Overwhelming Casualties: Medical Ethics in a Time of Terror

Codes of ethics and ethics guidelines define standards of professional conduct, and ways to prioritize or balance ethical principles when these appear to be in conflict. In 1991 an international and interdisciplinary group of scholars met at the University of Toronto to discuss these problems in a Workshop on Ethical Considerations in Scholarship and Science. A document, “The Toronto Resolution”; (TTR), was developed, providing twelve principles for incorporation into scientific and scholarly codes, with the object of ensuring that professionals in science recognize the potential consequences of their work in the broader social context. To examine the extent to which existing codes are consonant with The Toronto Resolution's 12 principles, a content analysis was conducted on the codes of 21 Ontario‐based scientific and scholarly organizations. Criteria used in the content analysis were standardized and determined to be reliable. Only a weak correspondence was found between the contents of the codes of the scientific and scholarly organizations surveyed here and the principles set out in TTR. In particular, guidelines on specific social issues such as environmental effects or conflict resolution are scarcely mentioned at all. This study encourages consideration of The Toronto Resolution by the ethics committees of scientific and scholarly associations, as codes are revised or as new interpretations of principles in the codes evolve.     

When RIP means research in progress--the use of brain dead subjects in medical research

Recent research reported in a number of medical journals highlights some of the problems associated with performing experiments with human subjects who have been declared dead using the brain death criteria of death. These reports provide interesting illustrations of some of the real dilemmas involved in the regulation of human subjects experimentation. In particular, the traditional method of balancing risks and benefits in determining the ethical acceptability of research on human subjects is thrown into question. It is suggested that there should be a moratorium on the use of brain-dead subjects in research until some of the issues can be clarified and appropriate guidelines for the conduct of this research can be prepared.     

Accountability in research using persons with mental illness

Although medical research involving the use of persons with mental illness is critically important, in order for the research to be ethical and legal there are certain considerations and restrictions which should be immediately readdressed in order to insure that the welfare of these vulnerable research subjects is protected, and their best interests are assured. A brief historical examination of medical research codes, guidelines, recommendations and Federal Regulations reveals the various considerations and restrictions on informed consent and accountability applicable to the use of persons with mental illness in medical research. Several concerns are raised about how these considerations and restrictions have been interpreted, and specific recommendations are offered to improve them immediately by means of representation from consumers and/or their families, and organizations, e.g., NAMI members.     

The Responsible Conduct of Bioethics Research

The responsible conduct of research in the biomedical and behavioral sciences has received significant attention since the late 1980s. However, very little has been written about the responsible conduct of bioethics research. Bioethics is an interdisciplinary field and brings together divergent ethical standards and practices which may be the source of tension or conflict. This article argues that bioethicists should reflect more on ethical issues in the responsible conduct of bioethics research through examination of authorship practices and peer review. I also outline three possible approaches to promote research integrity in bioethics.     

The responsible conduct of bioethics research

The responsible conduct of research in the biomedical and behavioral sciences has received significant attention since the late 1980s. However, very little has been written about the responsible conduct of bioethics research. Bioethics is an interdisciplinary field and brings together divergent ethical standards and practices which may be the source of tension or conflict. This article argues that bioethicists should reflect more on ethical issues in the responsible conduct of bioethics research through examination of authorship practices and peer review. I also outline three possible approaches to promote research integrity in bioethics.     

Ethical guidelines for research with children: A review of current research ethics documentation in New Zealand

Abstract

Children's rights to participate in matters affecting them, including research, have gained increasing recognition over recent decades. This recognition, and the growth in research with children as participants, has given rise to greater attention from researchers to ethical issues related to child research. This article reviews the current ethics documentation in New Zealand. The findings indicate that considerable variation exists between ethical codes and guidelines in relation to research with children. The dominant focus is on attending to issues of consent and protection from harm, at the outset of the research, rather than recognition of the ongoing nature of ethical issues throughout the research process. Although the findings indicate an increase in the consideration of ethical issues, the existing documentation is inconsistent and inadequate in attending to specific child‐related issues. Suggestions are made to enhance children's participation in research and demonstrate a respect for their participation rights.     

To Tell or Not to Tell? The Ethical Dilemma of the Would-Be Whistleblower

Despite the growing emphasis placed on the responsible conduct of research, little attention has been devoted to the question of what an individual should do upon discovering research misconduct. This article takes seriously the dilemma of a would-be whistleblower. It identifies ethical considerations that can be taken into account in moral decision-making about reporting research misconduct. It also offers rough guidelines about the moral significance of each consideration in the decision-making process based on the facts of the case in question. The article, therefore, offers tools for a would-be whistleblower to use to arrive at a defensible resolution to a difficult dilemma.     

Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand

Researchers designing and conducting studies using human data should consider the values and principles of ethical conduct. Research ethics committees (RECs) typically evaluate the ethical acceptability of research proposals. Sometimes, differences arise between how researchers and RECs interpret ethical principles, and how they decide what constitutes ethical conduct. This study aimed to explore the opinions of these two groups about the importance of core ethical issues in the proposal and in the informed-consent process. An anonymous online questionnaire was distributed to a target population in health-related academic/research institutes across Thailand; 219 researchers and 72 REC members participated. Significantly, more REC members than researchers attributed the highest importance to three core ethical considerations – risk/benefit, vulnerability, and confidentiality/privacy. For the informed-consent process, significant differences were found for communication of risks, decision-making authority for consent, process for approaching study participants, and availability of a contact for study deviations/violations. The different ratings indicate differences in the groups’ perspectives on ethical principles, which may affect focal congruence on ethical issues in the proposal. Communication of these findings should help close gaps between REC and researcher perceptions. Further study should investigate how RECs and researchers perceive equivocal ethics terms.     

The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."     

The Importance of the Preservation of the Ethical Principle of Equipoise in the Design of Clinical Trials: Relative Impact of the Methodological Quality Domains on the Treatment Effect in Randomized Controlled Trials

Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."     

Researching Vulnerable Groups: Ethical Issues and the Effective Conduct of Research in Local Authorities

The Data Protection Act 1998 and Research Governance Frameworkfor Health and Social Care (Department of Health, 2003a) havebrought consideration of ethical issues in the conduct of researchinto sharper focus. This paper, based primarily on the authors’experiences of conducting research on children in need and outcomesfor vulnerable children, examines the impact these changes havehad on the research process. The difficulties experienced byresearchers in gaining access to research participants in orderto develop evidence-based policy and practice are explored.Finally, the paper outlines some practical steps that can betaken to facilitate the effective conduct of research.     

Ethics in population-based genetic research

Population-based genetic research, including genetic epidemiology, shows tremendous potential to elucidate the role of genes as causal factors in complex and common human diseases. Like all research with human subjects, full realization of these benefits requires careful attention to its ethical conduct, establishing an appropriate balance between individual protections and the advancement of scientific and medical knowledge. This article reviews the growing literature on genetics research and ethics to describe some of the fundamental ethical issues in population-based genetics research, including research design, recruitment and informed consent, and dealing with research results. Its focus is on areas where consensus is forming and where future work is needed.     

Ethics in behavioral genetics research

As research in behavioral genetics uncovers the genetic contribution to human behavior, it will undoubtedly further our understanding of normal human variation in many behavioral traits, such as personality, intelligence, and sexuality. This research also shows great potential for the diagnosis, treatment, and prevention of mental illnesses. Recent findings underscore this potential and document the increasing validity of research methods--methods that in the past have led to mistaken inferences about genes "for" violent behavior and homosexuality. Although all research with human subjects requires adequate attention to its ethical aspects, certain ethical issues involved with behavioral genetics are particularly acute and deserve careful attention. This article reviews these selected major ethical issues arising in (1) the conduct of behavioral genetics research; and (2) the application of its research findings. While some of the ethical concerns in the latter category are likely to be of substantial importance and animate considerable popular concern, they currently fall outside the realm of traditional research review. Determining how to deal with these concerns should be a focus of future scholarly work.     

International research: Ethical imperialism or ethical pluralism? 1

Conflicts have arisen in international research when countries in which research is being carried out lack the ethical rules or mechanisms for review employed in the United States and Europe. It is objected that a requirement to adhere to regulations promulgated by the US government constitutes “ethical imperialism.”; But if researchers in some countries need not be bound by ethical standards widely accepted in the conduct of research, it could open the door to an ethical relativism allowing virtually any standard a country desires to accept. One example is the variations in informed consent, especially in countries that accord lesser importance to the individual than do the US and Europe. A recent controversy centered on a series of placebo‐controlled, HIV/AIDS trials sponsored by the United States and conducted in several developing countries. These trials could not ethically be carried out in the United States because a proven effective treatment exists. Attempts to avoid similar controversies in forthcoming HIV/AIDS vaccine trials have been initiated by the joint United Nations AIDS program, with a process of regional consultations in the countries where the research will be conducted.     

