Objectives: Clinical trials in humans in Germany—as in many other countries—must be approved by local research ethics committees . The current study has been designed to document and evaluate decisions of chairpersons of RECs in the problematic field of non-therapeutic research with minors. The authors’ purpose was to examine whether non-therapeutic research was acceptable for chairpersons at all, and whether there was certainty on how to decide in research trials involving more than minimal risk.Design: (...) In a questionnaire, REC chairpersons had to evaluate five different scenarios with non-therapeutic research. The scenarios described realistic potential research projects with minors, involving increasing levels of risk for the research participants. The chairpersons had to decide whether the respective projects should be approved.Methods: A total of 49 German REC chairpersons were sent questionnaires; 29 questionnaires were returned. The main measurements were approval or rejection of research scenarios.Results: Chairpersons of German RECs generally tend to accept non-therapeutic research with minors if the apparent risk for the participating children is low. If the risk is clearly higher than “minimal”, the chairpersons’ decisions differ widely.Conclusion: The fact that there seem to be different attitudes of chairpersons to non-therapeutic research with minors is problematic from an ethical point of view. It suggests a general uncertainty about the standards of protection for minor research participants in Germany. Therefore, further ethical and legal regulation of non-therapeutic research with minors in Germany seems necessary. (shrink)

The future health of children depends on clinical research which is an important part of medical progress. The principles of the child’s best interests standards and how it is applied in the context of research are explored. This review will show that there is a need for research involving children but there are gaps in the current legal and ethical framework which are not readily applicable to non-therapeutic research involving children. There are significant challenges in (...) trying to achieve a balance between what is socially good and the obligation to protect children who participate in research. (shrink)

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for (...) the Protection of Human Subjects of Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses. (shrink)

Experiences of substitute decision-makers with requests for consent to non-therapeutic research participation during the dying process, including to what degree such requests are perceived as burdensome, have not been well described. In this study, we explored the lived experiences of family members who consented to non-therapeutic research participation on behalf of an imminently dying patient. We interviewed 33 family members involved in surrogate research consent decisions for dying patients in intensive care. Non-therapeutic research (...) involved continuous physiological monitoring of dying patients prior to and for 30 min following cessation of circulation. At some study centres participation involved installation of bedside computers. At one centre electroencephalogram monitoring was used with a subset of participants. Aside from additional monitoring, the research protocol did not involve deviations from usual end-of-life care. Thematic analysis of interviews suggests most family members did not perceive this minimal-risk, non-therapeutic study to affect their time with patients during the dying process, nor did they perceive research consent as an additional burden. In our analysis, consenting for participation in perimortem research offered families of the dying an opportunity to affirm the intrinsic value of patients’ lives and contributions. This opportunity may be particularly important for families of patients who consented to organ donation but did not proceed to organ retrieval. Our work supports concerns that traditional models of informed consent fail to account for possible benefits and harms of perimortem research to surviving families. Further research into consent models which integrate patient and family perspectives is needed. All data relevant to the study are included in the article. (shrink)

Non-therapeutic research on children raises ethical concerns. Such research is not only conducted on individuals who are incapable of providing informed consent. It also typically involves some degree of risk or discomfort, without prospects of medically benefiting the participating children. Therefore, these children seem to be instrumentalized. Some ethicists, however, have tried to sidestep this problem by arguing that the children may indirectly benefit from participating in such research, in ways not related to the medical intervention (...) as such. It has been argued, for example, that non-therapeutic pediatric research does not instrumentalize the children enrolled since it has the prospects of furthering their moral development. We argue that this argument is far too undeveloped to be taken seriously. (shrink)

