Does benefit justify research with children?

The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical research can be justified. But the ethical justification for exposing children to research risks in the absence of consent remains unclear. One prevalent group of arguments aims to justify children's risk exposure by appealing to the concept of benefit. I call these ‘benefit arguments’. Prominent versions of this argument defend the idea that broadening our understanding of the notion of benefit to include non‐medical benefits (such as the benefit of a moral education) helps to justify children's research participation. I argue that existing benefit arguments are not persuasive and raise problems with the strategy of appealing to broader notions of benefit to justify children's exposure to research risk.     

Investigating assumptions of vulnerability: A case study of the exclusion of psychiatric inpatients as participants in genetic research in low‐ and middle‐income contexts

Psychiatric genetic research investigates the genetic basis of psychiatric disorders with the aim of more effectively understanding, treating, or, ultimately, preventing such disorders. Given the challenges of recruiting research participants into such studies, the potential for long‐term benefits of such research, and seemingly minimal risk, a strong claim could be made that all non‐acute psychiatric inpatients, including forensic and involuntary patients, should be included in such research, provided they have capacity to consent. There are tensions, however, regarding the ethics of recruiting psychiatric inpatients into such studies. In this paper our intention is to elucidate the source of these tensions from the perspective of research ethics committee interests and decision‐making. We begin by defining inpatient status and outline some of the assumptions surrounding the structures of inpatient care. We then introduce contemporary conceptions of vulnerability, including Florencia Luna’s account of vulnerability which we use as a framework for our analysis. While psychiatric inpatients could be subject to consent‐related vulnerabilities, we suggest that a particular kind of exploitation‐related vulnerability comes to the fore in the context of our case study. Moreover, a subset of these ethical concerns takes on particular weight in the context of genetic research in low‐ and middle‐income countries. At the same time, the automatic exclusion of inpatients from research elicits justice‐related vulnerabilities.     

Assaults by Mentally Disordered Offenders in Prison: Equity and Equivalence

Managing the violent behaviour of mentally disordered offenders (MDO) is challenging in all jurisdictions. We describe the ethical framework and practical management of MDOs in England and Wales in the context of the move to equivalence of healthcare between hospital and prison. We consider the similarities and differences between prison and hospital management of the violent and challenging behaviours of MDOs. We argue that both types of institution can learn from each other and that equivalence of care should extend to equivalence of criminal proceedings in court and prisons for MDOs. We argue that any adjudication process in prison for MDOs is enhanced by the relevant involvement of mental health professionals and the articulation of the ethical principles underpinning health and criminal justice practices.     

Informed consent and collaborative research: perspectives from the developing world

Introduction: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. Methods: A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. Results: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. Discussion: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research.     

Memory Interventions in the Criminal Justice System: Some Practical Ethical Considerations

In recent years, discussion around memory modification interventions has gained attention. However, discussion around the use of memory interventions in the criminal justice system has been mostly absent. In this paper we start by highlighting the importance memory has for human well-being and personal identity, as well as its role within the criminal forensic setting; in particular, for claiming and accepting legal responsibility, for moral learning, and for retribution. We provide examples of memory interventions that are currently available for medical purposes, but that in the future could be used in the forensic setting to modify criminal offenders’ memories. In this section we contrast the cases of (1) dampening and (2) enhancing memories of criminal offenders. We then present from a pragmatic approach some pressing ethical issues associated with these types of memory interventions. The paper ends up highlighting how these pragmatic considerations can help establish ethically justified criteria regarding the possibility of interventions aimed at modifying criminal offenders’ memories.     

