Research on environmental health interventions: ethical problems and solutions

This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro-research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

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

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

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

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

Intentional Exposure Studies of Environmental Agents on Human Subjects: Assessing Benefits and Risks∗

In this article, I assess the benefits and risks of studies that intentionally expose research subjects to environmental agents. I describe these types of studies, identify their benefits and risks, compare them to other research methods that can be used to investigate the relationship between environmental exposures and disease, and discuss some issues related to research design and risk minimization. I argue that the benefits of intentional environmental exposure studies outweigh the risks when 1) the knowledge gained is likely to improve our understanding of the relationship between environmental exposure and disease, 2) this knowledge cannot be obtained by other methods, 3) the experiments are well designed, 4) the subjects will receive some benefits, such as medical evaluations, 5) risks are minimized, and 6) the risks to human subjects are less than those encountered in a typical Phase I drug study. Only in rare circumstances (i.e., when an intentional environmental exposure study is needed to implement an important environmental or public health intervention or regulation) may such studies expose research subjects to risks as high as those encountered in a typical Phase I drug trail.     

Intentional exposure studies of environmental agents on human subjects: assessing benefits and risks

In this article, I assess the benefits and risks of studies that intentionally expose research subjects to environmental agents. I describe these types of studies, identify their benefits and risks, compare them to other research methods that can be used to investigate the relationship between environmental exposures and disease, and discuss some issues related to research design and risk minimization. I argue that the benefits of intentional environmental exposure studies outweigh the risks when 1) the knowledge gained is likely to improve our understanding of the relationship between environmental exposure and disease, 2) this knowledge cannot be obtained by other methods, 3) the experiments are well designed, 4) the subjects will receive some benefits, such as medical evaluations, 5) risks are minimized, and 6) the risks to human subjects are less than those encountered in a typical Phase I drug study. Only in rare circumstances (i.e., when an intentional environmental exposure study is needed to implement an important environmental or public health intervention or regulation) may such studies expose research subjects to risks as high as those encountered in a typical Phase I drug trail.     

Ethics and Research Assessing the Relative Roles of Genes and the Environment*

Research on the interaction of genes and the environment is revealing that many human diseases have both genetic and environmental components. Even traditional “environmental” diseases, such as infections, appear to interact with genetic components in the human host. Environmental genetics research will inevitably increase understanding of individual susceptibilities to toxic exposures in the environment and harmful side effects of medications; therefore, it has great promise for improving the prevention and treatment of human diseases. However, realizing the benefits of this research requires careful attention to ethical issues that are particularly relevant in this context. This article reviews some of the most pressing issues related to research design and methods, as well as from the application of research results (e.g., workplace genetic screening and legal toxic torts, personal medical responsibility, and the relationship between genetics and public health measures).     

Ethics and research assessing the relative roles of genes and the environment

Research on the interaction of genes and the environment is revealing that many human diseases have both genetic and environmental components. Even traditional "environmental" diseases, such as infections, appear to interact with genetic components in the human host. Environmental genetics research will inevitably increase understanding of individual susceptibilities to toxic exposures in the environment and harmful side effects of medications; therefore, it has great promise for improving the prevention and treatment of human diseases. However, realizing the benefits of this research requires careful attention to ethical issues that are particularly relevant in this context. This article reviews some of the most pressing issues related to research design and methods, as well as from the application of research results (e.g., workplace genetic screening and legal toxic torts, personal medical responsibility, and the relationship between genetics and public health measures).     

What a tangled web we weave: ethical and legal implications of deception in recruitment

Deception in human subject research is neither uncommon nor prohibited. The use of deception in the recruitment phase of clinical research has received relatively little attention. Given that informed consent is foundational to human subject research, the practice of misrepresenting the study purpose in clinical research would seem to contradict one of the fundamental tenets of ethical human subjects research. Using the example of prodromal psychosis, this article the ethical and legal implications of deception in recruitment and the sufficiency of current guidance on the practice when the study involves a stigmatizing condition, the collection of genetic samples, or both. I conclude that when these two elements are present, deception should only be used when absolutely necessary and, if used, researchers should be required to debrief participants before the collection of genetic samples and give particular attention to minimizing risks of privacy breaches.     

What a Tangled Web We Weave: Ethical and Legal Implications of Deception in Recruitment

Deception in human subject research is neither uncommon nor prohibited. The use of deception in the recruitment phase of clinical research has received relatively little attention. Given that informed consent is foundational to human subject research, the practice of misrepresenting the study purpose in clinical research would seem to contradict one of the fundamental tenets of ethical human subjects research. Using the example of prodromal psychosis, this article the ethical and legal implications of deception in recruitment and the sufficiency of current guidance on the practice when the study involves a stigmatizing condition, the collection of genetic samples, or both. I conclude that when these two elements are present, deception should only be used when absolutely necessary and, if used, researchers should be required to debrief participants before the collection of genetic samples and give particular attention to minimizing risks of privacy breaches.     

Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia

The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review.     

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 of research design

Discussions of ethical issues in research involving human subjects most usually provoke concerns about valid informed consent procedures. However, considering the recognized limitations of informed consent, arguably the way a study is designed is a more consequential concern for subject well‐being. This paper summarizes ethical issues in the design of clinical research, with reference to historic and current guidelines. Special attention is given to randomized clinical trials (RCTs) and psychiatric research.     

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.     

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.     

Ethical Dilemmas and Areas of Social Work Intervention in Spain

Abstract

The purpose of this study is to identify the types of ethical dilemmas that Spanish social workers face in their respective areas of intervention. The intervention areas that have been studied are health, children, immigrants, women, family, marginalized persons, ethnic minorities, young people, prisoners, elderly people, refugees and asylum seekers, schools and social and employment-related integration, mental health, disability and drug addictions. A quantitative methodology was chosen using a version of the questionnaire prepared by Eileen J. Ain in a sample of 700 Spanish social workers. The statistical analysis shows the correlation between the different areas of intervention in Social Work and the most significant ethical dilemmas that such professionals have to solve. The most pertinent ethical dilemmas are found in the healthcare sector (confidentiality, disclosure of personal information and patient autonomy). The article is an important contribution for Social Work at the national level that emphasizes the importance of the ethics of Social Work in social interventions. It is proposed to deepen the investigation of each of the areas of intervention for future research, as well as to carry out comparative studies between different countries.     

Noncompliance with Human Subjects’ Protection Requirements as a Reason for Retracting Papers: Survey of Retraction Notices on Medical Papers Published from 1981 to 2011

Though protection of human research subjects is universally recognized as a critical requirement for the ethical conduct of research, few studies have examined retractions of medical articles through apparent noncompliance with that requirement. From our survey of 99 retracted papers published from 1981 to 2011, we found that the basis for those decisions was poorly explained in retraction notices and that most of the articles continued to be cited. In retraction notices, the current manner of explaining failure to protect human subjects is misleading and confusing.     

The ethical review of medical research: a social movement to protect the interests of research subjects

This paper is based upon observations made in the United States regarding the operation of the Institutional Review Boards. Institutional Review Boards are an essential part of the American system for the ethical review of human subjects research and it is argued that their importance is due in part to the American approach to the protection of minority groups. It is important to evaluate the effectiveness of the Institutional Review Boards since a similar model is being proposed by the National Health & Medical Research Council as part of the ethical review of medical research projects conducted in Australia.     

Empirically supported ethical research practice: the costs and benefits of research from the participants' view

Researchers and institutional review boards are routinely called upon to evaluate the cost-benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses investigating its structure. Based on these findings, a revised version of the instrument and suggestions for future research are presented. This approach provides a foundation for scientifically informed protection of human subjects.