In this article, it is claimed that the protective provisions for adults with impaired decision-making capacity are misguided, insofar as they do not conclusively state whether research on this group should be permitted only as an exception, and as they arbitrarily allow for some groups to benefit from such research while others will not. Moreover, the presumed or former will of the subject is given insufficient weight, and the minimal risk standard does not make sense in this context. (...) Because of these problems, the present guidelines allow for the possibility of vulnerable people being exploited, something that is hidden behind a guise of solidarity. Instead we need to address the real issues at stake by rewriting the present statutes. It is suggested that new guidelines should be in some continuity with earlier efforts. However, in order to protect these subjects there is additional need for appointed representatives who monitor research and for legal obligations to compensate for any injuries suffered. Without these or similar measures we won't have an adequate system in place for the protection of non-benefiting persons who are unable to consent to research. (shrink)
OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with (...) regard to one of the leaflets. CONCLUSION: The results show that both readability and understanding can be improved by increased attention to the linguistic features of the information. (shrink)
Drawing on Lennart Nordenfelt’s distinction between the four distinct senses of dignity, I elucidate the meaning of dignity in the context of research involving human subjects. I acknowledge that different interpretations of the personal senses of dignity may be acceptable in human subject research, but that inherent dignity (Menschenwürde) is not open to interpretation in the same way. In order to map out the grounds for interpreting dignity, I examine the unique application of the principle of respect (...) for dignity in Canada’s research ethics guidelines. These guidelines are unique because they consider dignity to be a foundational concept and the protection of the dignity of researchsubjects is regarded as a measure that prevents “the impoverishment of humanity as a whole”. While the conception of humanity invoked here is incomplete, Canada’s research ethics guidelines nevertheless represent a more European approach to biomedical policy. Finally, in order to correct a pervasive blind spot in contemporary policy on research involving human subjects, I sketch a functional model for attributing inherent dignity that avoids the untenable connotations of speciesism. (shrink)
As Internet resources are usedmore frequently for research on social andpsychological behavior, concerns grow aboutwhether characteristics of such research affecthuman subjects protections. Early efforts toaddress such concerns have done more toidentify potential problems than to evaluatethem or to seek solutions, leaving bodiescharged with human subjects oversight in aquagmire. This article critiques some of theseissues in light of the US Code of FederalRegulations' policies for the Protection ofHuman Subjects, and argues that some of theissues have no (...) pertinence when examined in thecontext of common methodological approachesthat previous commentators failed to consider. By separating applicable contexts from thosethat are not, and by identifying cases wheresubjects' characteristics are irrelevant and/orimpossible to provide, oversight committees maybe able to consider research applications moreappropriately, and investigators may be lessethically bound to ascertain and demonstratethose characteristics. (shrink)
Offering cash payments to researchsubjects is a common recruiting method but there is significant debate about whether and in what amount such payments are appropriate. This paper is concerned with exploitation and whether there should be a lower limit on the amount researchers can pay their subjects. When subjects participate in research as a way to make money, fairness requires that researchers pay them a fair wage. This call for the establishment of a lower (...) limit meets resistance in two places: (1) denial that the payments offered by researchers are wages for participation; and (2) concern about undue inducement. This paper critically examines these arguments for and against a lower limit. It shows that the need for a lower limit cannot be avoided by adopting a non-wage payment model and that concerns about undue inducement are unjustified in all trials except those that present greater than minimal risk. This analysis suggests the following compromise position: there should be an unconditional lower limit on payment amounts so that researchers cannot offer less than a fair wage, and when researchers cannot satisfy this limit because fairness requires a problematically large payment, then researchers should offer no payment at all. (shrink)
The protection of human researchsubjects in clinical studies is regulated by international guidelines and national laws. Research Ethics Committees play an important role here, as they review the documentation for clinical studies under consideration of ethical aspects. This documentation includes an exclusion or wash-out period which designates when study subjects may not have participated in another study or be allowed to take part in a future one within a specified time period. However not all (...) class='Hi'>researchsubjects comply with their applicable exclusion period. This prohibited multi-participation in clinical studies is known as ‘research subject tourism,’ ‘clinical study overlapping’, or ‘guinea-pigging’. This practice brings with it additional risks for the research subject and the integrity of the research being conducted. No comprehensive data are available to demonstrate exactly how many researchsubjects participate in overlapping multiple studies. However, the number of them who ‘travel’ from one study to another seems to be significant. Preventing this practice is a matter of concern for ethics committees, but the responsibility for protecting researchsubjects in this respect apart from approving the ethics of a wash-out period and recruiting from a specific pool or database of patients is solely that of the investigating physician. But how can the investigating physician be certain that a research subject complies with their exclusion period? An international data bank for researchsubjects who have participated, or are participating, in clinical studies, is a measure that would serve to prevent prohibited multi-participation in clinical studies and thereby protect the research subject, the investigating physician and their institution. VIP Check, International, which was founded by the author in 1990, is an example of such a data bank. This article examines the existence of prohibited multi-participation in clinical studies, the additional risk this practice of itself poses to the researchsubjects and the integrity of clinical studies, and how this practice might best be reduce or even eliminated through use of an international data bank of researchsubjects such as that of VIP Check. (shrink)
