Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials.

When IRBs Say No to Participating in Research about Single IRBs.

In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study site. The goal of the single IRB approach is to increase the efficiency of IRB review of multisite research without jeopardizing protections for research subjects. Yet the extent to which these joint goals are being achieved is unclear. To better understand how single IRBs function, we recruited academic, government, and commercial single IRBs (N = 49) to participate in a study involving observation of protocol review meetings and/or interviews with their members, chairs, and administrators. Twenty (40.8%) agreed to participate, of which 50% agreed to both interviews and observation. While 81.8% (9/11) of academic and 50% (4/8) of government single IRBs participated in some way, only 23.3% (7/30) of commercial single IRBs did so. The four largest commercial single IRBs declined to participate. Because evaluation of single IRBs is important to inform development, implementation, monitoring, and refinement of federal policies, single IRBs should be encouraged to participate in research that examines how they function.

How Single Institutional Review Boards Manage Their Own Conflicts of Interest: Findings From a National Interview Study.

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.

Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions.

New federal policies require single IRB review for multisite studies, but many questions remain about how these IRBs will use local knowledge. The findings from our study, the first to examine how single IRBs perceive needs for local knowledge, reveal several challenges. Study respondents identified four potentially relevant types of local knowledge: about culture and linguistics, about geography and socioeconomics, about the researchers, and about the institutions. Such knowledge can potentially be obtained through local sites, but single IRBs may be unaware of potentially relevant local information, and lack of informal relationships may impede single IRBs' reviews and interactions with researchers. While a recent, commonly used, standardized single-IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research.

Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.

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.

The meaning of work for young adults diagnosed with serious mental health conditions.

OBJECTIVE: Despite the increased recognition of the importance of work for social and psychological well-being, the meaning of work for young adults with serious mental health conditions is understudied. This study uses a participatory action research approach to explore the economic, social and psychological significance of work for young adults diagnosed with psychiatric disabilities. METHOD: We conducted 57 one-hour semistructured interviews with young adults between the ages of 18 to 30 enrolled in 3 well established vocational support programs. NVivo 8 software was used to sort and systematically organize the interview data. RESULTS: Young adults with psychiatric disabilities work in part for financial independence from their family but also for additional reasons. Work provides the opportunity for social engagement and feelings of contributing to society as a whole. For some young adults, work provides the opportunity to enhance their self-esteem, self-confidence, and a positive self-image. For Latino young adults, work provides a way to cope with their mental illness. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Our findings provide pertinent information for vocational rehabilitation services, recovery programs, and even parents on the importance of connecting young adults to jobs that enhance self-esteem and self-efficacy and are in line with their personal interests. Future research is needed to understand potential cultural and age differences in the meaning of work. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

A Systematic Review of Evidence for the Clubhouse Model of Psychosocial Rehabilitation.

The Clubhouse Model has been in existence for over sixty-five years; however, a review that synthesizes the literature on the model is needed. The current study makes use of the existing research to conduct a systematic review of articles providing a comprehensive understanding of what is known about the Clubhouse Model, to identify the best evidence available, as well as areas that would benefit from further study. Findings are summarized and evidence is classified by outcome domains. Fifty-two articles met the selection criteria of Randomized Clinical Trials (RCT's), quasi-experimental studies, or observational studies for domains of employment (N = 29); quality of life/satisfaction (N = 10); reductions in psychiatric hospitalization(s) (N = 10); social relationships (N = 10); education (N = 3); and health promotion activities (N = 2). RCT results support the efficacy of the Clubhouse Model in promoting employment, reducing hospitalization(s), and improving quality of life. Quasi-experimental and observational studies offer support in education and social domains. The findings from this review indicate that Clubhouses are a promising practice but additional studies using rigorous methods that report the strength of the outcomes are needed to evaluate Clubhouse programs with fidelity to the Clubhouse Model.

Factors Influencing IACUC Decision Making: Who Leads the Discussions?

Decisions about the appropriate use of animals in research are largely made by Institutional Animal Care and Use Committees (IACUCs). Several commentators claim that scientists exert excessive influence on IACUC decisions. We studied 87 protocol reviews from 10 IACUCs to assess whether any group of participants appeared to dominate the protocol discussions. Audio recordings of the meetings were coded to capture the topics of the discussions. We found that animal research scientists made the largest total number of topic mentions while community members made the fewest. On a per person basis, chairpersons and attending veterinarians made the most mentions. Scientists presented the largest number of protocols, and the subsequent discussions tended to contain the same topics mentioned in the presentations. The large number of protocols presented by scientists and their total number of comments made during protocol discussions suggest that scientists may significantly influence IACUC decision making.

An exploratory study of therapeutic misconception among incarcerated clinical trial participants.

BACKGROUND: Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. Yet little attention has been paid to its presence among individuals who participate in research while incarcerated. METHODS: This study examined the extent to which seventy-two incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation. RESULTS: On average, participants endorsed 70% of items suggestive of therapeutic misconception. The tendency toward therapeutic misconception was significantly higher among: African Americans and Latinos compared to Whites; older and less educated participants; enrollment in a substance abuse-related trial; and correlated with a belief that the trial was the only way to obtain needed treatment. CONCLUSIONS: Therapeutic misconception may be particularly high among select incarcerated individuals and is associated with a perceived lack of treatment options. Further examination of therapeutic misconception among incarcerated research participants is needed.

Decision Making and the IACUC: Part 1- Protocol Information Discussed at Full-Committee Reviews.