Neuroimaging techniques in modern forensic psychiatry

Applied neuroscientific knowledge such as brain neuroimaging has widespread application in the medical diagnostic and treatment areas. Neuroscientific progress such as cognitive neuroscience has strong implications in specific medical fields such as forensic psychiatry. Significant progress in forensic psychiatry has affected the practice of law, in which an understanding of the complex relationship among mind, brain, and behavior is becoming necessary. Forensic psychiatry is concerned with the relationship between psychiatric abnormalities and legal violations and crimes. Due to the lack of available biological criteria, assessment, evaluation and therapy in forensic psychiatry have so far been restricted to psychosocial and mental criteria of offender personality. Recent advances in nuclear radiology such as brain imaging techniques (fMRI, DT-MRI, PET SPECT) allow a closer approach to the neural correlates of personality, moral judgments and decision-making. Introduction of neurobiological criteria (based on advanced neuroimaging techniques) in the field of forensic psychiatry and establishing the rules to what extent such biological criteria will be more reliable choice in evaluating mentally ill offenders would be of fundamental value in the modern forensic psychiatry. Psychosocial and subjective criteria in forensic evaluation will be more accomplished by biopsychosocial and objective criteria. Advances in the neuroimaging techniques bring specificity to the problems underlying the application of neuroscience to criminal law.     

National survey of current arrangements for diversion from custody in England and Wales.

OBJECTIVES--To assess the extent and nature of psychiatric assessment schemes based at magistrates'' courts in England and Wales for the early diversion of mentally disordered offenders from custody and to determine the response of the NHS to new initiatives concerning alternatives to custody for this group. DESIGN--Postal survey of the probation service, petty sessional divisions, mental health provider units, and district purchasing authorities in England and Wales. SUBJECTS--All chief probation officers (n = 55), clerks to the justices (n = 284), managers of mental health provider units (n = 190), and purchasers of mental health services (n = 190) in each of the district health authorities. MAIN OUTCOME MEASURES--Number of psychiatric assessment schemes, practical difficulties in their operation, extent of regular liaison with health and social services; current and future intentions to purchase or provide services for diversion from custody. RESULTS--Data were obtained from every magistrates'' court. Forty eight psychiatric assessment schemes were identified with another 34 under development. Particular problems were lack of adequate transport arrangements, difficulties with hospital admissions, and overdependence on key people. There was little liaison between health, social services, and members of the criminal justice system. Twenty five of the 106 purchasers who responded had a policy dealing with diversion, and 39 had a scheme under development; 56 purchasers had no current or future plans about diversion. Sixty nine of the 150 providers who responded reported that diversion was included in their current or next business plan. CONCLUSION--Schemes to divert mentally disordered offenders from the criminal justice system are often hampered by lack of adequate transport arrangements, difficulties in hospital admissions, and overdependence on key people.     

Reexamining the categorical exclusion of pediatric participants from controlled human infection trials

Controlled human infection (CHI) models have been developed for numerous pathogens in order to better understand disease processes and accelerate drug and vaccine testing. In the past, some researchers conducted highly controversial CHIs with vulnerable populations, including children. Ethical frameworks for CHIs now recommend vulnerable populations be excluded because they cannot consent to high risk research. In this paper we argue that CHI studies span a wide spectrum of benefit and risk, and that some CHI studies may involve minimal risk. The categorical exclusion of children from CHIs therefore departs from the standard approach to evaluating research risks, as international regulations and ethical guidance for pediatric research generally permit non-beneficial research with low risks. The paradigm in research ethics has also shifted from focusing on protecting vulnerable participants to recognizing that inclusion can be important as a matter of justice, providing new reasons to question this default exclusion of children from CHIs. Recognizing that pediatric CHIs can raise complex ethical issues and are easy to sensationalize in ways that may threaten the public’s trust in research and sponsor institutions, we conclude by describing additional complexities that must be addressed before pediatric CHIs beyond licensed vaccine studies might be ethically acceptable.     

Ethical issues surrounding controlled human infection challenge studies in endemic low-and middle-income countries

Controlled human infection challenge studies (CHIs) involve intentionally exposing research participants to, and/or thereby infecting them with, micro-organisms. There have been increased calls for more CHIs to be conducted in low- and middle-income countries (LMICs) where many relevant diseases are endemic. This article is based on a research project that identified and analyzed ethical and regulatory issues related to endemic LMIC CHIs via (a) a review of relevant literature and (b) qualitative interviews involving 45 scientists and ethicists with relevant expertise. In this article we argue that though there is an especially strong case for conducting CHIs in endemic (LMIC) settings, certain ethical issues related to the design and conduct of such studies (in such settings) nonetheless warrant particularly careful attention. We focus on ethical implications of endemic LMIC CHIs regarding (a) potential direct benefits for participants, (b) risks to participants, (c) third-party risks, (d) informed consent, (e) payment of participants, and (f) community engagement. We conclude that there is a strong ethical rationale to conduct (well-designed) CHIs in endemic LMICs, that certain ethical issues warrant particularly careful consideration, and that ethical analyses of endemic LMIC CHIs can inform current debates in research ethics more broadly.     