Resolving Beecher's Paradox: Getting beyond IRB reform

Protection of persons participating as research subjects is an essential element of ethical research conduct. There is growing concern that the existing system of institutional review boards (IRBs) and informed consent may not be adequate and is in need of reform. When science and medicine are “merged”; in clinical research, confusion of roles and conflicts of interests arise in relationships between patient‐subjects and physician‐investigators. IRBs have always had a primary role in protection of research participants. Their efforts to protect research subjects may make it more difficult for investigators to conduct research. This tension has lead to the development of an adversarial relationship between IRBs and investigators. Investigators and IRBs are also subject to external pressures that could impact efforts to protect research subjects. Efforts are underway to address these concerns. IRB reform, while needed, is not likely to be sufficient. Adoption of a new paradigm in which IRBs, investigators and research sponsors collectively accept protection of research subjects as their primary and shared responsibility may provide a more effective and efficient model that will be better able to deal with difficult ethical and social issues in clinical research.     

Engaging the Process of Transformation

The contributions included in this issue demonstrate the variety of ways in which participatory and interpretive methods are transforming the field of psychology and clarify the integration of the personal and political commitments of the authors within their research. A number of issues remain to be negotiated, however, before these methods take their full place in the field. This conclusion considers a few of these issues, including an examination of how these approaches demand a fundamental reassessment of validity in psychological research. It also considers the critical issue of the ownership of knowledge, and proposes a reframing of the ethical guidelines for research in the field. Finally, it invites further discussion and debate around the issues raised in this issue.     

Ethical Beliefs of Social Work Researchers

Abstract

The purpose of this study is to examine the beliefs of social work researchers about ethical practices. Surveys were mailed to a random sample of 240 members of the Society for Social Work and Research (SSWR) to elicit their views about ethical practices in social work research. Responses from 160 members (67% response rate) yielded information regarding the appropriateness of dual relationships, authorship practices, informed consent procedures, and other conduct in social work research. Age, gender, educational level, years of social work research experience, and current teaching of social work research were related to respondents' ethical views about practices with students and sexual relationships with research subjects. The need for additional resources on ethics in social work research is highlighted.     

Authorship and publication practices: evaluation of the effect of responsible conduct of research instruction to postdoctoral trainees

We have studied postdoctoral trainees funded by NIH F32 fellowship awards in order to test the effectiveness of responsible conduct of research (RCR) education in the areas of authorship and publication practices. We used a 3-wave telephone and on-line survey design, conducted over a period of two years, in order to test for individual change before and after completing RCR education. Overall the responses of the subjects suggested a clear awareness of standards and practices in publication. However, our results failed to suggest that RCR education in this group significantly increased the level of ethically appropriate behavioral responses measured in the study. Similarly we saw no significant effect on increasing awareness of or attention to ethical guidelines about authorship and publication practices. Our interpretation of these null findings was influenced by the significant publication experience of our cohort of subjects. We forward possible explanations for these null findings in this context. Most importantly, we do not suggest that our results argue against continued instruction in RCR education. Instead, we believe our data reinforce the importance of careful articulation of course goals and objectives with attention to the background and experience of the student audience when developing RCR curricula.     

A theoretical basis for accepting undergraduate academic record as a predictor of success in a research career. Implications for the validity of peer review

We have studied postdoctoral trainees funded by NIH F32 fellowship awards in order to test the effectiveness of responsible conduct of research (RCR) education in the areas of authorship and publication practices. We used a 3-wave telephone and on-line survey design, conducted over a period of two years, in order to test for individual change before and after completing RCR education. Overall the responses of the subjects suggested a clear awareness of standards and practices in publication. However, our results failed to suggest that RCR education in this group significantly increased the level of ethically appropriate behavioral responses measured in the study. Similarly we saw no significant effect on increasing awareness of or attention to ethical guidelines about authorship and publication practices. Our interpretation of these null findings was influenced by the significant publication experience of our cohort of subjects. We forward possible explanations for these null findings in this context. Most importantly, we do not suggest that our results argue against continued instruction in RCR education. Instead, we believe our data reinforce the importance of careful articulation of course goals and objectives with attention to the background and experience of the student audience when developing RCR curricula.     

Ethical Virtues in Scientific Research

Most approaches to promoting integrity in research are principle-based in that they portray ethical conduct as consisting of adherence to ethical rules, duties, or responsibilities. Bruce MacFarlane has recently criticized the principle-based approach to promoting integrity in research and offered a virtue-based alternative. MacFarlane argues that principle-based approaches do not provide adequate guidance for ethical decision-making and are not very useful in moral education. In this article, I examine and critique MacFarlane's defense of the virtue-based approach. I argue that virtue-based and principle-based approaches to ethics are complementary and that they both can help promote research integrity.