A Qualitative Analysis of Ethical Perspectives on Recruitment and Consent for Human Intracranial Electrophysiology Studies.
Ontology highlight
ABSTRACT:
SUBMITTER: Mergenthaler JV
PROVIDER: S-EPMC8168380 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BackgroundTeletherapy apps have emerged as a promising alternative to traditional in-person therapy, especially after the COVID-19 pandemic, as they help overcome a range of geographical and emotional barriers to accessing care. However, the rapid proliferation of teletherapy apps has occurred in an environment in which development has outpaced the various regulatory and ethical considerations of this space. Thus, researchers have raised concerns about the ethical implications and potential risks of teletherapy apps given the lack of regulation and oversight. Teletherapy apps have distinct aims to more directly replicate practices of traditional care, as opposed to mental health apps, which primarily provide supplemental support, suggesting a need to examine the ethical considerations of teletherapy apps from the lens of existing ethical guidelines for providing therapy.ObjectiveIn this study, we examined user reviews of commercial teletherapy apps to understand user perceptions of whether and how ethical principles are followed and incorporated.MethodsWe identified 8 mobile apps that (1) provided teletherapy on 2 dominant mobile app stores (Google Play and Apple App Store) and (2) had received >5000 app reviews on both app stores. We wrote Python scripts (Python Software Foundation) to scrape user reviews from the 8 apps, collecting 3268 user reviews combined across 2 app stores. We used thematic analysis to qualitatively analyze user reviews, developing a codebook drawing from the ethical codes of conduct for psychologists, psychiatrists, and social workers.ResultsThe qualitative analysis of user reviews revealed the ethical concerns and opportunities of teletherapy app users. Users frequently perceived unprofessionalism in their teletherapists, mentioning that their therapists did not listen to them, were distracted during therapy sessions, and did not keep their appointments. Users also noted technical glitches and therapist unavailability on teletherapy apps that might affect their ability to provide continuity of care. Users held varied opinions on the affordability of those apps, with some perceiving them as affordable and others not. Users further brought up that the subscription model resulted in unfair pricing and expressed concerns about the lack of cost transparency. Users perceived that these apps could help promote access to care by overcoming geographical and social constraints.ConclusionsOur study suggests that users perceive commercial teletherapy apps as adhering to many ethical principles pertaining to therapy but falling short in key areas regarding professionalism, continuity of care, cost fairness, and cost transparency. Our findings suggest that, to provide high-quality care, teletherapy apps should prioritize fair compensation for therapists, develop more flexible and transparent payment models, and invest in measures to ensure app stability and therapist availability. Future work is needed to develop standards for teletherapy and improve the quality and accessibility of those services.
| S-EPMC10559192 | biostudies-literature
Project description:IntroductionCochlear implants (CIs) are the treatment of choice for severe to profound hearing loss. Variability in CI outcomes remains despite advances in technology and is attributed in part to differences in cortical processing. Studying these differences in CI users is technically challenging. Spectrally degraded stimuli presented to normal-hearing individuals approximate input to the central auditory system in CI users. This study used intracranial electroencephalography (iEEG) to investigate cortical processing of spectrally degraded speech.MethodsParticipants were adult neurosurgical epilepsy patients. Stimuli were utterances /aba/ and /ada/, spectrally degraded using a noise vocoder (1-4 bands) or presented without vocoding. The stimuli were presented in a two-alternative forced choice task. Cortical activity was recorded using depth and subdural iEEG electrodes. Electrode coverage included auditory core in posteromedial Heschl's gyrus (HGPM), superior temporal gyrus (STG), ventral and dorsal auditory-related areas, and prefrontal and sensorimotor cortex. Analysis focused on high gamma (70-150 Hz) power augmentation and alpha (8-14 Hz) suppression.ResultsChance task performance occurred with 1-2 spectral bands and was near-ceiling for clear stimuli. Performance was variable with 3-4 bands, permitting identification of good and poor performers. There was no relationship between task performance and participants demographic, audiometric, neuropsychological, or clinical profiles. Several response patterns were identified based on magnitude and differences between stimulus conditions. HGPM responded strongly to all stimuli. A preference for clear speech emerged within non-core auditory cortex. Good performers typically had strong responses to all stimuli along the dorsal stream, including posterior STG, supramarginal, and precentral gyrus; a minority of sites in STG and supramarginal gyrus had a preference for vocoded stimuli. In poor performers, responses were typically restricted to clear speech. Alpha suppression was more pronounced in good performers. In contrast, poor performers exhibited a greater involvement of posterior middle temporal gyrus when listening to clear speech.DiscussionResponses to noise-vocoded speech provide insights into potential factors underlying CI outcome variability. The results emphasize differences in the balance of neural processing along the dorsal and ventral stream between good and poor performers, identify specific cortical regions that may have diagnostic and prognostic utility, and suggest potential targets for neuromodulation-based CI rehabilitation strategies.
