Despite the growing recognition for the need to improve the health of prisoners in Canada and the need for health research, there has been little discussion of the ethical issues with regards to health research with prisoners in Canada. The purpose of this paper is to encourage a national conversation about what it means to conduct ethically sound health research with prisoners given the current realities of the Canadian system. Lessons from the Canadian system could presumably apply (...) in other jurisdictions. Any discussion regarding research ethics with Canadian prisoners must begin by first taking into account the disproportionate number of Indigenous prisoners and the high proportion of prisoners suffering from mental illnesses. The main ethical challenges that researchers must navigate are the power imbalances between them, the correctional services staff, and the prisoners, and the effects this has on obtaining voluntary consent to research; and, the various challenges associated to protecting the privacy and confidentiality of study participants who are prisoners. In order to solve these challenges, a first step would be to develop clear and transparent processes for ethical health research, which ought to be informed by multiple stakeholders, including prisoners, the correctional services staff, and researchers themselves. Stakeholder and community engagement ought to occur in Canada with regards to ethical health research with prisoners that should also include consultation with various parties, including prisoners, correctional services staff, and researchers. It is important that national and provincial research ethics organizations examine the sufficiency of existing research ethics guidance and, where there are gaps, to develop guidelines and help craft policy. (shrink)

ABSTRACT The 2006 Institute of Medicine (IOM) report, ‘Ethical Considerations for Research Involving Prisoners’, recommended five main changes to current US Common Rule regulations on prisoner research. Their third recommendation was to shift from a category‐based to a risk‐benefit approach to research review, similar to current guidelines on pediatric research. However, prisoners are not children, so risk‐benefit constraints on prisoner research must be justified in a different way from those on pediatric research. (...) In this paper I argue that additional risk‐benefit constraints on prisoner research are unnecessary: the current Common Rule regulations, omitting category‐based restrictions but conjoined with the IOM report's other four main recommendations, ensure that prisoner research is as ethical as non‐prisoner research is. I explain why four problems which which may be more prevalent in prisons and which risk‐benefit constraints may seem to address – coercion, undue inducements, exploitation, and protection from harm – are in fact not solved by adding further risk‐benefit constraints on prisoner research. (shrink)

Terminally ill elderly and long-term disabled persons under our system of health care are eligible for Medicare and may qualify for the hospice care benefit. Despite such provisions, research shows that individuals still frequently do not receive the health care they need. But, as inadequate as end-of-life care can be for the general population, these inadequacies are exacerbated for individuals incarcerated in U.S. prisons and jails. Although inmates are guaranteed a basic level of health care under the Eighth Amendment (...) and Due Process Clause, they lack the mobility or freedom to choose their health care coverage, and they are dependent on an institutional system for such care. Inside prison, security and access issues affect the care inmates receive. Further, the availability of adequate clinical resources, especially for high-cost procedures, may be problematic in some jurisdictions.In addition to the practical, institutional, and legal barriers to providing and improving general end-of-life care, efforts to improve end-of-life care for prisoners may also encounter a lack of public sympathy. (shrink)

Terminally ill elderly and long-term disabled persons under our system of health care are eligible for Medicare and may qualify for the hospice care benefit. Despite such provisions, research shows that individuals still frequently do not receive the health care they need. But, as inadequate as end-of-life care can be for the general population, these inadequacies are exacerbated for individuals incarcerated in U.S. prisons and jails. Although inmates are guaranteed a basic level of health care under the Eighth Amendment (...) and Due Process Clause, they lack the mobility or freedom to choose their health care coverage, and they are dependent on an institutional system for such care. Inside prison, security and access issues affect the care inmates receive. Further, the availability of adequate clinical resources, especially for high-cost procedures, may be problematic in some jurisdictions.In addition to the practical, institutional, and legal barriers to providing and improving general end-of-life care, efforts to improve end-of-life care for prisoners may also encounter a lack of public sympathy. (shrink)

Much has been written about prisoner research and the controversies surrounding prisoners as human subjects. The Institute of Medicine recently released a report addressing some of these issues. This report, which generated further controversy, needs to be fully discussed in the literature and certain aspects are examined in this work. Further, in the body of literature there has been little acknowledgement of the concept of the right of prisoners to be involved in research. This needs to be (...) pursued from an ethical perspective and eventually a legal one. This paper explores that concept and documents some facilities in which a prisoner's right to research has occurred. (shrink)