There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to researchsubjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of researchsubjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence (...) of payments on researchsubjects' behaviour and risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort researchsubjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)
The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. (...) Because very few subjects with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the costs associated with their injuries, most injured subjects must shoulder the burden of those expenses alone. For 40 years, national advisory panels have concluded that this result is out of step with the Common Rule's otherwise protectionist promise. When the Department of Health and Human Services released an Advance Notice of Proposed Rulemaking (ANPRM) in 2011, suggesting potential changes to the Common Rule, the time seemed ripe to address research-related injuries. The ANPRM, however, makes no mention of compensation for research-related injuries, and the federal government once again seems poised to stop short of addressing what has arguably become the most longstanding, frequent, and consistent plea for regulatory reform of research: protections for injured subjects. This article asks why, despite decades of federal-level panels recommending no-fault compensation for research-related injuries, the United States has so strongly resisted change. I suggest that a central reason for our current impasse is that, despite consensus among federal advisory committees that there is an obligation to compensate injured subjects, the committees have not coalesced around a moral justification for that duty. Although multiple justifications can support and even strengthen a single ethical obligation, the reverse has occurred in this context. I demonstrate that the committees' articulation of multiple ethical principles – including humanitarianism, professional beneficence, and compensatory justice – results in incongruent obligations that favor different kinds of compensation systems. This outcome, which I call “moral gridlock,” makes it extremely difficult to determine what kind of compensation scheme to implement. Recognizing that each moral argument for compensation creates a slightly different trajectory is, however, an important first step in moving toward a more systematic approach to compensating injured researchsubjects. (shrink)
Professional standards in medicine and psychology treat concurrent sexual relationships with patients as violations of fiduciary trust, and they sometimes rule out sexual relationships even after a clinical relationship is over. These standards also rule out sex with researchsubjects who are also patients, but what about nonclinical relationships where there are not always parallels to the standards of clinical medicine? One way to treat sex in nonclinical research relationships is to treat it as sex is treated (...) elsewhere among adults, as a matter of individual choice and responsibility. Alternately, one could ask oversight bodies to draw lines between research that can safely accommodate sexual relationships and research that cannot. One could even ask researchers to avoid all concurrent sexual relationships with their research participants, as happens in clinical medicine. Each of these options has drawbacks that undermine its value as a definitive solution. The deficiencies of these options highlight the need for a professional code of conduct for nonclinical researchers. (shrink)
Offering cash payments to researchsubjects is a common recruiting method, but this practice continues to be controversial because of its potential to compromise the protection of human subjects. Federal regulations and guidelines currently allow researchers to pay subjects for participation, but they say very little about how much researchers can pay their subjects. This paper argues that the federal regulations and guidelines should implement a standard payment formula. It argues for a wage payment model, (...) and critically examines three candidates for a base wage: the nonfarm production wage, the FLSA minimum wage, and a living wage. After showing that the nonfarm production wage is too high to satisfy ethical criteria, and the minimum wage is too low, this paper concludes that the wage payment model with a base wage equivalent to a living wage is the best candidate for a standard payment formula in human subjectsresearch. (shrink)
: In light of information uncovered about human radiation experiments conducted during the Cold War, an important charge for the Advisory Committee on Human Radiation Experiments was to assess the current state of protections for human researchsubjects. This assessment was designed to enhance the Committee's ability to make informed recommendations for the improvement of future policies and practices for the protection of researchsubjects. The Committee's examination of current protections revealed great improvement over those from (...) the past, yet some problems remain. Although the data collected by the Committee highlight specific areas in need of attention, the Committee's work should be viewed in part as the beginning of a series of ongoing assessments of the adequacy and effectiveness of the protections afforded to human subjects. (shrink)
