While many books on ethics contain a chapter discussing prisoners’ rights and the ethical dimensions of research involving incarcerated persons, Vulnerability and Incarceration is the first monograph devoted to the subject. Victor interrogates the concept of vulnerability to examine prisoners’ right to medical research from a novel point of view.

Should incarcerated persons be able to participate in medical research? While this is a much-debated question, Elizabeth Victor offers a fresh perspective on current regulatory approaches to research with prisoners. She delivers exactly what her book title promises: a reevaluation of protective frameworks based on her adaptation of the concept of vulnerability.Victor employs a definition of vulnerability that is “dynamic, capturing the particularities of an individual’s situation within a community of practices, norms, and a specific history”. However, (...) she also emphasizes that “by reinforcing vulnerability in populations, these practices create, sustain, or reinforce asymmetric power relations”, which... (shrink)

Although there is great concern about protecting those who participate in research, little if any concern has been expressed in the literature about protecting “decliners”—individuals who were invited to participate, but did not. However, there are several situations in which potential participants may experience negative consequences if they choose not to participate—for example, the prison setting, where the power imbalance is obvious and the history of research is not a positive one. We offer several options to protect decliners (...) from possible adverse consequences. (shrink)

The number of older adults incarcerated in prisons is growing significantly, and there is a great need for legal authority, processes, and resources to mitigate individual and social burdens of elder neglect and abuse within these settings. Older adults in prison may be particularly vulnerable to abuse, neglect, or exploitation. They are dependent on the carceral system for basic resources, are at risk for retaliatory actions for reporting mistreatment, and bear disproportionately high health burdens. This essay first considers standards and (...) resources for mitigating elder mistreatment in the community and residential‐care settings in contrast to the available resources in prisons. Arguing that a conceptual model of elder abuse tailored to the prison population is needed, the essay proposes a research agenda through which such a model could be developed. The model could then be used in the creation of policy for detecting and mitigating elder mistreatment of incarcerated people. The essay concludes with a call to action to address the rift in legal protections and processes that leave older adults in prison at increased risk of abuse and neglect without a clear pathway for recourse. (shrink)

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)

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)

Friesen et al. (2023) describe barriers to research in patient populations that have been historically labeled as vulnerable and, as a result, are under-represented in research due to the Instituti...

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)

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)

Vulnerabilities often characterize the availability of immigrant populations of interest in social behavioral science, public health, and medical research. Refugees, asylum seekers, and undocumented immigrants present unique vulnerabilities relevant to protocol development as well as ethics review procedures and criteria. This paper describes vulnerable populations in relation to the Belmont Report and US federal regulations for the protection of human subjects, both of which are commonly used in international research contexts. It argues for safeguards for immigrants comparable to (...) protections for such populations as pregnant women, prisoners, and children. The paper further presents a two-part model for the review of protocols that involve immigrants. The model is intended to help identify the risks to immigrants associated with participation in research, and to suggest how researchers can responsibly frame studies and access to research participant immigrants through community-based, and/or non-governmental organizations that serve immigrants and immigrant communities. (shrink)

Biobanking in Europe has made major steps towards harmonization and shared standards for the collection and processing of data and samples stored in biobanks. Still, biobanks and researchers face substantial legal difficulties in the field of data protection and sample management. Data protection law was harmonized almost 15 years ago while rights in samples fall under the competence of the Member States of the EU. Despite the Data Protection Directive the field of data protection shows a substantial degree of deviation (...) as public health was excluded from the harmonization. Biobanks seem to have substantially fewer difficulties to cope with in terms of the legal requirements in the field of sample management. This paper discusses the legal framework, experiences of different biobanks in Europe and potential ways forward. It also highlights the need for a health economic analysis of the costs and benefits of privacy protection in Europe. At the moment, policymakers seem to build their decisions on an insufficient evidence base which underestimates the potential value of biobanks for European public health. Within the past few years little progress has been achieved with regards to the development of a unified legal framework in Europe, The diversity in the legal system is also reflected in the different approaches of ethics committees towards biobanking. To secure the responsible and effective use of data and samples, more efforts are needed to come up with pathways for a solution. (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)