Non-therapeutic research with imminently dying patients in intensive care presents complex ethical issues. The vulnerabilities of the imminently dying, together with societal disquiet around death and dying, contribute to an intuition that such research is beyond the legitimate scope of scientific inquiry. Yet excluding imminently dying patients from research hinders the advancement of medical science to the detriment of future patients. Building on existing ethical guidelines for research, we propose a framework for the ethical design (...) and conduct of research involving the imminently dying. To enable rapid translation to practice, we frame the approach in the form of eight ethical questions that researchers and research ethics committees ought to answer prior to conducting any research with this patient population. (1) Does the study hypothesis require the inclusion of imminently dying patients? (2) Are non-therapeutic risks and burdens minimised consistent with sound scientific design? (3) Are the risks of these procedures no more than minimal risk? (4) Are these non-therapeutic risks justified insofar as they are reasonable in relation to the anticipated benefits of the study? (5) Will valid informed consent be obtained from an authorised surrogate decision maker? (6) How will incidental findings be handled? (7) What additional steps are in place to protect families and significant others of research participants? (8) What additional steps are in place to protect clinical staff and researchers? Several ethical challenges hinder research with imminently dying patients. Nonetheless, provided adequate protections are in place, non-therapeutic research with imminently dying patients is ethically justifiable. Applying our framework to an ongoing study, we demonstrate how our question-driven approach is well suited to guiding investigators and research ethics committees. (shrink)

Zusammenfassung. In der Medizin kommt der Differenzierung in „therapeutische” versus „nicht-therapeutische” Forschung große klinische, ethische und rechtliche Bedeutung zu. Diese Unterscheidung spielt nicht nur in der klinischen Forschungspraxis eine große Rolle, sondern sie findet sich auch in zahlreichen Gesetzen, internationalen Richtlinien und Deklarationen. Der Artikel argumentiert, dass diese Unterscheidung sowohl auf medizinischer (deskriptiver) als auch auf ethischer (normativer) Ebene problematisch ist. Durch theoretische Analyse und anhand eines klinischen Beispieles wird gezeigt, dass Patienten durch den Begriff „therapeutische Forschung” manipuliert werden können. (...) Dadurch wird eine angemessene Nutzen-Risiko-Abwägung im Prozess des Informed Consent erschwert. (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.

The Kennedy Krieger lead paint study received a lot of attention after a US Court of Appeals ruled that a parent cannot consent to the participation of a child in non-therapeutic research. The ruling has raised fears that, if it goes unchallenged, valuable research might not proceed and ultimately all children would be harmed. The author discusses significant aspects of the study that have been neglected, and argues that the study was unethical because it involved injustice and (...) its design meant that the study lacked importance and value. Issues of benefit, risk, and consent are vital, but it is sometimes a mistake to consider these issues before settling questions about justice and the importance and value of a research project. The author concludes by offering a strategy for researchers and reviewers of research to appreciate, in a vivid way, the implications of research participation. (shrink)

Background: Knowledge about assent or dissent of children to non-therapeutic research is poor.Objectives: To assess sociodemographic characteristics in healthy children and adolescents who were invited to participate in non-therapeutic research, to evaluate their motives for assent or dissent and their understanding of the information given.Methods: A total of 1281 healthy children and adolescents six to sixteen years of age were invited to participate in a non-therapeutic study and a questionnaire.Results: Assenting children were motivated by a (...) desire to help sick children and to gain experience with participating in a research study . Dissenting children made their decision because of worries about having a blood or a urine sample taken or because of worries about a doctor’s examination . Fewer children in the assent group than in the dissent group worried about the doctor’s examination . In the assent and dissent group, 568 and 343 children, respectively, said they were able to understand some or all of the written information , and 650 and 330 , respectively, were able to understand some or all of the verbal information .Conclusions: Sociodemographic characteristics may not influence healthy children’s decision to volunteer for non-therapeutic research. Assenting children have altruistic and educational motives, whereas worries about procedures may cause children to dissent. A great majority of school children and adolescents feel capable of understanding and giving assent or dissent to non-therapeutic research. (shrink)

This paper considers what are the appropriate limits of parental or guardian proxy consent for a child's participation in medical or social science research. Such proxy consent, it is proposed, is invalid in regards “non-therapeutic research.” The latter research may add to scientific knowledge and/or benefit others, but any benefit to the child research participant is but a coincidental theoretical possibility and not a primary objective. Research involving children, without intended and acceptable prospect of (...) beneficial outcome to the individual participant, even if with negligible risk, does not meet the test for “best interests.” Proxy consent for children's involvement in research is justifiable only when given for and on behalf of the child in his or her best interest to enhance the child's well-being. Only in the latter case is the parental proxy consent situation analogous in regards key criteria to a competent individual consenting to research participation. (shrink)

The quality of the consent obtained from 41 volunteer subjects in eight experiments is evaluated. Five subjects (all physicians) gave informed consent; 22 subjects gave partially informed consent; and 14 subjects merely gave consent. It is argued that 'informed' consent is obtainable only from medically trained people, and that lip service to this concept in laymen should cease. The concept of medical competence should instead be introduced and a personal medical referee appointed to adjudicate on behalf of the volunteer.