Study objectives The emergency department (ED) provides an arena for patient enrolment into a variety of research studies even for non-critically ill patients. Given the types of illness, time constraints and sense of urgency that exists in the ED environment, concern exists about whether researchsubjects in the ED can provide full consent for participation. We sought to identify enrolled researchsubjects' perspectives on the informed consent process for research conducted in the ED. Methods (...) This was a prospective, observational study of ED subjects, 18 years or older, who had been approached to participate in research in the ED and who were judged to have decision-making capacity. Exclusions were critical illness and refusal to participate. Subjective were followed up within 1 week after enrolling using structured phone interviews by trained interviewers. Results During the study period, 229 eligible patients were approached to participate in both a target study and this study. Of these, 66% (150/229) agreed to participate in this study, at least to the extent of allowing us access to their demographic data. The study participant group was similar in terms of gender to this particular ED's patient population but had significantly more African-Americans and persons older than 45. Conclusion Despite rigorous time constraints and rapid throughput times, the majority of subjects who consented to research participation in the ED felt that they were sufficiently informed and had adequate time to decide to participate. (shrink)
The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for (...) biomedical research involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (shrink)
It is widely agreed that clinical research should satisfy a number of ethical requirements. These include requirements to address a valuable question, to select subjects fairly, and to pose appropriate risks. In contrast, there remains considerable debate over the ethical relevance of investigator intentions: Does it matter ethically whether investigators intend to collect generalizable knowledge or to benefit subjects, or both? Some commentators do not mention investigator intentions when evaluating what makes clinical research ethical (Emanuel, Wendler, (...) and Grady 2000). Others regard investigator intentions as central to the ethics of clinical research (Jonas 1969). These commentators argue that .. (shrink)
Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1–8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65–81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75–98, 2010) and “sham” surgery (Macklin in N Engl J Med 341:992–996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research (...) is more than minimal risk with no promise of direct benefit. The principal reason given for allowing research that is more than minimal risk without benefit is that we should respect the autonomy of competent subjects. I argue that though the moral intuitions informing respect for autonomy are sound, there is another set of intuitions regarding what we take to be just treatment of another when one agent knowingly causes or allows suffering on another agent. I argue that concerns generated by commutative justice serve as limitations on permissible research. I highlight our intuitions informing this notion of justice by appealing to work done on theodicy; what counts as a morally sufficient reason for God to allow suffering in humans is applicable also to the researcher-subject relationship. I conclude that all human subjects who are exposed to more than minimal risk research should enjoy the same actual protections (e.g., subpart D) as those given subjects who cannot consent. (shrink)
This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research.
Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring “additional protections,” often referred to as “vulnerable populations.” The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential researchsubjects needing additional protections. In (...) this paper, I assess critically the role of this categorization of pregnant women involved in research as “vulnerable,” both as separate entities and in combination with the fetuses they carry. In particular, I do three things: (1) demonstrate that pregnant women qua pregnancy are either not “vulnerable” according to any meaningful definition of that term or that such vulnerability is irrelevant to her status as a research participant; (2) argue that while a fetus may be vulnerable in terms of dependency, this categorization does not equate to the vulnerability of the pregnant woman; and (3) suggest that any vulnerability that appends to women is precisely the result of federal regulations and dubious public perceptions about pregnant women. I conclude by demonstrating how this erroneous characterization of pregnant women as “vulnerable” and its associated protections have not only impeded vital research for pregnant women and their fetuses, but have also negatively affected the inclusion of all women in clinical research. (shrink)
Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous (...)research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)
Both international and federal regulations exist to ensure that scientists perform research on human subjects in an environment free of coercion and in which the benefits of the research are commensurate with the risks involved. Ensuring that these conditions hold is difficult, and perhaps even more so when protocols include the issue of monetary compensation of researchsubjects. The morality of paying human researchsubjects has been hotly debated for over 40 years, and (...) the grounds for this debate have ranged from discussion of legal rights, economic rights, philosophical principles of vulnerability and altruism to bioethical concepts of consent, best-interest determination, and justice theory. However, the thought surrounding these issues has evolved over time, and the way we think about the role of the human research subject today is markedly different than the way we thought in the past. Society first thought of the research subject as an altruist, necessarily giving of his time to benefit society as a whole. As time progressed, many suggested that the subject should not need to sacrifice himself for research: if something goes wrong, someone should compensate the subject for injuries. The concept of redress evolved into a system in which subjects were offered money as an inducement to participate in research, sometimes merely to offset the monetary costs of participation, but sometimes even to mitigate the risks of the study. This article examines ethical and legal conversations regarding compensation from the 1960s through today, examining theories of the ethics of compensation both comparatively and critically. In conclusion, we put forward an ethical framework for treating paid researchsubjects, with an attempt to use this framework as a means of resolving some of the more difficult problems with paying human subjects in research. (shrink)
