we think about risks, benefits, and precautions. I observed that as individuals we make decisions involving precautions in a variety of situations that we face each day, ranging from deciding whether to drive to work when snow is in the forecast, to taking a new job, to seeking medical treatmen...
Chapter
In the previous two chapters, I considered approaches to precautionary reasoning stemming from decision theory and moral theory.
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Scientific research benefits society in many ways. The knowledge generated by science has practical applications in medicine, public health, engineering, industry, transportation, navigation, communication, education, public policy, and numerous other aspects of human life. However, knowledge can also be used to cause harm to individuals, society,...
Book
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This book fills a gap in the literature on the Precautionary Principle by placing the principle within the wider context of precautionary reasoning and uses philosophical arguments and case studies to demonstrate when it does—and does not—apply. The book invites the reader to take a step back from the controversy surrounding the Precautionary Princ...
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A standard of evidence is a rule or norm pertaining to the type or amount of evidence that is required to prove or support a conclusion. Standards of evidence play an important role in institutional review board (IRB) decision-making, but they are not mentioned in the federal research regulations. In this article, I examine IRB standards of evidenc...
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Scientific authorship serves to identify and acknowledge individuals who “contribute significantly” to published research. However, specific authorship norms and practices often differ within and across disciplines, labs, and cultures. As a consequence, authorship disagreements are commonplace in team research. This study aims to better understand...
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Authorship is commonly used as the basis for the measurement of research productivity. It influences career progression and rewards, making it a valued commodity in a competitive scientific environment. To better understand authorship practices amongst collaborative teams, this study surveyed authors on collaborative journal articles published betw...
Chapter
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Studies have shown that various types of biases can impact scientific peer review. These biases may contribute to a type of groupthink that can make it difficult to obtain funding or publish innovative or controversial research. The desire to achieve consensus and uniformity within a research group or scientific discipline can make it difficult for...
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We conducted a cross-sectional survey of 1,540 researchers concerning their experiences with and attitudes towards the ethics of equal contribution (EC) designations in publications. Over half the respondents (58.3%) said they had been designated as an EC at least once. Although most respondents agreed that EC designations can be a useful way of pr...
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Financial relationships in academic research can create institutional conflicts of interest (COIs) because the financial interests of the institution or institutional officials may inappropriately influence decision-making. Strategies for dealing with institutional COIs include establishing institutional COI committees that involve the board of tru...
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There is an emerging consensus among scientists, ethicists, and public health officials that substantive and effective engagement with communities and the wider public is required prior to releasing genetically modified mosquitoes into the environment. While there is little disagreement about the need for community and public engagement prior to re...
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Open science practices such as publishing data and code are transforming water science by enabling synthesis and enhancing reproducibility. However, as research increasingly bridges the physical and social science domains (e.g., socio‐hydrology), there is the potential for well‐meaning researchers to unintentionally violate the privacy and security...
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Background: The open science movement is transforming scientific practice with the goal of enhancing the transparency, productivity, and reproducibility of research. Nevertheless, transparency is a complex concept, and efforts to promote some forms of transparency may do relatively little to advance other important forms of transparency. Objectiv...
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Researchers have used drones to track wildlife populations, monitor forest fires, map glaciers, and measure air pollution but have only begun to consider how to use these unmanned aerial vehicles to study human beings. The potential use of drones to study public gatherings or other human activities raises novel issues of privacy, confidentiality, a...
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Bioethicists and institutional review boards often worry that paying human subjects too much money for research participation might compromise informed consent by coercing or unduly influencing individuals to enroll in studies against their better judgment. However, empirical research does not support the hypothesis that payments adversely impact j...
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A central ethical and policy issue regarding minimizing and managing risks of engineered nanomaterials (ENMs) is whether existing legal frameworks sufficiently protect public health and the environment. This article argues that policymakers should (1) use existing laws to regulate ENMs and the best available evidence to inform appropriate levels of...
Article
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Citizen Science refers to the consultation, participation, engagement or involvement of the general public in research. Rationales for this interaction include increased public access and involvement of citizens in research, immersion of community values relevant to research, outreach, and educational potential with the public, and ultimately, the...
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An increasing number of human studies are asking participants to have substantial involvement in research. Citizens in human studies may contribute to various research activities, including study design, recruitment, data interpretation, and data and sample collection. Citizen involvement in research raises novel ethical issues for human studies, b...
