Dheensa S, Fenwick A, Lucassen A.‘Is this knowledge mine ….

Ethical issues are of foremost importance in modern bio-medical science. Ethical guidelines and socio-cultural public awareness exist for modern samples, whereas for ancient mummy studies both are de facto lacking. This is particularly striking considering the fact that examinations are done without informed consent or that the investigations are invasive due to technological aspects and that it affects personality traits. The aim of this study is to show the pro and contra arguments of ancient mummy research from an (...) ethical point of view with a particular focus on the various stakeholders involved in this research. Relevant stakeholders in addition to the examined individual are, for example, a particular researcher, and the science community in general, likely descendents of the mummy or any future generation. Our broad discussion of the moral dilemma of mummy research should help to extract relevant decision-making criteria for any such study in future. We specifically do not make any recommendations about how to rate these decision-factors, since this is highly dependent on temporal and cultural affiliations of the involved researcher. The sustainability of modern mummy research is dependent on ethical orientation, which can only be given and eventually settled in an interdisciplinary approach such as the one we attempt to present here. (shrink)

Los avances científicos y su aplicación técnica en el ámbito de la odontología, ha motivado la reflexión bioética de la práctica en esta disciplina planteando las siguientes interrogantes: ¿cómo entender el papel del odontólogo?, ¿cómo se configura el universo bioético del odontólogo?, ¿cómo se posibilita el consentimiento válidamente informado? Para explorar la respuesta a estos cuestionamientos, se tiene como punto de partida la relación odontólogo-paciente, y se transita por aspectos de la bioética del odontólogo y las características del consentimiento informado (...) en la práctica odontológica. La conclusión destaca la importancia de hacer del consentimiento informado el medio por el cual se recupera la dignidad de la persona mediante una relación ética y dialógica en tanto proceso mediante el cual se reconoce la alteridad del paciente durante la relación odontólogo- paciente además de coadyuvar a la educación en salud del paciente promoviendo su responsabilidad frente a la autonomía y sus derechos. Scientific advances and their technical application in the field of Dentistry, have led to a bioethical reflection about practice in this discipline by asking questions like: how to understand the dentist´s role, how to set the dentist´s bioethical universe?, how is the valid informed consent made possible? To answer these questions, the patient-dentist relationship is taken as a starting point, and goes through the dentist´s bioethical aspects and informed consent characteristics in dental practice. The conclusion highlights the importance of the informed consent as a way to recover a person´s dignity by which the otherness of the patient is recognized as well as to contribute to the patient´s health education promoting responsibility towards autonomy and rights. (shrink)

BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby (...) adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews : Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs followed by accessibility, comprehension engagement, autonomy, confidentiality, language, and parental consent. Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/rec members during a review process on electronic informed consent and useful to the future preparation of a checklist. (shrink)

In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses (...) a major problem to informed consent. The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

Informed consent is at the core of the clinical relationship. With the introduction of machine learning in healthcare, the role of informed consent is challenged. This paper addresses the issue of whether patients must be informed about medical ML applications and asked for consent. It aims to expose the discrepancy between ethical and practical considerations, while arguing that this polarization is a false dichotomy: in reality, ethics is applied to specific contexts and situations. (...) Bridging this gap and considering the whole picture is essential for advancing the debate. In the light of the possible future developments of the situation and the technologies, as well as the benefits that informed consent for ML can bring to shared decision-making, the present analysis concludes that it is necessary to prepare the ground for a possible future requirement of informed consent for medical ML. (shrink)

Research focused on the prodromal period prior to the onset of psychosis is essential for the further development of strategies for early detection, early intervention, and disease pre-emption. Such efforts necessarily require the enrollment of individuals who are at risk of psychosis but have not yet developed a psychotic illness into research and treatment protocols. This work is becoming increasingly internationalized, which warrants special consideration of cultural differences in conceptualization of mental illness and international differences in health care practices and (...) rights regarding research participation. The process of identifying and requesting informed consent from individuals at elevated risk for psychosis requires thoughtful communication about illness risk and often involves the participation of family members. Empirical studies of risk reasoning and decisional capacity in young people and individuals with psychosis suggest that most individuals who are at-risk for psychosis can adequately provide informed consent; however ongoing improvements to tools and procedures are important to ensure that this work proceeds with maximal consideration of relevant ethical issues. This review provides a discussion of these issues in the context of international research efforts. (shrink)

