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Purpose Conflicts of interest (COIs) are important ethical concerns because they may affect scientific decision making, research integrity, and the safety and fairness of studies. No research to date has examined COIs of single institutional review boards (sIRBs), which are now mandated by the National Institutes of Health, and will be by the revised Common Rule in 2020, for all multisite research. This study investigated how different types of sIRBs manage their own COIs by documenting existing processes for and comparing commercial, government, and academic sIRBs. Method One hundred three personnel from 20 commercial, government, or academic sIRBs participated in semistructured interviews about their processes for and experiences with managing COIs when conducting multisite research review. Results Variability in COI management policies exist across types of sIRBs. Commercial sIRBs were aware of their own COIs given their for-profit model, and managed them by using firewalls, relying on external reviewers, and turning down potential clients. Government sIRBs described unique COIs stemming from the same agency funding the sIRB and the research being reviewed. They addressed these by discussing concerns about COIs, using firewalls, relying on nonaffiliated reviewers, and having broad COI policies. In contrast to commercial and government sIRBs, academic sIRBs did not report any specific policies to manage their COIs, which are similar to those of local IRBs. Conclusions As sIRBs become increasingly common, researchers will need to weigh the different COIs inherent to each type of sIRB. Additionally, academic sIRBs may consider implementing specific policies for managing their COIs.

An understanding of astrophysical feedback is important for constraining models of galaxy formation and for extracting cosmological information from current and future weak lensing surveys. The thermal Sunyaev-Zel'dovich effect, quantified via the Compton-$y$ parameter, is a powerful tool for studying feedback, because it directly probes the pressure of the hot, ionized gas residing in dark matter halos. Cross-correlations between galaxies and maps of Compton-$y$ obtained from cosmic microwave background surveys are sensitive to the redshift evolution of the gas pressure, and its dependence on halo mass. In this work, we use galaxies identified in year one data from the Dark Energy Survey and Compton-$y$ maps constructed from Planck observations. We find highly significant (roughly $12\sigma$) detections of galaxy-$y$ cross-correlation in multiple redshift bins. By jointly fitting these measurements as well as measurements of galaxy clustering, we constrain the halo bias-weighted, gas pressure of the Universe as a function of redshift between $0.15 \lesssim z \lesssim 0.75$. We compare these measurements to predictions from hydrodynamical simulations, allowing us to constrain the amount of thermal energy in the halo gas relative to that resulting from gravitational collapse., Comment: 21 pages, 12 figures, comments welcome

As a 2006 Institute of Medicine report highlights, surprisingly little empirical attention has been paid to how prisoners arrive at decisions to participate in modern research. With our study, we aimed to fill this gap by identifying a more comprehensive range of factors as reported by prisoners themselves during semistructured interviews. Our participants described a diverse range of motives, both favoring and opposing their eventual decision to join. Many are well-recognized considerations among nonincarcerated clinical research participants, including a desire for various forms of personal benefit, altruism, and concern about study risks and inconveniences. However, a number of influences seem unique to prisoners. Participants did not report that they were not coerced into enrolling, and they have even been under pressure not to enroll. However, many sought to enroll in order to obtain access to better health care, raising a concern about whether they were unfairly exploited.

Objective: Youth and young adults with serious mental health conditions have particularly poor records of stable employment, but stable employment is a key to recovery. Employment specialists have a key role in supported employment services in assisting them with employment. This article describes the thoughts and concerns of employment specialists about finding and supporting employment for youth and young adults with serious mental health conditions. Method: The authors undertook 12 intensive interviews with supported employment specialists in two states. These interviews were transcribed and coded by the authors. A number of themes were identified and prototypical examples identified and included in the findings. Results: Although the employment specialists varied in their enthusiasm and optimism about the job, they agreed on key problems that they face in supporting employment for young adults that include employer resistance to hiring people with mental illness, increasing use of online appli...

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.