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Data sharing is crucial to the advancement of science because it facilitates collaboration, transparency, reproducibility, criticism, and re-analysis. Publishers are well-positioned to promote sharing of research data by implementing data sharing policies. While there is an increasing trend toward requiring data sharing, not all journals mandate th...
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Unmanned aerial vehicles (UAVs), commonly called drones, have generated a great deal of controversy, partly because of their use for military and police purposes and because of concerns that they pose threats to privacy and safety. At the same time, environmental scientists are finding drones to be a powerful research tool. Because the use of drone...
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Most accounts of research ethics focus on the importance of a handful of ethical and epistemological norms for the conduct of science, such as honesty, integrity, transparency, accountability, objectivity, collegiality, fairness, social responsibility, but have little to say about another, less well-known norm that also deserves attention: stewards...
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U.S. federal policy defines research misconduct as fabrication of data, falsification of data, or plagiarism (FFP). In recent years, some have argued or suggested that the definition of research misconduct should also include sexual harassment, sabotage, deceptive use of statistics, and failure to disclose a significant conflict of interest (COI)....
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The idea that the degree of infringement public health interventions have on individual rights should be proportional to the degree of expected benefits has emerged as an influential principle in public health ethics and policy. While proportionality makes sense in theory, it may be difficult to implement in practice, due to the inherent conflict b...
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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 posit...
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Background: In biomedical research, there have been numerous scandals highlighting conflicts of interest (COIs) leading to significant bias in judgment and questionable practices. Academic institutions, journals, and funding agencies have developed and enforced policies to mitigate issues related to COI, especially surrounding financial interests....
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Phishing is a fraudulent form of email that solicits personal or financial information from the recipient, such as a password, username, or social security or bank account number. The scammer may use the illicitly obtained information to steal the victim’s money or identity or sell the information to another party. The direct costs of phishing on c...
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One of the most significant changes to the Common Rule is the requirement that institutions use a single institutional review board (IRB) for cooperative research in the U.S., unless more than one IRB is required by state, local or tribal law, or a signatory federal agency decides an exception is warranted. We surveyed human research protection pro...
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We performed a content analysis of reliance agreement templates from 73 of the top U.S. research institutions ranked by research funding. 67.1% of institutions in our sample use the Office of Human Research Protections (OHRP) template and 8.2% use the SMART IRB template. Although a significant percentage of institutions (45.2%) use their own custom...
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In this article, we explore the ethical issues related to the reporting of suspected abuse or neglect in research involving children. Ethical dilemmas related to reporting child maltreatment are often complex because the rights of children and their adult caregivers may conflict and determinations of abuse or neglect are socially constructed judgme...
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Various U.S. laws, such as the Clean Air Act and the Food Quality Protection Act, require additional protections for susceptible subpopulations who face greater environmental health risks. The main ethical rationale for providing these protections is to ensure that environmental health risks are distributed fairly. In this article, we (1) consider...
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The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and ex...
Chapter
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In the previous chapter, I examined the ethical issues informed consent in research and argued that thinking about the importance of trust can help us address this issues. In this chapter I will continue some of the themes developed in the previous chapter by reflecting on the relationship between trust and protection of privacy and confidentiality...
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In the previous chapter, I applied the trust-based approach to ethical issues related risks to research with human subjects. In this chapter, I will shift the focus from risks to benefits. As noted in the last chapter, the federal regulations require that risks be reasonable in relation to the benefits to the subjects or the importance of the knowl...
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To understand the ethics of research with human subjects it is important to have some familiarity with important events and trends that have entered the public’s consciousness. (See Table 2.1 for a summary of important events.) Examining this historical background will help to frame the issues and provide us with the social, political, economic, an...
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In the previous two chapters, I applied the trust-based approach to ethical issues related to protecting human rights (i.e. autonomy and privacy) in research. In this chapter, I will shift the focus away from protection of rights toward the protection of welfare by examining issues related to managing risks to human research subjects.
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All vulnerable groups and individuals should receive specifically considered protection. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the k...
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In Chaps. 5, 6, 7, 8, and 9 I have focused on specific issues related to research with human subjects, such as informed consent, confidentiality, risks, benefits, and vulnerability. In this chapter, I will shift gears and examine a topic that indirectly impacts human subjects but which is nevertheless very important: research integrity. Research in...
