We examined institutional review board policies from the top U.S. research universities to determine how many have policies that define or provide examples of what constitutes a “minor change” to previously approved research. We sought to describe differences among definitions and to ascertain whether funding level, accreditation, public versus private status, and geographic region impact the inclusion of a definition or example of this term. Of the 184 universities that we obtained policies from, 52.2% defined “minor change,” 43.5% gave examples (...) of what would constitute one, and 67.9% provided either a definition or examples. We found that higher funding and accreditation were positively associated with having a definition or giving examples of minor changes, but that public versus private status and geographic region had no significant impact. While our study indicates that most of the top U.S. research institutions define the term “minor change” to previously approved research, we found that the definitions vary considerably. Additional guidance from federal agencies could help promote consistency in institutional policies and ensure uniformity in protections for human research participants. (shrink)

We examined all 208 closed cases involving official findings of research misconduct published by the US Office of Research Integrity from 1992 to 2011 to determine how often scientists mention in a retraction or correction notice that there was an ethical problem with an associated article. 75 of these cases cited at least one published article affected by misconduct for a total of 174 articles. For 127 of these 174, we found both the article and a retraction or correction statement. (...) Since eight of the 127 published statements consisted of simply the word ‘retracted,’ our analysis focused on the remaining 119 for which a more detailed retraction or correction was published. Of these 119 statements, only 41.2% mentioned ethics at all (and only 32.8% named a specific ethical problem such as fabrication, falsification or plagiarism), whereas the other 58.8% described the reason for retraction or correction as error, loss of data or replication failure when misconduct was actually at issue. Among the published statements in response to an official finding of misconduct (within the time frame studied), the proportion that mentioned ethics was significantly higher in recent years than in earlier years, as was the proportion that named a specific problem. To promote research integrity, scientific journals should consider adopting policies concerning retractions and corrections similar to the guidelines developed by the Committee on Publication Ethics. Funding agencies and institutions should take steps to ensure that articles affected by misconduct are retracted or corrected. (shrink)

Ethics in scientific research has never been more important. Recent controversies over the integrity of data in federally funded science, the manipulation and distortion of privately sponsored research, cloning, stem cell research, and the patenting of DNA and cell lines, illustrate the need for a more thorough education in ethics for researchers at all levels. Now in its second edition, Responsible Conduct of Research provides an introduction to many of the social, ethical, and legal issues facing scientists today. The fully (...) updated volume includes three brand new chapters and additional cases for discussion, as well as analysis of the latest issues and problems in research ethics. Featuring chapters that treat such topics as ethical decision-making, research misconduct, and intellectual property, this new edition will be an indispensable resource for students and teachers, academics and industry professionals alike. (shrink)

: In the last two decades, scientists, government officials, and science policy experts have expressed concerns about the increasing role of financial interests in research. Many believe that these interests are undermining research by causing bias and error, suppression of results, and even outright fraud. This paper seeks to shed some light on this view by (1) explicating the concept research bias, (2) describing some ways that financial interests can cause research biases, and (3) discussing some strategies for mitigating or (...) managing the influence of financial interests. These strategies include (a) using government funds to counter-balance privately funded research, (b) increasing public input into government funding decisions, (c) disclosing and managing conflicts of interest in research, (d) auditing data, (e) expanding access to data. Since it is neither possible nor desirable to eliminate financial interests from research, the wisest policy is to manage and counter-balance these interests for the good of science and society. (shrink)

Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...) healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors. *Disclaimer: The ideas and opinions expressed in this article are the authors' personal views and do not represent the views of the National Institute of Environmental Health Sciences, the National Institutes of Health, or the United States government. (shrink)

This essay analyzes the concept of public trust in science and offers some guidance for ethicists, scientists, and policymakers who use this idea defend ethical rules or policies pertaining to the conduct of research. While the notion that public trusts science makes sense in the abstract, it may not be sufficiently focused to support the various rules and policies that authors have tried to derive from it, because the public is not a uniform body with a common set of interests. (...) Well-focused arguments that use public trust to support rules or policies for the conduct of research should specify (a) which public is being referred to (e.g. the general public or a specific public, such as a particular community or group); (b) what this public expects from scientists; (c) how the rule or policy will ensure that these expectations are met; and (d) why is it important to meet these expectations. (shrink)