Conducting research in a prison setting is ethically challenging. Because history is full of unethical research conducted in prison settings, researchers are often afraid of doing research in this area. It is argued that too much emphasis has been put on the protection of prison inmates as a vulnerable population. Consequently, too little research is being conducted where the focus is on those factors which serve to make the prison population vulnerable. In this paper ethical questions, (...) emerging when conducting a study on literacy and mental health among Norwegian prison inmates, are presented and discussed. Relevant questions relate to topics which include ethical clearance of the research protocol, the consent procedure, clarification of roles and the publication of the results. The ethical questions are discussed in relation to the four principles of ‘respect for the client's rights and dignity’, ‘competence’, ‘responsibility’ and ‘integrity’ set out in the meta-code of ethics, formulated by the European Federation of Professional Psychologists Associations. The wider relationships between ethics in society, research ethics in general, and ethics when conducting research in a prison setting are also considered. (shrink)

Conducting research in a prison setting is ethically challenging. Because history is full of unethical research conducted in prison settings, researchers are often afraid of doing research in this area. It is argued that too much emphasis has been put on the protection of prison inmates as a vulnerable population. Consequently, too little research is being conducted where the focus is on those factors which serve to make the prison population vulnerable. In this paper ethical questions, (...) emerging when conducting a study on literacy and mental health among Norwegian prison inmates, are presented and discussed. Relevant questions relate to topics which include ethical clearance of the research protocol, the consent procedure, clarification of roles and the publication of the results. The ethical questions are discussed in relation to the four principles of ‘respect for the client's rights and dignity’, ‘competence’, ‘responsibility’ and ‘integrity’ set out in the meta-code of ethics, formulated by the European Federation of Professional Psychologists Associations. The wider relationships between ethics in society, research ethics in general, and ethics when conducting research in a prison setting are also considered. (shrink)

Background:Prisons are contexts where nurses are required to have specific skills to ensure that, in a setting designed for the expiation of crime, prisoners receive the same type of care as anyone else. But this is not always the case, giving rise to ethical issues.Research questions:‘How do correctional nurses describe their working experience in prisons? What issues emerged?’Methodology:This is a qualitative descriptive study. Following purposive sampling, we conducted five focus groups. Thematic analysis was used to analyse the data.Participants and (...) research context:Our sample included 31 correctional nurses in seven prisons in Northern Italy.Ethical considerations:The scientific merit of this study was recognized by the Academic Board of the University of Genoa. Approval to conduct the study was obtained from the Liguria Regional Government that funded this study and from the Local Health Authority that was the prison nurses’ employer. Formal consent was obtained from all the nurses who volunteered to participate in this study.Findings:Five themes emerged from the focus groups: prisoners’ healthcare needs, negotiation between custody and care, satisfaction of working in prisons, obstacles to quality care and safety. ‘Manipulation’ was a transversal theme that emerged from all the focus groups.Discussion:The problems generated by the clash between prison security and nursing care priorities did not enable nurses to practice autonomously and provide the best possible to care prisoners, giving rise to ethical issues and moral distress. This in turn causes high nursing turnover rates that negatively impact continuum of care.Conclusion:In Italy, correctional nurses urgently require specific education interventions with the participation of all those who work in prisons. Interventions based on the post-modern concept of restorative nursing could offer prison nurses the opportunity to both resolve ethical issues and reduce moral distress. (shrink)

Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

This article poses a response to one argument supporting the force feeding of political prisoners. This argument assumes that prisoners have moral autonomy and thus cannot be force fed in the early stages of their hunger strike. However, as their fasting progresses, their cognitive competence declines, and they are no longer autonomous. Since they are no longer autonomous, force feeding becomes justified. This article questions the recurrent citation of a paper in empirical support of the claim that hunger strike causes (...) mental disorders or cognitive impairments. The paper, written by Daniel Fessler, partially relies on the Minnesota Starvation Experiment conducted in 1944 to 1945 for scientific support. Using widely accepted criteria for assessing the ethical acceptability of clinical research, we argue that the Minnesota Starvation Experiment had significant scientific shortcomings and is a case of unethical research. From this, we question the appropriateness of citing the Minnesota Starvation Experiment and consequently Fessler’s paper. If Citing Fessler’s paper becomes problematic, this particular argument for the force feeding of prisoners loses much of its strength. (shrink)