Human dignity is the supreme criterion for protecting research participants, and likewise for numerous ethical matters of ultimate importance. But what is meant by “human dignity”? Isn’t this some vague criterion, some sort of lip service of questionable relevance and application? We shall see that it is nothing of the sort, that to the contrary, it is a very definite and very accessible criterion. However, how is this criterion applied in protecting research participants? These are the matters that (...) we will examine now. My presentation is divided into four parts. 1/Recognizing Human Dignity; 2/Practical Definition of Human Dignity; 3/The Human Being in a Weakened State; 4/ Conclusion. (shrink)

Historically, prisoners in the United Stateshave served as an inexpensive and readilyavailable source of human subjects forresearch. Coinciding with the civil rightsmovement, however, was an emerging conceptionof prisoners'' rights that led to the NationalCommission for the Protection of Human Subjectsof Biomedical and Behavioral Research beingcharged with investigating the use of prisonersas research subjects. The recommendations thatevolved and the subsequent guidelines that havebeen implemented by the Department of Healthand Human Services significantly curtail theuse of prisoners as (...) research subjects. Whilethese measures are designed to protect inmatesfrom the abuses of the past, of particularconcern to many health care officials isexclusion of inmates from experimental HIV/AIDSand hepatitis treatments. This paper addresseswhether the vulnerability of prisoners in theUnited States due to their incarceration issufficient to prohibit them from participationin clinical trials that offer the possibilityof life-saving treatment. It first outlinesthe evolution in moral thinking that has led tolaws broadly prohibiting prisoners frombiomedical research studies and then analyzescases in the law to develop ethical argumentsin support of the view that prisoners should beallowed to participate in clinical trials. Theconclusion is that prisoners should be allowedto participate in such trials. (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)

From the Supreme Court to the bedroom, privacy is an intensely contested interest in our everyday lives and privacy law. Some people appeal to privacy to protect such critical areas as abortion, sexuality, and personal information. Yet, privacy skeptics argue that there is no such thing as a right to privacy. I argue that we cannot abandon the concept of privacy. If we wish to avoid extending this elusive concept to cover too much of our lives or shrinking it to (...) cover too little, we must come to understand it. After exploring the privacy arguments of philosophers and constitutional and tort privacy law, I argue for a new definition of privacy and an explanation of its value that clarifies and resolves many of our conflicts. Privacy is critical because it allows us to protect a realm in which we can have intimate relations with others. (shrink)

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)

Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 (...) editions. This update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

Biobanking in Europe has made major steps towards harmonization and shared standards for the collection and processing of data and samples stored in biobanks. Still, biobanks and researchers face substantial legal difficulties in the field of data protection and sample management. Data protection law was harmonized almost 15 years ago while rights in samples fall under the competence of the Member States of the EU. Despite the Data Protection Directive the field of data protection shows a substantial degree of deviation (...) as public health was excluded from the harmonization. Biobanks seem to have substantially fewer difficulties to cope with in terms of the legal requirements in the field of sample management. This paper discusses the legal framework, experiences of different biobanks in Europe and potential ways forward. It also highlights the need for a health economic analysis of the costs and benefits of privacy protection in Europe. At the moment, policymakers seem to build their decisions on an insufficient evidence base which underestimates the potential value of biobanks for European public health. Within the past few years little progress has been achieved with regards to the development of a unified legal framework in Europe, The diversity in the legal system is also reflected in the different approaches of ethics committees towards biobanking. To secure the responsible and effective use of data and samples, more efforts are needed to come up with pathways for a solution. (shrink)

The author describes the role of the research subject advocate (RSA), inaugurated in 2001, which adds a fourth level of protection for human research subjects.

