Search

Glucocorticoids are understood to represent useful biomarkers of stress and can be measured in saliva, hair, and breastmilk. The collection of such biosamples is increasingly included in biobank and cohort studies. While collection is considered “non-invasive” by biomedical researchers (compared to sampling blood), community perspectives may differ. This cross-sectional, qualitative study utilising eight focus groups aimed to determine the feasibility and acceptability of collecting ostensibly “non-invasive” biological samples in Malawi. Breastfeeding women, couples, field workers, and healthcare providers were purposively sampled. Data about prior understandings of, barriers to, and feasibility of “non-invasive” biosampling were analysed. Participants described biomaterials intended for “non-invasive” collection as sometimes highly sensitive, with sampling procedures raising community concerns. Sampling methods framed as physically “non-invasive” within biomedicine can consequently be considered socially “invasive” by prospective sample donors. Biomedical and community framings of “invasiveness’ can therefore diverge, and the former must respond to and be informed by the perspectives of the latter. Further, considerations of collection procedures are shaped by therapeutic misconceptions about the immediate health-related utility of biomedical and public health research. When researchers engage with communities about biosampling, they must ensure they are not furthering therapeutic misconceptions and actively seek to dispel these.

Engagement with genomic medicine and research has increased globally during the past few decades, including rapid developments in Sri Lanka. Genomic research is carried out in Sri Lanka on a variety of scales and with different aims and perspectives. However, there are concerns about participants' understanding of genomic research, including the validity of informed consent. This article reports a qualitative study aiming to explore the understanding, knowledge, and attitudes of the Sri Lankan public towards genomic medicine and to inform the development of an effective and appropriate process for informed consent in that setting. Purposive sampling was employed. Participants were recruited from a sub-group of the public in Colombo, Sri Lanka who had either consented or refused to donate genetic material for a biobank. Data were collected using face-to-face semi-structured interviews. Interview data were transcribed verbatim and translated into English. Conventional content analysis was used. The analysis developed three key themes: a) 'Scientific literacy' describes an apparent lack of scientific knowledge that seems to affect a participant's ability to understand the research, b) 'Motivation' describes narratives about why participants chose (not) to take part in the research, despite not understanding it, and c) 'Trust' describes how trust served to mitigate the apparent ethical deficit created by not being fully informed. In this article, we argue that informed trust is likely an acceptable basis for consent, particularly in settings where scientific literacy might be low. However, researchers must work to be worthy of that trust and ensure that misconceptions are actively addressed. [ABSTRACT FROM AUTHOR]

Clinical trials play a crucial role in generating evidence about healthcare interventions and improving outcomes for current and future patients. For individual trial participants, however, there are inevitably trade‐offs involved in clinical trial participation, given that trials have traditionally been designed to benefit future patient populations rather than to offer personalised care. Failure to understand the distinction between research and clinical care and the likelihood of benefit from participation in clinical trials has been termed the 'therapeutic misconception'. The evolution of the clinical trials landscape, including greater integration of clinical trials into healthcare and development of novel trial methodologies, may reinforce the significance of the therapeutic misconception and other forms of misunderstanding while at the same time (paradoxically) challenging its salience. Using cancer clinical trials as an exemplar, we describe how methodological changes in early‐ and late‐phase clinical trial designs, as well as changes in the design and delivery of healthcare, impact upon the therapeutic misconception. We suggest that this provides an impetus to re‐examine the ethics of clinical research, particularly in relation to trial access, participant selection, communication and consent, and role delineation. [ABSTRACT FROM AUTHOR]

Introduction. The obligatory study of medical drugs during clinical trials conduction can be named as one of the fundamental principles of evidence-based medicine. The article deals with the phenomenon of a therapeutic misconception occurring in volunteers participating in such experiments, who failed to understand the scientific goals of clinical trials and incorrectly expect the therapeutical advantages linked with such a participation. It is analyzed which methodological decisions can cause a therapeutic misconception, and also the main bioethical risks associated with this phenomenon are indicated. Theoretical analysis. It is shown that the procedure of the receipt of informed consent form is the main problematic aspect for an adequate understanding of clinical trials’ goals by its volunteers, and violation of the principle of patient autonomy can be named as a primary bioethical risk. During the COVID-19 pandemic there has been a heterogeneity of therapeutic strategies fixed because of the lack of knowledge about the new pathogen. As a result, the inability to adequately assess the risks of the intended treatment both by a patient and a doctor became a new factor that caused the therapeutic misconception. Conclusion. The procedure for obtaining informed consent form is supposed to be revised, the additional analysis of the methodology of clinical trials should be done to reduce the risk of a therapeutic misconception.

