Recently, Indigenous commentators have begun to analyse the way in which institutional Research Ethics Boards engage with Indigenous researchers and participants, respond to Indigenous peoples’ concerns with academic research activities, and scrutinise the ethics proposals of Indigenous scholars. Of particular concern for Indigenous commentators is that the work of REBs often results in the marginalisation of Indigenous approaches to knowledge construction and dissemination, especially in relation to the vexed issue of informed consent. Based on analysis of (...) the results of research with Indigenous researchers and research participants, this paper argues that institutionalised REBs’ preference for ‘universal’ and ‘individualised’ approaches for determining ethical research conduct marginalises Indigenous approaches to ethical research conduct. The paper concludes by calling for a decolonisation of REB processes through recognition of the validity of communal processes for attaining the informed conse... (shrink)

The doctor-patient relationship is built on an implicit covenant of trust, yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion that (...) the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically. (shrink)

We examined differences in the knowledge and beliefs that exist among nurse researchers in the USA (n = 119) regarding informed consent and the use of data from patients’ medical records. Using a mail survey, two domains of ethical knowledge and beliefs were assessed: the legal right to privacy and the moral right to privacy. More than half of the participants were very confident in their knowledge of institutional review board procedures, research ethics, informed consent, (...) the legal right to privacy, and the moral right to privacy. In contrast, most rated themselves as uncertain about US federal research regulations and there was wide variation in knowledge about current federal guidelines. Those who were more confident in their knowledge of or had more practical experience with research ethics, were no more likely to answer correctly a question about current federal guidelines regulating the use of patient data from medical records than those who reported less confidence or experience. (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)

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)

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)

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)

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)

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)

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 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)

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)

To ensure informed consent is tailored to ethnic Asian communities, it is necessary to establish an ethical foundation that is relevant to the specific populations. We hypothesized that certain communitarian factors unique to traditional Kyrgyz culture may influence an individual's decision to participate in research. Guided by Seedhouse's (2005) Rational Field Theory, we conducted qualitative, in‐depth interviews with cultural experts in Kyrgyzstan to identify the ethical foundations of decision‐making for informed consent in Kyrgyz culture. The (...) results indicate that Kyrgyz people have a distinctive decision‐making style influenced by their nomadic culture and history, which values and prioritizes family integrity and reputation. These findings indicate that a multidimensional approach based on socio‐cultural sensitivities is necessary to assess the appropriateness of consent procedures. We believe our results may have implications for revising the guidelines of local and regional research ethics committees in Kyrgyzstan and other Central Asian countries. (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)

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)

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)

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)

BackgroundThe conduct of research is critical to advancing human health. However, there are issues of ethical concern specific to the design and conduct of research in conflict settings. Conflict-affected countries often lack strong platform to support technical guidance and monitoring of research ethics, which may lead to the use of divergent ethical standards some of which are poorly elaborated and loosely enforced. Despite the growing concern about ethical issues in research, there is a dearth of information (...) about ethical compliance in conflict areas. Valid and ethically informed decision-making is a premier pact with research participants in settling possible ethical issues before commencing the research, which is ensured by gaining informed consent from prospective participants of the research.AimsThis research aimed to explore compliance with research ethics and consent validity in community-based epidemiological research conducted previously.MethodsResearch participants were recruited in the western part of Ethiopia in three districts subjected to conflicts. A community-based cross-sectional study design was utilized, and 338 residents were enrolled as study participants. All participants had previously been enrolled as research participants in epidemiological studies. Data was collected using a questionnaire that was pilot-tested before the commencement of the main data collection. The questionnaire focused on participants’ experiences of the informed consent process followed when they were recruited for an epidemiological study and covered themes such as essential information provided, level of comprehension, and voluntarism of consent.ResultsOver half of the study participants, 176 (52%), were not provided with essential information before consenting. And 135 (40%) of them did not comprehend the information provided to them. One hundred and ninety (56%) participants freely and voluntarily agreed to partake in one of these epidemiological studies, with over a quarter (97; 28.7%) of them reporting they were subjected to undue influence. Written consent was obtained from only 32 (9.4%) of the participants. (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)

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research (...) activity in low-and middle-income countries in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent. (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 (...) class='Hi'>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)

To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in (...) early 1996 led to a response from drug companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually – based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences. (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)

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 paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: the data protection regime which follows the application of the European Union General Data Protection Regulation, and the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable (...) and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper. (shrink)