Research studies and interventions sometimes offer potential benefits to subjects that compensate for the risks they face. Other studies and interventions, which I refer to as “nonbeneficial” research, do not offer subjects a compensating potential for benefit. These studies and interventions have the potential to exploit subjects for the benefit of others, a concern that is especially acute when investigators enroll individuals who are unable to give informed consent. US regulations for research with human subjects attempt to (...) address this concern by mandating strict protections for nonbeneficial research with subjects who cannot consent. Typically, humans who cannot consent, such as children, may be enrolled in nonbeneficial research only when it poses low risks and has the potential to gather information of sufficient value to justify the risks, an appropriate surrogate gives permission on the individual’s behalf and the individual agrees (assents). In contrast, US regulations for nonbeneficial research with nonhuman primates do not include these protections, even though it too involves subjects who cannot consent and who face risks for the benefit of others. Is this difference in regulatory protections justified? Or does the principle of fairness—treat like cases alike—imply that regulations for nonbeneficial research with nonhuman primates should include protections similar to those that apply to nonbeneficial research with humans who cannot consent? (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)

As scientists target communities for research into the etiology, especially the genetic determinants of common diseases, there have been calls for the protection of communities. This paper identifies the distinct characteristics of aboriginal communities and their implications for research in these communities. It also contends that the framework in the Belmont Report is inadequate in this context and suggests a fourth principle of respect for communities. To explore how such a principle might be specified and operationalized, it reviews (...) existing guidelines for protecting aboriginal communities and points out problems with these guidelines and areas for further work. (shrink)

Is freedom of research protected at the constitutional level? No obvious answer can be given to this question, as European and Northern American constitutional systems are not unequivocal and the topic has not been discussed deeply enough.Looking at the constitutions of some European and Northern American countries, it is possible to immediately note that there are essentially two ways to deal with freedom of scientific research. On the one hand, in Canada and in the US, constitutions have no (...) specific provisions to protect freedom of scientific research, with the result that such freedom ends up having to be protected as a specific aspect of the wider freedom of thought and expression . On the other hand, other countries’ constitutional systems, mainly European ones, expressly recognise freedom of research and teaching arts and science. For instance, article 5 of the German Constitution states that “Art and science, research and teaching are free”, article 33 of the Italian Constitution1i establishes that “The arts and sciences as well as their teaching are free” and article 59 of the Slovenian Constitution states that “Freedom of scientific research and artistic endeavor shall be guaranteed”.Within this second group, some constitutions limit their protection to the provision of freedom of scientific research, whereas other fundamental laws engage governments in promoting and supporting it. For example, the Italian Constitution, which states that “The Republic promotes cultural development and scientific and technical research” , the Spanish Constitution, according to which “public authorities shall promote science and scientific and technical research for the benefit of general interest” and, also, the Greek Constitution, whose article 16 establishes that art, science, research and their teaching are free, and their promotion is mandatory for the State.2 It …. (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)

This paper looks at the issue of consent from children and whether the test of Gillick competency, applied in medical and healthcare practice, ought to extend to participation in research. It is argued that the relatively broad usage of the test of Gillick competency in the medical context should not be considered applicable for use in research. The question of who would and could determine Gillick competency in research raises further concerns relating to the training of the (...) researcher to make such a decision as well as to the obvious issue of the researcher’s personal interest in the project and possibility of benefiting from the outcome. These could affect the judgment of Gillick competency if the researcher is charged with making this decision. The above notwithstanding, there are two exceptional research situations in which Gillick competency might be legitimately applied: when the research is likely to generate significant advantages for the participants while exposing them to relatively minor risks, and when it is likely to generate great societal benefit, pose minimal risks for the participants and yet raise parental objection. In both cases, to ensure that autonomy is genuinely respected and to protect against personal interest, Gillick competency should be assessed by an individual who has no interest or involvement in the research. (shrink)