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. Suppose that an article is retracted because one of the authors fabricated or falsified some data, but the researchers decide to salvage the useable data, make appropriate revisions, (...) and resubmit the article for publication. If the person who committed misconduct has made a significant contribution to the research reported in the revised paper, should they be named as an author to recognize this contribution or should they be denied authorship because they committed misconduct? This is a challenging issue because it involves the confluence of two research ethics domains that are usually dealt with separately, i.e., resolution of authorship disputes and adjudication of misconduct findings, as well as potential conflicts among norms that underlie authorship practices and misconduct adjudication. In this paper, we describe some actual cases involving articles that were retracted for misconduct and republished; review policies from the International Committee of Medical Journal Editors, Committee on Publication Ethics, and top fifteen biomedical journals to determine whether they provide adequate guidance for cases like these; and analyze the ethical and policy issues that may arise in these situations. (shrink)

Unequal treatment of human research subjects is a significant ethical concern, because justice in research involving human subjects requires equal protection of rights and equal protection from harm and exploitation. Disputes sometimes arise concerning the issue of unequal treatment of research subjects. Allegedly unequal treatment occurs when subjects are treated differently and there is a genuine dispute concerning the appropriateness of equal treatment. Patently unequal treatment occurs when subjects are treated differently and there is not a genuine dispute about the (...) appropriateness of equal treatment. Allegedly unequal treatment will probably always occur in research with human subjects due to disagreements about fundamental questions of justice. The best way to deal with allegedly unequal treatment is to promote honest and open discussions of the issues at stake. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, ethical review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Federal agencies have provided interpretive guidance that can help promote consistent review and oversight of human subjects research. Additional direction may be needed on topics that are not adequately covered by current guidance or regulations. International guidelines can help promote equal treatment of human subjects around the globe. While minor variations in the treatment of research subjects should be tolerated and even welcomed, major ones (i.e. those that significantly impact human rights or welfare) should be avoided or minimized. (shrink)

This paper develops three arguments for increasing the strength of database protection under U.S. law. First, stronger protections would encourage private investment in database development, and private databases have many potential benefits for science and industry. Second, stronger protections would discourage extensive use of private licenses to protect databases and would allow for greater public control over database laws and policies. Third, stronger database protections in the U.S. would harmonize U.S. and E.U. laws and would thus enhance international trade, commerce, (...) and research. The U.S. should therefore follow the European example and develop two tiers of protection for databases: 1) protection for creative databases under copyright law; 2) protection for non-creative databases through a special type of sui generis protection. In order to balance private control of data and public access to data, sui generis protections should define a “fair use” exemption that permits some unauthorized extraction of data for private, educational, and research purposes, provided that such extraction does not adversely impact the economic value of the database. (shrink)

During a prostate exam, Mr. Watson, age 65, learns that his prostate appears to be abnormal. The family physician conducting the exam, Dr. Kleinman, informs Mr. Watson that he may have prostate cancer. Mr. Watson agrees to a variety of tests, including blood tests, bone scans, ultrasound scanning, and a biopsy. After learning about this possible diagnosis and these tests, Mr. Watson surfs the Web for information about prostate cancer and gathers data from many different sources, including the National Cancer (...) Society, the National Institutes of Health, Johns Hopkins University, the Mayo Clinic, and medicine sites. He also searches for information from medical journals using MEDLINE, visits several chat rooms on prostate cancer, and joins some e-mail lists. He arrives in Dr. Kleinman's office for a follow-up appointment with a stack of material and many questions. Dr. Kleinman is surprised, irritated, and offended. He recommends that Mr. Watson have a prostatectomy followed by radiation, but Mr. Watson does not want this operation. He would rather receive a form of radiation therapy recently approved by the FDA that he learned about through his own research. Dr. Kleinman admits that he does not know much about this new treatment, but he says that he would read up on it and consult an oncologist. (shrink)

The COVID-19 pandemic has highlighted the importance of biosafety in the biomedical sciences. While it is often assumed that biosafety is a purely technical matter that has little to do with philosophy or the humanities, biosafety raises important ethical issues that have not been adequately examined in the scientific or bioethics literature. This article reviews some pivotal events in the history of biosafety and biosecurity and explores three different biosafety topics that generate significant ethical concerns, i.e., risk assessment, risk management, (...) and risk distribution. The article also discusses the role of democratic governance in the oversight of biosafety and offers some suggestions for incorporating bioethics into biosafety practice, education, and policy. (shrink)

InExplaining Science: A Cognitive Approach, Ronald Giere (1988), proposes what he calls a cognitive theory of science (p. 2). Giere intends his view to be a broadly scientific account employing the resources of the cognitive sciences (Giere, 1988, p. 2). This paper argues that Giere does not secure a firm foundation for a cognitive theory of science because he leaves the door wide open for social constructivist interpretations of his views. In order to avoid social constructivism, Giere needs to adopt (...) or develop an objective (i.e. non-conventionalist) concept of similarity. (shrink)