Acquiring the correct meanings of words expressing quantities (seven, most) and qualities (red, spotty) present a challenge to learners. Understanding how children succeed at this requires understanding, not only of what kinds of data are available to them, but also the biases and expectations they bring to the learning task. The results of our word-learning task with 4-year-olds indicate that a “syntactic bootstrapping” hypothesis correctly predicts a bias toward quantity-based interpretations when a novel word appears in the syntactic position of a determiner but also leaves open the explanation of a bias towards quality-based interpretations when the same word is presented in the syntactic position of an adjective. We develop four computational models that differentially encode how lexical, conceptual, and perceptual factors could generate the latter bias. Simulation results suggest it results from a combination of lexical bias and perceptual encoding.

Purpose – Retrospective studies of therapeutic community (TC) treatment for drug abuse found reductions in drug use, criminality, and increased work participation after treatment completion. These studies have also shown treatment benefits, even without completion, are correlated with days of stay in residential treatment. However, others have found that high rates of early leaving from TC treatment reduce the proportion of clients with positive outcomes, raise the total cost per treated client, and lower the treatment benefit-to-costs ratio. The purpose of this paper is to describe an experimental approach to raising the days in residential treatment using earlier vocational access for clients. Design/methodology/approach – The current study used a random assignment design to compare earlier integration of on-site vocational training in a vocationally integrated therapeutic community to off-site vocational training initiated after one year of residence in a traditional therapeutic community. Findings – The resulting data support the hypotheses that client expectations and early training in job skills increase rate of treatment affiliation, the proportion of clients having effective lengths of stay, and the rate of treatment completion. Research limitations/implications – Research limitations/implications include the difficulty of assuring unbiased selection and controlling treatment assignment and conditions. Practical implications – Practical implications of this research project are to support practitioners striving for longer, more effective lengths of stay, while at the same time attempting to reduce treatment time and increase effectiveness. Social implications – Social Implications of this project are to encourage social support for addiction treatment and emphasize the value of paired residential treatment and vocational education. Originality/value – The originality and value of this research project lies in the adoption of a working model at Phoenix House TC (in-house vocational preparation), which utilizes early in-house vocational education as a means to increase residential program participation, increase employment skills and prospects, and decrease overall length of treatment.

Formal grammatical theories make extensive use of syntactic relations (e.g. c-command, Reinhart, 1983) in the description of constraints on antecedent-anaphor dependencies. Recent research has motivated a model of processing that exploits a cue-based retrieval mechanism in content-addressable memory (e.g. Lewis, Vasishth, & Van Dyke, 2006) in which item-to-item syntactic relations such as c-command are difficult to use as retrieval cues. As such, the c-command constraints of formal grammars are predicted to be poorly implemented by the retrieval mechanism. We tested whether memory access mechanisms are able to exploit relational information by investigating the processing of bound variable pronouns, a form of anaphoric dependency that imposes a c-command restriction on antecedent-pronoun relations. A quantificational NP (QP, e.g., no janitor) must c-command a pronoun in order to bind it. We contrasted the retrieval of QPs with the retrieval of referential NPs (e.g. the janitor), which can co-refer with a pronoun in the absence of c-command. In three off-line judgment studies and two eye-tracking studies, we show that referential NPs are easily accessed as antecedents, irrespective of whether they c-command the pronoun, but that quantificational NPs are accessed as antecedents only when they c-command the pronoun. These results are unexpected under theories that hold that retrieval exclusively uses a limited set of content features as retrieval cues. Our results suggest either that memory access mechanisms can make use of relational information as a guide for retrieval, or that the set of features that is used to encode syntactic relations in memory must be enriched.

Next-generation 21cm observations will enable imaging of reionization on very large scales. These images will contain more astrophysical and cosmological information than the power spectrum, and hence providing an alternative way to constrain the contribution of different reionizing sources populations to cosmic reionization. Using Convolutional Neural Networks, we present a simple network architecture that is sufficient to discriminate between Galaxy-dominated versus AGN-dominated models, even in the presence of simulated noise from different experiments such as the HERA and SKA., Contributed talk for the IAU Symposium 333 "Peering towards Cosmic Dawn", Dubrovnik, October 2-6, 2017; to appear in the proceedings, eds. Vibor Jelic and Thijs van der Hulst [5 pages, 3 figures]

Previous research on the acquisition of adjunct control has observed non-adultlike behavior for sentences like “John bumped Mary after tripping on the sidewalk.” While adults only allow a subject control interpretation for these sentences (that John tripped on the sidewalk), preschool-aged children have been reported to allow a much wider range of interpretations. A number of different tasks have been used with the aim of identifying a grammatical source of children’s errors. In this paper, we consider the role of extragrammatical factors. In two comprehension experiments, we demonstrate that error rates go up when the similarity increases between an antecedent and a linearly intervening noun phrase, first with similarity in gender, and next with similarity in number marking. This suggests that difficulties with adjunct control are to be explained (at least in part) by the sentence processing mechanisms that underlie similarity-based interference in adults.