Background: Informed consent can be obtained by various methods, by various people, and with use of various types of consent forms. Persistent effort is necessary to reveal the practical realities of informed consent to improve ethical and legal standards. Objective: To determine the ethical challenges of obtaining informed consent from surgical patients. Methods: The present study was a descriptive cross-sectional study using two researcher-made questionnaires and a checklist for data collection. Data were collected (...) from nursing personnel ( n = 95) and surgical patients ( n = 203) on the surgical wards of three university hospitals in Isfahan, Iran. Data were analyzed using descriptive statistics, Spearman’s rank correlation, Pearson’s correlation coefficient, and the t-test. Ethical considerations: The study was approved by the Ethics Committee of Isfahan University of Medical Sciences (No: 396478). Results: The mean scores (maximum 100) of awareness, competency, and authority were 36.3, 67.7, and 57.6, respectively. The overall quality of the informed consent was poor (score 53.9 of 100). The higher educational level in patients was correlated with lower awareness of and less authority to give informed consent. Only 12.6% of the nurses stated that patients were given sufficient information to assure informed consent. In 89.2% of the consent forms, the risks of the treatment were mentioned. However, alternative methods and risks and advantages of rejecting the treatment were not mentioned in any of the forms. Conclusion: Ethical challenges to obtaining informed consent include patients’ poor awareness of their rights, a failure to provide adequate information to patients, absence of consideration of patients’ educational level, an unclear definition of who is responsible for obtaining informed consent from the patients, time constraints, and use of unclear language and medical jargon. Constructing an ethical framework may guide nursing staff in dealing with the ethical challenges involved in obtaining informed consent. (shrink)

The results of the first randomized controlled trial of a medical treatment were reported in 1947. The antibiotic streptomycin was demonstrated to be dramatically superior to bed rest alone in treating tuberculosis. Looking back on this trial in 1990, A. B. Hill, the distinguished medical statistician who played a prominent role in the use of randomization in this study, made a telling statement about the moral climate of clinical research at the time: "Of course, there were no ethical problems (...) in those days: we did not ask the patient’s permission or anybody’s permission. We did not tell them they were in a trial—we just did it" (1990, 78). From our perspective today it is obvious that it is not true that there .. (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 collection of microbiome samples by swabbing the perianal region of severely burned patients shortly after their admission to an intensive care unit (ICU). We argue that it is ethically permissible to waive informed consent requirements for the perianal swab and that the IRB should approve a waiver as permitted by (...) regulations. (shrink)

BackgroundAn increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects’ motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking. The present study therefore aimed to empirically investigate ethical concerns regarding informed consent and voluntariness in Parkinson’s (...) disease patients undergoing deep brain stimulator (DBS) placement who participated in an intraoperative neuroscience study.MethodsTwo semi-structured 30-minute interviews were conducted preoperatively and postoperatively via telephone. Interviews assessed participants’ motivations for participation in the parent intraoperative study, recall of information presented during the informed consent process, and participants’ postoperative reflections on the research study.ResultsTwenty-two participants (mean age = 60.9) completed preoperative interviews at a mean of 7.8 days following informed consent and a mean of 5.2 days prior to DBS surgery. Twenty participants completed postoperative interviews at a mean of 5 weeks following surgery. All participants cited altruism or advancing medical science as “very important” or “important” in their decision to participate in the study. Only 22.7% (n = 5) correctly recalled one of the two risks of the study. Correct recall of other aspects of the informed consent was poor (36.4% for study purpose; 50.0% for study protocol; 36.4% for study benefits). All correctly understood that the study would not confer a direct therapeutic benefit to them.ConclusionEven though research coordinators were properly trained and the informed consent was administered according to protocol, participants demonstrated poor retention of study information. While intraoperative studies that aim to advance neuroscience knowledge represent a unique opportunity to gain fundamental scientific knowledge, improved standards for the informed consent process can help facilitate their ethical implementation. (shrink)

Nursing research in China is at an early stage of development and little is known about the practices of Chinese nurse researchers. This interview study carried out at a university in central China explores the informed consent practices of Chinese nurse researchers and the cultural considerations of using a western technique. Nine semistructured interviews were conducted in English with assistance and simultaneous translation from a Chinese nurse with research experience. The interviews were analyzed by one western (...) and two Chinese researchers and major themes were identified. All participants endorsed informed consent as ethically required. Differences were noted between some of the informed consent practices typically recommended in the USA and those identified in this study, such as: recruitment using local and government officials, recruiting directly from medical records without special permission, family consultation in consent and consent control, and not revealing randomization to intervention groups receiving different treatments. (shrink)