In this article, we discuss ethical issues related to using and disclosing artificial intelligence (AI) tools, such as ChatGPT and other systems based on large language models (LLMs), to write or edit scholarly manuscripts. Some journals, such as Science, have banned the use of LLMs because of the ethical problems they raise concerning responsible authorship. We argue that this is not a reasonable response to the moral conundrums created by the use of LLMs because bans are unenforceable and would encourage (...) undisclosed use of LLMs. Furthermore, LLMs can be useful in writing, reviewing and editing text, and promote equity in science. Others have argued that LLMs should be mentioned in the acknowledgments since they do not meet all the authorship criteria. We argue that naming LLMs as authors or mentioning them in the acknowledgments are both inappropriate forms of recognition because LLMs do not have free will and therefore cannot be held morally or legally responsible for what they do. Tools in general, and software in particular, are usually cited in-text, followed by being mentioned in the references. We provide suggestions to improve APA Style for referencing ChatGPT to specifically indicate the contributor who used LLMs (because interactions are stored on personal user accounts), the used version and model (because the same version could use different language models and generate dissimilar responses, e.g., ChatGPT May 12 Version GPT3.5 or GPT4), and the time of usage (because LLMs evolve fast and generate dissimilar responses over time). We recommend that researchers who use LLMs: (1) disclose their use in the introduction or methods section to transparently describe details such as used prompts and note which parts of the text are affected, (2) use in-text citations and references (to recognize their used applications and improve findability and indexing), and (3) record and submit their relevant interactions with LLMs as supplementary material or appendices. (shrink)

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 Principle and consider the overarching rationales for responding to threats to the environment or public health. It provides practical guidance and probing insight for the intended audience, including (...) scholars, students, journalists, and policymakers. (shrink)

Bioethics, Volume 36, Issue 7, Page 735-741, September 2022.

Green bioethics is an area of research and scholarship that examines the impact of healthcare practices and policies on the environment and emphasises environmental values, such as ecological sustainability and stewardship. Some green bioethicists have argued that healthcare providers should inform patients about the environmental impacts of treatments and advocate for options that minimise adverse impacts. While disclosure of information pertaining to the environmental impacts of treatments could facilitate autonomous decision-making and strengthen the patient–provider relationship in situations where patients have (...) clearly expressed environmental concerns, it may have the opposite effect in other situations if makes patients feel like they are being judged or manipulated. We argue, therefore, that there is not a generalisable duty to disclose environmental impact information to all patients during the consent process. Providers who practice green bioethics should focus on advocating for system-level changes in healthcare financing, organisation and delivery and use discretion when bringing up environmental concerns in their encounters with patients. (shrink)

Traditional debates about scientific realism tend to focus on issues concerning scientific representation and de-emphasize issues concerning scientific intervention. Questions about the relation between theories and the world, the nature of scientific inference, and the structure of scientific explanations have occupied a central place in the realism debate, while questions about experimentation and technology have not. Ian Hacking's experimental realism attempts to reverse this trend by shifting the defense of realism away from representation to intervention. Experimental realism, according to Hacking, (...) does not require us to believe that our theories are true, nor does its defense depend on inference to the best explanation. For Hacking, the strongest proof for realism is that we can manipulate objects: 'So far as I'm concerned, if you can spray them, then they are real'. (shrink)

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 examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society, the reasonable expectation of substantial (...) public benefit should be a necessary condition for regarding research as ethical only when it imposes more than minimal risks on non-consenting subjects; or it is supported by public resources. (shrink)

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, (...) social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade‐Related Aspects of Intellectual Property Rights agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying. (shrink)

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 trials should develop a robust community engagement strategy that meets widely recognized standards for seeking approval from the affected population, such as timeliness, consent, information sharing, transparency, understanding, responsiveness, mutual understanding, inclusiveness, and respectfulness. (...) Additional research is needed on the effectiveness of different methods of engaging communities in field trials of genetically modified mosquitoes and how to respond to public opposition to genetically modified organisms. For research programs involving the genetic modification of disease vectors to move forward, they must have public acceptance and support, which cannot be achieved without effective community engagement. (shrink)

Artificial intelligence (AI), large language models (LLMs), such as Open AI’s ChatGPT, have a remarkable ability to process and generate human language but have also raised complex and novel ethica...