On June 21, 2016, the US government announced changes that are arguably the most significant of the last quarter century concerning the protection of human research participants—a requirement for use of central or single institutional review boards (IRBs) in multisite National Institutes of Health (NIH)–funded research. Specifically, the NIH announced a new policy (effective September 25, 2017) to mandate that nonexempt multisite research with humans funded by the NIH be reviewed by a single IRB.1 On January 19, 2017, final amendments to the federal human research participant protection regulations (the Common Rule) were also published, requiring use of a single IRB,2 although implementation will be delayed until January 20, 2020. The NIH directive seems straightforward, but effective implementation will require that institutions, researchers, and policy makers decide how to address a number of critical issues. The Common Rule amendments explicitly recognize that further guidance will need to be developed, necessitating that these stakeholders confront several dilemmas.

Background: The validity of results from clinical trials depends on both clinical researchers and participants consistently and strictly following research protocols. However, clinical trial researchers are also expected to provide excellent medical care to the participants. These two commitments may conflict under some circumstances. Methods: A questionnaire previously used for a national Internet-based survey was adapted to conduct in-depth, semistructured interviews in order to further explore reported attitudes and/or behaviors that indicated that patient well-being sometimes took precedence over strict adherence to the study protocol. We conducted 96 interviews with researchers working on Phase II and/or Phase III clinical trials in a variety of medical fields at four major academic medical centers. Results: Due to concerns for the welfare of their patients, the researchers we interviewed described decisions that involved “individualized” rather than protocol-driven decisions about recruitment, proto...

Background Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. Methods This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10–50), and willingness to participate in the clinical trial. Results 154 participants completed the study (age range, 23–87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. Conclusions An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in therapeutic misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.

We investigated the processing of pronouns in Strong and Weak Crossover constructions as a means of probing the extent to which the incremental parser can use syntactic information to guide antecedent retrieval. In Experiment 1 we show that the parser accesses a displaced wh-phrase as an antecedent for a pronoun when no grammatical constraints prohibit binding, but the parser ignores the same wh-phrase when it stands in a Strong Crossover relation to the pronoun. These results are consistent with two possibilities. First, the parser could apply Principle C at antecedent retrieval to exclude the wh-phrase on the basis of the c-command relation between its gap and the pronoun. Alternatively, retrieval might ignore any phrases that do not occupy an Argument position. Experiment 2 distinguished between these two possibilities by testing antecedent retrieval under Weak Crossover. In Weak Crossover binding of the pronoun is ruled out by the argument condition, but not Principle C. The results of Experiment 2 indicate that antecedent retrieval accesses matching wh-phrases in Weak Crossover configurations. On the basis of these findings we conclude that the parser can make rapid use of Principle C and c-command information to constrain retrieval. We discuss how our results support a view of antecedent retrieval that integrates inferences made over unseen syntactic structure into constraints on backward-looking processes like memory retrieval. © 2017 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See http://creativecommons.org/licenses/by/4.0/.

This chapter addresses role of cognitive, information processing and learning mechanisms underlying children’s acquisition of quantifiers in natural language. We discuss the cognitive mechanisms that provide content to quantificational expressions, constraints on possible quantifier meanings, and the role of syntax in identifying a novel word as quantificational. We also examine the syntax and semantics of quantifiers in development, examining interactions between multiple scope bearing expressions in a single sentence. We explore the grammatical and psycholinguistic constraints at play in shaping children’s acquisition and use of quantificational expressions, highlighting factors that can mask children’s competence in this domain.