Maternal mental health (MMH) is recognised as globally significant. The prevalence of depression and factors associated with its onset among perinatal women in Malawi has been previously reported, and the need for further research in this domain is underscored. Yet, there is little published scholarship regarding the acceptability and ethicality of MMH research to women and community representatives. The study reported here sought to address this in Malawi by engaging with communities and healthcare providers in the districts where MMH research was being planned. Qualitative data was collected in Lilongwe and Karonga districts through 20 focus group discussions and 40 in-depth interviews with community representatives and healthcare providers from January through April 2021. All focus groups and interviews were audio recorded, transcribed verbatim (in local languages Chichewa and Tumbuka), translated into English, and examined through thematic content analysis. Participants' accounts suggest that biopsychosocial MMH research could be broadly acceptable within the communities sampled, with acceptability framed in part through prior encounters with biomedical and public health research and care in these regions, alongside broader understandings of the import of MMH. Willingness and consent to participate do not depend on specifically biomedical understandings of MMH, but rather on familiarity with individuals regarded as living with mental ill-health. However, the data further suggest some ‘therapeutic misconceptions’ about MMH research, with implications for how investigations in this area are presented by researchers when recruiting and working with participants. Further studies are needed to explore whether accounts of the acceptability and ethicality of MMH research shift and change during and following research encounters. Such studies will enhance the production of granular recommendations for further augmenting the ethicality of biomedical and public health research and researchers' responsibilities to participants and communities.

Artificial intelligence (AI)-powered chatbots have the potential to substantially increase access to affordable and effective mental health services by supplementing the work of clinicians. Their 24/7 availability and accessibility through a mobile phone allow individuals to obtain help whenever and wherever needed, overcoming financial and logistical barriers. Although psychological AI chatbots have the ability to make significant improvements in providing mental health care services, they do not come without ethical and technical challenges. Some major concerns include providing inadequate or harmful support, exploiting vulnerable populations, and potentially producing discriminatory advice due to algorithmic bias. However, it is not always obvious for users to fully understand the nature of the relationship they have with chatbots. There can be significant misunderstandings about the exact purpose of the chatbot, particularly in terms of care expectations, ability to adapt to the particularities of users and responsiveness in terms of the needs and resources/treatments that can be offered. Hence, it is imperative that users are aware of the limited therapeutic relationship they can enjoy when interacting with mental health chatbots. Ignorance or misunderstanding of such limitations or of the role of psychological AI chatbots may lead to a therapeutic misconception (TM) where the user would underestimate the restrictions of such technologies and overestimate their ability to provide actual therapeutic support and guidance. TM raises major ethical concerns that can exacerbate one's mental health contributing to the global mental health crisis. This paper will explore the various ways in which TM can occur particularly through inaccurate marketing of these chatbots, forming a digital therapeutic alliance with them, receiving harmful advice due to bias in the design and algorithm, and the chatbots inability to foster autonomy with patients.

The social and ethical implications of large-scale biobank donor recruitment campaigns have remained understudied. We use two recent campaigns of the population-based genetic biobank in Estonia as an example to demonstrate how campaign spokespersons try to persuade potential donors by appealing to (1) gaining self-knowledge, (2) gaining control over one's health, (3) fear of illness, (4) contributing to healthcare, (5) contributing to science, and (6) contributing to one's country. While these campaigns succeeded in recruiting 15 percent of the country's adult population as donors, we explain how the use of some of these appeals may (a) create unrealistic expectations regarding the benefits donors could receive and (b) conceal the risks regarding health data. The study lays a necessary groundwork for future empirical research on the ethics of biobank recruitment campaigns. [ABSTRACT FROM AUTHOR]

Many of the world's most pressing issues, such as the emergence of zoonotic diseases, can only be addressed through interdisciplinary research. However, the findings of interdisciplinary research are susceptible to miscommunication among both professional and non-professional audiences due to differences in training, language, experience, and understanding. Such miscommunication contributes to the misunderstanding of key concepts or processes and hinders the development of effective research agendas and public policy. These misunderstandings can also provoke unnecessary fear in the public and have devastating effects for wildlife conservation. For example, inaccurate communication and subsequent misunderstanding of the potential associations between certain bats and zoonoses has led to persecution of diverse bats worldwide and even government calls to cull them. Here, we identify four types of miscommunication driven by the use of terminology regarding bats and the emergence of zoonotic diseases that we have categorized based on their root causes: (1) incorrect or overly broad use of terms; (2) terms that have unstable usage within a discipline, or different usages among disciplines; (3) terms that are used correctly but spark incorrect inferences about biological processes or significance in the audience; (4) incorrect inference drawn from the evidence presented. We illustrate each type of miscommunication with commonly misused or misinterpreted terms, providing a definition, caveats and common misconceptions, and suggest alternatives as appropriate. While we focus on terms specific to bats and disease ecology, we present a more general framework for addressing miscommunication that can be applied to other topics and disciplines to facilitate more effective research, problem-solving, and public policy.