Biomedical ethics requires that clinical trial participants be accurately informed of the potential risks associated with investigational medical products. We found that the vaccine manufacturer Merck made false statements to the trial participants about the safety of Gardasil in its Future II HPV vaccine trial in Denmark. The clinical study protocol specified that safety testing was one of the trial’s primary objectives, but the recruitment brochure given to trial participants stated this was not the case, as allegedly the vaccine (...) had already been proven safe in previous trials. The advertising material for the trial and the informed consent forms stated that the comparator was saline or an inactive substance, when, in fact, it contained Merck’s proprietary aluminum adjuvant which is highly immunogenic. Several trial participants experienced long-term disabling symptoms during the trial, also some randomized to the adjuvant “placebo” control group. In all cases, their serious adverse events were dismissed as unrelated to the study treatment by Merck’s clinical investigators. We demonstrate that Merck’s published statements about the safety of their proprietary aluminum adjuvant is contradicted by the research evidence. The use of adjuvants as “placebos” in vaccine clinical trials is unethical as it makes it difficult to discover serious vaccine harms. (shrink)

BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation (...) have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives.DiscussionAlthough assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad.SummaryPrevious research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated. (shrink)

In longitudinal cohort studies involving large populations over extended periods, informed consent entails numerous urgent challenges. This paper explores challenges regarding informed consent in long‐term, large‐scale longitudinal cohort studies based on the longitudinal and dynamic nature of such research. It analyzes and evaluates widely recognized broad consent and dynamic consent methods, highlighting limitations concerning their ability to adapt to evolving research objectives and participant perspectives. This paper discusses trust‐based informed consent (...) and emphasizes the needs to establish and maintain trust with research participants and to balance information disclosure with respect for participants' autonomy. Informed consent in long‐term studies is an evolving process that must adapt to changing research environments. Based on participant trust, researchers should observe and assess potential research risks. Finally, the paper recommends enhancing institutional credibility, implementing reconsent procedures, and ensuring robust ethical oversight to safeguard participants' rights despite the complexity of modern biomedical research. (shrink)

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform (...) patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients. (shrink)

Informed consent and confidentiality supposedly minimize harm for research participants in all qualitative research methodologies, inclusive of one-on-one unstructured interviews and focus groups. This is not the case for the latter. Confidentiality and informed consent uniquely manifest themselves as endemic ethical dilemmas for focus group researchers. The principle of caveat emptor (let the buyer beware) may be a more useful tool for those involved in focus group research: that is, let the researcher, the (...) participants and the ethics committee beware that the only ethical assurance that can be given to focus group participants is that there are few ethical assurances. These ethical dilemmas are not sufficiently realized in the literature, and if they are discussed, they are often dealt with within the focus group moderator’s preamble to the group discussion. This paper encourages the mandatory use of a participant information sheet sufficiently detailed to engender the participant’s active consent. Sufficient here means the participant must be made adequately aware of these endemic ethical dilemmas in advance, to allow them to consent to share responsibility for any ensuing harm. The focus group moderator is not their sole protector. (shrink)

Informed by interviews conducted with members of a local research ethics committee (REC), this article reflects upon how RECs can act to improve the quality of patient consent to clinical trials. Two emergent narratives which trial participants have drawn upon to account for their experiences are explored: the narrative of the clinical trial itself and a narrative of individualized treatment. Informed consent requires participants to recognize that only the first of these narratives is relevant to (...) the design, and their experience, of randomized controlled trials. Improving the clarity of patient information is argued to be a relevant, but insufficient, strategy for increasing patient familiarity with the methodology of clinical trials. In the concluding sections of the article, other approaches, and the role of RECs, are considered. (shrink)

There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a conceptual analysis of ethical tensions inherent in the informed consent process for randomized clinical trials for emergency obstetric care and suggest ways in which these could be mitigated. A valid consenting process, leading to an informed consent, is a cornerstone of this aspect necessary for preservation (...) and maintenance of respect for autonomy and dignity. In emergency obstetric care research, obtaining informed consent can be problematic, leading to ethical tension between different moral considerations. Potential participants may be vulnerable due to severity of disease, powerlessness or impaired decisional capacity. Time for the consent process is limited, and some interventions have a narrow therapeutic window. These factors create ethical tension in allowing potentially beneficial research while avoiding potential harms and maintaining respect for dignity, human rights, justice and autonomy of the participants. Informed consent in emergency obstetric care in low- and middle-income countries poses numerous ethical challenges. Allowing research on vulnerable populations while maintaining respect for participant dignity and autonomy, protecting participants from potential harms and promoting justice underlie the ethical tensions in the research in emergency obstetric and newborn care. Those involved in research conduct or oversight have a duty of fair inclusion, to avoid denying participants the right to participate and to any potential research benefits. (shrink)

Informed consent is a central concept in the literature on the ethics of clinical care and human subjects research. There is a broad consensus that ethical practice in these domains requires the informed consent of patients and subjects. The requirements of informed consent in these domains, however, are matters of considerable controversy. Some argue that the requirements of informed consent have been inflated, others that they have not been taken seriously enough. (...) This essay argues that both sides are partly right. To advance this argument, the essay distinguishes a general doctrine of informed consent from what it characterizes as “models of informed consent.” A general doctrine articulates a set of requirements for informed consent and then adjusts these requirements to fit the context in which they are to be applied. In contrast, different models of informed consent impose different requirements in different contexts. The essay contends that different models of informed consent are needed for clinical care and clinical research. It outlines these two models, articulates the rationale for distinguishing them, and considers and rebuts the objection that clinical care and clinical research are too deeply intertwined in contemporary medicine for the models approach to apply to them. (shrink)