This paper explores the use of advance directives in clinical dementia research. The focus is on advance consent to participation of demented patients in non-therapeutic research involving more than minimal risks and/or burdens. First, morally relevant differences between advance directives for treatment and care, and advance directives for dementia research are discussed. Then attention is paid to the philosophical issue of dementia and personal identity, and the implications for the moral authority of research advance directives. (...) Thirdly, a number of practical shortcomings of advance directives for non-therapeutic dementia research are explored and attention is paid to the role of proxies. It is concluded that upon a closer look the initial attractiveness of advance directives for dementia research is lessened, and that it is doubtful whether these instruments can compensate for the lack of subject consent in case of non-therapeutic dementia research involving more than minimal risks and/or burdens for the incompetent demented subject. (shrink)

The distinction between therapeutic and non-therapeutic research is a familiar one in research ethics. This chapter argues that the term “therapeutic research” is a misnomer. I consider two broad types of ostensibly therapeutic research: controlled trials, and innovative/experimental treatments. I argue that in the former case the term therapeutic research is a misnomer because no reasonable researcher can expect patients/subjects to derive any therapeutic advantage from being entered into an (...) ethically conducted controlled trial. In the latter case, while accepting that there may well be a reasonable expectation of therapeutic benefit from innovative treatments, I argue that the decision whether it is in the interests of a given patient to receive a given treatment is properly made on purely clinical grounds. There is no special feature of the research situation, in either of these types of case, which serves to ensure that participation, qua research subject, is in a patient’s interests. (shrink)

Female genital cutting (FGC) is generally understood as a gendered harm, abusive cultural practice and human rights violation. By contrast, male genital cutting (MGC) is held to be minimally invasive, an expression of religious identity and a legitimate parental choice. Yet scholars increasingly problematize this dichotomy, arguing that male and female genital cutting can occasion comparable levels of harm. In 2015 this academic critique received judicial endorsement, with Sir James Munby's acknowledgement that all genital cutting can cause ‘significant harm’. This (...) article investigates the harm occasioned by MGC. It is informed by a Freedom of Information (FoI) study which provides some empirical evidence of the nature and frequency of physical harm caused by MGC in U.K. hospitals. While acknowledging the challenges and limitations of FoI research, we outline important lessons that this preliminary study contains for medical ethics, law and policy. It provides some empirical evidence to support claims regarding the risks which accompany the procedure and the obligation of health professionals to disclose them, and reveals the paucity of measures in place to ensure that harms are recorded, disclosed and monitored. (shrink)

This qualitative research is a philosophical review about analyzing how circumcision can (cannot) be morally justified. It is typically assumed among Muslims that circumcision is mandatory according to Islamic law (Sharia). However, in this paper, I will argue that this is not clear in Islamic texts. Because firstly there is no textual evidence in the Quran about this matter and secondly permissibility of circumcision is not an agreed topic among Muslim scholars. This entails that circumcision is not a necessary (...) part of being a Muslim. Although this idea seems idiosyncratic according to the majority of Muslims, I’m inclined to emphasize that we should not marginalize this idea, rather we have to support it for educational prosperity in Muslim communities. But perhaps more importantly this paper helps to introduce new Muslim intellectuals’ argument that moral reasoning is independent from (and even superior to) Islamic law. Since we do not have ultimate and decisive secular reason (e.g., medical reason) against male circumcision in every occasion, therefore, morally speaking, I believe it is not reasonable to say that male circumcision is always wrong. Muslims who support male circumcision still can find some secular reasons to defend this from their cultural identity. (shrink)