Adjusting the focus: A public health ethics approach to data research

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population‐level research and big data because it results in a primary focus on consent (meta‐, broad, dynamic and/or specific consent). Two recent guidelines – the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health‐related research involving humans – both focus on the growing reliance on health data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision‐making capacity? I propose that a public health ethics framework – based on public benefit, proportionality, equity, trust and accountability – provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest.     

Research involving prisoners: consensus and controversies in international and European regulations

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.     

TWO CONCEPTS OF EMPIRICAL ETHICS

The turn to empirical ethics answers two calls. The first is for a richer account of morality than that afforded by bioethical principlism, which is cast as excessively abstract and thin on the facts. The second is for the facts in question to be those of human experience and not some other, unworldly realm. Empirical ethics therefore promises a richer naturalistic ethics, but in fulfilling the second call it often fails to heed the metaethical requirements related to the first. Empirical ethics risks losing the normative edge which necessarily characterizes the ethical, by failing to account for the nature and the logic of moral norms. I sketch a naturalistic theory, teleological expressivism (TE), which negotiates the naturalistic fallacy by providing a more satisfactory means of taking into account facts and research data with ethical implications. The examples of informed consent and the euthanasia debate are used to illustrate the superiority of this approach, and the problems consequent on including the facts in the wrong kind of way.     

Consent and confidentiality in the light of recent demands for data sharing

Many attempts have been made to formalize ethical requirements for research. Among the most prominent mechanisms are informed consent requirements and data protection regimes. These mechanisms, however, sometimes appear as obstacles to research. In this opinion paper, we critically discuss conventional approaches to research ethics that emphasize consent and data protection. Several recent debates have highlighted other important ethical issues and underlined the need for greater openness in order to uphold the integrity of health‐related research. Some of these measures, such as the sharing of individual‐level data, pose problems for standard understandings of consent and privacy. Here, we argue that these interpretations tend to be overdemanding: They do not really protect research subjects and they hinder the research process. Accordingly, we suggest another way of framing these requirements. Individual consent must be situated alongside the wider distribution of knowledge created when the actions, commitments, and procedures of researchers and their institutions are opened to scrutiny. And instead of simply emphasizing privacy or data protection, we should understand confidentiality as a principle that facilitates the sharing of information while upholding important safeguards. Consent and confidentiality belong to a broader set of safeguards and procedures to uphold the integrity of the research process.     

Mentally abnormal prisoners on remand: II—Comparison of services provided by Oxford and Wessex regions

Most regional health authorities have or plan to have secure units for treating mentally abnormal offenders. A retrospective study was carried out to compare the effectiveness of the health care services for men remanded to Winchester prison from Oxford and Wessex regions over the five years 1979-83. Thirty seven (30%) of 124 prisoners from Oxford region were rejected for treatment compared with 36 (16%) of the 220 men from Wessex region. Men from Oxford region were significantly more likely to be recommended for admission to a special hospital than those from Wessex (13/124 (10%) v 9/220 (4%), respectively) and significantly less likely to be recommended for admission to a hospital in the catchment area (35/124 (28%) v 94/220 (43%)). Men on remand from Oxford region were significantly more often perceived as being disruptive or aggressive by hospital staff and more likely to be labelled as having psychopathic or personality disorders. These differences may have reflected different attitudes towards mentally abnormal offenders and the allowances in the services available in the two regions; in particular, Oxford region did not have a secure unit or a forensic psychiatrist.If mentally ill prisoners do not receive the treatment that they need they run the risk of being criminalised. Most such men are best treated in general psychiatric units; only a few require secure conditions and staff with specialised psychiatric skills.     