The practice of paying prisoners to for their participation in research has long been debated, and the controversy is reflected in the differing policies in the U.S. prison systems. Empirical study of financial payments to inmates who enroll in research has focused on whether this practice is coercive. In this study, we examined whether monetary incentives have the potential to be unduly influential among fifty HIV‐positive prisoners. The majority of prisoners surveyed believed that inmates should receive some compensation (...) for their involvement in research and disagreed with statements suggesting that the offer of payment constitutes undue influence. However, a sense of potentially being susceptible to undue influence was significantly higher among participants who had spent a longer time in prison and had less education. Overall, our findings suggest that most prisoners feel that they would be able to make a decision about research enrollment that is not solely based on an offer of monetary payment. (shrink)

Roughly 80,000 U.S. prisoners are held in solitary confinement at any given time. A significant body of research shows that solitary confinement has severe, long-term effects, and the United Nations has condemned the practice of solitary confinement as torture. For years, prisoners have been organizing hunger strikes in order to protest solitary confinement. But such action is not without consequences, and some inmates have suffered serious injury or death. The question I raise in this paper is whether we ought (...) to force-feed hunger striking prisoners when serious harm is imminent. Both the World Medical Association and the American Medical Association have denounced the practice of force-feeding prisoners on hunger strike, and yet, the practice is common. Such prevalence is likely a result of the tension between the person-as-patient and person-as-prisoner and cannot easily be resolved. Instead, we must take seriously the complaint that solitary confinement is inhumane and avoid placing health professionals in the position where they must choose to force-feed the prisoner against his will or not. I argue that a conventional bioethics debate centering on polarizing principles of prisoner autonomy and a duty-to-protect the prisoner from harm is an inadequate framework for this complex issue. Instead, we must examine the prisoner’s intent and his right to freedom of speech. I argue that when the prisoner’s intent is to raise awareness and communicate with others, his hunger strike is a form of speech. Protest-as-speech is constitutionally protected—even for prisoners—and remains a minimum ethical obligation for society to uphold. (shrink)

The rapidly changing field of genetics affects society through advances in health-care and through implications of genetic research. This study addresses the impacts of new genetic discoveries and technologies on different segments of today's society. The book begins with a chapter on genetic complexity, and subsequent chapters discuss moral and ethical questions arising from today's genetics from the perspectives of health care professionals, the media, the general public, special interest groups and commercial interests.

This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as law (...) and medicine, truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

Why devote an issue of an ethics journal to prison medicine? Why conduct ethics research in prisons in the first place? In this editorial, we explain why prison ethics research is vitally important and illustrate our argument by introducing and briefly discussing the fascinating papers in this special issue of the Journal of Bioethical Inquiry.Ethics is often regarded as a theoretical discipline. This is in large part due to ethics’ origin as a type (...) of moral philosophy, which is frequently associated with armchair theorising about principles and virtues and seems to have little connection with the “real world.” However, medical ethics and bioethics are increasingly becoming empirical disciplines. The “empirical turn” in ethics has led to an explosion in field research in ethics that uses the empirical methods of sociology, anthropology, and the health sciences to investigate a variety of ethical issues. The results of such research are often of much more value than purely theoret. (shrink)

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict (...) or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

Often overlooked once they are remanded to custody, incarcerated former business executives can provide valuable insight into the inner workings of organizations while also contributing to the dialogue on of business ethics within the undergraduate business curricula. This paper summarizes experiences of white collar offenders obtained through a questionnaire-based research method to elicit lessons on ethics from prisoners and to provide a unique learning experience for undergraduate business students. Data was collected from 12 questionnaire responses (n = (...) 12) which resulted in four major themes involving business ethics: core values, ethical responsibility, ethics training, and ethical culture. Narrative responses, integration of ethical decision-making research and student discoveries are included for each theme. (shrink)

Our society gives certain rights and protections to those who are punished and incarcerated, deeming them a vulnerable group in need of additional protections because they are under state control. Despite these protections, prisoners are still susceptible to mistreatment and abuse. This paper delves into one area in which prisoners are particularly vulnerable—the use of prison labor to fight wildfires in the western United States. In this paper, I first broadly discuss prison labor, before going into the current ethical principles (...) and guidelines in the field of corrections that address the treatment of prisoners and prison labor. I argue that these principles and guidelines should be augmented to help those in corrections to make decisions about what is ethical; suggesting that how researchers evaluate proposed research projects could serve as a model for decision-making. I then introduce prison fire camps, considering whether they are ethical by research ethics principles, and suggesting how they can be changed to better reflect the values professed by our society. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- (...) cause the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

The value of and the need for rich data for criminal justice research is increasingly apparent, especially following recent restrictions on primary data collection due to COVID-19. Whilst the benef...