There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. Previous work on determining whether incentives are unethical considers them as a form of undue influence or coercive offer. We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. By doing so we find that, for the most part, the use of incentives to recruit and retain researchsubjects is innocuous. But (...) there are some instances where it is not. Specifically, incentives become problematic when conjoined with the following factors, singly or in combination with one another: where the subject is in a dependency relationship with the researcher, where the risks are particularly high, where the research is degrading, where the participant will only consent if the incentive is relatively large because the participant's aversion to the study is strong, and where the aversion is a principled one. The factors we have identified and the kinds of judgments they require differ substantially from those considered crucial in most previous discussions of the ethics of employing incentives in research with human subjects. (shrink)
This study examined the quality of children's assent to a clinical trial. In subjects younger than 9 years of age, understanding of most aspects of the study was found to be poor to non-existent. Understanding of procedures was poor in almost all subjects. In addition, voluntariness may have been compromised in many subjects by their belief that failure to complete the study would displease others. If the fact that a child's assent has been obtained is used to (...) justify the exposure of that child to the potential harm of a non-therapeutic blood sample, the assent must be meaningful. In the nutrition study observed here, the quality of the assent of children younger than 9 years of age was very poor. The assent therefore did not provide a valid justification for requesting a blood sample from these children. This study indicates that most children younger than 9 years of age cannot be expected to consent or assent to clinical research in a meaningful way. The current age of 7 years for initiating assent (in addition to parental consent) is possibly not appropriate and should be reconsidered. (shrink)
All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjectsresearch and guidelines instituted since World War II. It then covers various stages and components of the clinical (...) trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)
Research involving children or other incompetent subjects who are deemed unable to provide informed consent is complex, particularly in the case of research that does not directly benefit the researchsubjects themselves. The Helsinki Declaration, the World Medical Association's landmark document for research ethics, therefore states that incompetent researchsubjects must not be included in such research unless it entails only minimal risk and minimal burden. In this paper, we argue that (...) now that research in these groups is expected to expand, this undifferentiated minimal risk and burden requirement does not suffice any more. In the upcoming revision of the Declaration, the paragraph at stake should be refined in such a way that it is not unnecessarily restrictive or more permissive than can be ethically justified. Our first recommendation is to stimulate research ethics committees to identify more accurately those risks and burdens that the researchsubjects must undergo solely for research purposes by distinguishing between two types of study procedures instead of between two types of studies. Our second recommendation is to allow for exceptions to the minimal risk and burden requirement in cases of exceptionally valuable studies that involve subjects who can give their assent to participate in the study and that involve at most a minor increase over minimal risk and/or burden. (shrink)
Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there (...) is insufficient provision in the current patient guidelines of the Association of the British Pharmaceutical Industry, since they make "no legal commitment" to paying compensation for injury to patient subjects. There is a need for the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable. (shrink)
This paper addresses the growing concern over violation of research ethics in marketing, in particular rights of human subjects in fieldwork, notably the right to informed consent; right to privacy and confidentiality; and right not to be deceived or harmed as a result of participation in a research. The paper highlights the interaction of the three main parties involved in most marketing research: the sponsoring organization (client or user), researcher, and participant in the survey, focusing on (...) researcher’s ethical responsibilities in interacting with human subjects in surveys. The paper stresses the importance of ethical integrity in marketing research and emphasizes the need to establish a universal model for regulatory requirements and well institutionalized practice of ethical research. (shrink)
Human beings with diminished decision-making capacities are usually thought to require greater protections from the potential harms of research than fully autonomous persons. Animal subjects of research receive lesser protections than any human beings regardless of decision-making capacity. Paradoxically, however, it is precisely animals’ lack of some characteristic human capacities that is commonly invoked to justify using them for human purposes. In other words, for humans lesser capacities correspond to greater protections but for animals the opposite is (...) true. Without explicit justification, it is not clear why or whether this should be the case. Ethics regulations guiding human subject research include principles such as respect for persons—and related duties—that are required as a matter of justice while regulations guiding animal subject research attend only to highly circumscribed considerations of welfare. Further, the regulations guiding research on animals discount any consideration of animal welfare relative to comparable human welfare. This paper explores two of the most promising justifications for these differences␣between the two sets of regulations. The first potential justification points to lesser moral status for animals on the basis of their lesser capacities. The second potential justification relies on a claim about the permissibility of moral partiality as␣found in common morality. While neither potential justification is sufficient to justify the regulatory difference as it stands, there is possible common ground between supporters of some regulatory difference and those rejecting the current difference. (shrink)
This paper explores the vulnerability of Latin American human subjects, and how their vulnerability is ignored due to the complexities and inconsistencies of oversight committees and institutional policies. Secondly, the concept of apology is examined and its meaning to victims of past research abuses.