Objective To document the legal guardian-related barriers to consent procurement, and their stated reasons for non-participation in a paediatric critical care research study.Study design A multicentre, prospective, cohort study.Participants Legal guardians of children who participated in a multicentre study on adrenal insufficiency in paediatric critical illness. Data were collected on all consent encounters in the main study.Methods Screening data, reasons for consent not being obtained, paediatric risk of mortality scores and age were collected on all 1707 patients eligible for (...) participation in the Adrenal Insufficiency Study.Results The main barriers to approaching legal guardians for consent were lack of availability of the legal guardians and language barriers . Legal guardians of 917 patients were approached with an overall consent rate of 42% . 81% of the 528 legal guardians who declined consent provided an unsolicited reason for refusal. The three most commonly stated reasons were: being overwhelmed , not wanting anything else done to their child and not wanting an additional medication . In addition, 14.2% cited research-related concerns as the reason for their non-participation.Conclusions Barriers to consent procurement in a non-therapeutic paediatric critical care study appear to occur at many levels with lack of availability of legal guardians, and legal guardians feeling overwhelmed, being the most commonly recorded reasons. Further research into the impact of these findings on the validity and generalisability of the results of such studies is necessary prior to the development and study of future consent models. (shrink)

Background Non-therapeutic trials in which terminally ill cancer patients are asked to undergo procedures such as biopsies or venipunctures for research purposes, have become increasingly important to learn more about how cancer cells work and to realize the full potential of clinical research. Considering that implementing non-therapeutic studies is not likely to result in direct benefits for the patient, some authors are concerned that involving patients in such research may be exploitive of vulnerable patients and (...) should not occur at all, or should be greatly restricted, while some proponents doubt whether such restrictions are appropriate. Our objective was to explore clinician-researcher attitudes and concerns when recruiting patients who are in advanced stages of cancer into non-therapeutic research. Methods We conducted a qualitative exploratory study by carrying out open-ended interviews with health professionals, including physicians, research nurses, and study coordinators. Interviews were audio-recorded and transcribed. Analysis was carried out using grounded theory. Results The analysis of the interviews unveiled three prominent themes: 1) ethical considerations; 2) patient-centered issues; 3) health professional issues. Respondents identified ethical issues surrounding autonomy, respect for persons, beneficence, non-maleficence, discrimination, and confidentiality; bringing to light that patients contribute to science because of a sense of altruism and that they want reassurance before consenting. Several patient-centered and health professional issues are having an impact on the recruitment of patients for non-therapeutic research. Facilitators were most commonly associated with patient-centered issues enhancing communication, whereas barriers in non-therapeutic research were most often professionally based, including the doctor-patient relationship, time constraints, and a lack of education and training in research. Conclusions This paper aims to contribute to debates on the overall challenges of recruiting patients to non-therapeutic research. This exploratory study identified general awareness of key ethical issues, as well as key facilitators and barriers to the recruitment of patients to non-therapeutic studies. Due to the important role played by clinicians and clinician-researchers in the recruitment of patients, it is essential to facilitate a greater understanding of the challenges faced; to promote effective communication; and to encourage educational research training programs. (shrink)

The mental illness of substance dependence or addiction is responsible for major economic, social, and personal costs. If we are to elucidate its etiology, understand its mechanisms, and eventually bring it under control, scientific investigation is essential. Research in animals and humans has enhanced our understanding of this disease through examination of genetic, neurophysiological, biochemical, and behavioral factors. But because animals cannot verbalize their subjective responses to drugs and because significant symptoms of addiction cannot be observed in non-drug-dependent humans, (...) it is not surprising that certain investigations of substance dependence have required the participation of addicted or substance-dependent humans. (shrink)

The mental illness of substance dependence or addiction is responsible for major economic, social, and personal costs. If we are to elucidate its etiology, understand its mechanisms, and eventually bring it under control, scientific investigation is essential. Research in animals and humans has enhanced our understanding of this disease through examination of genetic, neurophysiological, biochemical, and behavioral factors. But because animals cannot verbalize their subjective responses to drugs and because significant symptoms of addiction cannot be observed in non-drug-dependent humans, (...) it is not surprising that certain investigations of substance dependence have required the participation of addicted or substance-dependent humans. (shrink)