Intracranial electrophysiological research methods, including those applying electrodes on the cortical surface or in deep structures, have become increasingly important in human neuroscience. They also pose novel ethical concerns, as human studies require the participation of neurological patients undergoing surgery for conditions such as epilepsy and Parkinson's disease. Research participants in this setting may be vulnerable to conflicts of interest, therapeutic misconception, and other threats to valid recruitment and consent. We conducted semi-structured interviews with investigators from NIH-funded studies involving recording or stimulation inside the human skull. We elicited perspectives on study recruitment and consent procedures, and analyzed transcripts using a modified grounded theory approach. We interviewed 26 investigators from 19 separate intracranial electrophysiology studies, who described two study types: opportunity studies (n = 15) and experimental trials (n = 4). Respondents described significant heterogeneity in recruitment and consent procedures, even among studies employing similar techniques. In some studies, clinician-investigators were specifically barred from obtaining consent, while in other studies clinician-investigators were specifically required to obtain consent; regulatory guidance was inconsistent. Respondents also described various models for subject selection, the timing of consent, and continuing consent for temporally extended studies. Respondents expressed ethical concerns about participants' vulnerability and the communication of research-related risks. We found a lack of consensus among investigators regarding recruitment and consent methods in human intracranial electrophysiology. This likely reflects the novelty and complexity of such studies and indicates a need for further discussion and development of best practices in this research domain.

Empirical studies have found that altruism and self-interest are the two primary motivations for enrollment in clinical trials. Some studies have shown that in some cases these two motivations are contingent upon each other, which complicates our understanding of motivation. In this study, we interviewed 27 people with Parkinson's disease about their willingness to enroll in a hypothetical clinical trial. Through inductive, grounded theory analysis of the interview transcripts, we find four different contingent relationships between altruism and self-interest. It is important for ethicists to be aware of these more complex motivations because some are ethically problematic and others not. Moreover, practitioners need to be aware of these contingent relationships so that they can understand the motivations of the research participants.

Many factors influence patients' decisions to participate in clinical trials. For many, the primary motivation is the possibility that they might derive some benefit from participation. This is particularly true for patients with limited treatment options, such as patients with advanced cancer. While this is not surprising, it is potentially problematic if patients fail to recognise the distinction between research and clinical care (a phenomenon known as the 'therapeutic misconception'). This is becoming increasingly problematic as clinical trial designs become more complex, as clinical trials become more embedded in routine clinical care, and as trials are increasingly used by patients and clinicians to access new diagnostic platforms and therapies. We outline some of these recent trends, focusing on the cancer clinical trials landscape as this provides a good case study of the phenomenon. We conclude by making preliminary suggestions that changes to the consent process, perhaps using 'dynamic consent' platforms, might help to mitigate the therapeutic misconception and note the need for further research to guide strategies for improving communication and decision‐making. [ABSTRACT FROM AUTHOR]

Academic Medical Centers (AMCs) offer patient care and perform research. Increasingly, AMCs advertise to the public in order to garner income that can support these dual missions. In what follows, we raise concerns about the ways that advertising blurs important distinctions between them. Such blurring is detrimental to AMC efforts to fulfill critically important ethical responsibilities pertaining both to science communication and clinical research, because marketing campaigns can employ hype that weakens research integrity and contributes to therapeutic misconception and misestimation, undermining the informed consent process that is essential to the ethical conduct of research. We offer ethical analysis of common advertising practices that justify these concerns. We also suggest the need for a deliberative body convened by the Association of American Medical Colleges and others to develop a set of voluntary guidelines that AMCs can use to avoid in the future, the problems found in many current AMC advertising practices.

IntroductionInformation on treatment expectations in diabetes is scarce for Mexican and Latino populations. We determined idealistic, realistic, and unrealistic expectations for metformin, insulin, and glyburide in primary care. We also explored the association between sociodemographic attributes, time since diagnosis, and expectations.MethodsThis was a cross-sectional study conducted during 2020–2022 in governmental primary care centers. We consecutively included persons with type 2 diabetes aged 30–70 years under pharmacological medication (n = 907). Questions were developed using information relevant to expectation constructs. Data were collected by interview. We used descriptive statistics, a test of the difference between two proportions, and multivariate ordinal logistic regression.ResultsA high percentage of participants would like to have fewer daily pills/injections or the option of temporarily stopping their medication. Realistic expectations ranged from 47% to 70%, and unrealistic expectations from 31 to 65%. More insulin users wished they could take a temporary break (p < 0.05) or would like to be able to change the route of administration (p < 0.001) than metformin users. More persons with diabetes on insulin expected realistic expectations compared to those on metformin or glyburide (p ≤ 0.01). Being able to interrupt medication upon reaching the glucose goal was higher in combined therapy users (p < 0.001).ConclusionTime since diagnosis, place of residence, sex, and diabetes education were factors associated to expectations. Management of expectations must be reinforced in primary care persons with type 2 diabetes undergoing pharmacological medication.