A diverse panel convened in June 2011 to explore a dilemma in human research: some traits may make individuals or communities particularly vulnerable to a variety of harms in research; however, well-intended efforts to protect these vulnerable individuals and communities from harm may actually generate a series of new harms. We have presented a consensus statement forged by the panel through discussion during a 2-day meeting and the article-writing process. We have identified practical problems that sometimes arise in connection with providing additional safeguards for groups labeled as vulnerable and offered recommendations on how we might better balance concerns for protection with concerns for justice and participant autonomy.

Nearly half of all external grants from the US National Institutes of Health require approval by the recipient organization's Institutional Animal Care and Use Committee (IACUC) before the funds can be used for research with animals. Given that large sums of money are spent annually on research involving animals, studies evaluating the strengths, weaknesses and overall effectiveness of IACUCs and similar animal welfare committees are needed. The authors designed and carried out a self-assessment survey on IACUC function and effectiveness. They found that 98% of all respondents believed that their IACUCs advanced animal welfare, but in many instances, veterinarians' responses to individual survey items were significantly different from those of other IACUC members. Protocol compliance, protocol review training and better understanding among non-committee members of the need for regulatory oversight are some areas where improvements could be made. Less than 50% of respondents stated that literature searches to find alternatives to animal use or painful or distressful procedures were helpful.

Institutional review boards (IRBs) play a critical role in protecting human research subjects in the United States. Federal regulations mandate that every institution receiving federal research funds establish a committee to review certain ethical issues in research involving human subjects. Review is only required for federally-supported research involving human subjects, however most medical and academic institutions require IRB review for all research involving human subjects, with a narrow list of exceptions, regardless of the funding source.1–2 Despite the importance then of IRBs in human subjects research, we know relatively little about how they function. Several studies, dating to the 1970s, included surveys of the composition, staffing, and workload of IRBs, and the types of protocols that they reviewed.2–7 These studies, however, primarily assessed the outputs of the review process, e.g., the number and type of changes requested in protocols, and found that IRBs focused principally on consent forms.8 Other studies looked at the variation in decisions when IRBs at different sites reviewed the same protocol and found substantial differences between IRB decisions, calling into question the reliability of such determinations.9–11 However, the existing research has not examined what IRBs discuss when they review a protocol. What is known on this subject stems largely from surveys of IRB members.7, 12–17 In the 1970s, Gray and Cooke examined the performance of a single IRB by reviewing its meeting minutes.18 More recently, there have been several ethnographic descriptions of one or two IRB panels.6, 19 One of the most important questions that remains unanswered is the degree to which IRB deliberations address the primary elements of human subjects protection regulations. We studied the factors that contribute to IRB decision-making at ten major academic medical centers (AMCs) by observing and audio-recording IRB meetings. Our analyses, presented here, focus on the extent to which these committee discussions addressed the ethical criteria in the federal regulations for the protection of human subjects, known as the Common Rule.20

The goal of this study was to describe the contributions of community members (unaffiliated members) who serve on institutional review boards (IRBs) at large medical research centers and to compare their contributions to those of other IRB members. We observed and audiotaped 17 panel meetings attended by community members and interviewed 15 community members, as well as 152 other members and staff. The authors coded transcripts of the panel meetings and reviewed the interviews of the community members. Community members played a lesser role as designated reviewers than other members. They were infrequently primary reviewers and expressed hesitation about the role. As secondary or tertiary reviewers, they were less active participants than other members in those roles. Community members were more likely to focus on issues related to confidentiality when reviewing an application than other reviewers. When they were not designated reviewers, however, they played a markedly greater role and their discussion focused more on consent disclosures than other reviewers. They did not appear to represent the community so much as to provide a nonscientific view of the protocol and the consent form.