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The previous two chapters have provided some historical and philosophical background to set the stage for the discussions that will take place in this chapter. In Chap. 2, I examined the history of the ethics of research with human subjects and argued that existing regulations and guidelines were adopted to restore and maintain public trust and pre...
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In Chaps. 5, 6, 7, 8, 9, and 10 I examined various ethical and policy issues pertaining to research with human subjects through the lens of five principles—respect for autonomy and dignity, non-maleficence, beneficence, justice, and trust. Along the way, I also discussed how federal regulations, agency guidance, and professional codes apply to thos...
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In the previous chapter I argued that a review of the history of the ethics of research with human subjects indicates that the regulations and ethical guidelines have evolved in response to egregious abuses of human subjects and ethically questionable research. Society has adopted rules to prevent these problems from occurring again and to restore...
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In this book I have covered a broad array of issues pertaining to the ethics and regulation of research involving human subjects, ranging from theoretical and historical matters to practical and policy dilemmas. In the first chapter, I observed that moral predicaments involving research with human subjects often boil down to a conflict between prot...
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This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions,...
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This chapter examines the ethical considerations for developing and implementing strategies for protecting fetuses, neonates, children, and adolescents from exposures to harmful environmental agents. Scientific research plays a key role in developing strategies to protect these groups from harmful environmental exposures, but it also raises a numbe...
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On May 22, 2017, administrative law Judge Leslie Rogall of the Department of Health and Human Services’ Departmental Appeals Board, Civil Remedies Division, ruled in favor of the Office of Research Integrity (ORI) concerning its decision to charge former University of California at Riverside biochemistry professor Frank Sauer with research miscondu...
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In this commentary, we consider questions related to research integrity in data-intensive science and argue that there is no need to create a distinct category of misconduct that applies to deception related to processing, analyzing, or interpreting data. The best way to promote integrity in data-intensive science is to maintain a firm commitment t...
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Effective community engagement is an important legal, ethical, and practical prerequisite for conducting field trials of genetically modified mosquitoes, because these studies can substantially impact communities and it is usually not possible to obtain informed consent from each community member. Researchers who are planning to conduct field trial...
Article
A large volume of trials involve invasive, nontherapeutic research procedures, like organ biopsy or sham surgeries, that can pose risks comparable with the experimental treatment itself but that have no direct benefit for volunteers. Though such procedures can enhance the value of clinical investigations, recent studies suggest that many studies in...
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Objective: The aim of this study was to analyze conflict of interest (COI) and funding disclosure policies of 224 journals listed in Journal Citation Reports as focusing on environmental, occupational, or public health research. Methods: A survey of journal policies and content analysis. Results: About 96.0% of the policies required COI disclo...
Article
On March 28, 2017, the National Academy of Sciences, Engineering, and Medicine (NASEM) released a much-anticipated report on the Environmental Protection Agency’s controlled human inhalation exposure studies. This essay reviews the ethical controversies that led to the genesis of the report, summarizes its key findings, and comments on its approach...
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Dual-use research is research that can be readily employed for beneficial or harmful purposes. Using recent examples from biomedical science, this chapter argues that scientists who are assessing the risks and benefits of dual-use research face issues of practical inductive risk because they must consider the ethical and social implications of mist...
Conference Paper
Table of contents I1 Proceedings of the 4th World Conference on Research Integrity Concurrent Sessions: 1. Countries' systems and policies to foster research integrity CS01.1 Second time around: Implementing and embedding a review of responsible conduct of research policy and practice in an Australian research-intensive university Susan Patricia O'...
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One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decision...
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Two articles published in Bioethics recently have explored the ways that bioethics can contribute to the climate change debate. Cheryl Cox Macpherson argues that bioethicists can play an important role in the climate change debate by helping the public to better understand the values at stake and the trade-offs that must be made in individual and s...
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The patent system appears to make three ontological assumptions often associated with scientific realism: there is a natural world that is independent of human knowledge and technology; invented products can be unobservable things; and invented products have causal powers. Although a straightforward reading of patent laws implies these ontological...
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This chapter describes the causes and consequences of climate change and discusses some of the ethical and policy issues pertaining to climate change mitigation and adaptation. Bioethics scholarship helps individuals and government leaders think about how their decisions impact public health, the economy, social justice, the environment, and the we...