Background: The absence of effective treatments may render patients with degenerative cerebellar ataxias susceptible to a placebo response, which could affect the outcome of clinical trials. Objective: To retrospectively examine expectations of benefit in participants of an ataxia trial and identify determinants of possible therapeutic misestimation. Methods: Individuals with spinocerebellar ataxia type 3 who participated in a randomized, double‐blind, sham‐controlled trial received a custom‐designed questionnaire about short‐term and long‐term treatment expectations, allocation preferences, and interpretation of treatment arm assignment based on the presence or absence of clinical improvement. To evaluate whether expectations were specifically related to the application of cerebellar transcranial direct current stimulation (tDCS) or more generally reflect an overly positive attitude of patients with ataxia toward trial participation and results, the last questions involved a hypothetical scenario in which an oral drug was tested against placebo with an aim identical to that of our tDCS study. Results: All 20 trial participants completed the questionnaire. If allocated to the active treatment arm, 75% of patients expected short‐term health benefits and 55% thought they would still have less severe ataxia at 1‐year follow‐up compared with baseline. After 2 weeks, an average reduction in ataxia severity of 31.5% (standard deviation, 22.2%) was anticipated. Conversely, 65% associated a lack of improvement with probable or definite allocation to the placebo group. High expectations of benefit were neither related to the type of intervention nor to clinical or demographic characteristics. Conclusion: Therapeutic misestimation is common in patients with degenerative ataxia and requires special attention in future trials. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Investigators commonly offer payments to research participants to promote recruitment and retention. Yet the ethics of offering monetary incentives to research participants continues to be debated. Prior conceptual work has addressed some of these concerns; there is, however, also a need for empirical evidence to understand the effects of payment on participants. Here, we report the results of a qualitative study comprising (1) discourse analysis of recruitment conversations between study coordinators and potential participants for an actual clinical trial and (2) semistructured interviews with participants addressing the effects of an incentive on their decision‐making. Many participants reported that money had been a motivation for enrolling in the clinical trial but did not use reasoning that suggested undue influence or unjust inducement. These findings add to a growing body of literature suggesting that payment is an ethically acceptable tool for promoting recruitment and retention in clinical trials. [ABSTRACT FROM AUTHOR]

Abstract Objectives/Goals: The Rare and Atypical DIAbetes NeTwork (RADIANT) aims to discover the underlying pathoetiology of atypical diabetes by conducting both genotyping and non-genetic deep phenotyping. While the return of genetic test results in research settings has been investigated, the return of non-genetic results (RoR-NG) has received less attention. We explore the RoR-NG with RADIANT investigators and participants. Methods/Study Population: We conducted one-on-one interviews with 10 adult RADIANT participants and 10 RADIANT investigators. Participants also completed two health literacy screening tools and a survey on perspectives regarding return of results (RoR). Investigators completed one survey on experience and confidence in explaining clinical tests utilized in the RADIANT study and another survey on perspectives regarding RoR. Results: Most participants were non-Hispanic White. All participants had high scores on health literacy screens. Both RADIANT participants and investigators expressed strong support for RoR-NG. RADIANT participants and investigators acknowledged the different roles and responsibilities between research and clinical care for interpreting and acting on non-genetic results. However, the lines between clinical care and research in returning and acting on results were often blurred by both participants and investigators. Discussion/Significance: Our study provides important insight into how both investigators and participants simultaneously distinguish and blur clinical and research roles and responsibilities when discussing non-genetic research results and the return of these results. Further study should engage individuals from diverse racial and ethnic backgrounds and with varying levels of health literacy to understand how best to support all participants when returning research results.

Patients with epilepsy (PWE) may experience seizure emergencies including acute repetitive seizures despite chronic treatment with daily antiseizure medications. Seizures may adversely impact routine daily activities and/or healthcare utilization and may impair the quality of life of patients with epilepsy and their caregivers. Seizures often occur at home, school, or work in a community setting. Appropriate treatment that is readily accessible for patients with seizure urgencies and emergencies is essential outside the hospital setting. When determining the best acute antiseizure therapy for PWE, clinicians need to consider all of the available rescue medications and their routes of administration including the safety and efficacy profiles. Benzodiazepines are a standard of care as a rescue therapy, yet there are several misconceptions about their use and safety. Reevaluating potential misconceptions and formulating best practices are necessary to maximize usage for each available option of acute therapy. We examine common beliefs associated with traditional use of acute seizure therapies to refute or support them based on the current level of evidence in the published literature.