This article examines international and European regulations on research involving prisoners for consensus, differences, and their consequences, and offers a critical evaluation of the various approaches. Agreement exists that prisoners are at risk of coercion, which might interfere with their ability to provide voluntary informed consent to research. Controversy exists about the magnitude of this risk and the consequences that should follow from this risk. Two strategies are proposed for a method of protecting prisoners that does not lead (...) to discrimination: first, more caution to assure non-coerced consent and second, restrictions on the type of research. Most regulations stress the importance of the principle of equivalence of healthcare in places of detention as part of an efficient protection against research risks and discrimination. All the presented approaches have shortcomings. While 'over-use' of prisoners for research as compared to the general population is ethically unjustified, not granting prisoners access to studies beneficial to their own health because of over-strict regulations is equally unjustified. A middle solution should be preferred, one that grants a minimum of protection together with the lowest possible barriers. Research that does not entail a direct benefit for the individual detainee should be restricted to types of research that have a benefit for detainees as a group and that are of low risk. What will ultimately protect prisoners best, while producing the greatest benefit for them, is access to the same healthcare available to members of the community including research as a true option. (shrink)

Bowman-Smart et al. (2023) argue for a framework to examine the ethical issues associated with genetic screening for non-medical traits in the context of noninvasive prenatal testing (NIPT). Such s...

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 20 Heft: 1 Seiten: 237-240.

The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some (...) less so. For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, medical research on (...) human subjects is in the best interest of the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to experimentation on subjects from these groups. In the light of current initiatives for law reform pertaining to research ethics the world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have been devoted to epidemiological research and related issues. (shrink)

ABSTRACT The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and (...) some less so. For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold (...) out direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Research Ethics after World War II: The Insular Culture of BiomedicineAllan M. Brandt (bio) and Lara Freidenfelds (bio)Human subjects research in the United States has only recently emerged as an important area of historical investigation. Over the last quarter century, scholars have begun the process of grounding within an historical context both the complex relationship between researchers and subjects and the processes by which biomedical knowledge (...) is produced. Their studies examine topics ranging from the impact of the anti-vivisectionist movement on human experimentation in the early twentieth century (Lederer 1995) to the development of the discipline of bioethics in the 1960s and 1970s (Rothman 1991) and the emergence of the legal concept of informed consent for human research (Katz, Glass, and Capron 1972). Many of the discussions focus on isolated incidents of scandal, such as the Tuskegee Syphilis Study (Jones 1993; Brandt 1978) and the Willowbrook School hepatitis study (Rothman and Rothman 1984). In doing so, they attempt to explain how such clearly unethical research could have been initiated and what consequences have resulted from public knowledge of such research.Nonetheless, the broader historical contexts and implications of human subjects research have yet to be fully delineated. This project will be of crucial importance, not only for historians, but also for those concerned with research policy and medical ethics. The historical examination of human subjects research will provide further insight into the details of research methods, the construction of protocols, and the historically specific interest in certain diseases. In addition, scholars will better understand the relationships of power and authority between researcher and subject, as well as the social and scientific mechanisms for the production of new biomedical knowledge. The process of enlisting research subjects illuminates the significance of class, gender, ethnicity, and race in science, in biomedicine, and in society. The fact that, historically, much research has employed research subjects from vulnerable populations, who participated in coercive contexts, has exposed powerful social assumptions embedded in the research enterprise. [End Page 239]The revelation of new documents indicating past abuses has sparked much of the investigation into human subjects research and the recent investigation of human radiation experiments during the Cold War era. One of the most important achievements of the Advisory Committee on Human Radiation Experiments was the uncovering of thousands of documents, a remarkable mine of archival data, that had been previously inaccessible to researchers. Jonathan Moreno and Susan Lederer’s article on the history of Cold War research ethics in this issue of the Kennedy Institute ofEthics Journal represents the first attempt since the publication of the Committee’s Final Report to analyze the Committee’s findings in a serious historical context.Historical accounts of the emergence of bioethics traditionally have left a great void in their discussions of human experimentation, generally ignoring the period between the writing of the Nuremberg Code in 1947 and the publication of Henry Beecher’s 1966 New England Journal ofMedicine article condemning systematic, unethical practices in human experimentation (Rothman 1991). The period from 1946 to 1966, however, was a time of vigorous research characterized by a fragmented community of medical researchers who applied inconsistent ethical standards and employed highly variable research practices. Both military and civilian medical researchers were intensely interested in radiation and thus conducted human subjects research along those lines, including examinations of the effects of plutonium injections and of total body irradiation, the use of trace radioisotopes to study various body processes, and observations of the effects of radiation intentionally released into the environment. The U.S. Government sponsored several thousand such studies (ACHRE 1995 [GPO, pp. 227–31; Oxford, pp. 135–38]), some of which were conducted on hospital patients, institutionalized children, military personnel, and prisoners. The Cold War scientific culture that produced this research must be examined from an historical ethical perspective.A central aspect of the culture of biomedical science after World War II was its insularity. Increasingly high standards of admission and challenging training had come to ensure that only a select group of individuals was admitted to the professions of medicine and research science. In this culture of experts, trustworthiness and ethical judgment were considered to be dependent upon expertise... (shrink)