| S-EPMC10839784 | biostudies-literature
Project description:ObjectiveClinical trials and studies in intensive care units (ICUs) have complex consent processes and often encounter problems in recruiting patients. By interviewing research team members about the challenges in critical care research, we aimed to identify strategies to enhance recruitment and consent to ICU studies.MethodsSemistructured interviews with UK-based researchers (N=17) and patient-public involvement (PPI) contributors (N=8) with experience of ICU studies. Analysis of transcripts of audio-recorded interviews drew on thematic approaches.ResultsSeven themes were identified. Participants emphasised the need for substitute decision-making processes in critical care studies, yet some researchers reported that research ethics committees (RECs) were reluctant to approve such processes. Researchers spoke about the potential benefits of research without prior consent (RWPC) for studies with narrow recruitment windows but believed RECs would not approve them. Participants indicated that the activity of PPI contributors was limited in critical care studies, though researchers who had involved PPI contributors more extensively were clear that their input when designing consent processes was important. Researchers and PPI contributors pointed to resource and staffing limitations as barriers to patient recruitment. Researchers varied in whether and how they used professional consultees as substitute decision-makers, in whether they approached families by telephone to discuss research and in whether they disclosed details of research participation to bereaved relatives.ConclusionCritical care research could benefit from RECs having expertise in consent processes that are suited to this setting, better staffing at research sites, more extensive PPI and an evidence base on stakeholder perspectives on critical care research processes. Guidance on professional consultee processes, telephoning relatives to discuss research, RWPC and disclosure of research participation to bereaved relatives could help to harmonise practice in these areas and enhance recruitment and consent to critical care studies.
| S-EPMC8461270 | biostudies-literature
Project description:BackgroundTerms and conditions define the relationship between social media companies and users. However, these legal agreements are long and written in a complex language. It remains questionable whether users understand the terms and conditions and are aware of the consequences of joining such a network. With children from a young age interacting with social media, companies are acquiring large amounts of data, resulting in longitudinal data sets that most researchers can only dream of. The use of social media by children is highly relevant to their mental and physical health for 2 reasons: their health can be adversely affected by social media and their data can be used to conduct health research.ObjectiveThe aim of this paper is to offer an ethical analysis of how the most common social media apps and services inform users and obtain their consent regarding privacy and other issues and to discuss how lessons from research ethics can lead to trusted partnerships between users and social media companies. Our paper focuses on children, who represent a sensitive group among users of social media platforms.MethodsA thematic analysis of the terms and conditions of the 20 most popular social media platforms and the 2 predominant mobile phone ecosystems (Android and iOS) was conducted. The results of this analysis served as the basis for scoring these platforms.ResultsThe analysis showed that most platforms comply with the age requirements issued by legislators. However, the consent process during sign-up was not taken seriously. Terms and conditions are often too long and difficult to understand, especially for younger users. The same applies to age verification, which is not realized proactively but instead relies on other users who report underaged users.ConclusionsThis study reveals that social media networks are still lacking in many respects regarding the adequate protection of children. Consent procedures are flawed because they are too complex, and in some cases, children can create social media accounts without sufficient age verification or parental oversight. Adopting measures based on key ethical principles will safeguard the health and well-being of children. This could mean standardizing the registration process in accordance with modern research ethics procedures: give users the key facts that they need in a format that can be read easily and quickly, rather than forcing them to wade through chapters of legal language that they cannot understand. Improving these processes would help safeguard the mental health of children and other social media users.
| S-EPMC8103294 | biostudies-literature
Project description:BackgroundAlthough recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively explore the experiences of both patients and pharmacists related to recruitment for ACCESS, a large trial involving low-income seniors, given that two of our most successful recruitment strategies were direct patient recruitment materials and use of community pharmacists.MethodsUsing qualitative descriptive methods, we collected data from pharmacists and study participants. Pharmacists were asked about their impressions of the study, as well as challenges they faced and methods they used to recruit potential participants. Focus groups with trial participants centered on the patient recruitment materials. Interviews and focus groups were recorded, transcribed and analyzed using thematic analysis.ResultsPharmacists noted that their first impressions of the study were positive as they described being enticed to help the study team by the potential benefit of copayment elimination for their patients and the low time commitment. Pharmacists noted they were more likely to recruit if they were well informed on the study, as they could answer their patients' questions. Participants noted that their primary motivations for participating were the tangible benefits of free medications and the intrinsic value of participating in research.ConclusionsWe noted that recruitment through pharmacies was an effective method as most patients have trusting relationships with their pharmacist. To optimize recruitment through pharmacies, study procedures should be straightforward, and pharmacists need to be equipped with good knowledge of the study. When promoting a study to potential participants, messaging should ensure the individuals are aware of the tangible benefits of participation while still presenting a full overview of the trial.Trial registrationTrial Registration Number: NCT02579655 - initially registered Oct 19, 2015.