IACUC protocols can be reviewed by either the full committee or designated members. Both review methods use the principles of the 3 Rs (reduce, refine, replace) as the overarching paradigm, with federal regulations and policies providing more detailed guidance. The primary goal of this study was to determine the frequency of topics discussed by IACUC during full-committee reviews and whether the topics included those required for consideration by IACUC (for example, pain and distress, number of animals used, availability of alternatives, skill and experience of researchers). We recorded and transcribed 87 protocol discussions undergoing full-committee review at 10 academic institutions. Each transcript was coded to capture the key concepts of the discussion and analyzed for the frequency of the codes mentioned. Pain and distress was the code mentioned most often, followed by the specific procedures performed, the study design, and the completeness of the protocol form. Infrequently mentioned topics were alternatives to animal use or painful or distressful procedures, the importance of the research, and preliminary data. Not all of the topics required to be considered by the IACUC were openly discussed for all protocols, and many of the discussions were limited in their depth.

Why is therapeutic misconception so prevalent?

Therapeutic misconception (TM)-when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care-has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants' incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers' frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial.

What the ANPRM missed: additional needs for IRB reform.

Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection.

The utility of patients' self-perceptions of violence risk: consider asking the person who may know best.

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.

Competing commitments in psychiatric research: an examination of psychiatric researchers' perspectives.

Clinician-researchers have responsibilities both to seek the best interests of the people they treat and to advance scientific knowledge. The purpose of this study was to examine researchers' beliefs and behaviors regarding areas of tension between their clinical and scientific roles. We conducted and analyzed 19 in-depth interviews with psychiatric clinical researchers to explore these issues. Responses usually indicated that researchers recognize limits on their abilities to be helpful to patients, since they cannot know in advance whether a specific research intervention will help and whether participation is in the patient's best interest. Hence, most researchers did not make special efforts to recruit patients doing poorly in standard care, although they occasionally tolerated minor deviations from recruitment and treatment protocols when they might be in participants' interests. Often respondents asked the IRB to approve these deviations or change the protocol for all subjects, though it was unclear how often they may have acted without this approval. Despite researchers' high regard for following the research protocol, clinical judgment remained the ultimate guide if patients were not doing well and needed alternative care. Hence, respondents expressed a strong commitment both to protecting patients' interests and to advancing science. In cases of direct conflict between the two, many of the researchers tended to promote patients' best interests even at some cost to scientific research.

Therapeutic misconception in research subjects: development and validation of a measure.

BACKGROUND: Therapeutic misconception (TM), which occurs when research subjects fail to appreciate the distinction between the imperatives of clinical research and ordinary treatment, may undercut the process of obtaining meaningful consent to clinical research participation. Previous studies have found that TM is widespread, but progress in addressing TM has been stymied by the absence of a validated method for assessing its presence. PURPOSE: The goal of this study was to develop and validate a theoretically grounded measure of TM, assess its diagnostic accuracy, and test previous findings regarding TM's prevalence. METHODS: A total of 220 participants were recruited from clinical trials at four academic medical centers in the United States. Participants completed a 28-item Likert-type questionnaire to assess the presence of beliefs associated with TM, and a semistructured TM interview designed to elicit their perceptions of the nature of the clinical trial in which they were participating. Data from the questionnaires were subjected to factor analysis, and items with poor factor loadings were excluded. This resulted in a 10-item scale, with three strongly correlated factors and excellent internal consistency; the fit indices of the model across 10 training sets were consistent with the original results, suggesting a stable factor solution. RESULTS: The scale was validated against the TM interview, with significantly higher scores among subjects coded as displaying evidence of TM. Receiver operating curve (ROC) analysis based on a 10-fold internal cross-validation yielded area under the ROC (AUC) = 0.682 for any evidence of TM. When sensitivity (0.72) and specificity (0.61) were both optimized, positive predictive value was 0.65 and negative predictive value was 0.68, with a positive likelihood ratio of 1.89 and a negative likelihood ratio of 0.47. In all, 50.5% (n = 101) of the participants manifested evidence of TM on the TM interview, a somewhat lower rate than in most previous studies. LIMITATIONS: The predictive value of the scale compared with the 'gold standard' clinical interview is modest, although similar to other instruments based on self-report assessing states of mind rather than discrete symptoms. Thus, although the scale can offer evidence of which subjects are at risk for distortions in their decisions and to what degree, it will not allow researchers to conclude definitively that TM is present in a given subject. CONCLUSIONS: The development of a reliable and valid TM scale, even with modest predictive power, should permit investigators in clinical trials to identify subjects with tendencies to misinterpret the nature of the situation and to provide additional information to them. It should also stimulate research on how best to decrease TM and facilitate meaningful informed consent to clinical research.

A self-assessment survey of the Institutional Animal Care and Use Committee, part 2: structure and organizational functions.

Support for Institutional Animal Care and Use Committees (IACUCs) varies among those in animal use-related professions. The authors designed and carried out an anonymous survey to solicit opinions on the structure and organizational functions of IACUCs. They found that most respondents believed a single, institution-based IACUC was an appropriate venue for institutional approval of animal care and use, that their IACUCs represented their institutions' constituencies and that the unaffiliated IACUC members adequately represented their surrounding communities. Respondents believed that members came prepared for IACUC meetings, and a majority agreed that full committee reviews were more thorough than designated member reviews. The quality of veterinary care for animals was deemed to be very good. Participants reported that the status of the person submitting an animal use protocol, the perceived monetary value of a grant associated with a protocol and pressure for a rapid protocol review did not alter the quality of the protocol review. On many of the survey items, opinions of IACUC members differently significantly from those of non-members, and opinions of non-member IACUC administrators differed from those of IACUC chairpersons, perhaps owing to differences in responsibilities and perceived status.