In this chapter we outline the need to develop ethical frameworks to guide research on the role of animal-orientated health, therapeutic, and service interventions. We discuss findings from our research on uses of animals in therapeutic settings and benefits of human–canine interactions for human health. These stories from the field reveal that current ethics review processes do not recognise the animal as an equal partner in the potential reciprocal benefits and risks of therapeutic human–animal relationships. (...) We explore how these review processes frame research on the relationships between humans and non-human animals and use the ethical review system of Aotearoa/New Zealand as an example. We propose an ethical framework that goes beyond animal welfare legislation and recognises a range of non-human animal capacities. (shrink)

Research on animal-assisted interventions has increased massively in the last few years. But it is still not clear how AAIs work and how important the animal is in such interventions. The aim of this systematic review was to compile the existing state of knowledge about the working mechanisms of AAIs. We searched 12 major electronic databases for previous AAI studies with active control groups. Of 2001 records identified, we included 172 studies in the systematic review. We extracted previously published (...) hypotheses about working mechanisms and factors that have been implicitly considered specific or non-specific in AAI research by categorizing control conditions using content analysis. We analyzed the categories using descriptive statistics. We found that 84% of the included studies mentioned a hypothesis of working mechanisms, but 16% did not define specific hypotheses. By analyzing their control conditions, we found that in most controlled studies, the animal or the interaction with the animal was implicitly considered as a specific factor for the effects of the AAI. Non-specific factors such as therapeutic aspects, social interactions, or novelty have also been controlled for. We conclude that AAI research still cannot answer the question of how and why AAIs work. To address this important research gap, we suggest using component studies with innovative control conditions and results from placebo research to address both the specific and non-specific, contextual factors of AAIs to disentangle its mechanisms.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158103, identifier: CRD42020158103. (shrink)

In this paper we address the ethical challenges of research on cytoplasmic hybrid embryos, or “cybrids”. The controversial pronouncement of the UK’s Human Embryology and Fertilisation Authority of September 2007 on the permissibility of this area of research is the starting point of our discussion, and we argue in its favour. By a rigorous definition of the entities at issue, we show how the terms “chimera” and “hybrid” are improper in the case of cybrids, and how their use (...) can bias the debate creating moral prejudices. After analysing the scientific aspects of cybrids research and sketching out current alternatives, we enter the ethical debate, starting from the premise that research on early human embryos is ethically permissible under some circumstances. We emphasise how research on cybrids has positive consequences in terms of scientific and therapeutic applications, since it allows the derivation of human embryonic stem cells genetically tailored to the somatic cell donor. Such cell lines offer a unique in vitro model both for studies of human pathogenesis and for drug screening and discovery. Research on cybrids also circumvents the problem of the scarcity of human oocytes and their ethically dubious donation. Finally, we object to the most common arguments against cybrids research, that is, moral repugnance, the slippery slope argument, the appeal to “nature”, and the unfair distribution of economical resources. (shrink)

Despite recurring efforts, a gap exists across a variety of contexts between the protection of patients' safety in theory and in practice. This timely Research Handbook highlights these critical issues and suggests both legal and policy changes are necessary to better protect patients' safety. Multidisciplinary in nature, this Research Handbook features contributions from eminent academics, policy makers and medical practitioners from the Global North and South, discussing the essential facets concerning patient safety and the law. It highlights how (...) the role of legislation and case law has the potential to influence, both positively and negatively, medical practice and the quality of care. Chapters explore patient safety and the global health agenda; physiotherapy; 'non-therapeutic' clinical research with children; patient safety awareness in healthcare education; and the increasing use of robotics and artificial intelligence in healthcare. Outlining a wide range of international perspectives on patient safety and the law, this Research Handbook will appeal to academics and researchers specialising in health and medical law, human rights and healthcare regulation. It will also serve as a valuable resource for legal and medical practitioners alike, as well as clinicians and professionals working in healthcare governance. (shrink)

This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non‐therapeutic research should be upheld; 2) the questions of whether the currently demanded best proven diagnostic and therapeutic method of treatment for all research subjects is feasible both in developed and in developing countries, and whether it (...) should be upheld; 3) the questions of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely. (shrink)