Intracranial electrical recordings and stimulation of neurosurgical patients have been central to the advancement of human neuroscience. The use of these methods has rapidly expanded over the last decade due to theoretical and technical advances, as well as the growing number of neurosurgical patients undergoing functional procedures for indications such as epilepsy, tumor resection, and movement disorders. These methods pose the potential for ethical conflict, as they involve basic neuroscientific research utilizing invasive procedures in human patients undergoing treatment for neurological illnesses. This review addresses technical aspects, clinical contexts, and issues of ethical concern, utilizing a framework that is informed by, but also departs from, existing bioethical literature on matters in clinical research. We conclude with proposals for improving informed consent processes to address potential problems specific to intracranial electrophysiology research, a general schema for scrutinizing research-related risk associated with different methods, and a call for the development of consensus to ensure continuing scientific progress alongside crucial patient protections in this promising area of human neuroscience.

Glucocorticoids are understood to represent useful biomarkers of stress and can be measured in saliva, hair, and breastmilk. The collection of such biosamples is increasingly included in biobank and cohort studies. While collection is considered "non-invasive" by biomedical researchers (compared to sampling blood), community perspectives may differ. This cross-sectional, qualitative study utilising eight focus groups aimed to determine the feasibility and acceptability of collecting ostensibly "non-invasive" biological samples in Malawi. Breastfeeding women, couples, field workers, and healthcare providers were purposively sampled. Data about prior understandings of, barriers to, and feasibility of "non-invasive" biosampling were analysed. Participants described biomaterials intended for "non-invasive" collection as sometimes highly sensitive, with sampling procedures raising community concerns. Sampling methods framed as physically "non-invasive" within biomedicine can consequently be considered socially "invasive" by prospective sample donors. Biomedical and community framings of "invasiveness' can therefore diverge, and the former must respond to and be informed by the perspectives of the latter. Further, considerations of collection procedures are shaped by therapeutic misconceptions about the immediate health-related utility of biomedical and public health research. When researchers engage with communities about biosampling, they must ensure they are not furthering therapeutic misconceptions and actively seek to dispel these., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Research participants should be drawn as fairly as possible from the potential volunteer population. Underlying personality traits are underexplored as factors influencing research decision‐making. Dispositional optimism, known to affect coping, physical health, and psychological well‐being, has been minimally studied with respect to research‐related attitudes. We conducted an exploratory, online survey with 151 individuals (with self‐reported mental illness [n = 50], physical illness [n = 51], or neither [n = 50]) recruited via MTurk. We evaluated associations between dispositional optimism (assessed with the Life Orientation Test—Revised) and general research attitudes, perceived protectiveness of five research safeguards, and willingness to participate in research using safeguards. Strongly optimistic respondents expressed more positive research attitudes and perceived four safeguards as more positively influencing willingness to participate. Optimism was positively associated with expressed willingness to participate in clinical research. Our findings add to a limited literature on the influence of individual traits on ethically salient research perspectives. [ABSTRACT FROM AUTHOR]

Purpose: The coronavirus disease 2019 (COVID-19) vaccine is the key to getting out of the pandemic. However, acceptance of the vaccine has been affected by false information and rumors, which have kept people from getting the shot since it was rolled out. Materials and Methods: This study aimed to investigate the various misconceptions surfaced about the COVID-19 vaccines in Africa. We performed an online survey using an anonymous questionnaire to reach out to African respondents by social media and all possible online platforms such as Facebook, WhatsApp, Instagram, Twitter, YouTube, and so forth. The web-based questionnaires about the myths surrounding the vaccines were extracted from nonscientific information, unproven statements, social media posts, news reports, and people's concerns about the safety of the COVID-19 vaccines. Participants indicated their level of agreement with each statement. Results: A total of 2,500 people responded to the online survey in Africa. The two common myths that respondents agreed with were that "since vaccines for COVID-19 have been developed, we can make vaccines for the common cold, human immunodeficiency viruses, and other diseases" (n=892, 35.7%) and that "researchers rushed the development of the COVID-19 vaccines; therefore, it is not very effective, safe and cannot be trusted" (n=595, 23.8%). The range of respondents who neither agreed nor disagreed with these myths was 12.4%--33.0%. The majority (1,931, 77.2%) indicated disagreement with the statement "after getting the COVID- 19 vaccine, one can stop wearing a mask as well as taking safety precautions." Conclusion: Myths surrounding the COVID-19 vaccines have impact on acceptance. Exploring them helps public health authorities in Africa dispel them and provide accurate information to promote vaccination campaigns, education, and acceptance. [ABSTRACT FROM AUTHOR]

"Therapeutic misconception" (TM) refers to inappropriate assumptions and beliefs on the part of research participants regarding key distinctions between the purpose, methods, intended benefits, and potential disadvantages of research compared to those of clinical care. Despite an extensive literature describing TM across varied types of research and populations, minimal work has addressed TM in the context of dementia research. This is a serious gap, for several reasons: people with dementia are at significant risk of diminished capacity; surrogate decision makers are typically asked to provide consent on behalf of the person with dementia; and available treatments for dementia are quite limited. More research is needed on the prevalence, nature, and impact of TM in the context of clinical dementia research.