| S-EPMC7603682 | biostudies-literature
Project description:COVID-19 poses an extraordinary threat to global public health and an effective vaccine could provide a key means of overcoming this crisis. Human challenge studies involve the intentional infection of research participants and can accelerate or improve vaccine development by rapidly providing estimates of vaccine safety and efficacy. Human challenge studies of low virulence coronaviruses have been done in the past and human challenge studies with severe acute respiratory syndrome coronavirus 2 have been proposed. These studies of coronaviruses could provide considerable benefits to public health; for instance, by improving and accelerating vaccine development. However, human challenge studies of severe acute respiratory syndrome coronavirus 2 in particular might be controversial, in part, for ethical reasons. The ethical issues raised by such studies thus warrant early consideration involving, for example, broad consultation with the community. This Personal View provides preliminary analyses of relevant ethical considerations regarding human challenge studies of severe acute respiratory syndrome coronavirus 2, including the potential benefits to public health and to participants, the risks and uncertainty for participants, and the third-party risks (ie, to research staff and the wider community). We argue that these human challenge studies can reasonably be considered ethically acceptable insofar as such studies are accepted internationally and by the communities in which they are done, can realistically be expected to accelerate or improve vaccine development, have considerable potential to directly benefit participants, are designed to limit and minimise risks to participants, and are done with strict infection control measures to limit and reduce third-party risks.
| S-EPMC7259898 | biostudies-literature
Project description:BACKGROUND:Non-Invasive Prenatal Testing (NIPT) is a technology which provides information about fetal genetic characteristics (including sex) very early in pregnancy by examining fetal DNA obtained from a sample of maternal blood. NIPT is a morally complex technology that has advanced quickly to market with a strong push from industry developers, leaving many areas of uncertainty still to be resolved, and creating a strong need for health policy that reflects women's social and ethical values. We approach the need for ethical policy-making by studying the use of NIPT and emerging policy in the province of Ontario, Canada. METHODS:Using an adapted version of constructivist grounded theory, we conducted interviews with 38 women who have had personal experiences with NIPT. We used an iterative process of data collection and analysis and a staged coding strategy to conduct a descriptive analysis of ethics issues identified implicitly and explicitly by women who have been affected by this technology. RESULTS:The findings of this paper focus on current ethical issues for women seeking NIPT, including place in the prenatal pathway, health care provider counselling about the test, industry influence on the diffusion of NIPT, consequences of availability of test results. Other issues gain relevance in the context of future policy decisions regarding NIPT, including funding of NIPT and principles that may govern the expansion of the scope of NIPT. These findings are not an exhaustive list of all the potential ethical issues related to NIPT, but rather a representation of the issues which concern women who have personal experience with this test. CONCLUSIONS:Women who have had personal experience with NIPT have concerns and priorities which sometimes contrast dramatically with the theoretical ethics literature. These findings suggest the importance of engaging patients in ethical deliberation about morally complex technologies, and point to the need for more deliberative patient engagement work in this area.
| S-EPMC5902938 | biostudies-literature
Project description:Over the past 60 years, human intracranial electrophysiology (HIE) has been used to characterize seizures in patients with epilepsy. Secondary to the clinical objectives, electrodes implanted intracranially have been used to investigate mechanisms of human cognition. In addition to studies of memory and language, HIE methods have been used to investigate emotions. The aim of this review is to outline the contribution of HIE (electrocorticography, single-unit recording and electrical brain stimulation) to our understanding of the neural representations of emotions. We identified 64 papers dating back to the mid-1950s which used HIE techniques to study emotional states. Evidence from HIE studies supports the existence of widely distributed networks in the neocortex, limbic/paralimbic regions and subcortical nuclei which contribute to the representation of emotional states. In addition, evidence from HIE supports hemispheric dominance for emotional valence. Furthermore, evidence from HIE supports the existence of overlapping neural areas for emotion perception, experience and expression. Lastly, HIE provides unique insights into the temporal dynamics of neural activation during perception, experience and expression of emotional states. In conclusion, we propose that HIE techniques offer important evidence which must be incorporated into our current models of emotion representation in the human brain.