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 (...)subjectsresearch 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)
Preventing exploitation in human subjectsresearch requires a benchmark of fairness against which to judge the distribution of the benefits and burdens of a trial. This paper proposes the ideal market and its fair market price as a criterion of fairness. The ideal market approach is not new to discussions about exploitation, so this paper reviews Wertheimer's inchoate presentation of the ideal market as a principle of fairness, attempt of Emanuel and colleagues to apply the ideal market to (...) human subjectsresearch, and Ballantyne's criticisms of both the ideal market and the resulting benchmark of fairness. It argues that the criticism of this particular benchmark is on point, but the rejection of the ideal market is mistaken. After presenting a complete account of the ideal market, this paper proposes a new method for applying the ideal market to human subjectsresearch and illustrates the proposal by considering a sample case. (shrink)
Through the continuous investigation of humans in organizations, we have learned much about motivation, attitudes, and performance. For example, Yukl and others have helped increase our understanding of influence tactics and the effect they have on the performance of subordinates, supervisors, and peers. Some tactics (and combinations of tactics) lead to resistance, some lead to compliance, and some lead to commitment. In this study, we raise the question of whether or not we incorporate our knowledge of these research findings (...) into the design, implementation, and interpretation of our own research studies that require the participation of human subjects. In a survey of 134 subjects from a previous social science study, we found that performance varied across the sample, consistent with the concepts of resistance, compliance, and commitment. In addition, the variance in performance could be explained, in part, by task interest and perceived task demands. Implications are discussed. (shrink)
The use of experimental animals, mostly rodents, in biomedical research and especially in oncology and immunology should be acknowledged with respect, recognizing the contribution of animal experimentation in the fascinating scientific progress in these disciplines of research. It is an obligation of the investigator to justify the scientific and ethical aspects of each study requiring the use of animals. The international guiding principles for using animals in biomedical research are well defined and have been distributed worldwide by (...) the International Council for Laboratory Animal Science (ICLAS) since 1956, when this Organization was founded. In Poland the ICLAS philosophy and principles are highly respected and were implemented firstly by the members of the Commission on Biology of Experimental Animals appointed in 1962 by the Department of Medical Science of the Polish Academy of Science in Warsaw. Animal Protection Acts, first proclaimed in 1928 were gradually modified and improved. Actual legislation (enacted in 1997, 2003 and 2005) is consistent with EU Directives (86/609/EEC) and follows the internationally recommended principles that include ICLAS guidelines concerning animal welfare and care condition in biomedical research. The problem of “alternative methods” is briefly discussed. Dr. Donald Boisvert, CCAC — Canadian Council on Animal Care. (shrink)
The contemporary system of prospective oversight of human subjectsresearch has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.
This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjectsresearch: 1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)? 2. What conceptual framework should guide the ethical analysis of risk? 3. What changes to U.S. regulations would the implementation of such a framework require?
Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devasting conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider (...) to what extent these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions. (shrink)
In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews (...) and document analysis to study how and why 11 US institutions have set up their monitoring programmes. Although these programmes varied considerably, we were able to distinguish two general types. ‘Compliance’ programmes on the one hand were part of the institutional review board office and set up to ensure compliance with regulations. Investigators’ participation was mandatory. Monitors focused on documentation. Investigators could be disciplined, and could be obliged to take corrective actions. ‘Quality-improvement’ programmes on the other hand were part of a separate office. Investigators requested to be monitored. Monitors focused more on actual research conduct. Investigators and other parties received feedback on how to improve the research process. Although both types of programmes have their drawbacks and advantages, we argue that if institutions want to set up monitoring programmes, quality improvement is the better choice: it can help foster an atmosphere of trust between investigators and the institutional review board, and can help raise the standards for the protection of human subjects. (shrink)
Objectives The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries. Methods In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug (...) tests were surveyed by questionnaires. Results The CFs of medical researches in public hospitals with ethics committees in Shanghai were generally acceptable. However, there were some defects in the CFs. Although most of the surveyed PIs had correct recognition of informed consent, some processes of informed consent were not in accordance with generally accepted requirements. A large number of the PIs considered the greatest difficulty with informal consent was lack of correct recognition of subjects or legally authorised representatives on medical research. Discussion Informed consent in medical research should consider the research ethics, the background of potential subjects, the local resources and culture of medical research. In addition, special protection is needed for student subjects in informed consent as well as efforts for building and restoring the public's trust in biomedical research. Conclusion The informed consent in Shanghai's public hospitals with ethics committees was generally acceptable and the achievement of adequate informed consent is influenced by many factors. (shrink)
The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjectsresearch (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR (...) provides an occasion to think systematically about appropriate oversight, especially early in the evolution of a technology, when hazard and risk information may remain incomplete. This paper presents the consensus recommendations of a multidisciplinary, NIH-funded project group, to ensure a science-based and ethically informed approach to HSR issues in nanomedicine, and to integrate HSR analysis with analysis of occupational, bystander, and environmental concerns. We recommend creating two bodies, an interagency Human SubjectsResearch in Nanomedicine (HSR/N) Working Group and a Secretary's Advisory Committee on Nanomedicine (SAC/N). HSR/N and SAC/N should perform 3 primary functions: (1) analysis of the attributes and subsets of nanomedicine interventions that raise HSR challenges and current gaps in oversight; (2) providing advice to relevant agencies and institutional bodies on the HSR issues, as well as federal and federal-institutional coordination; and (3) gathering and analyzing information on HSR issues as they emerge in nanomedicine. HSR/N and SAC/N will create a home for HSR analysis and coordination in DHHS (the key agency for relevant HSR oversight), optimize federal and institutional approaches, and allow HSR review to evolve with greater knowledge about nanomedicine interventions and greater clarity about attributes of concern. (shrink)
In the mid-1990s, the Internet rapidly changedfrom a venue used by a small number ofscientists to a popular phenomena affecting allaspects of life in industrialized nations. Scholars from diverse disciplines have taken aninterest in trying to understand the Internetand Internet users. However, as a variety ofresearchers have noted, guidelines for ethicalresearch on human subjects written before theInternet's growth can be difficult to extend toresearch on Internet users.In this paper, I focus on one ethicalissue: whether and to what extent to (...) disguisematerial collected online in publishedaccounts. While some people argue thatvulnerable human subjects must always be madeanonymous in publications for their ownprotection, others argue that Internet usersdeserve credit for their creative andintellectual work. Still others argue thatmuch material available online should betreated as ``published.'' To attempt to resolvethese issues, I first review my own experiencesof disguising material in research accountsfrom 1992 to 2002. Some of the thorniestissues emerge at the boundaries betweenresearch disciplines. Furthermore, manyhumanities disciplines have not historicallyviewed what they do as human subjectsresearch. Next, I explore what it means to do humansubjects research in the humanities. Inspiredby issues raised by colleagues in thehumanities, I argue that the traditional notionof a ``human subject'' does not adequatelycharacterize Internet users. A useful alternatemental model is proposed: Internet users areamateur artists. The Internet can be seen as aplayground for amateur artists creatingsemi-published work. I argue that thisapproach helps make some ethical dilemmaseasier to reason about, because it highlightskey novel aspects of the situation,particularly with regard to disguisingmaterial. Finally, I conclude by proposing aset of practical guidelines regardingdisguising material gathered on the Internet inpublished accounts, on a continuum from nodisguise, light disguise, moderate disguise, toheavy disguise. (shrink)