In phase I trials, some biospecimens are used both for research and patient care and some for research only. Some research participants have therapeutic misconception, assuming all biospecimens are for patient care. This study's aim was to test if a simple information chart would improve understanding of nontherapeutic research procedures. A two‐arm study was conducted. Participants in the control group (C) were asked whether biospecimens were for their care, for research only, or for both. The experimental group (E) was asked the same questions but provided with a study‐specific information chart labeling the purpose of each biospecimen. One hundred one patients were interviewed. In both arms, understanding that pretreatment blood draws were for patient care and research was moderate (49% for C and 62% for E). Understanding that posttreatment blood draws were for research only was significantly higher in the experimental arm (16% for C and 44% for E; p = 0.002). Providing a simple information chart may help alleviate this aspect of therapeutic misconception. [ABSTRACT FROM AUTHOR]

Abstract Background For many rare diseases, few treatments are supported by strong evidence. Patients, family members, health care providers, and policy-makers thus have to consider whether to accept, recommend, or fund treatments with uncertain clinical effectiveness. They must also consider whether and how to contribute to clinical research that may involve receiving or providing the therapy being evaluated. Objective To understand why and how patients and families with rare metabolic diseases, specialist metabolic physicians, and health policy advisors choose whether to participate in studies and how they use and value research. Methods We conducted separate focus group interviews with each stakeholder group (three groups in total); two groups were conducted by telephone and the third was held in-person. Participants were recruited using purposive sampling. We analyzed each interview transcript sequentially using a qualitative description approach to inductively identify key themes. Several strategies to ensure credibility and trustworthiness were used including debriefing sessions after each focus group and having multiple team members review transcripts. Results Four patients/caregivers, six physicians, and three policy advisors participated. Our findings did not support conventional perspectives that therapeutic misconception (gaining access to treatment) is the main motivating factor for patients/caregivers to participate in clinical research. Rather, patients’/caregivers’ expressed reasons for participating in research included advancing science for the next generation and having an opportunity to share their experiences. Patients/caregivers and physicians described the difficulties in weighing risks versus benefits of accepting treatments not well-supported by evidence. Physicians also reported feeling conflicted in their dual role as patient advisor/advocate and evaluator of the evidence. Policy advisors were primarily focused on critically appraising the evidence to make recommendations for the health system. Conclusions Stakeholders differ in their perspectives on rare disease research but share concerns about the risks versus benefits of therapies when making individual- and population-level decisions.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Clinical innovation and research on maternal–fetal interventions have become an essential for the development of perinatal medicine. In this paper, we present an ethical argument that the professional virtue of integrity should guide perinatal investigators. We present an historical account of the professional virtue of integrity and the key distinction that this account requires between intellectual integrity and moral integrity. We identify implications of both intellectual and moral integrity for innovation, research, prospective oversight, the role of equipoise in randomized clinical trials, and organizational leadership to ensure that perinatal innovation and research are conducted with professional integrity. Perinatal investigators and those charged with prospective oversight should be guided by the professional virtue of integrity. Leaders in perinatal medicine should create and sustain an organizational culture of professional integrity in fetal centers, where perinatal innovation and research should be conducted. [ABSTRACT FROM AUTHOR]

Biomedical research often enrolls people living with HIV (PLWH) receiving effective treatment to complete invasive procedures. This mixed methods study characterized determinants of willingness to undergo specific biomedical procedures among PLWH. In 2017, 61 participants (77% Black) from Miami completed a quantitative assessment examining willingness to participate. A subset of 19 participants completed an in-depth qualitative interview. Across all procedures, there was greater willingness to participate if asked by a primary care provider and if experimental results were shared. However, half of participants reported that they would experience undue influence (i.e., excessive persuasion) to participate from their primary care provider. In thematic analyses, altruism and personal benefit were identified as facilitators while medication changes, confidentiality, and perceived stigma were identified as barriers to participation in HIV biomedical research. Addressing participants' expectations and mitigating potential undue influence from primary care providers could optimize the ethical conduct of HIV biomedical studies. [ABSTRACT FROM AUTHOR]