| S-EPMC4249472 | biostudies-literature
Project description:ImportancePragmatic clinical trials that seek informed consent after randomization (ie, postrandomization consent) are increasingly used, but debate on ethics persists because control arm patients are not specifically informed about the trials and randomization occurs before consent for the trials. The public's attitude toward postrandomization consent trials is unknown, but the way the trials are described could bias people's views.ObjectivesTo assess the attitudes of the US general public toward postrandomization informed consent for pragmatic trials and to measure potential framing and other factors associated with those attitudes.Design, setting, and participantsAn online, 2 × 2 experimental survey (fielded between February 23 and April 3, 2018) portraying 4 scenarios of postrandomization informed consent (with prior broad consent for medical record use) was conducted. These scenarios included traditional randomized clinical trial language framing vs alternative framing in a high-stakes trial (ie, survival in leukemia) or low-stakes trial (ie, blood glucose level in diabetes). A total of 3793 individuals invited to participate were part of an existing panel representative of the US general public (GfK KnowledgePanel).Main outcomes and measuresThe proportion of participants who would recommend that an ethics review board approve a postrandomization consent pragmatic trial.ResultsA total of 2042 of 3739 invitees (54.6%) responded; after exclusion of 38 incomplete surveys, 2004 participants were included in the analysis. Of these, 997 (49.8%) were women, 1440 (71.9%) were white non-Hispanic, 199 (9.9%) were black non-Hispanic, and 233 (11.6%) were Hispanic. Mean (SD) age was 47.5 (17.4) years. Across scenarios, weighted data showed that 75.4% of the participants would recommend approval of the postrandomization consent pragmatic trial, 20.4% would probably not recommend approval, and 4.2% would definitely not recommend approval. Approval was not sensitive to framing language (traditional vs new framing in high-stakes scenario, 74.3% vs 76.8%, P = .40; in low-stakes scenario, 77.7% vs 72.9%, P = .10) or to the stakes (low vs high stakes in traditional framing, 77.7% vs 74.3%, P = .25; in new framing, 72.9% vs 76.8%, P = .18). Better understanding of the postrandomization consent design was associated with higher rate of approval (78.1% vs 65.0%, P = .002 for high-stakes scenario; 77.2% vs 64.9%, P = .004 for low-stakes scenario), especially among those with less education. However, opinions about personal involvement in the control arm were more cautious (range depending on scenario, 45.6%-59.7%) and sensitive to stakes but not to framing.Conclusions and relevanceThe public's generally high rate of approval of the ethics of postrandomization informed consent for pragmatic trial designs does not appear to be affected by whether postrandomization consent design is framed using traditional randomized clinical trial terminology, regardless of the stakes of the trial. Promoting better understanding of the design may increase its acceptance by the public.
| S-EPMC6324565 | biostudies-literature
Project description:Understanding cortical processing of spectrally degraded speech in normal-hearing subjects may provide insights into how sound information is processed by cochlear implant (CI) users. This study investigated electrocorticographic (ECoG) responses to noise-vocoded speech and related these responses to behavioral performance in a phonemic identification task. Subjects were neurosurgical patients undergoing chronic invasive monitoring for medically refractory epilepsy. Stimuli were utterances /aba/ and /ada/, spectrally degraded using a noise vocoder (1-4 bands). ECoG responses were obtained from Heschl's gyrus (HG) and superior temporal gyrus (STG), and were examined within the high gamma frequency range (70-150 Hz). All subjects performed at chance accuracy with speech degraded to 1 and 2 spectral bands, and at or near ceiling for clear speech. Inter-subject variability was observed in the 3- and 4-band conditions. High gamma responses in posteromedial HG (auditory core cortex) were similar for all vocoded conditions and clear speech. A progressive preference for clear speech emerged in anterolateral segments of HG, regardless of behavioral performance. On the lateral STG, responses to all vocoded stimuli were larger in subjects with better task performance. In contrast, both behavioral and neural responses to clear speech were comparable across subjects regardless of their ability to identify degraded stimuli. Findings highlight differences in representation of spectrally degraded speech across cortical areas and their relationship to perception. The results are in agreement with prior non-invasive results. The data provide insight into the neural mechanisms associated with variability in perception of degraded speech and potentially into sources of such variability in CI users.
| S-EPMC6309487 | biostudies-literature