Background The goal of this investigation is to discover whether or not patients with psychiatric diagnoses are less likely to be prescribed opioids for pain in emergency departments compared with other patients. Methods Pain-related visits to US emergency departments were identified using reason-for-visit and physician diagnosis codes for 13 years (1993–2005) of the National Hospital Ambulatory Medical Care Survey. The outcome measure was the prescription or administration of an opioid analgesic. Results Roughly 10 million pain-related visits were made by persons with psychiatric diagnoses in the USA between 1993 and 2005. Across all years, only 18% (95% CI 16 to 20) of pain-related visits by patients with psychiatric diagnoses resulted in an opioid prescription, whereas 33% (95% CI 32 to 34) of visits by other patients did. Lower prescription rates for patients with psychiatric diagnoses were seen for every year of the survey and this difference occurred at every level of pain severity. Controlling for confounding factors did not attenuate this difference. In a multivariate model, patients with psychiatric diagnoses were about half as likely as other patients to be prescribed opiates (adjusted OR 0.49; 95% CI 0.44 to 0.56). Major limitations of the study include the uncertain precision of psychiatric and drug/alcohol diagnoses and the lack of detail about each patient visit. Conclusion Having a psychiatric diagnosis was associated with a lower likelihood of receiving an opioid among persons presenting with pain to the ED.

Word learners are able to use the syntactic context of a word as one source of information to narrow down the space of possible meanings. We examine this bootstrapping process in the domain of adjectives, focusing on the acquisition of subcategories of Gradable Adjectives (GAs). We first show that robust patterns of adverbial modification in natural language sort GAs according to scalar structure: proportional modifiers (e.g., completely) tend to modify absolute maximum standard GAs (e.g., full), while intensifiers (e.g., very) tend to modify relative GAs (e.g., big). We then show in a word-learning experiment that 30-month-olds appear to be aware of such distributional differences and recruit them in word learning, assigning an interpretation to a novel adjective based on its modifier. We argue that children track both the range of adjectives modified by a given adverb and the range of adverbs modifying a given adjective, and use such surface-level information to classify new words according to possible ...

We identify three components of any learning theory: the representations, the learner's data intake, and the learning algorithm. With these in mind, we model the acquisition of the English anaphoric pronoun one in order to identify necessary constraints for successful acquisition, and the nature of those constraints. Whereas previous modeling efforts have succeeded by using a domain-general learning algorithm that implicitly restricts the data intake to be a subset of the input, we show that the same kind of domain-general learning algorithm fails when it does not restrict the data intake. We argue that the necessary data intake restrictions are domain-specific in nature. Thus, while a domain-general algorithm can be quite powerful, a successful learner must also rely on domain-specific learning mechanisms when learning anaphoric one.

To characterize predictors of impairment in research decision-making capacity, we undertook a direct comparison of schizophrenia/schizoaffective (n=52), medically ill (diabetic; n=51), and non-ill (n=57) subjects. Scores on the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) were correlated with demographic variables and scores on the Positive and Negative Syndrome Scale (PANSS), Mini-Mental State Examination (MMSE), and Short-Form-36 (SF-36). Across diagnoses, cognitive capacity, physical functioning, and a diagnosis of mental illness had the greatest impact on decision-making capacity, with level of education also having an impact. 69-89% of schizophrenia/schizoaffective subjects attained MacCAT-CR subscale scores achieved by almost all comparison (98-100%) and medically ill (94-100%) subjects. Positive, negative, and general psychotic symptoms correlated with poorer scores. Prior research experience, number of queries used during interview, and emotional functioning also predicted MacCAT-CR scores. These data suggest that investigators and IRBs should consider a number of variables, many of which reach across diagnoses, as they decide which populations and individual subjects may require more intensive screening for decisional impairment or educational interventions to improve their abilities to make capable decisions about research participation.

In this chapter we look at how BYOD in educational “classroom” environments is touching each individual where they communicate, get their information, and connect socially and globally. We aim to provide perspectives which include the learner, faculty, and staff in higher education. Additionally, teaching methods, use and needs of faculty and staff are considered, as well as privacy, security and policy. This is an investigative look at the trends and possibilities of BYOD and its future, and a consideration of the impact on faculty, students, and staff in university settings.

