Del discurso capitalista al neoliberalismo: apuntes sobre la producción del sujeto / From capitalist discourse to neoliberalism: notes on the production of the subject

Las economías globalizadas de mercado conllevan consecuencias de inequidad social basadas en la privatización de sectores laborales y productivos donde los sujetos se involucran en modos singulares de concebirse y construir la realidad. Propone el psicoanálisis lacaniano que el discurso capitalista deshace el lazo social, al obrar con una lógica que consiste en gozar del consumo que supone felicidad. El neoliberalismo promueve un sistema aparentemente horizontal que incorpora las capacidades empoderadas del sujeto promoviéndolo a ser emprendedor y, por tanto, convirtiendo a cada uno en gestor de su propio bienestar pero impedidos para forjar lazos solidarios. No porque el sujeto pueda consumir más, queda desprovisto de su falta constitutiva; paradójicamente, la subjetividad neoliberal reproduce incesantemente un vacío que socava el reconocimiento de las diferencias del otro

Globalized market economies entail consequences of social inequality, based on the privatization of labor and productive sectors, where subjects engage in unique ways of conceiving and constructing reality. Lacanian psychoanalysis proposes that capitalist discourse undoes the social bond, by acting with a logic that consists in enjoying the consumption that supposes happiness. Neoliberalism promotes an apparently horizontal system that incorporates the empowered capacities of the subject by promoting him to be an entrepreneur and, therefore, turning each one into a manager of his own well-being, but prevented from forging solidarity ties. Not because the subject can consume more, he is devoid of his constitutive lack; paradoxically, neoliberal subjectivity incessantly reproduces a vacuum that undermines the recognition of each other's differences.

Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States.

Importance: Representative enrollment in clinical trials is critical to ensure equitable and effective translation of research to practice, yet disparities in clinical trial enrollment persist. Objective: To examine person-level factors associated with invitation to and participation in clinical trials. Design, Setting, and Participants: This cross-sectional study analyzed responses from 3689 US adults who participated in the nationally representative Health Information National Trends Survey, collected February through June 2020 via mailed questionnaires. Exposures: Demographic, clinical, and health behavior-related characteristics. Main Outcomes and Measures: History of invitation to and participation in a clinical trial, primary information sources, trust in information sources, and motives for participation in clinical trials were described. Respondent characteristics are presented as absolute numbers and weighted percentages. Associations between respondent demographic, clinical, and health behavior-related characteristics and clinical trial invitation and participation were estimated using survey-weighted logistic regression models. Results: The median (IQR) age of the 3689 respondents was 48 (33-61) years, and most were non-Hispanic White individuals (2063 [59%]; non-Hispanic Black, 452 [10%]; Hispanic, 521 [14%]), had more than a high school degree (2656 [68%]), were employed (1809 [58%]), and had at least 1 medical condition (2535 [61%]). Overall, 439 respondents (9%) had been invited to participate in any clinical trial. Respondents with increased odds of invitation were non-Hispanic Black compared with non-Hispanic White (adjusted odds ratio [aOR], 1.85; 95% CI, 1.13-3.02), had greater than a high school education compared with less than high school education (eg, ≥college degree: aOR, 4.84; 95% CI, 1.89-12.39), were single compared with married or living as married (aOR, 1.68; 95% CI, 1.04-2.73), and had at least 1 medical condition compared to none (eg, 1 medical condition: aOR, 2.25; 95% CI, 1.32-3.82). Respondents residing in rural vs urban areas had 77% decreased odds of invitation to a clinical trial (aOR 0.33; 95% CI 0.17-0.65). Of invited respondents, 199 (47%) participated. Compared with non-Hispanic White respondents, non-Hispanic Black respondents had 72% decreased odds of clinical trial participation (aOR, 0.28; 95% CI, 0.09-0.87). Respondents most frequently reported "health care providers" as the first and most trusted source of clinical trial information (first source: 2297 [59%]; most trusted source: 2597 [70%]). The most frequently reported motives for clinical trials participation were "wanting to get better" (2294 [66%]) and the standard of care not being covered by insurance (1448 [41%]). Conclusions and Relevance: The findings of this study suggest that invitation to and participation in clinical trials may differ by person-level demographic and clinical characteristics. Strategies toward increasing trial invitation and participation rates across diverse patient populations warrant further research to ensure equitable translation of clinical benefits from research to practice.

Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis.

BACKGROUND: Randomised trials (also referred to as 'randomised controlled trials' or 'trials') are the optimal way to minimise bias in evaluating the effects of competing treatments, therapies and innovations in health care. It is important to achieve the required sample size for a trial, otherwise trialists may not be able to draw conclusive results leading to research waste and raising ethical questions about trial participation. The reasons why potential participants may accept or decline participation are multifaceted. Yet, the evidence of effectiveness of interventions to improve recruitment to trials is not substantial and fails to recognise these individual decision-making processes. It is important to synthesise the experiences and perceptions of those invited to participate in randomised trials to better inform recruitment strategies. OBJECTIVES: To explore potential trial participants' views and experiences of the recruitment process for participation. The specific objectives are to describe potential participants' perceptions and experiences of accepting or declining to participate in trials, to explore barriers and facilitators to trial participation, and to explore to what extent barriers and facilitators identified are addressed by strategies to improve recruitment evaluated in previous reviews of the effects of interventions including a Cochrane Methodology Review. SEARCH METHODS: We searched the Cochrane Library, Medline, Embase, CINAHL, Epistemonikos, LILACS, PsycINFO, ORRCA, and grey literature sources. We ran the most recent set of searches for which the results were incorporated into the review in July 2017. SELECTION CRITERIA: We included qualitative and mixed-methods studies (with an identifiable qualitative component) that explored potential trial participants' experiences and perceptions of being invited to participate in a trial. We excluded studies that focused only on recruiters' perspectives, and trials solely involving children under 18 years, or adults who were assessed as having impaired mental capacity. DATA COLLECTION AND ANALYSIS: Five review authors independently assessed the titles, abstracts and full texts identified by the search. We used the CART (completeness, accuracy, relevance, timeliness) criteria to exclude studies that had limited focus on the phenomenon of interest. We used QSR NVivo to extract and manage the data. We assessed methodological limitations using the Critical Skills Appraisal Programme (CASP) tool. We used thematic synthesis to analyse and synthesise the evidence. This provided analytical themes and a conceptual model. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach to assess our confidence in each finding. Our findings were integrated with two previous intervention effectiveness reviews by juxtaposing the quantitative and qualitative findings in a matrix. MAIN RESULTS: We included 29 studies (published in 30 papers) in our synthesis. Twenty-two key findings were produced under three broad themes (with six subthemes) to capture the experience of being invited to participate in a trial and making the decision whether to participate. Most of these findings had moderate to high confidence. We identified factors from the trial itself that influenced participation. These included how trial information was communicated, and elements of the trial such as the time commitment that might be considered burdensome. The second theme related to personal factors such as how other people can influence the individual's decision; and how a personal understanding of potential harms and benefits could impact on the decision. Finally, the potential benefits of participation were found to be key to the decision to participate, namely personal benefits such as access to new treatments, but also the chance to make a difference and help others. The conceptual model we developed presents the decision-making process as a gauge and the factors that influence whether the person will, or will not, take part. AUTHORS' CONCLUSIONS: This qualitative evidence synthesis has provided comprehensive insight into the complexity of factors that influence a person's decision whether to participate in a trial. We developed key questions that trialists can ask when developing their recruitment strategy. In addition, our conceptual model emphasises the need for participant-centred approaches to recruitment. We demonstrated moderate to high level confidence in our findings, which in some way can be attributed to the large volume of highly relevant studies in this field. We recommend that these insights be used to direct or influence or underpin future recruitment strategies that are developed in a participant-driven way that ultimately improves trial conduct and reduces research waste.