Ethics and Educational Research: An Introduction Robert G. Burgess Ethical questions are the subject of interdisciplinary discussions and debates. ...

The human subjects researchmodel is increasingly invoked in discussions ofethics for Internet research. Here we seek toquestion the widespread application of thismodel, critiquing it through the two themes ofspace and textual form. Drawing on ourexperience of a previous piece ofresearch, we highlightthe implications of re-considering thetextuality of the Internet in addition to thespatial metaphors that are more commonlydeployed to describe Internet activity. Weargue that the use of spatial metaphors indescriptions of the Internet has shaped theadoption of the human subjects (...) research model.Whilst this model is appropriate in some areasof Internet research such as emailcommunication, we feel that researchers, whennavigating the complex terrain of Internetresearch ethics, need also to consider theInternet as cultural production of texts. (shrink)

The social sciences playa variety of multifaceted roles in the policymaking process. So varied are these roles, indeed, that it is futile to talk in the singular about the use of social science in policymaking, as if there were one constant relationship between two fixed and stable entities. Instead, to address this issue sensibly one must talk in the plural about uses of dif ferent modes of social scientific inquiry for different kinds of policies under various circumstances. In some cases, (...) the influence of social scientific research is direct and tangible, and the connection between the find ings and the policy is easy to see. In other cases, perhaps most, its influence is indirect-one small piece in a larger mosaic of politics, bargaining, and compromise. Occasionally the findings of social scientific studies are explicitly drawn upon by policymakers in the formation, implementation, or evaluation of particular policies. More often, the categories and theoretical models of social science provide a general background orientation within which policymakers concep tualize problems and frame policy options. At times, the in fluence of social scientific work is cognitive and informational in nature; in other instances, policymakers use social science primarily for symbolic and political purposes in order to le gitimate preestablished goals and strategies. Nonetheless, amid this diversity and variety, troubling general questions persistently arise. (shrink)

In Britain doctors and others concerned with the treatment of offenders in prison may consult the Butler Report (see Focus, pp 157) and specialist journals, but these sources are concerned with the system in Britain only. In America the situation is different, both in organization and in certain attitudes. Dr Peter L Sissons has therefore provided a companion article to that of Dr Paul Bowden (page 163) describing the various medical issues in prisons. The main difference between the treatment of (...) offenders in prisons in America and in Britain lies in the nature of the federal system which means that each state may operate a different system in a variety of prisons and prison medical services are as various. Nationally, the prison systems are 'structured to treat and cure the offender'. Therefore it follows that the prison medical officer is only one of the professionals concerned with this 'cure' of the offender. This principle also applies to any form of research: medical research in prisons is part of a programme which covers a wide field of social and judicial research. The prison medical officer (where there is one) has of course to look after sick prisoners, and the American idea of 'cure' is also expressed in the need for more corrective surgery where, for example, it is necessary to remove physical impediments to social rehabilitation. But a doctor is only found on the staff of those institutions which are large: in the smaller prisons there may be only first-aid facilities, and no specially appointed doctor in the community. Moreover medicines are often dispensed by medical auxiliaries who are sometimes prisoners themselves. Finally, in America prisoners are regularly invited to volunteer as subjects for medical and social research for which they are paid. In short, although it is hoped to 'cure' a prisoner he is a criminal first and a patient second. (shrink)

