Capacity to consent to research: The evolution and current concepts

The ethical problem of the need to conduct research on the very conditions that impair the ability to consent to such research is widely acknowledged. People with cognitive impairment and mental illness have an equitable right to research being conducted in areas relevant to their treatment and care, and should be given an equitable opportunity to participate in such research, even if they lack capacity. They also have a right to adequate safeguards to protect their interests and respect their wishes in regards to research participation. Provisions for involvement in research of those who are unable to give consent have only developed over the last 50 years. Over this period we have witnessed a proliferation of policies, regulations and laws that govern research involving subjects unable to give consent. There has been a parallel increase in our understanding of the concepts of consent and capacity, specifically as it relates to the research context, with development of standards for research consent and instruments to guide capacity evaluation. We review the evolution of research governance and the underlying ethical principles that underpin such regulations, approaches to capacity evaluation and the use of proxies and advance research directives to facilitate research participation in adults who lack capacity.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/94739/1/appy210.pd

The Interplay Between Use of Biological Therapies, Psychological State, and the Microbiome in IBD

BackgroundThis study examines longitudinal bio-psychological dynamics and their interplay in IBD patients undergoing conventional and biological therapies.MethodsFifty IBD participants (24 UC, 26 CD) in clinical remission were followed for 12 months. Complete longitudinal datasets, biological samples, validated scores of psychological status were collected monthly for analysis of association. Microbiome analysis was performed to identify microbial dynamics and signatures. Patients were grouped on disease phenotype (CD, UC) and mode of treatment (biological therapies, non-biological treatment). General linear models, mixed models, cluster analysis, and analyses of variance were used to examine the longitudinal trends of the variables and their associations over time. Results were corrected for multiple testing.ResultsResults substantiated different interactions between biological therapy and longitudinal trends of inflammatory biomarkers in remission CD and UC patients as well as significant differences between CD and UC patients in their psychological measures during clinical remission, with UC patients having inferior condition compared to CD. A significant reduction in microbial diversity in CD patients compared to UC was identified. Results characterized considerable differences in longitudinal microbial profile between those taking and not taking biological treatment in UC patients, but not in CD patients.ConclusionA different trajectory of interdependence was identified between psychological state, sleep, and microbial dynamics with mode of treatment when compared between CD and UC patients. Further studies should investigate the causal relationships between bio-psychological factors for improved treatment purposes

Rapid ethical assessment on informed consent content and procedure in Hintalo-Wajirat, Northern Ethiopia: a qualitative study

Background Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. Methodology A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. Results The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. Conclusion This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the study

What's new, pussycat? : on talking to babies and animals

The uncanny similarity of pet- to infant-directed speech has been noted previously. The authors in a study made objective comparisons of 12 mothers' speech to their infant, their pet and another adult in three domains, including pitch

Empathy as a function of clinical exposure--reading emotion in the eyes.

BACKGROUND: Evidence based largely on self-report data suggests that factors associated with medical education erode the critical human quality of empathy. These reports have caused serious concern among medical educators and clinicians and have led to changes in medical curricula around the world. This study aims to provide a more objective index of possible changes in empathy across the spectrum of clinical exposure, by using a behavioural test of empathic accuracy in addition to self-report questionnaires. Moreover, non-medical groups were used to control for maturation effects. METHODS: Three medical groups (N = 3×20) representing a spectrum of clinical exposure, and two non-medical groups (N = 2×20) matched for age, sex and educational achievements completed self-report measures of empathy, and tests of empathic accuracy and interoceptive sensitivity. RESULTS: Between-group differences in reported empathy related to maturation rather than clinical training/exposure. Conversely, analyses of the "eyes" test results specifically identified clinical practice, but not medical education, as the key influence on performance. The data from the interoception task did not support a link between visceral feedback and empathic processes. CONCLUSIONS: Clinical practice, but not medical education, impacts on empathy development and seems instrumental in maintaining empathetic skills against the general trend of declining empathic accuracy with age

Vowel hyperarticulation in parrot-, dog- and infant- directed speech

Vowel triangle area is a phonetic measure of the clarity of vowel articulation. Compared with speech to adults, people hyperarticulate vowels in speech to infants and foreigners but not to pets, despite other similarities in infant- and pet-directed-speech. This suggests that vowel hyperarticulation has a didactic function positively related to the actual, or even the expected, degree of linguistic competence of the audience. Parrots have some degree of linguistic competence yet no studies have examined vowel hyper- articulation in speech to parrots. Here, we compared the speech of 11 adults to another adult, a dog, a parrot, and an infant. A significant linear increase in vowel triangle area was found across the four conditions, showing that the degree of vowel hyperarticulation increased from adult- and dog-directed speech to parrot-directed speech, then to infant-directed speech. This suggests that the degree of vowel hyperarticulation is related to the audience's actual or expected linguistic competence. The results are discussed in terms of the relative roles of speakers' expectations versus listeners' feedback in the production of vowel hyperarticulation; and suggestions for further studies, manipulating speaker expectation and listener feedback, are provided

Gene expression in response to exercise in patients with chronic fatigue syndrome: A pilot study

Chronic fatigue syndrome (CFS) is a debilitating disorder of unknown pathogenesis, characterized by fatigue, which is exacerbated after minimal exercise. We examined the effect of a single bout of aerobic exercise on leucocyte mRNA expression of genes putatively linked to exaggerated afferent signaling as an under-pinning of the fatigue state. A carefully-characterized sample of patients with CFS (N = 10) and healthy matched control participants (N = 12) were included. Participant ratings of fatigue and other symptoms, as well as blood samples, were obtained at baseline, and five other time-points up to 72 h after 25 min of moderate-intensity cycling exercise. Leucocyte mRNA of 19 metabolite-sensing, adrenergic, immune, and neurotransmission genes was examined using quantitative polymerase chain reaction. Patients with CFS reported substantial fatigue, functional impairment, and poor sleep at baseline (all p < 0.02), and exercise immediately induced worsened patients' fatigue (effect size, ES = 1.17). There were no significant changes in gene expression after exercise and patients did not differ from control participants at any time point. Higher levels of expression of ficolin (FCN1) and a purinergic receptor (P2RX4) in patients with CFS were found when all time points were combined. Patients with CFS did not show significant exercise-induced changes in leucocyte mRNA of 19 metabolite-sensing, adrenergic, immune and neurotransmission genes despite a prominent exacerbation of fatigue

Mean scores for the Empathy Quotient questionnaire (EQ-60) for the five participant groups.

<p>Error bars represent the standard error of the mean.</p