Assessing Parent Decisions About Child Participation in a Behavioral Health Intervention Study and Utility of Informed Consent Forms.

Importance: Obtaining informed consent is an important ethical obligation for clinical research participation that is imperfectly implemented. Research on improving consent processes often focuses on consent forms, but little is known about consent forms' influence on decision-making compared with other types of engagement. Objective: To evaluate whether parents decide whether to enroll their children in research before or after they receive the consent form. Design, Setting, and Participants: An online survey of 88 parents who enrolled or declined to enroll their child in a weight management intervention study between January 2, 2018, and June 24, 2019, was conducted; surveys were completed between February 2, 2018, and July 9, 2019. A 31-item survey asked about impressions of the study throughout the enrollment process, timing of enrollment decisions, and decision-making factors. Responses were summarized descriptively and subgroups were compared using the Fisher exact test or χ2 test. Main Outcomes and Measures: Self-reported timing of enrollment decision. Results: A total of 106 parents were approached and gave permission for their contact information to be shared with the study team; 22 additional parents declined to allow their information to be shared, and 24 lost contact with the partner study before they could be asked for permission. A total of 88 parents (67 enrollees, 21 decliners) completed the survey (83% participation rate); 79 of 88 reporting gender (instead of sex, as biological sex was not relevant to survey) information were women (91%), 66 participants (75%) were non-Hispanic White, and 63 participants (72%) had annual household incomes greater than or equal to $70 000. No significant differences in respondent characteristics between enrollees and decliners were identified. Fifty-nine parents (67%) responded that they decided whether to enroll in the weight management study before receiving the consent form. Only 17 of 69 parents (25%) who remembered receiving the consent form responded that it taught them new information. Conclusions and Relevance: The findings of this study suggest that interventions to improve informed consent forms may have limited influence on decision-making because many research decisions occur before review of the consent form. It appears that regulatory review and interventions to improve decision-making should focus more on early engagement (eg, recruitment materials). Future studies should test timing of decisions in other types of research with different populations and clinical settings.

In Different Voices: The Views of People with Disabilities about Return of Results from Precision Medicine Research.

PURPOSE: Returning genetic results to research participants is gaining momentum in the USA. It is believed to be an important step in exploring the impact of efforts to translate findings from research to bedside and public health benefits. Some also hope that this practice will incentivize research participation, especially among people from historically marginalized communities who are commonly underrepresented in research. However, research participants' interest in receiving nongenomic medical and nonmedical results that may emerge from precision medicine research (PMR) is understudied and no study to date has explored the views of people with disabilities about return of genomic and nongenomic results from PMR. METHODS: In a national online survey of people with disabilities, participants were queried about their interest in receiving biological, environmental, and lifestyle results from PMR (n = 1,294). Analyses describe findings for all of the participants and comparisons for key demographic characteristics and disability subgroups. RESULTS: The participants expressed high interest in biological and health-related results and less interest in other findings. However, the interest among the study participants was lower than that found in comparable studies of the general population. Moreover, this interest varied significantly across gender, race/ethnicity, and disability subgroups. Possible reasons for these differences are discussed. CONCLUSION: Insofar as return of results from PMR may impact translational efforts, it is important to better understand the role of sociomedical marginalization in decisions about return of results from PMR and to develop strategies to address existing barriers.

Return of Research-Related Genetic Test Results and Genetic Discrimination Concerns: Facilitators and Barriers of Genetic Research Participation in Diverse Groups.