Rising numbers of ageing prisoners and goals on implementing equivalent health care in prison raise issues surrounding end-of-life care for prisoners. The paucity of research on this topic in Europe means that the needs of older prisoners contemplating death in prison have not been established. To investigate elderly prisoners’ attitudes towards death and dying, 35 qualitative interviews with inmates aged 51 to 71 years were conducted in 12 Swiss prisons. About half of the prisoners reported having thought about dying (...) in prison, with some mentioning it in relation with suicidal thoughts and others to disease and old age. Themes identified during data analysis included general thoughts about death and dying, accounts of other prisoners’ deaths, availability of end-of-life services, contact with social relations, and wishes to die outside of prison. Study findings are discussed using Allmark’s concept of “death without indignities,” bringing forth two ethical issues: fostering autonomy and removing barriers. Attributing the identified themes to these two ethical actions clarifies the current needs of ageing prisoners in Switzerland and could be a first step towards the implementation of end-of-life services in correctional systems. (shrink)

Restricting a person’s liberty presents society with many inherent ethical challenges. The historical purposes of confinement have included punishment, penitence, containment, rehabilitation, and habilitation. While the purposes are indeed complex, multifaceted, and at times ambiguous or contradictory, the fact of incarceration intrinsically creates many ethical challenges for psychiatrists working in correctional settings. Role definition of a psychiatrist may be ambiguous, with potential tensions between forensic and therapeutic demands. Privacy may be limited or absent and confidentiality may be compromised. Patient autonomy (...) may be threatened to address real or perceived security concerns. Care delivery may actually have harmful consequences in court cases for pretrial detainees or lethal consequences for those under a death sentence. An absence of data and targeted research hampers the development of evidence-based care delivery for the disenfranchised, understudied, and disproportionately ill prisoner population. In this review paper, I discuss a few of the challenges and dilemmas routinely faced and present a series of questions. Where feasible, proposed resolutions are offered. (shrink)

Purpose This article aims to describe the personal experience and ethical dilemmas that the author encountered when conducting qualitative research on a highly sensitive topic, i.e. interviews with offenders convicted of child pornography. Design/methodology/approach This study uses an autoethnographic approach to describe and reflect on my personal experience, emotions and ethical dilemmas when undertaking sensitive research that examines illegal acts. Findings Ethical dilemmas and emotional challenges highlighted refer to the issue of access to useful empirical material, conducting interviews (...) with convicted offenders in prison environments, the complexity surrounding confidentiality when interviewing offenders about their criminal activities, vulnerability and insecurity for the researcher and emotional challenges for the researcher when listening to the offenders’ stories describing serious crimes against children. Originality/value This article contributes with insights and reflections on conducting qualitative research with a marginalized and stigmatized group in prison environments. (shrink)

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

Schools of economic ethics inspired by Buchanan propose viewing ethical conflicts as prisoners’ dilemmas to facilitate solutions based on Pareto-improving institutional changes. Given that healthcare is determined by complex institutional arrangements, it has been claimed that this approach is also suitable for business ethics in healthcare. To scrutinize this claim, this research systematically searched for studies reporting PD structures in healthcare. PubMed, EconLit, and EconBiz were searched to find articles in German and English. Study type, characteristics of (...) the game, and the proposed means to overcome the dilemma were extracted and analyzed for aspects supporting or challenging the claim. Across 53 studies, 68 descriptions of various dilemmas in healthcare and public health were identified. Many authors successfully developed proposals for institutional change to overcome these dilemmas. However, many of these analyses exhibited limitations such as oversimplifications or inconsistencies. Also, the quality of evidence on both the characteristics of dilemmas and the effectiveness of proposed solutions was very poor. The subsamples of studies that explicitly cited the ethical approach were disjunct from those that applied empirical methods to analyze the dilemmas. The large number of identified PDs indicates that economic ethics is relevant to healthcare. However, there is a need for further evidence to substantiate both the descriptive and prescriptive claims of this ethical theory. It should thus be seen as a complement that needs justification, rather than a substitute superior to other ethical frameworks. (shrink)