The concept of vulnerability has been the topic of considerable discussion in research bioethics, largely because of dissatisfaction with early constructions of the concept that were based on subpopulations of research subjects. These subpopulations have attributes likely to undermine their capacity to provide autonomous informed consent: persons who are relatively or absolutely incapable of protecting their own interests through negotiations for informed consent. Several subpopulations were seen as requiring special protections, including children, pregnant women, prisoners, racial (...) minorities, the economically disadvantaged, the very sick, and the institutionalized. Recent years have witnessed the identification of other subpopulations with attributes that could render them vulnerable, as well. For example, the Council for the International Organization of Medical Societies has named such potentially vulnerable groups as the homeless, nursing home residents, patients with incurable diseases, patients in the emergency department, employees, students, and members of communities who are unfamiliar with modern medicine. (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)

As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly (...) cohesive. Although some protections may be applicable to less-cohesive communities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto beyond the aboriginal communities for which they were developed. (shrink)

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such (...) as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research. (shrink)

Background Regulations on research ethics in France have evolved considerably over the past four years: the implementation of the Jardé law and of the General Data Protection Regulations have changed the landscape of research ethics for research involving or not involving human persons. In a context of creation of an Institutional Review Board at the University of Bordeaux, France, we sought to explore research ethics practices and perceptions in the medical community of our University Hospital. Methods (...) A short questionnaire was sent to all physicians of the University Hospital of Bordeaux. The questionnaire included closed questions and main topics were: physicians’ education in research ethics, ethics practices concerning researches non implying human persons, and physicians’ perceptions about current regulations. Results 86 questionnaires were sent back. If a majority of physicians have validated Good Clinical Practices trainings, there was a low rate of specific training on fundamental references in research ethics and a high proportion of responders do not consider themselves as educated in research ethics after completion of GCPs. Regulations on research ethics have many implications on medical research, especially by inducing changes in protocols in order to alleviate ethical requirements. Malpractices were acknowledged like false mention of positive opinion from an ethics committee. If If a majority of responders considers regulations as a positive answer to research ethics, a large majority considers it as a constraint and a complexification of research process. For 58%, regulations in research ethics are perceived as a hindrance for research initiatives. Conclusion Because of their impact on research process, regulations seem to constitute a scarecrow for physicians. Lack of training, bad representations and questionable practices highlight the need to improve education and to propose concrete guidance for medical researchers. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be (...) vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research (...) without direct benefit that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent. (shrink)

The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or (...) Spanish about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)

In gender mythology woman is nature, the embodiment of life, destruction, and death. Semantically encoded in good and evil, the one conceptual stability woman represents is ambivalence. As a walled garden in which nature works its demonic sorcery, she turns a gob of refuse into a spreading web of sentient being, floating on the snaky umbilical by which she leashes every man. But as an ontological entity, woman is the real First Mover. The pregnant woman is devilishly complete. She needs (...) nothing and no one.2 Confronted with the terrible sense of woman's power, man is forced to wrestle with her nature to gain his identity, never to fall back into her. Man is the essential, the norm, the absolute One without reciprocity. Woman is “the Other, posed by the One to define itself, the inessential who never goes back to being the essential and the absolute Other without reciprocity. (shrink)

Personal data protection is an ethical issue. In this study we analyzed how research ethics committees (RECs) and data protection officers (DPOs) handle personal data protection issues in research protocols. We conducted a mixed-methods study. We included heads (or delegated representatives) of RECs and DPOs from universities and public research institutes in Croatia. The participants provided information about data protection issues in research and their mutual collaboration on those issues through structured interviews that contained closed and (...) open-ended questions. Qualitative description was used to analyze open-ended questions. The results showed that 55% of the REC representatives were not aware who was DPO in their institution. Among RECs, 65% never contacted the DPO. There were 61% of RECs who reported that they received no training from the organization on personal data protection. When asked about barriers to personal data protection in their institutions, 26% of REC members highlighted the lack of a clear protocol for assessing personal data protection issues, while 30% of DPOs mentioned lack of knowledge among researchers about personal data. In conclusion, we found that when it came to protecting personal data in research protocols, RECs and DPOs hardly ever worked together. When developing future personal data protection policies for academic and scientific research institutions, it is essential that RECs and DPOs should collaborate and both continue to expand/update their knowledge on personal data protection procedures. (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)