This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non‐therapeutic research should be upheld; 2) the questions of whether the currently demanded best proven diagnostic and therapeutic method of treatment for all research subjects is feasible both in developed and in developing countries, and whether it (...) should be upheld; 3) the questions of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely. (shrink)

The objective of this study is twofold: to examine the patterns that govern social reporting with reference to an Islamic framework and to identify the moral legitimacy factors that influence them. We select 146 publicly listed Sharia‐compliant companies and classify the disclosures in their annual reports according to an Islamic framework that categorises items as either Required, Expected or Desired to indicate the degree of importance each item carries from an Islamic perspective. Based on this framework, we then analyse moral (...) legitimacy factors, specifically the type of Sharia screening body and the proportion of Muslims in the population, that may influence the prioritisation of the different categories of social reporting. We find that disclosures that fall into the Required category of our framework—especially those that relate to companies’ involvement in “haram” activities (activities not permissible in Islam)—are still few among the companies studied. Our research also reveals that both moral legitimacy factors under investigation influence the three categories of social reporting, although in different ways. This research contributes to the existing literature by empirically examining how organisations prioritise their disclosure of virtues and the moral legitimacy factors that influence that prioritisation. (shrink)

Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic research. However, there appears to be very little work conducted with participants who have joined non-therapeutic research. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the (...) potential benefits of enrollment.Methods: In-depth interviews lasting between 45 and 60 minutes were conducted with a convenient sample of 25 ill patients and 25 healthy accompanying relatives enrolled in a genetic epidemiological study of tuberculosis. Recorded interviews were transcribed and analyzed using content analysis.Results: Participants perceived that research was beneficial and some of the benefits included the generation of new knowledge, finding the cause of diseases, as well as the control, eradication and prevention of disease. Some thought that research was risky whilst others thought that the benefits outweighed the risks.Conclusion: Participants perceived research to be beneficial and most of them thought that, though it was risky, the benefits outweighed the risks. It is our view that researchers need to give serious consideration to participant's perception of benefits in designing their consent forms, to see to the fulfillment of achievable goals. (shrink)

The June 1975 issue of the Hastings Center Report published the Deliberations and Recommendations of the National Commission for the Protection of Human Subjects concerning the regulation of fetal experimentation. The Commission's most controversial conclusions were as follows: First, it voted to allow non‐therapeutic research on the human fetus, provided important biomedical knowledge could not be gained in any other way, proper consent had been obtained, and the research imposed “minimal or no risk to the well‐being of (...) the fetus” (Recommendation 4). Because interpretations of the last phrase varied in the case of fetuses scheduled for abortion, the Commission recommended that a national ethical review body be able to rule on disputed cases (Recommendation 5). In the case of research during abortion and research on the non‐viable fetus ex utero, the Commission's interpretation of permissible “harm” was restricted to the proviso that “no intrusion into the fetus [may be] made which alters the duration of life” (Recommendation 6). The Commission also recommended further research on abortion techniques (Recommendation 12). The Secretary of Health, Education and Welfare accepted the Commission's Recommendations almost without change—the major modification was to request paternal consent rather than to rely on the fact that “the father has not objected.” The DHEW regulations were published in the Federal Register on Friday, August 8, 1975, and written comments on them were invited. Already, however, a number of commentators including several members of the Commission had offered either dissenting or qualifying remarks. Some are printed here. (shrink)

Background: Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. However, little attention has been paid to its presence among individuals who participate in research while incarcerated. Methods: This study examined the extent to which 72 incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation. Results: On average, participants (...) endorsed 70% of items suggestive of therapeutic misconception. The tendency toward therapeutic misconception was significantly higher among African Americans and Latinos compared to Whites, among older and less educated participants, and among enrollment in a substance-abuse-related trial; it was also correlated with a belief that the trial was the only way to obtain needed treatment. Conclusions: Therapeutic misconception may be particularly high among select incarcerated individuals and is associated with a perceived lack of treatment options. Further examination of therapeutic misconception among incarcerated research participants is needed. (shrink)