Mosquito-borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito-borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease-resistant, genetically modified mosquitoes. Some of these (...) issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un-enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito-borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case-by-case basis. (shrink)

Valid Informed consent to medical treatment or research participation has traditionally been viewed as consisting of the following requirements: the person has t...

BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

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 how several influential theories of justice deal with issues related to the distribution of environmental health risks; (2) show that these theories often fail to provide specific guidance concerning policy (...) choices; and (3) argue that an approach to public decision making known as accountability for reasonableness can complement theories of justice in establishing acceptable environmental health risks for the general population and susceptible subpopulations. Since accountability for reasonableness focuses on the fairness of the decision-making process, not the outcome, it does not guarantee that susceptible subpopulations will receive a maximum level of protection, regardless of costs or other morally relevant considerations. (shrink)

This article reports the results of an anonymous survey of researchers at a government research institution concerning their perceptions about ethical problems with journal peer review. Incompetent review was the most common ethical problem reported by the respondents, with 61.8% (SE = 3.3%) claiming to have experienced this at some point during peer review. Bias (50.5%, SE = 3.4%) was the next most common problem. About 22.7% (SE = 2.8%) of respondents said that a reviewer had required them to include (...) unnecessary references to his/her publication(s), 17.7% (SE = 2.6%) said that comments from reviewers had included personal attacks, and 9.6% (SE = 2.0%) stated that reviewers had delayed publication to publish a paper on the same topic. Two of the most serious violations of peer review ethics, breach of confidentiality (6.8%, SE = 1.7%) and using ideas, data, or methods without permission (5%, SE = 1.5%) were perceived less often than the other problems. We recommend that other investigators follow up on our exploratory research with additional studies on the ethics of peer review. (shrink)

The precautionary principle is a useful strategy for decision-making when physicians and patients lack evidence relating to the potential outcomes associated with various choices. According to a version of the principle defended here, one should take reasonable measures to avoid threats that are serious and plausible. The reasonableness of a response to a threat depends on several factors, including benefit vs. harm, realism, proportionality, and consistency. Since a concept of reasonableness plays an essential role in applying the precautionary principle, this (...) principle gives physicians and patients a decision-making strategy that encourages the careful weighing and balancing of different values that one finds in humanistic approaches to clinical reasoning. Properly understood, the principle presents a worthwhile alternative to approaches to clinical reasoning that apply expected utility theory to decision problems. (shrink)

This study presents the results of a survey of student satisfaction with electronic discussion boards in a course on the responsible conduct of research (RCR). On a 1–5 scale, the respondents stated that the use of the electronic discussion board was an effective teaching tool (4.71), that it enabled them to get feedback from their peers (4.43), that it helped promote discussion and debate (4.36), that it helped them learn how to analyze ethical dilemmas in research (4.36), and that they (...) would consider using an electronic discussion board, if they ever taught a course themselves (4.76). In their written comments, the respondents indicated that electronic discussion boards are a convenient way of promoting debate and in-depth discussion. These results suggest, but do not prove, that discussion boards can promote debate and discussion in courses on research ethics. Instructors who teach RCR should consider using electronic discussion boards in regular or online courses, and they should consider studying the effectiveness of electronic discussion boards in research ethics education. Although electronic discussion boards cannot replace the face-to-face interaction that occurs in a classroom setting, they may provide a useful medium for the exchange of ideas and opinions online. (shrink)

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 between individual rights and the common good underlying the principle. To apply the proportionality principle to a decision of policy, one must still find a reasonable way (...) of balancing these competing values in light of the available options and empirical evidence. In this article, I consider how the proportionality principle applies to the regulation of dietary supplements and examine some critiques of the current oversight system. I argue that it may be difficult maintain proportional oversight because the risks of dietary supplements vary considerably. Strengthening the regulations may therefore promote an appropriate level of regulation in some cases but lead to overregulation in others. (shrink)

Environmental Health Ethics illuminates the conflicts between protecting the environment and promoting human health. In this study, David B. Resnik develops a method for making ethical decisions on environmental health issues. He applies this method to various issues, including pesticide use, antibiotic resistance, nutrition policy, vegetarianism, urban development, occupational safety, disaster preparedness and global climate change. Resnik provides readers with the scientific and technical background necessary to understand these issues. He explains that environmental health controversies cannot simply be reduced (...) to humanity versus environment and explores the ways in which human values and concerns - health, economic development, rights and justice - interact with environmental protection. (shrink)

According to a popular view of scientific methodology, scientific methods are prescriptive rules (methodological rules) which are justified in so far as they realize or promote the aims of science. This paper considers several different interpretations of the phrase aims of science, arguing that none of these interpretations allow aims to provide a satisfactory justification of methodological rules.