BACKGROUND: Most genetics studies lack the diversity necessary to ensure that all groups benefit from genetic research. OBJECTIVES: To explore facilitators and barriers to genetic research participation. METHODS: We conducted a survey on genetics in research and healthcare from November 15, 2017 to February 28, 2018 among adult Kaiser Permanente (KP) members who had been invited to participate in the KP biobank (KP Research Bank). We used logistic regression to calculate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) comparing the willingness to participate in genetic research under different return of results scenarios and genetic discrimination concerns between groups, according to their demographic characteristics. RESULTS: A total of 57,331 KP members were invited to participate, and 10,369 completed the survey (18% response rate). Respondents were 65% female, 44% non-Hispanic White (NH White), 22% Asian/Native Hawaiian or other Pacific Islander (Asian/PI), 19% non-Hispanic Black (NH Black), and 16% Hispanic. Respondents willing to participate in genetic research ranged from 22% with no results returned to 87% if health-related genetic results were returned. We also found variation by race/ethnicity; when no results were to be returned, Asian/PIs, Hispanics, and NH Blacks were less likely to want to participate than NH Whites (p < 0.05). However, when results were returned, disparities in the willingness to participate disappeared for NH Blacks and Hispanics. Genetic discrimination concerns were more prevalent in Asian/PIs, Hispanics, and NH Blacks than in NH Whites (p < 0.05). CONCLUSIONS: Policies that prohibit the return of results and do not address genetic discrimination concerns may contribute to a greater underrepresentation of diverse groups in genetic research.

A cross-sectional survey examining motivation and beliefs to participating in a web-based prospective cohort study on nutrition and health among individuals with a low socioeconomic status.

BACKGROUND: Prospective cohort studies may support public health efforts in reducing health inequalities. However, individuals with a low socioeconomic status (SES) are generally underrepresented in health research. This study aimed to examine the intention and determinants of intention of individuals with a low SES towards participation in a Web-based prospective project on nutrition and health (NutriQuébec) in order to develop recruitment and retention strategies. METHODS: A cross-sectional survey based on the Theory of planned behaviour was conducted in the Province of Québec, Canada. Low SES individuals (high school or less and annual household income < $55,000 CAN) were recruited through a Web panel of a polling firm to assess intention, attitude, subjective norm and perceived behavioural control (PBC) towards participation in the NutriQuébec project. Linear regression and logistic regression analyses were conducted. RESULTS: Mean age of respondents (184 women, 141 men) was 57.6 y (SD = 13.6). Attitude (ß = 0.54, 95%CI: 0.41-0.68) and PBC (ß = 0.50, 95%CI: 0.37-0.63) were significantly associated with intention. Participants who agreed that participating in the study would contribute to an improvement in 1) collective health (odds ratio [OR] = 2.15, 95%CI: 1.27-3.64) and in 2) one's lifestyle habits (OR = 1.70, 95%CI: 1.04-2.78) were more likely to express positive intention compared to participants who did not agree with these statements. Participants who agreed to participate in the study even 1) in the absence of a financial incentive (OR = 1.43, 95%CI: 1.04-1.99) and even 2) if the completion of questionnaires took up to two hours (OR = 1.78, 95%CI: 1.27-2.48) were also more likely to express high intention. Receiving a personalized brief health assessment (OR = 1.61, 95%CI: 1.13-2.30) and the use of simple questions in the questionnaires (OR = 1.54, 95%CI: 1.05-2.25) were facilitating factors associated with high intention. Participants believing that participation would be too time-consuming were less likely to have positive intention (OR = 0.57, 95%CI: 0.43-0.75). CONCLUSIONS: The development of a positive attitude and a high PBC towards participation in the NutriQuébec project will be necessary to obtain representative data of low SES adults.

Retaining Hispanics: Lessons From the Hispanic Community Health Study/Study of Latinos.