This article develops a model of informed consent for fresh oöcyte donation for stem cell research, during in vitro fertilisation (IVF), by building on the importance of patients’ embodied experience. Informed consent typically focuses on the disclosure of material information. Yet this approach does not incorporate the embodied knowledge that patients acquire through lived experience. Drawing on interview data from 35 patients and health professionals in an IVF clinic in Australia, our study demonstrates the uncertainty of (...) IVF treatment, and the tendency for patients to overestimate their chances of success prior to the experience of treatment. Once in active treatment, however, patients identify their oöcytes as both precious and precarious. We argue that it is necessary to formally include embodied experience as a source of knowledge in informed consent procedures, both for gratuitous donation and for egg-sharing regimes. We recommend that at least one full cycle of IVF be completed before approaching women to divert eggs away from their own fertility treatment. (shrink)

We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one (...) of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials. (shrink)

In this paper we analyze some of the major difficulties of informed consent. We consider insufficient to base IC on the principle of autonomy. We must not forget that the patient may be in a situation of extreme vulnerability and the good doctor should assume a degree of commitment and responsibility with his/her decisions. Our aim is to introduce the ethics of responsibility of Levinas in practice and theory of IC in order to generate a beneficent medical (...) practice in which the supervision and overseeing of the patient do not undermine his/her autonomy. (shrink)

In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who may not be literate or have limited education. In (...) some CHIs in LMICs, researchers have attempted to address this potential concern by limiting access to literate or educated populations. In this paper, we argue that this practice is unjustified, as it does not increase the chances of obtaining valid informed consent and therefore unfairly excludes illiterate populations and populations with lower education. Instead, we recommend that investigators improve the informed consent process by drawing on existing data on obtaining informed consent in these populations and interventions aimed at improving their understanding. Based on a literature review, we provide concrete suggestions for how to follow this recommendation and ensure that populations with lower literacy or education are given a fair opportunity to protect their rights and interests in the informed consent process. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical (...) studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. (...) They argue that consent needs distinctive communicative transactions, by which other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law. (shrink)

BackgroundApproval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.MethodsWe obtained ethical approval from UK and Sri Lanka. (...) A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.ResultsTwenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form.The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.ConclusionThe number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent. (shrink)

Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, (...) data sharing and feedback of test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. (shrink)

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most (...) important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)

The case (Dawson et al. 2024) describes an Institutional Review Board (IRB) chair who seeks consultation about waiving the requirement that investigators obtain prospective, informed consent for co...

Cluster randomised trials are an increasingly important methodological tool in health research but they present challenges to the informed consent requirement. In the relatively limited literature on the ethics of cluster research there is not much clarity about the reasons for which seeking informed consent in cluster randomised trials may be morally challenging. In this paper, I distinguish between the cases where informed consent in cluster trials may be problematic due to the distinct (...) features of ‘population-based’ interventions, which have not been adequately discussed in the research ethics literature, and the cases where informed consent may be problematic for reasons that investigators also encounter in other research designs. I claim that informed consent requirements in cluster trials should be adjusted to the level of risk involved, arguing for a more comprehensive notion of research risk than that currently found in the research ethics guidelines, and the amount of freedom to be sacrificed in relation to a particular research aim. I conclude that these two factors are the most important to consider when assessing whether a cluster study should proceed when informed consent is infeasible or difficult to obtain. (shrink)

Informed consent, a cornerstone of research ethics, ensures participant protection and informed participation, particularly in online settings. Despite its significance, engagement with online consent forms remains low, underscoring the need for improved presentation strategies. This study investigates the impact of interactive elements and diverse presentation formats on the comprehension and engagement of online informed consent documents among a broad demographic beyond the commonly studied student populations. Employing a between-subjects experimental design, we explored six (...) versions of online consent forms varying in interactivity, readability, and visual formatting to identify optimal strategies for enhancing participant comprehension and engagement. Our findings reveal that interactive formats significantly improve comprehension and perceived readability, highlighting the pivotal role of design in facilitating informed consent. The study also examines the influence of individual differences, such as self-efficacy and trust in science, on the effectiveness of consent forms, providing insights into the nuanced dynamics between participant characteristics and consent form engagement. These results advocate for integrating interactive elements and thoughtful design in consent forms to foster a more informed and engaged participant base. Implications for research ethics, best practices in consent form development, and future research directions are also discussed, emphasizing the need for ongoing innovation in the consent process to adapt to the evolving landscape of online research. This study contributes to the body of knowledge on research ethics by offering evidence-based recommendations for enhancing the informed consent process, ultimately promoting participant-centered research practices. (shrink)