Propositional attitude verbs, such as think and want, have long held interest for both theoretical linguists and language acquisitionists because their syntactic, semantic, and pragmatic properties display complex interactions that have proven difficult to fully capture from either perspective. This paper explores the granularity with which these verbs' semantic and pragmatic properties are recoverable from their syntactic distributions, using three behavioral experiments aimed at explicitly quantifying the relationship between these two sets of properties. Experiment 1 gathers a measure of 30 propositional attitude verbs' syntactic distributions using an acceptability judgment task. Experiments 2a and 2b gather measures of semantic similarity between those same verbs using a generalized semantic discrimination (triad or "odd man out") task and an ordinal (Likert) scale task, respectively. Two kinds of analyses are conducted on the data from these experiments. The first compares both the acceptability judgments and the semantic similarity judgments to previous classifications derived from the syntax and semantics literature. The second kind compares the acceptability judgments to the semantic similarity judgments directly. Through these comparisons, we show that there is quite fine-grained information about propositional attitude verbs' semantics carried in their syntactic distributions-whether one considers the sorts of discrete qualitative classifications that linguists traditionally work with or the sorts of continuous quantitative classifications that can be derived experimentally.

The effects of sponsorship and financial relationships on the conduct of clinical trials were examined by surveying 321 authors who had published reports of pharmaceutical clinical trials. The survey asked about research sponsorship, financial relationships, who controlled the research, and who carried it out. When a commercial sponsor was the exclusive research sponsor, authors reported less control over and less contribution to the research, and more sponsor control and contribution, as compared with noncommercial or mixed sponsorship. Similarly, financial relationships with firms were associated with less author contribution to and more sponsor control over and contribution to the research. The results raise concerns about bias in the design, conduct, or reporting of research.

Given the availability of violence risk assessment tools, clinicians are now better able to identify high-risk patients. Once these patients have been identified, clinicians must monitor risk state and intervene when necessary to prevent harm. Clinical practice is dominated by the assumption that increases in psychiatric symptoms elevate risk of imminent violence. This intensive study of patients (N = 132) at high risk for community violence is the first to evaluate prospectively the temporal relation between symptoms and violence. Symptoms were assessed with the Brief Symptom Inventory and threat/control override (TCO) scales. Results indicate that a high-risk patient with increased anger in 1 week is significantly more likely to be involved in serious violence in the following week. This was not true of other symptom constellations (anxiety, depression, TCO) or general psychological distress. The authors found no evidence that increases in the latter symptoms during 1 week provide an independent foundation for expecting violence during the following week.

Responding to the paper by Miller and Joffe, we review the development of the concept of therapeutic misconception (TM). Our concerns about TM's impact on informed consent do not derive from the belief that research subjects have poorer outcomes than persons receiving ordinary clinical care. Rather, we believe that subjects with TM cannot give an adequate informed consent to research participation, which harms their dignitary interests and their abilities to make meaningful decisions. Ironically, Miller and Joffe's approach ends up largely embracing the very position that they inaccurately attribute to us: the belief that, with some exceptions, it is only the prospect of poorer outcomes that should motivate efforts to dispel TM. In the absence of empirical studies on the steps required to dispel TM and the impact of such procedures on subject recruitment, it is premature to surrender to the belief that TM must be widely tolerated in clinical research.

Background There is little information about the prevalence of research integrity problems in the scientific literature. We sought to determine how frequently authors of published pharmaceutical clinical trials reported fabrication of data or misrepresentation of research. Methods We conducted a mail survey of 549 authors who had published reports of pharmaceutical clinical trials from 1998 to 2001 that appeared in the Cochrane Database of Systematic Reviews. We asked authors about fabricated data or misrepresentations of research in three contexts: the target study (the report from which their name was obtained), another study they had participated in, or a study that they personally knew about. Results We received replies from 64% of authors with valid addresses. Two authors (1%) reported that the target article misrepresented the research. Almost 5% reported fabrication or misrepresentation in a study they had participated in the last 10 years, and 17% of authors personally know about a case of fabrication or misrepresentation in the last 10 years from a source other than published accounts of research misconduct. Conclusions Fraud and misrepresentation in clinical trials appear to be rare on a per-published report basis. However, they occur sufficiently frequently that scientists have a significant chance of participating in a project affected by fraud or misrepresentation during their research careers. These rates of exposure justify vigorous efforts to prevent research misconduct.

To increase rates of employment and improve overall rehabilitation in methadone maintenance treatment, three prevocational trainings, Vocational Problem Solving, Job Seekers Workshop, and the two combined, were evaluated as adjunctive services. Between March 1995 and April 1998, subjects in treatment were interviewed at baseline, randomly assigned to one of the trainings, and followed up at 6 and 12 months postbaseline. None of the three models produced significantly greater employment or better overall rehabilitation. Experience from the study suggests that closer integration of prevocational training with treatment, individualizing efforts to meet training needs, and providing support during job-finding and early job-holding might improve program effectiveness.