We aimed to examine the retention of Hispanics/Latinos participating in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a prospective cohort study of 16,415 adults in 4 US cities who were enrolled between 2008 and 2011. We summarized retention strategies and examined contact, response, and participation rates over 5 years of annual follow-up interviews. We then evaluated motivations for participation and satisfaction with retention efforts among participants who completed a second in-person interview approximately 6 years after their baseline interview. Finally, we conducted logistic regression analyses estimating associations of demographic, health, and interview characteristics at study visit 1 (baseline) with participation, high motivation, and high satisfaction at visit 2. Across 5 years, the HCHS/SOL maintained contact, response, and participation rates over 80%. The most difficult Hispanic/Latino populations to retain included young, single, US-born males with less than a high school education. At visit 2, we found high rates of motivation and satisfaction. HCHS/SOL participants primarily sought to help their community and learn more about their health. High rates of retention of Hispanics/Latinos can be facilitated through the employment of bilingual/bicultural staff and the development of culturally tailored retention materials.

Are the MORECare guidelines on reporting of attrition in palliative care research populations appropriate? A systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: Palliative care trials have higher rates of attrition. The MORECare guidance recommends applying classifications of attrition to report attrition to help interpret trial results. The guidance separates attrition into three categories: attrition due to death, illness or at random. The aim of our study is to apply the MORECare classifications on reported attrition rates in trials. METHODS: A systematic review was conducted and attrition classifications retrospectively applied. Four databases, EMBASE; Medline, CINHAL and PsychINFO, were searched for randomised controlled trials of palliative care populations from 01.01.2010 to 08.10.2016. This systematic review is part of a larger review looking at recruitment to randomised controlled trials in palliative care, from January 1990 to early October 2016. We ran random-effect models with and without moderators and descriptive statistics to calculate rates of missing data. RESULTS: One hundred nineteen trials showed a total attrition of 29% (95% CI 28 to 30%). We applied the MORECare classifications of attrition to the 91 papers that contained sufficient information. The main reason for attrition was attrition due to death with a weighted mean of 31.6% (SD 27.4) of attrition cases. Attrition due to illness was cited as the reason for 17.6% (SD 24.5) of participants. In 50.8% (SD 26.5) of cases, the attrition was at random. We did not observe significant differences in missing data between total attrition in non-cancer patients (26%; 95% CI 18-34%) and cancer patients (24%; 95% CI 20-29%). There was significantly more missing data in outpatients (29%; 95% CI 22-36%) than inpatients (16%; 95% CI 10-23%). We noted increased attrition in trials with longer durations. CONCLUSION: Reporting the cause of attrition is useful in helping to understand trial results. Prospective reporting using the MORECare classifications should improve our understanding of future trials.

Towards Identifying an Upper Limit of Risk: A Persistent Area of Controversy in Research Ethics.

Whether there is an upper limit of net risk that volunteers can consent to in research, and what that limit happens to be, has been the subject of persistent controversy in research ethics. This article defends the concept of an upper limit of risk in research against recent critics and supports the most promising approach for identifying this limit, that of finding comparator activities that are generally accepted in society and pose high levels of risk. However, high-risk activities that have been proposed as relevant comparators involve more certain benefits and confer considerable social esteem to those who take on the risks. This suggests that developing a robust approach to identifying social value, whether by developing a procedural safeguard or a systematic framework, could more effectively identify research with sufficient social value to justify high net risk. Additionally, the social status of research participants should be elevated to be more on par with others who laudably take on high risk for the benefit of others. By attending to the benefits necessary for the justification of high-risk research, the level of allowable risk will no longer be so controversial.

Minimizing Risks Is Not Enough: The Relevance of Benefits to Protecting Research Participants.

Forty years ago, the Belmont Report counseled that a "systematic, nonarbitrary analysis of risks and benefits" is vital to ensuring the ethical appropriateness of research with human subjects. Since then, research ethics has devoted considerable attention to the first half of this advice, emphasizing the ethical importance of assessing and minimizing the risks of research with human subjects. Significantly less attention has been devoted to a systematic assessment of the potential benefits of research participation. To the extent that benefits for individual participants are considered at all, commentators tend to focus on their potential to undermine the goal of minimizing risks. A chance for clinical benefit may obscure the fact that research poses risks not present in clinical care, while an offer of financial compensation or ancillary care may induce individuals to accept risks that conflict with their long-term interests. This article argues that, while undoubtedly important, minimizing risks fails to offer sufficient protection for research participants, especially those who cannot consent, because it neither ensures that the risks of research are justified nor protects participants from exploitation. Belmont's advice to develop systematic and nonarbitrary ways to ensure that research participants receive appropriate benefits needs to be heeded as well.