BackgroundApproximately 20% of adult cancer patients are eligible to participate in a clinical trial, but only 2.5-9% do so. Accrual is even less for minority and medically underserved populations. As a result, critical life-saving treatments and quality of life services developed from research studies may not address their needs. This study questions the utility of the bioethical concern with therapeutic misconception (TM), a misconception that occurs when research subjects fail to distinguish between clinical research and ordinary treatment, and therefore attribute therapeutic intent to research procedures in the safety net setting. This paper provides ethnographic insight into the ways in which research is discussed and related to standard treatment.MethodsIn the course of two years of ethnographic fieldwork in a safety net hospital, I conducted clinic observations (n=150 clinic days) and in-depth in-person qualitative interviews with patients (n=37) and providers (n=15). I used standard qualitative methods to organize and code resulting fieldnote and interview data.ResultsFindings suggest that TM is limited in relevance for the interdisciplinary context of cancer clinical trial recruitment in the safety net setting. Ethnographic data show the value of the discussions that happen prior to the informed consent, those that introduce the idea of participation in research. These preliminary discussions are elemental especially when recruiting underserved and vulnerable patients for clinical trial participation who are often unfamiliar with medical research and how it relates to medical care. Data also highlight the multiple actors involved in research discussions and the ethics of social justice and patient advocacy they mobilize, suggesting that class, inequality, and dependency influence the forms of ethical engagements in public hospital settings.ConclusionOn the ground ethics of social justice and patient advocacy are more relevant than TM as guiding ethical principles in the context of ongoing cancer disparities and efforts to diversify clinical trial participation.

There has never been a pandemic of this magnitude in contemporary human history. In less than 16 months after the outbreak of the pandemic, almost 188 million confirmed COVID-19 cases and 2.5 million fatalities have been reported globally. In addition, a great deal of work has been done to discover vaccinations that are both safe and effective. In May 2021, 184 SARS-Cov-2 vaccine contestants were in pre-clinical trials, 105 were in clinical trials, and 18 vaccines had been licensed for emergency use by at least one national or international regulatory body. Till date, only 5 vaccines are given approval by WHO for emergency use that includes, Pfizer-BioNTech, Moderna, AstraZeneca, Sinopharm, Johnson & Johnson. These vaccines include entire virus inactivated or live attenuated, virus vector, protein-based, and nucleic acid vaccines. Currently, confusing information about the COVID-19 vaccination is being disseminated across the world. During health emergency, rumors spread and caused panic, insanity, and anxiety. SARS-CoV-2 strains, on the other hand, are constantly appearing over the world. This article provides a Pakistan's perspective towards COVID-19 vaccines with an updated review. [ABSTRACT FROM AUTHOR]

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. [ABSTRACT FROM AUTHOR]

Background: For many rare diseases, few treatments are supported by strong evidence. Patients, family members, health care providers, and policy-makers thus have to consider whether to accept, recommend, or fund treatments with uncertain clinical effectiveness. They must also consider whether and how to contribute to clinical research that may involve receiving or providing the therapy being evaluated.Objective: To understand why and how patients and families with rare metabolic diseases, specialist metabolic physicians, and health policy advisors choose whether to participate in studies and how they use and value research.Methods: We conducted separate focus group interviews with each stakeholder group (three groups in total); two groups were conducted by telephone and the third was held in-person. Participants were recruited using purposive sampling. We analyzed each interview transcript sequentially using a qualitative description approach to inductively identify key themes. Several strategies to ensure credibility and trustworthiness were used including debriefing sessions after each focus group and having multiple team members review transcripts.Results: Four patients/caregivers, six physicians, and three policy advisors participated. Our findings did not support conventional perspectives that therapeutic misconception (gaining access to treatment) is the main motivating factor for patients/caregivers to participate in clinical research. Rather, patients'/caregivers' expressed reasons for participating in research included advancing science for the next generation and having an opportunity to share their experiences. Patients/caregivers and physicians described the difficulties in weighing risks versus benefits of accepting treatments not well-supported by evidence. Physicians also reported feeling conflicted in their dual role as patient advisor/advocate and evaluator of the evidence. Policy advisors were primarily focused on critically appraising the evidence to make recommendations for the health system.Conclusions: Stakeholders differ in their perspectives on rare disease research but share concerns about the risks versus benefits of therapies when making individual- and population-level decisions. [ABSTRACT FROM AUTHOR]

New developments in cancer research provide opportunities to reduce the amount or intensity of chemotherapy for patients with early-stage breast cancer (EBC), with the goal of achieving recurrence-free survival rates equivalent to the current standard of care while reducing the short- and long-term toxicities that are associated with more aggressive chemotherapy regimens. Clinical trials are necessary to determine the lowest effective dosage of chemotherapy, and there is interest from patients and providers to enroll eligible patients in these trials. Currently, the word being used to describe these trials is 'de-escalation'. This paper considers the reactions of EBC patients and patient advocates to the word 'de-escalation' and how best to describe this approach and its anticipated benefits. Based on a patient survey and on interviews that were coded with the assistance of a content analysis program, we found that the participants tended to react negatively to 'de-escalation', with many associating this word with giving up in the war against cancer. Instead, the participants prefer positive, patient-centered language. This information will be useful to providers in considering how best to describe de-escalation clinical trials to eligible patients in ways that avoid therapeutic misconception and facilitate the shared decision-making process regarding treatment. [ABSTRACT FROM AUTHOR]