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

ABSTRACT A complex problem exists about how to promote the best interests of children as a group through research while protecting the rights and welfare of individual research subjects. The Nuremberg Code forbids studies without consent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Council for the International Organizations of Medical Science, the U.S. Federal Research Guidelines, (...) and many other national policies. They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how to balance them nor explain the meaning of pivotal concepts, like “minimal risk.” Paths to the improvement of balancing or consequentialist approaches include improving standardizing of risk assessment, rejecting crude utilitarianism, identifying and justifying normative or moral judg-ments, and acknowledging extra-regulatory thresholds and deontological or non-negotiable duties to children. (shrink)

The Mental Incapacity Bill not only paves the way for euthanasia, but invites wholesale abuse and homicide, writes Jacqueline Laing. On 19 October 2004, when the Mental Capacity Bill was at its crucial committee stage, the Law Society issued a statement of ‘strong support’, claiming that it empowers patients and in no way introduces euthanasia. Laing argues that the Bill threatens the incapacitated by granting a raft of new third parties power to require that health professionals withhold ‘treatment’, which, after (...) the controversial decision in Airedale NHS Trust v Bland [1993] AC 789, includes food and fluids delivered both by tube and, in certain cases, by spoon. The Bill further endangers the vulnerable, first, by allowing non-therapeutic research on the non-consenting mentally incapacitated, in breach of the Nuremberg Code and First Declaration of Helsinki, and secondly, by permitting new agents power to undertake on people with learning disabilities certain questionable procedures currently authorised by the High Court, such as non-voluntary sterilisation. (shrink)

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical (...) only when the risks to participants are reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)

Taking post-traumatic stress disorder (PTSD) as an example, we present a concept for transdisciplinary cooperation between life sciences and humanities. PTSD is defined as a long-term persisting anxiety disorder after severe psychological traumata. Initially recognized in war veterans, PTSD also appears in victims of crime and violence or survivors of natural catastrophes, e.g., earthquakes. We consider PTSD as a prototype topic to realize transdisciplinary projects, because this disease is multifacetted from different points of view. Based on physiological and molecular biological (...) research to understand the causes of this disease, conventional academic medicine (to Western medicine) and pharmacology can offer a panel of drugs for treatment, albeit only with limited success. Hence, other treatment options are indispensable. Chinese medicine is frequently regarded as alternative to complement Western medicine. In fact, Chinese medicine offers a large array of both pharmacological and non-pharmacological treatments for PTSD patients. Narrative therapy represents a non-pharmacological approach combating PTSD both in Western medicine as well as in Chinese medicine to improve quality of life of affected patients. Narratives on traumatic experiences form a new genre of life writing in Asian American literature, whose excitement is considerably fueled by the tension between fictitious and very personal narratives taken from reality. Systematic academic reflections on narratives from PTSD patients in the field of Asian American studies may support the improvement of narrative therapy in medical practice. Chinese medicine has a strong philosophical background and may, therefore, serve as junction between life sciences with their strong rational and reductionistic way to generate new knowledge and more holistic approaches in traditional medicines and humanities. In this regard, Chinese medicine may represent a missing link between life science and life writing. (shrink)

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non-minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address (...) the question of whether there should be limits of permissible risks in non-therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high-risk research’. I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees. (shrink)

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to (...) give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only.. Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject’s life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject’s participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject’s consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject’s autonomy and rights it is necessary to add to them two other conditions: the emergency research could not be conducted using other research participants capable of giving informed consent; and informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible. A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible. (shrink)

Design: Qualitative interview study. Participants: Fifty-nine patients with a family history of cancer who attend a regional cancer genetics clinic in the UK were interviewed about their current and previous research experiences. Findings: Interviewees gave a range of explanations for research participation. These were categorised as social—research participation benefits the wider society by progressing science and improving treatment for everyone; familial—research participation may improve healthcare and benefit current or future generations of the participant’s family; and personal— (...) class='Hi'>research participation provides therapeutic or non-therapeutic benefits for oneself. Conclusions: We discuss the distinction drawn between motives for research participation focused upon self and others, and observe that personal, social and familial motives can be seen as interdependent. For example, research participation that is undertaken to benefit others, particularly relatives, may also offer a number of personal benefits for self, such as enabling participants to feel that they have discharged their social or familial obligations. We argue for the need to move away from simple, static, individualised notions of research participation to a more complex, dynamic and inherently social account. (shrink)