The Impact of Participation in Research About Abuse and Intimate Partner Violence: An Investigation of Harms, Benefits, and Regrets in Young Adolescents in the Western Cape of South Africa.

There is very little evidence whether recalling and answering questions about abuse or interpersonal violence has a positive or negative impact on participants of such research. This is an important ethical dilemma to ensure an appropriate risk-benefit ratio in research with young people is maintained. We assessed reported harms, benefits, and regrets of young adolescents who participated in a sensitive research project, and compared the harms and benefits in those who had and had not been victims and/or perpetrators of abuse or intimate partner violence. Participants were 3,264 adolescents aged 12 to 15 years in 41 public schools in the Western Cape, South Africa, who completed a survey about intimate partner violence, verbal, physical, and sexual abuse, as part of an HIV prevention cluster randomized controlled trial. The majority of participants reported research participation as beneficial (70.3%), while 27.7% reported harms and 14% regrets. Victims of abuse were more likely than non-victims to report benefits (71.9% vs. 67.1%; p = .02) and harms (31% vs. 20.9%; p < .01) and were less likely to report regret (13.1% vs. 16.7%; p = .02). Perpetrators of abuse were less likely than non-perpetrators to report benefits (67.4% vs. 72.8%; p = .01) and more likely to report harms (36.4% vs. 26.1%; p < .01) and regrets (17.4% vs. 13.3%; p = .01). Our findings suggested that research participation was more likely to have a positive rather than a negative emotional impact on young adolescents and that relatively few regretted participating. Victims and perpetrators of abuse were more likely to report benefits than harms, supporting the ethical appropriateness of ongoing research on abuse and violence. We recommend that further research is required to clarify and standardize terminology and instruments to quantify these kinds of evaluations, including measurement of the severity and intensity of reported benefits, harms and regrets, and the longer term impact of participation in sensitive research.

Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document.

The US government recently updated the Common Rule, a set of federal regulations to ensure the ethical conduct of human subjects research. The new regulations require that consent documents provide information that is clear and concise enough to enable truly informed consent. This study explores potential American Indian research participants' understanding and perceptions of an example consent document, focusing on possible improvements to better serve the requirements of the revised Common Rule. Participants completed a survey that collected demographic data and measured health literacy, numeracy, and comprehension of the example document. Next, they participated in focus groups to answer open-ended questions regarding their views on the example document. We calculated mean scores and frequencies of response to analyze quantitative survey data and performed a qualitative thematic analysis of focus group transcripts. Results demonstrated that American Indian participants with relatively strong health literacy skills clearly understood key elements of the consent document, including the purpose of signing it, confidentiality, compensation, and whom to contact for questions. However, they were overwhelmed by details on research procedures and were concerned about the document's layout. To make consent documents more readily comprehensible, participants recommended the addition of headings, bullets, graphics, and relevant pictures. They also recommended a two-step consent process, comprising a short introduction to the research project followed by a longer explanation of procedures. These results illustrate the potential advantages of community engagement in drafting consent materials. Health researchers would likely benefit from community recommendations like the ones we elicited as they design consent documents adherent to the revised Common Rule.

A research tool for measuring non-participation of older people in research on digital health.