Recent studies indicate that a small, but critical subgroup of psychiatric patients is involved in a disproportionately large number of violent incidents among the mentally ill. This subgroup is an appropriate focus for intensive community-based treatment programs designed to reduce violence. However, little research has been conducted on methods for identifying patients who repeatedly become involved in violent incidents. This article describes a large follow-up study in which these patients were identified using a simple screening process that is feasible for routine use. This screening process efficiently and effectively identified a small minority of patients who were at risk for repeated involvement in violence. Patients deemed “at risk” by the screening process had an average of 7 violent incidents during a six-month follow-up period. The characteristics of these patients are described, and implications of the screening tool for conducting future research, targeting individuals for more intensive treatment services, and developing violence-focused treatment programs are discussed.

Informed consent is one of the great puzzles of modern medical research and practice. As Professor Henderson has argued in her article, there is ample reason to be concerned that many, and maybe all, of the goals announced for informed consent law and ethics have not been reached. In this article, I will review the goals that theorists and judges have assigned to the doctrine and discuss some of the evidence concerning the difficulties of meeting those goals. Finally, I will suggest some of the reasons that might account for our continued commitment to informed consent despite its difficulties.

Risk factors for HIV infection were examined in 520 female sex partners (SPs) of injecting drug users (IDUs); 16% tested HIV positive (40% among former IDUs). In multivariate analyses, sex trade was associated with lower risk of HIV infection, whereas race, age, history of pneumonia or genital herpes, high self-rated AIDS risk, and IDU history were related to greater risk. Among women with no IDU history, cohabitation with a SP (not trading sex) predicted higher risk; having a female SP was also associated with higher risk. Secondary analyses suggest that total unprotected contacts with IDUs and both sex trade and cohabitation might account for these findings. The data suggest that, for female SPs of IDUs, reducing numbers of sex partners per se may not confer adequate protection from HIV. For women in committed relationships with IDUs, interventions should address contextual factors in relationships that elevate risk and complicate prevention.

Objective: Coercion during psychiatric admissions has been a topic of debate for many years. Although there has been considerable research on patients' perceptions of coercion, there has been no work on who places pressures on patients to be admitted. Method: This article integrates interview data from interviews with patients, admitting staff and family and friends to describe the pressures brought to bear on patients to be admitted. Results: Health-care professionals appear to be the most important source of pressures on patients, and to have the most impact on patients' perceptions of coercion. However, there are differences in type of pressure, and the pressures used by family and friends appear to having the most longstanding impact. Conclusion: Legal and clinical efforts to reduce the level of coercive pressures on patients need to recognize the importance of mental-health professionals, including especially those who are not legally mandated to participate in the admission process.

OBJECTIVE: An influential rationale for involuntary hospitalization is that prospective patients who refuse hospitalization at the time it is offered are likely to change their belief about the necessity of hospitalization after receiving hospital treatment. The authors examine how patients changed their evaluations of psychiatric hospitalization following hospital treatment. METHOD: The authors studied 433 patients who were interviewed about their hospitalization within 2 days of their admission to a psychiatric hospital; 267 of these patients were reinterviewed 4–8 weeks following discharge. RESULTS: When reinterviewed at follow-up, 33 (52%) of 64 patients who said at admission that they did not need hospitalization said that, in retrospect, they believed they had needed it. Only 9 (5%) of 198 patients who said at admission that they needed hospitalization shifted to saying that they had not needed it. CONCLUSIONS: Many of the patients who initially judged that they did not need hospitalization revised ...

Comprehensive services, including employment/vocational interventions, family therapy, medical care, and case management, have been shown by the literature to be critical elements of programs that provide effective treatment for substance abusers. Despite clear research findings, clients are often unable to obtain needed adjunctive services at their clinics. When services are not provided on site, clients typically are not effectively placed for services at other agencies. This article reviews the recent literature on comprehensive services as elements of substance abuse treatment, focusing on four areas that the National Institute on Drug Abuse (NIDA) has established as priorities for health services research: (a) the effectiveness and outcomes of treatment services, (b) the organization and management of treatment services, (c) the actual availability of services to clients, and (d) the impact of managed care on the provision of adjunctive treatment services. Recommendations are also made for future research, and policy implications are discussed.