Research involving pediatric populations has important ethical and regulatory considerations. As children generally cannot consent to research, there are special protections put in place to ensure that the decisional vulnerability is protected, including parental permission and often the child's assent. Assent is an ethically important part of the research because it allows the child to participate in the process of agreeing to research, develop their autonomy, and express their values. This article explores a case where the child and parent disagree about the child's participation. In doing so, the regulatory requirements of pediatric research are outlined and the process and product of obtaining assent from a minor is described., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Dental student performance on examinations has traditionally been estimated by calculating the percentage of correct responses rather than by identifying student misconceptions. Although misconceptions can impede student learning and are refractory to change, they are seldom measured in biomedical courses in dental schools. Our purpose was to determine if scaling student confidence and the clinical impact of incorrect answers could be used on multiple-choice questions (MCQs) to identify potential student misconceptions. To provide a measure of student misconception, faculty members indicated the correct answer on twenty clinically relevant MCQs and noted whether the three distracters represented potentially benign, inappropriate, or harmful application of student knowledge to patient treatment. A group of 105 third-year dental students selected what they believed was the most appropriate answer and their level of sureness (1 to 4 representing very unsure, unsure, sure, and very sure) about their answer. Misconceptions were defined as sure or very sure incorrect responses that could result in inappropriate or harmful clinical treatment. In the results, 5.2 percent of the answers represented student misconceptions, and 74 percent of the misconceptions were from four case-based interpretation questions. The mean student sureness was 3.6 on a 4.0 scale. The students' sureness was higher with correct than with incorrect answers (p0.05). This study found that scaling student confidence and clinical impact of incorrect answers provided helpful insights into student thinking in multiple-choice assessment.

Abstract Background Clinical trials (CTs) are the “gold standard” to ensure the development of new effective treatments in medicine. A study was conducted to assess knowledge of, and attitudes toward, clinical trials among patients with Parkinson’s disease (PD), along with factors that motivate them to participate. Methods A 50-item questionnaire on the views of patients with PD about CTs was developed. It included statements that the respondents assessed on a Likert scale from 1 (“strongly disagree”) to 5 (“strongly agree”). The questionnaire was mailed to a random sample (n = 2000) of members of the patient organization the Finnish Parkinson Association. In all, 708 response forms were returned, of which 681 were accepted after exclusion (a 34% response rate). Results In general, attitudes of patients with PD toward CTs were positive. Older subjects and patients with lower education levels had inadequate knowledge of general issues related to CTs. Older age, low level of education, and lower number of PD medications were significant predictors for failure to understand the nature and purpose of clinical research. Additionally, significant positive correlation was found between education level and willingness to participate in CTs. Conclusions Patients with PD have important gaps in their knowledge of methodological issues associated with CTs. The oldest subjects and those with a low level of education have the greatest information needs. Investigators should pay more attention to ensuring the comprehensibility of the information provided to potential CT participants.

Clinical trials are essential to advancing knowledge to reduce disease morbidity and mortality; however, ethnic and racial minorities remain under-represented in those studies. We explored knowledge and perceptions of clinical trials among Mexican-Americans in Texas. We conducted focus groups (N = 128) stratified by gender, language preference, and geographical location. This paper presents four emergent, primary themes: 1) knowledge and understanding of clinical trials, 2) fears and concerns about participating, 3) perceived benefits of participating, and 4) incentives to participate. Results suggest that lack of knowledge and understanding of clinical trials leads to misunderstanding about research, including fears and lack of trust. Participants indicated that fears related to perceived experimentation, harm, immigration status, and lack of clinical trial opportunities within their communities were barriers to participation. On the other hand, free healthcare access, helping family members in the future, and monetary incentives could facilitate participation. We also found differences across themes by language, gender, and place of residence. Findings from our study could inform the development of interventions to enhance recruitment of Mexican-American participants into clinical trials.

Background: Non-adherence to medical care programs in transplant recipients is considered one of the life-threatening factors in transplant recipients, which can prevent achieving the desired levels of health care. Objective: To determine perceptions of liver transplant recipients about the barriers to their adherence to medical care programs. Methods: This study was conducted based on a qualitative content analysis method using semi-structured interviews with 23 liver transplant recipients, their families, and the transplant teams. A purposive sampling method was used in liver transplant clinics affiliated to Tehran University of Medical Sciences, Tehran, Iran, from May to November 2017. Results: Three main categories including factors related to therapeutic problems (educational problems and medication challenges), personal factors (self-management disability), as well as social problems (cultural conditions and passive family) were identified as the barriers to adherence to medical care programs. Conclusion: Paying attention to barriers to adherence to medical care and planning for moderating them in a collaborative effort between transplant recipients and health care providers could increase the likelihood of survival and quality of life in these patients.