During the past decade scientists, public policy analysts, politicians, and laypeople, have become increasingly aware of the importance of ethical conduct in scientific research. In this timely book, David B. Resnik introduces the reader to the ethical dilemmas and questions that arise in scientific research. Some of the issues addressed in the book include ethical decision-making, the goals and methods of science, and misconduct in science. The Ethics of Science also discusses significant case studies such as human and animal (...) cloning, the Challenger accident and Tobacco research. This is essential reading for anyone who wishes to understand the importance of ethics in science. (shrink)

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, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, (...) such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust. (shrink)

Openness is one of the most important principles in scientifi c inquiry, but there are many good reasons for maintaining secrecy in research, ranging from the desire to protect priority, credit, and intellectual property, to the need to safeguard the privacy of research participants or minimize threats to national or international security. This article examines the clash between openness and secrecy in science in light of some recent developments in information technology, business, and politics, and makes some practical suggestions for (...) resolving confl icts between openness and secrecy. (shrink)

The environmental justice movement began in 1982, when residents of Shocco Township, a low-income, African-American community located in Warren County, North Carolina, protested the state’s plan to...

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on (...) research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks. (shrink)

Scientists and policy‐makers have long understood that the products of research can often be used for good or evil. Nuclear fission research can be used to generate electricity or create a powerful bomb. Studies on the genetics of human populations can be used to understand relationships between different groups or to perpetuate racist ideologies. While the notion that scientific research often has beneficial and harmful uses has been discussed before, the threat of bioterrorism—a concern that has only grown since 2001—has (...) led to increased awareness about the need to prevent the misuse of biomedical research, particularly when it involves dangerous pathogens or toxins. In 2012, the concern was ratcheted up another notch by two papers reporting the results of research on genetically engineered strains of the H5N1 avian influenza virus. Although the H5N1 papers have potential scientific and social value, some scientists and policy‐makers opposed their publication because they feared that terrorists (or others with nefarious motives) could use the research to create a bioweapon that could trigger a global pandemic. The H5N1 papers raise difficult questions concerning the ethics of knowledge. Should scientific research with dangerous applications be published? Should some types of research be kept secret or not be conducted at all? What type of government oversight of dangerous research is appropriate? In this essay, I will develop a framework for thinking about the ethics of knowledge and apply it to the H5N1 controversy, focusing on issues related to publication. I will argue that redacted publication would have been a reasonable response to the dilemmas posed by the H5N1 papers if not for practical and legal problems with this option. Given these problems, full publication seems appropriate. (shrink)

In Playing Politics with Science, David B. Resnik explores the philosophical, political, and ethical issues related to the politicalization of science and ...

This essay provides an explanation and interpretation of the undertreatment of pain by discussing some of the scientific, clinical, cultural, and philosophical aspects of this problem. One reason why pain continues to be a problem for medicine is that pain does not conform to the scientific approach to health and disease, a philosophy adopted by most health care professionals. Pain does not fit this philosophical perspective because (1) pain is subjective, not objective; (2) the causal basis of pain is often (...) poorly understood; (3) pain is often regarded as a mere symptom, not as a disease; (4) there often are no magic bullets for pain; (5) pain does not fit the expert knowledge model. In order for health care professionals to do a better job of treating pain, some changes need to occur in medical philosophy, education, and practice. (shrink)

This essay discusses some of the problems with current authorship practices and puts forward a proposal for a new system of credit allocation: in published works, scientists should more clearly define the responsibilities and contributions of members of research teams and should distinguish between different roles, such as author, statistican, technician, grant writer, data collector, and so forth.

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

When environmental health researchers study hazards in the home, they often discover information that may be relevant to protecting the health and safety of the research subjects and occupants. This article describes the ethical and legal basis for a duty to warn research subjects and occupants about hazards in the home and explores the extent of this duty. Investigators should inform research subjects and occupants about the results of tests conducted as part of the research protocol only if the information (...) is likely to be accurate, reliable, and medically useful. Investigators should warn subjects and occupants about hazards they happen to discover while they are in the home, if a reasonable person would warn the subjects and occupants about those hazards. Investigators should not report illegal hazards discovered in the home to the authorities, unless those hazards constitute abuse or neglect of children or mentally disabled people living in the home. When investigators decide to warn research subjects and occupants about hazards in the home, they should take some steps to help them make effective use of this information, such as providing additional counselling or making a referral for remediation or medical treatment. Investigators should discuss these issues with research subjects during the informed consent process. (shrink)