In his paper, “The Relevance of Rawls’ Principle of Justice for Research on Cognitively Impaired Patients” (Theoretical Medicine and Bioethics 23 (2002):45–53), Giovanni Maio has developed a thought-provoking argument for the permissibility of non-therapeutic research on cognitively impaired patients. Maio argues that his conclusion follows from the acceptance of John Rawls’s principles of justice, specifically, Rawls’s “liberty principle” Maio has misinterpreted Rawls’s “libertyprinciple” – correctly interpreted it does notsupport non-therapeutic research on cognitivelyimpaired patients. Three other (...) ‘Rawlsian’ arguments are suggested by Maio’s discussion –two “self-respect” arguments and a “presumed consent” argument – but none of them are convincing. However, an alternative argument developed from Rawls’s discussion of “justice in health care” in his most recent book, Justice as Fairness: A Restatement, may justify certain kinds of non-therapeutic research on some cognitively impaired patients in special circumstances. We should not expect anything more permissive from a liberal theory of justice. (shrink)

Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be (...) practicable for regulators to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize. (shrink)

In my recent article, I addressed the question of whether a potential categorical exclusion of decisionally impaired patients from non-therapeutic medical research would be inaccordance with the Principle of Justice as Fairness. I came to the conclusion that a categorical exclusion of decisionally impaired persons from relevant research projects may collide with Rawls’s understanding of Justice as Fairness. Derek Bell has criticized my paper by denying that it is legitimate to apply Rawls to this bioethical problem. In (...) my restatement I try to show that an extrapolation of John Rawls’s thought to such bioethical cases is possible, because Rawls himself has written that his orientation towards decisionally non-impaired persons is an idealized situation that allows extrapolations. In a second part I try to show that Bell hasroughly misunderstood my concept of “presumed consent” which I make a prerequisite for the legitimisation of research on decisionally impaired persons. In using advance consent as a proposal for resolving the problem, Bell has indirectly confirmed my approach because he is using a similar construct of consent, which operates with similar hypotheses and probabilities of error. I see here no categorical difference between Bell’s conclusion and my discussion. Thus, Bell’s reply does not represent a refutation of my thoughts, but rather it is a para phrased confirmation of my central theses. I conclude by showing the relevance of Rawls, pointing out that the discussion between Bell and me illustrates how Rawls’s concept of reflective equilibrium is an appropriate approach to finding a solution to this bioethical problem. (shrink)

: The principle of equipoise traditionally is grounded in the special obligations of physician-investigators to provide research participants with optimal care. This grounding makes the principle hard to apply in contexts with limited health resources, to research that is not directed by physicians, or to non-therapeutic research. I propose a different version of the principle of equipoise that does not depend upon an appeal to the Hippocratic duties of physicians and that is designed to be applicable (...) within a wider range of research contexts and types—including health services research and research on social interventions. I consider three examples of ethically contentious research trials conducted in three different social settings. I argue that in each case my version of the principle of equipoise provides more plausible and helpful guidance than does the traditional version of the principle. (shrink)

This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under what (...) conditions consent is valid or successful in waiving a right. The most influential account of validity conditions is non-moralized, in the sense that the conditions make no essential reference to whether the researcher soliciting consent has obtained it in a way that wrongs the subject. The article examines the implications of this account, and compares it with recent accounts that moralize some of the validity conditions. -/- . (shrink)

Recently, several researchers and philosophers argued that clinical research trials are not therapy. Their position is based on foundational research ethics documents, such as the Belmont Report, on conceptual analysis, and on the general way clinical trials are conducted. After examining and rejecting these arguments, we claim that good research is consistent with good therapy; that often trials are good therapy; and that a blanket attack on clinical trials as non-therapeutic creates a research misconception. This (...) misconception is potentially harmful because it could weaken trial recruitment, could adversely affect funding for trials, and could overturn needed moral safeguards on therapeutic trials. Our more careful and accurate analysis of the nature of clinical trials can avoid such problems. (shrink)