This pilot study used snowball recruitment methods and intensive interviews to assess personal drug-using networks and HIV risk behavior of injection drug users (IDUs). Index subjects were 22 methadone maintenance patients reporting current drug injection who were interviewed about personal drug-using networks both current and prior to treatment entry. The index subjects were then asked to recruit other network members to the study. Ninety-seven network members were identified and 40 interviewed, including 18 not in treatment. Index IDUs reported fewer co-IDUs for the treatment period than the pre-treatment period, suggesting a reduction in risk of exposure to HIV. The combination of snowball recruitment and intensive interview procedures constitutes a useful method for studying IDU networks.

Children acquiring languages with noun classes (grammatical gender) have ample statistical information available that characterizes the distribution of nouns into these classes, but their use of this information to classify novel nouns differs from the predictions made by an optimal Bayesian classifier. We use rational analysis to investigate the hypothesis that children are classifying nouns optimally with respect to a distribution that does not match the surface distribution of statistical features in their input. We propose three ways in which children's apparent statistical insensitivity might arise, and find that all three provide ways to account for the difference between children's behavior and the optimal classifier. A fourth model combines two of these proposals and finds that children's insensitivity is best modeled as a bias to ignore certain features during classification, rather than an inability to encode those features during learning. These results provide insight into children's developing knowledge of noun classes and highlight the complex ways in which statistical information from the input interacts with children's learning processes.

The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards (IRBs) should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects.

OBJECTIVE The authors compared the predictive accuracy of two risk assessment methods that are feasible to use in routine clinical settings: brief risk assessment tools and patients' self-perceptions of risk. METHODS In 2002-2003, clinical interviewers met with 86 high-risk inpatients with co-occurring mental and substance use disorders (excluding schizophrenia) to carefully elicit the patients' global rating of their risk of behaving violently and to complete two brief risk assessment tools-the Clinically Feasible Iterative Classification Tree (ICT-CF) and the Modified Screening Tool (MST). Two months after discharge, patients were reinterviewed in the community to assess their involvement in violence. RESULTS Patients' self-perceptions of risk performed quite well in predicting serious violence (area under the curve [AUC]=.74, sensitivity=50%), particularly compared with the ICT-CF (AUC=.59, sensitivity=40%) and the MST (AUC=.66, sensitivity=30%). Self-perceived risk also added significant incremental utility to these tools in predicting violence. CONCLUSIONS Patients' self-perceptions hold promise as a method for improving risk assessment in routine clinical settings. Assuming it replicates and generalizes beyond the research context, this finding encourages a shift away from unaided clinical judgment toward a feasible method of risk assessment built on patient collaboration.

This article (1) argues that ancient Greek medicine had a significant effect on the way in which Plato conceived of ethics, and (2) explores some ways in which Plato integrated medical concepts such as "health" into his ethics. Specific parallels between ancient medicine and such concepts as eudaimonia, soul, nature and convention, etc., are discussed, as is the relation between conceptions of health and medical treatment.

OBJECTIVE: This study examined differences in factors associated with violence toward others by female and male patients evaluated in a psychiatric emergency service. METHODS: A sample of 812 psychiatric patients recruited in the emergency service of an urban psychiatric hospital were followed in the community over a six-month period. Patients provided self-reports of violent incidents, and collateral informants also provided reports of the incidents. Official records were also reviewed. During the followup period, 369 patients (213 male and 156 female patients) engaged in violence, defined as laying hands on another person in a threatening manner or threatening another person with a weapon. RESULTS: Male and female patients did not differ significantly in frequency and seriousness of violence, but they did differ on who the co-combatant was and where the incident took place. CONCLUSIONS: Gender is not a strong predictor of involvement in violence by psychiatric patients. The observed gender differences in location in which violence took place and identity of the co-combatant may be related to differences in the social worlds of men and women, with men having more opportunity for public violence with strangers. Language: en