Since the Nuremberg trials (1947–1949), informed consent has become central for ethical practice in patient care and biomedical research. Codes of ethics emanating from the Nuremberg Code (1947) recognize the importance of protecting patients and research subjects from abuses, manipulation and deception. Informed consent empowers individuals to autonomously and voluntarily accept or reject participation in either clinical treatment or research. In some cases, however, the underlying mental or physical condition of the individual may (...) alter his or her cognitive abilities and compromise the informed consent process. This is particularly true in chronic psychiatric conditions such as Treatment-Resistant Depression (TRD), where individuals may fail to respond to traditional antidepressant treatments (e.g., psychotherapy, pharmacotherapy). Moreover, it may raise further concerns for an individual’s motivation to consent and the level of understanding of the treatment or research procedure. This paper focuses on the informed consent process for Vagus Nerve Stimulation (VNS) in the treatment of individuals diagnosed with TRD. Specifically, the paper addresses how depression may affect the decision-making capacity of an individual and the potential ethical and legal impact of failure to appreciate the seven elements of the consenting process (competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization). To ensure the protection of vulnerable individuals with psychiatric disorders such as TRD and promote ethical behavior in biomedical research and patient care while avoiding potential legal pitfalls, we propose a paradigm that requires a stringent evaluation process of decision-making capacity for informed consent. (shrink)

A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded (...) as a cornerstone in the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework. (shrink)

To obtain reliable results, some psychological experiments need to involve the deception of human subjects. This contradicts the ethical principle of autonomy and the process of informed consent that is required to ensure the subjects’ autonomy. Some solutions to this dilemma have been proposed, but all of them have drawbacks. As solution I propose a procedure that combines proxy consent and prior consent.

Importance Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.Objective To examine cancer clinical trial (CCT) participants’ perceptions of informed consent processes and variations in perceptions by cancer type.Design and Setting and Participants Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: (...) CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer (N = 334).Main Outcome Measures Percentages satisfied with consent process and information provided; and assessing participation’s perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.Results Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did—47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.Conclusions and Relevance Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making. (shrink)

BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers (...) of participants of a clinical trial on Pemba Island, Tanzania.MethodsA total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65).ResultsIn contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures).ConclusionsIn conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent. (shrink)

ABSTRACT In Mexico informed consent is a legal requirement that ensures that patients who are invited to participate in clinical trials are provided with all the information needed to decide whether to participate, or not, in a research protocol. To improve our understanding of the problems physicians in developing countries encounter, when obtaining informed consent (IC), we examined their opinion on the importance of IC in clinical research, the quantity and quality of the information (...) provided to the participant, and the conditions in which the IC is obtained. Investigators considered that IC was useful to the patients, providing information that helped the patient to make a decision about his/her participation. Nevertheless, they felt that for some aspects of the research, like drug development in general, the use of placebos, and the randomization process, many of the patients were not capable of fully understanding the information provided, referring to the complexity of the information and illiteracy as the main reasons. Many investigators were not acquainted with some of the guidelines established in the Mexican General Law of Health,1 36% of them admitting to not having completed their IC letters. Most investigators gave only minutes to the patient to make a decision and 20% of ICs were obtained while the patient was hospitalized. Except for one investigator, all of them considered that specific training in medical ethics would be useful for the daily clinical work. (shrink)

Background. Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants’ understanding of IC conclude that recall and understanding of IC is often low, and researchers recommend that interactive multimedia interventions should be implemented to optimise understanding. Objectives. To assess participants’ understanding of IC of the research trial that they (...) agreed to participate in.Methods. A descriptive survey design, within a quantitative research approach, was used to conduct the study at two government hospitals in the Eastern Cape Province. A semi-structured, self-administered questionnaire was used to collect information from 170 participants in research studies. Descriptive statistics were used to analyse the results.Results. Participants were recruited from among women who enrolled in any of the three studies that were ongoing at the two sites during the recruitment period. The study participants had a mean age of 25.9 years. Nearly one-third (30%) could not recall the purpose of the original trial that they consented to. The concept of randomisation was not understood by any of the participants.Conclusion. Regardless of extensive efforts to ensure that participants understood their participation, this study unveiled poor recall of essential information on IC. It is proposed that IC should be short and only address essential components such as purpose, procedure, possible risks or benefits, alternative options if not participating and explaining the concept of voluntary participation. (shrink)