The process of seeking the consent of a patient to a medical procedure is, arguably, one of the most important skills a doctor, or indeed any clinician, should learn. In fact, the very idea that doctors may institute diagnostic or treatment processes of any sort without a patient's consent is utterly counter-intuitive to the modern practice of medicine. It was not always thus, and even now it can be reliably assumed that consent is still not sought and (...) gained appropriately in every clinical encounter. To say that it should be sought and gained in this manner elevates the value of consent to a high level. It can be instructive to ask oneself why such a value might be held to be the case. The answer to this question lies in the philosophical underpinning of clinical consent, which sits within a notion of personal autonomy, and respect for autonomous decision making. (shrink)

Ethical codes help guide the methods of research that involves samples gathered from ?at-risk? populations. The current article reviews general as well as specific ethical principles related to gathering informed consent from partner violent offenders mandated to outpatient treatment, a group that may be at increased risk of unintentional coercion in behavioral sciences research due to court mandates that require outpatient treatment without the ethical protections imbued upon prison populations. Recommendations are advanced to improve the process of (...) class='Hi'>informed consent within this special population and data supporting the utility of the recommendations in a sample 70 partner violent offenders are provided. Data demonstrate that participants were capable of comprehending all essential elements of consent. (shrink)

The article discusses the issue of the necessity of obtaining informed consent from an individual who is to be a participant in an experiment. Codes of ethics concerning the behaviour of a psychologist fundamentally do not permit conducting experiments without informing their participants in advance that they will be conducted. Meanwhile, the act of obtaining prior consent can have a significant impact on results. The article describes an experiment in the field of social influence psychology during (...) which one group was asked for their informed consent to participate in a study, while the second was simply presented with the main request. The results demonstrate the strong influence of awareness that a study is being conducted on the decisions taken in the course of the experiment. (shrink)

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain (...) class='Hi'>informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA. (shrink)

This timely book analyses and evaluates ethical and social implications of recent developments in reporting surgeon performance. It contains chapters by leading international specialists in philosophy, bioethics, epidemiology, medical administration, surgery, and law, demonstrating the diversity and complexity of debates about this topic, raising considerations of patient autonomy, accountability, justice, and the quality and safety of medical services. Performance information on individual cardiac surgeons has been publicly available in parts of the US for over a decade. Survival rates for individual (...) cardiac surgeons in the UK have recently been released to the public. This trend is being driven by various factors, including concerns about accountability, patients' rights, quality and safety of medical care, and the need to avoid scandals in medical care. This trend is likely to extend to other countries, to other clinicians, and to professions beyond health care, making this text an essential addition to the literature available. (shrink)

ZusammenfassungHistorische, theoretische und ethische Aspekte der Medizin sind Lehrinhalte des medizinischen Ausbildungscurriculums, die in dem neu eingeführten Querschnittsbereich 2 "Geschichte, Theorie, Ethik der Medizin" vermittelt werden sollen. Gegenstand dieser Arbeit ist die Darstellung von Unterrichtskonzept und Evaluationsergebnissen eines medizinhistorische und -ethische Inhalte intergrierenden Lehrmoduls zum Thema der Aufklärung und Einwilligung in Klinik und medizinischer Forschung. Die integrierte Vermittlung medizinethischer und -historischer Inhalte wurde von den Studierenden positiv bewertet. Die von den Kursteilnehmenden im Rahmen der Evaluation gezeigten Kenntnisse sowie die Selbsteinschätzung (...) ausgewählter Fähigkeiten und Fertigkeiten können als Hinweis für eine effektive Vermittlung der korrespondierenden Lehrinhalte gewertet werden. Die Definition fachübergreifender Lehrziele sowie die Entwicklung geeigneter Evaluationsinstrumente sind Voraussetzungen für die die Evaluation zukünftiger Lehrveranstaltungen, in denen historische und ethische Aspekte integriert vermitteltwerden sollen. Neben einem Beitrag zur wissenschaftlich fundierten medizinischen Ausbildung im Querschnittsbereich GTE bieten interdisziplinäre Lehrprojekte mit Begleitforschung auch die Möglichkeit das Verhältnis von Geschichte und Ethik der Medizin hinsichtlich der für beide Fächer relevanten Lehrinhalte und Lehrmethoden zu reflektieren. (shrink)