BACKGROUND: Healthcare services are being increasingly digitalised in European countries. However, in studies evaluating digital health technology, some people are less likely to participate than others, e.g. those who are older, those with a lower level of education and those with poorer digital skills. Such non-participation in research - deriving from the processes of non-recruitment of targeted individuals and self-selection - can be a driver of old-age exclusion from new digital health technologies. We aim to introduce, discuss and test an instrument to measure non-participation in digital health studies, in particular, the process of self-selection. METHODS: Based on a review of the relevant literature, we designed an instrument - the NPART survey questionnaire - for the analysis of self-selection, covering five thematic areas: socioeconomic factors, self-rated health and subjective overall quality of life, social participation, time resources, and digital skills and use of technology. The instrument was piloted on 70 older study persons in Sweden, approached during the recruitment process for a trial study. RESULTS: Results indicated that participants, as compared to decliners, were on average slightly younger and more educated, and reported better memory, higher social participation, and higher familiarity with and greater use of digital technologies. Overall, the survey questionnaire was able to discriminate between participants and decliners on the key aspects investigated, along the lines of the relevant literature. CONCLUSIONS: The NPART survey questionnaire can be applied to characterise non-participation in digital health research, in particular, the process of self-selection. It helps to identify underrepresented groups and their needs. Data generated from such an investigation, combined with hospital registry data on non-recruitment, allows for the implementation of improved sampling strategies, e.g. focused recruitment of underrepresented groups, and for the post hoc adjustment of results generated from biased samples, e.g. weighting procedures.

Investigating strategies to improve clinical trial opportunities for patients with cancer in New Zealand-INSIGHT.

AIMS: Fewer than 5% of adult cancer patients participate in clinical trials, with multiple patient, clinician and institutional barriers identified. This study aimed to explore patient factors that impact access to cancer trials in New Zealand. METHODS: A questionnaire that included demographics and factors that might impact trial participation was circulated via nine district health boards (DHBs) and four cancer foundations to patients with a cancer diagnosis. RESULTS: Between July 2016 and August 2017, 691 patients responded, 62% female and 77% aged >50 years. Most patients (86%) would consider trial participation, which differed by income (p=0.0001) but not by age, tumour type or gender. Patients would consider attending another hospital (44%) or relocating (11%); 10% considered trials a last resort. Advantageous factors to participation included: benefiting others (92%), better treatment (82%), more scans and longer follow-up (47% and 51%). Disincentives included fear of randomisation (78%), treatment toxicities (71%), time and cost of more visits (40%) and unspecified future research (32%). CONCLUSION: Identified barriers to trial participation were similar in New Zealand to other developed countries. In this motivated cohort, patients are very interested in trial participation at any stage of their treatment and did not mind extra travel or tests.

Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.

Importance: The US Food and Drug Administration (FDA) created the exception from informed consent (EFIC) pathway in 1996 to allow some emergency trials to enroll patients without informed consent. To protect individual autonomy and preserve public trust, the FDA requires that EFIC trial investigators consult with community members before a trial may begin. Objectives: To analyze data from surveys conducted as part of community consultation ahead of EFIC trials and assess levels of public approval. Data Sources: All trials granted an EFIC must submit documentation of compliance with EFIC regulations to a publicly available docket at the FDA. Submissions between November 1, 1996, and October 23, 2017, were reviewed. Study Selection: Trials with survey data were included. Data Extraction and Synthesis: Data were extracted between January 2018 and June 2018 and were analyzed between June 2018 and August 2018. The quality and validity of data were assessed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A random-effects metaregression was used to assess the association of demographic characteristics with EFIC approval. Main Outcomes and Measures: The primary study outcome was EFIC approval. Results: The FDA docket contained 15 958 pages of material with survey data for 42 448 individuals submitted by 27 trials. Public approval of EFIC varied by question type, with more people willing to approve initiation of EFIC trials in their community (86.5%) than personal enrollment (73.0%), enrollment of a family member (68.6%), or the principle of enrollment without consent (58.4%) (P < .001 for all comparisons). In the United States, African American individuals made up 29.3% of those enrolled in EFIC trials that reported data on race (5064 of 17 302) but only 16.7% of those surveyed as part of community consultation. In the United States and Canada, men made up 42.9% of the surveyed population but 65.6% of those eventually enrolled in EFIC trials (29 961 of 45 694). Groups surveyed with higher proportions of African American and male respondents had lower rates of EFIC approval. Conclusions and Relevance: Public approval of EFIC trials varied by question type and by the respondents' reported race and sex. The demographic characteristics of those surveyed did not match the demographic characteristics of EFIC enrollees. The FDA could strengthen community consultation by standardizing survey instruments and reporting, requiring broader inclusion of African American and male respondents, clarifying the function of surveys in the development and modification of trial protocols, and building more public consensus around the acceptable use of EFIC.