Longueur du chromosome Y,intelligence et comportement dans une population de médico-légaux

Summary The Y/F ratio was established in 128 mentally disordered offenders in a maximum security hospital. The 50 Y/F 0.90 subjects were compared with the 78 Y/F<0.90 subjects as regards intelligence and behaviour. With the exception of the highest frequency of intelligence quotients lower than 70 in the criminal patients Y/F 0.90, no statistical correlation exists to support the theory of a relation between a long Y chromosome and the type of psychiatric (psychopathy, psychosis) or criminality diagnosis.

---

---

To whom offprint requests should be sent     

What risks should be permissible in controlled human infection model studies?

Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible risks according to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies.     

XENOTRANSPLANTATION, CONSENT AND INTERNATIONAL JUSTICE

The risk posed to the community by possible xenozoonosis after xenotransplantation suggests that some form of 'community consent' is required before whole organ animal-to-human xenotransplantation should take place. I argue that this requirement places greater obstacles in the path of ethical xenotransplantation than has previously been recognised. The relevant community is global and there are no existing institutions with democratic credentials sufficient to establish this consent. The distribution of the risks and benefits from xenotransplantation also means that consent is unlikely to be forthcoming. Proceeding on the basis of hypothetical consent to a package of global health measures that includes xenotransplantation, as Rothblatt has recently advocated, is more problematic than she acknowledges. Given that it may place the lives of citizens of poor nations at risk to benefit the citizens of wealthy nations, xenotransplantation raises significant questions of international justice.     

Violence and psychosis. II--Effect of psychiatric diagnosis on conviction and sentencing of offenders.

An examination of the records of all sick and violent men remanded to a large English prison suggested a tendency among police to consider men to be exceptionally dangerous simply because of their mental illness. On further study, however, there was no evidence that the mentally ill were more vulnerable to detention without subsequent conviction than their normal peers. Remand was rarely followed by help for the mentally abnormal men studied; this is disturbing as requests for psychiatric help constitute an important reason for custodial remand. Less than a third of the men with active symptoms went to hospital, although some of the less disturbed received supervision (including probation) orders, occasionally with treatment. As there is evidence that most of the few mentally abnormal offenders who subsequently receive treatment benefit from it, psychiatrists should do more for offender patients.     

Mentally abnormal prisoners on remand: I—Rejected or accepted by the NHS?

Increasing numbers of mentally abnormal offenders are sentenced to prison. The decision to treat or imprison them is influenced by the attitudes of consultant psychiatrists and their staff. The process whereby those decisions were made and the willingness of consultants to offer treatment were investigated. A retrospective survey of all (362) mentally abnormal men remanded to Winchester prison for psychiatric reports over the five years 1979-83 showed that one in five were rejected for treatment by the NHS consultant psychiatrist responsible for their care. Those with mental handicaps, organic brain damage, or a chronic psychotic illness rendering them unable to cope independently in the community were the most likely to be rejected. They posed the least threat to the community in terms of their criminal behaviour yet were more likely to be sentenced to imprisonment. Such subjects were commonly described by consultants as too disturbed or potentially dangerous to be admitted to hospital or as criminals and unsuitable for treatment. Consultants in mental hospitals were most likely and those in district general hospitals and academic units least likely to accept prisoners.The fact that many mentally ill and mentally handicapped patients can receive adequate care and treatment only on reception into prison raises serious questions about the adequacy of current management policies and the range of facilities provided by regional health authorities.     

Prioritising African perspectives in psychiatric genomics research: Issues of translation and informed consent

Psychiatric genomics research with African populations comes with a range of practical challenges around translation of psychiatric genomics research concepts, procedures, and nosology. These challenges raise deep ethical issues particularly around legitimacy of informed consent, a core foundation of research ethics. Through a consideration of the constitutive function of language, the paper problematises like‐for‐like, designative translations which often involve the ‘indigenization’ of English terms or use of metaphors which misrepresent the risks and benefits of research. This paper argues that effective translation of psychiatric genomics research terminology in African contexts demands substantive engagement with African conceptual schemas and values. In developing attenuated forms of translational thinking, researchers may recognise the deeper motivational reasons behind participation in research, highlighting the possibility that such reasons may depart from the original meaning implied within informed consent forms. These translational issues might be ameliorated with a critical re‐examination of how researchers develop and present protocols to institutional ethics review boards.