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Human genome and exome sequencing are powerful research tools that can generate secondary findings beyond the scope of the research. Most secondary genomic findings are of low importance, but some (for a current estimate of 1%-3% of individuals) confer high risk of a serious disease that could be mitigated by timely medical intervention. The impact...
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Scientific (or research) misconduct has become a global concern. This entry reviews famous cases of misconduct or alleged misconduct; definitions of misconduct; policies for reporting, investigating, and adjudicating misconduct; incidence and causes of misconduct; and strategies for preventing misconduct.
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We analysed the authorship policies of a random sample of 600 journals from the Journal Citation Reports database. 62.5% of the journals we sampled had an authorship policy. Having an authorship policy was positively associated with impact factor. Journals from the biomedical sciences and social sciences/humanities were more likely to have an autho...
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Very few people who read Carl Schneider's The Censor's Hand: The Misregulation of Human-Subject Research (MIT Press, 2015) will have a neutral opinion of his book. Schneider defends the radical thesis that the system of regulating human subjects research is not just broken but deeply misguided and therefore needs to be abolished. While some researc...
Article
Purpose: Institutional conflicts of interest (ICOIs) occur when the institution or leaders with authority to act on behalf of the institution have conflicts of interest (COIs) that may threaten the objectivity, integrity, or trustworthiness of research because they could impact institutional decision making. The purpose of this study was to gather...
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Most commentators agree that it is important to conduct empirical research on the effectiveness of institutional review board (IRB) review and oversight but the studies that have been published so far do not directly address this question because they do not attempt to measure the impact of the IRB on the welfare or rights of human subjects. Additi...
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Study participants who fabricate, falsify, or fail to disclose important information can undermine the integrity of clinical trials, with negative consequences for both future patients and the participants themselves. What can investigators do to address the problem?
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Health research in the context of an environmental disaster with implications for public health raises challenging ethical issues. This article explores ethical issues that arose in the Gulf Long-term Follow-up Study (GuLF STUDY) and provides guidance for future research. Ethical issues encountered by GuLF STUDY investigators included a) minimizing...
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In September 2012, Gilles-Eric Séralini and seven coauthors published an article in Food and Chemical Toxicology claiming that rats fed Roundup©-resistant genetically modified maize alone, genetically modified maize with Roundup©, or Roundup© for 2 years had a higher percentage of tumors and kidney and liver damage than normal controls. Shortly aft...
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Social responsibility is an essential part of the responsible conduct of research that presents difficult ethical questions for scientists. Recognizing one's social responsibilities as a scientist is an important first step toward exercising social responsibility, but it is only the beginning, since scientists may confront difficult value questions...
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This study gathered information about the retraction policies of the top 200 scientific journals, ranked by impact factor. Editors of the top 200 science journals for the year 2012 were contacted by email. One hundred forty-seven journals (74%) responded to a request for information. Of these, 95 (65%) had a retraction policy. Of journals with a re...
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The collaboration between laypeople and professional scientists known as “citizen science” is an important trend in research and data gathering. Citizen science offers important benefits to science and society. For example, citizens can help scientists with data collection and provide advice on research design and implementation. Citizens can also...
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Offering research subjects financial incentives for their participation is a common practice that boosts recruitment but also raises ethical concerns, such as undue inducement, exploitation, and biased enrollment. This article reviews the arguments for providing participants with financial incentives, ethical concerns about payment, and approaches...
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Research misconduct is an international concern. Misconduct policies can play a crucial role in preventing and policing research misconduct, and many institutions have developed their own policies. While institutional policies play a key role in preventing and policing misconduct, national policies are also important to ensure consistent promulgati...
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Alan Wertheimer argues that those who promulgate principles of research ethics have a responsibility to take into account the diversion effects of those principles. In this commentary, I argue that Wertheimer's proposal that diversion effects should be considered when promulgating principles of research ethics makes sense, but it often may be best...
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A growing body of literature has identified potential problems that can compromise the quality, fairness, and integrity of journal peer review, including inadequate review, inconsistent reviewer reports, reviewer biases, and ethical transgressions by reviewers. We examine the evidence concerning these problems and discuss proposed reforms, includin...
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In 2000, the U.S. federal government adopted a uniform definition of research misconduct as fabrication, falsification, or plagiarism (FFP), which became effective in 2001. Institutions must apply this definition of misconduct to federally-funded research to receive funding. While institutions are free to adopt definitions of misconduct that go bey...

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Project
To explore research integrity and misconduct issues in data-driven science.