Patient and Physician Preferences for Reporting Research Findings.

BACKGROUND AND OBJECTIVES: Although absolute risks provide useful information on the number of excess cases attributable to a harmful exposure or the number of fewer cases attributable to an effective treatment, most research findings are reported in terms of multiplicative effects of exposure on the outcome. We aimed to examine patient and physician preferences for communicating research findings in terms of additive and multiplicative measures of effect and measures of heterogeneity of treatment effects. METHODS: We conducted a cross-sectional study of 76 patients and 26 physicians at an academic medical center in Boston, Massachusetts. Trained study staff conducted interviews about interpretations of study findings. RESULTS: Physicians were equally likely to prefer the number needed to harm or the risk ratio as the most useful measure for making informed health decisions, and patients strongly preferred risk ratios. Participants perceived changes in risk as larger when they were presented using multiplicative measures such as risk ratios than when presented as additive measures such as the risk differences or number needed to treat or harm. CONCLUSIONS: Despite the importance of considering absolute risks and benefits of treatment options, patients and physicians who rely on study findings for making informed decisions often prefer relative measures.

The Role of Inclusion Benefits in Ethics Committee Assessment of Research Studies.

The relationship between risks and benefits is central to the ethics of research involving human participants. Traditionally, to be ethically justifiable, risks should be reasonable in relation to anticipated benefits (if any) to subjects and to the potential social benefits resulting from research. This calculus is being further complicated by findings from an increasing number of social science studies that reveal that prospective and actual research participants frequently describe various types of inclusion benefits (for example, personal benefits such as access to or improved health care, increased knowledge about their disease or condition, and greater solidarity with the local community) as important to them. What is the ethical significance of such inclusion benefits, particularly those nonmedical in nature, for research ethics committees' risk-benefit assessment of research studies? We argue that, unless participants are clearly mistaken in their perceptions, ethics committees should take these types of inclusion benefits into account, and we suggest a few ways this might look in practice.

Broadening the Debate About Post-trial Access to Medical Interventions: A Qualitative Study of Participant Experiences at the End of a Trial Investigating a Medical Device to Support Type 1 Diabetes Self-Management.

Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood glucose to help keep it within clinically recommended ranges. Individuals were recruited from UK sites and interviewed following trial close-out, at which point the closed-loop had been withdrawn. While individuals were stoical and accepting of the requirement to return the closed-loop, they also conveyed varying degrees of distress. Many described having relaxed diabetes management practices while using the closed-loop and having become deskilled as a consequence, which made reverting back to pre-trial regimens challenging. Participants also described unanticipated consequences arising from using a closed-loop. As well as deskilling, these included experiencing psychological and emotional benefits that could not be sustained after the closed-loop had been withdrawn and participants reevaluating their pre- and post-trial life in light of having used a closed-loop and now perceiving this life much more negatively. Participants also voiced frustrations about experiencing better blood glucose control using a closed-loop and then having to revert to using what they now saw as antiquated and imprecise self-management tools. We use these findings to argue that ethical debates about post-trial provisioning need to be broadened to consider potential psychological and emotional harms, and not just clinical harms, that may result from withdrawal of investigated treatments. We also suggest that individuals may benefit from information about potential nonclinical harms to help make informed decisions about trial participation.