Objective: Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans.Methods: By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed.Results: The adoption and debate of informed consent in neurosurgery took place (...) in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician–patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence.Conclusion: To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent. (shrink)

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most (...) important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. (shrink)

Respect for autonomy has become a fundamental principle in human research ethics. Nonetheless, this principle and the associated process of obtaining informed consent do have limitations. This can lead to some groups, many of them vulnerable, being left understudied. This book considers these limitations and contributes through legal and philosophical analyses to the search for viable approaches to human research ethics. It explores the limitations of respect for autonomy and informed consent both in law (...) and through the examination of cases where autonomy is lacking (infants), diminished (addicts), and compromised (low socio-economic status). It examines alternative and complementary concepts to overcome the limits of respect for autonomy, including beneficence, dignity, virtue, solidarity, non-exploitation, vulnerability and self-ownership. It takes seriously the importance of human relationality and community in qualifying, tempering and complementing autonomy to achieve the ultimate end of human research - the good of humankind. (shrink)

Adolescent pregnancy results from the complex interaction between various internal and external vulnerabilities. These vulnerabilities persist after the infant's birth when the adolescent becomes a parent. Adolescent parents are unfairly stereotyped as unmotivated and incompetent. Some legislations prohibit adolescents from giving consent on the grounds of incompetency. Despite being different, “competency” is frequently used interchangeably with “capacity”; thus, incompetent individuals are often mistaken to lack capacity. Consequently, legally incompetent adolescents who became parents are frequently disregarded during their infant's decision-making (...) process. This article discusses the distinction between the competence and capacity of adolescent parents, the various vulnerabilities that contribute to an adolescent's incompetency, and advocates respect for the adolescent's capacity in making decisions for her infant. We propose a workflow for obtaining informed consent for infants born to adolescents ethically guided by the respect for individuals principle while staying within the country's legal framework. (shrink)

The ‘no-suicide contract’ is a frequently utilized tool in both the assessment and dispersal of suicidal patients. However, little attention has been given to questioning whether suicidal persons are able to give informed consent to enter such a contract. This article utilizes both the existing literature on no-suicide contracts and the results of recent research into the effects of this tool, to examine whether its use is consistent with the legal and ethical doctrine of informed consent. (...) Particular attention is given to issues of competence, fullness of information, voluntariness and paternalistic intervention when no-suicide contracts are used. This analysis finds the tool to be problematic and suggests that individual patients’ ability to give informed consent about a no-suicide contract needs to be carefully considered by clinicians. (shrink)

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; (...) and third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies. (shrink)

Several attempts have been made to transfer the concept of informed consent from medical and research ethics to dealing with affected groups in other areas such as engineering, land use planning, and business management. It is argued that these attempts are unsuccessful since the concept of informed consent is inadequate for situations in which groups of affected persons are dealt with collectively (rather than individually, as in clinical medicine). There are several reasons for this. The (...) affected groups from which informed consent is sought cannot be identified with sufficient precision. Informed consent is associated with individual veto power, but it does not appear realistic to give veto power to all individuals who are affected for instance by an engineering project. Most importantly, the concept of informed consent puts focus on the public’s acceptance of ready-made proposals rather than on its participation in the decision-making process as a whole, which includes the development of alternatives for the decision. Therefore, the concept of informed consent is not applicable to a company’s relations with groups and collectives. It may, however, be applicable to a company’s relations with individual persons such as customers and employees. (shrink)

Implantable brain–computer interface technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified—short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, (...) and privacy and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains—risks pertaining to identity, agency, and stigma—are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants. (shrink)

The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a (...) concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent. Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism. (shrink)

The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent. This study aimed to identify, quantitatively and qualitatively, consent-related issues in (...) different types of malaria proposals submitted to the Faculty of Tropical Medicine, Ethics Committee. This study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews. Of the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase the consent process elements that were considered to involve inadequate information exchange between researcher and study participant. This study aimed to describe lessons for malaria researchers about common informed-consent process issues in different types of malaria proposals. The information and analysis of informed-consent elements should assist the preparation of malaria-research proposals. (shrink)

The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate inf...

This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.