: The model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants for it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The ethical review of research needs to take seriously the particularities of the research context as well as the situations of potential participants. A variety of conclusions (...) are drawn for changes to the system for ethical review. Most significant is a call for effective consultation with the various communities affected by research and greater reliance on subject representatives. Also proposed is national review for selected research. (shrink)
Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results (...) of an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other sponsored by POG, covering a twenty-year time span are presented. The POG trials had far fewer eligibility criteria than the NSABP studies, suggesting that large numbers of criteria may not be necessary for high quality research. In the third chapter, the impact of subjective eligibility criteria on enrollment and investigator uncertainty is explored. Subjective criteria were associated with more variable enrollment decisions and greater uncertainty. Such criteria represent a threat to the validity, conduct and interpretation of trials and, therefore, should only be included when carefully justified. The fourth chapter examines the accuracy of the reporting of eligibility criteria in sets of corresponding study protocol, methods paper, journal article, and Clinical Alert. Important information is lost at each step in the dissemination of study results. Unnecessary criteria ought to be dropped at a trial's inception; all other criteria must be reported faithfully. The fifth chapter attempts to provide a comprehensive philosophical account of just selection procedures for clinical research using the political philosophy of Michael Walzer. The sixth, and last, chapter, discusses explanatory and pragmatic approaches to clinical trial design, overlapping scientific and ethical concerns related to eligibility criteria, and questions for further study. (shrink)
Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to (...) exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions. (shrink)
OBJECTIVES: Cognitive and sensory difficulties frequently jeopardize informed consent of frail elderly patients This study is the first to test whether preliminary research experience could enhance geriatric patients' capacity to consent. DESIGN/SETTING: A step-wise consent procedure was introduced in a study on fluid balance in geriatric patients. Eligible patients providing verbal consent participated in a try-out of a week, during which bioelectrical impedance and weight measurements were performed daily. Afterwards, written informed consent was requested. Comprehension, risk and inconvenience scores (...) (ranges: 0-10) were obtained before and after the try-out by asking ten questions about the study's essentials and by asking for a risk and inconvenience assessment on a ten-points rating scale. SUBJECTS AND RESULTS: Seventy of the 78 eligible subjects started the try-out and 53 (68%) provided written consent. The comprehension score increased from 5.0 (+/- 2.3) to 7.0 (+/- 1.9) following the try-out (P < 0.001). The number of subjects capable of weighing risks and inconveniences increased from 32 to 48 (P < 0.001). CONCLUSIONS: Research experience improved the capacity to consent, still enabling an acceptable participation rate. Therefore, experienced consent seems a promising tool to optimize informed consent in frail elderly subjects. (shrink)
Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjectsresearch, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the ethical fact (the fact that the action the rule prescribes is ethically obligatory), whereas rules of policy are implemented to achieve a goal. We should be skeptical, I argue, that (...) the actions prescribed by the rules are ethically obligatory, and consequently we should focus our attention on how to craft the rules so as to promote the legitimate goals of human subjectsresearch. Unfortunately, this cannot be done without evidence about the likely effects of various candidate policies—evidence we currently lack. Therefore, we should take the rules as mere starting points, subject to revision as the evidence comes in. (shrink)
Following the publication of the Weatherall report on the use of non-human primates in research, this paper reflects on how to provide appropriate and ethical models for research beneficial to humankind. Two of the main justifications for the use of non-human primates in biomedical research are analysed. These are the “least-harm/greatest-good” argument and the “capacity” argument. This paper argues that these are equally applicable when considering whether humans are appropriate subjects of biomedical research.
Recruitment of healthy children for drugresearch has emerged due in part to several newAmerican laws and policies that have led to asurge in pharmaceutical research involvingchildren-subjects. In this paper, I review theethical and scientific issues and the argumentsin favor and against this new practice.
The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical (...)research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)
The question of whether or not children may be used as subjects in non-therapeutic research projects has generated a great deal of debate and received answers varying from 'no, never' to 'yes, if societal interests are served'. It has been claimed that a Kantian, deontological ethics would necessarily rule out such research, since valid consent would be impossible. The present paper gives a deontological argument for allowing children to be subjects in certain types of research.