Conducting industrial and organizational psychological research: institutional review of research in work organizations

Although informed consent is a primary mechanism for ensuring the ethical treatment of human participants in research, both federal guidelines and American Psychological Association ethical standards recognize that exceptions to it are reasonable under certain conditions. However, agreement about what constitutes a reasonable exception to informed consent is sometimes lacking. We presented the same protocols to samples of respondents drawn from 4 populations: Institutional review board (IRB) members, managers, employees, and university faculty who were not members of IRBs. Differences in perceptions of IRB members from the other samples with respect to the risks of the protocols without informed consent and on the feasibility of conducting the research in employment organizations are discussed in terms of implications for industrial and organizational psychology research.     

Conducting Industrial and Organizational Psychological Research: Institutional Review of Research in Work Organizations

Although informed consent is a primary mechanism for ensuring the ethical treatment of human participants in research, both federal guidelines and American Psychological Association ethical standards recognize that exceptions to it are reasonable under certain conditions. However, agreement about what constitutes a reasonable exception to informed consent is sometimes lacking. We presented the same protocols to samples of respondents drawn from 4 populations: Institutional review board (IRB) members, managers, employees, and university faculty who were not members of IRBs. Differences in perceptions of IRB members from the other samples with respect to the risks of the protocols without informed consent and on the feasibility of conducting the research in employment organizations are discussed in terms of implications for industrial and organizational psychology research.     

Human participants challenges in youth tobacco cessation research: researchers' perspectives

Recruiting adolescents into smoking cessation studies is challenging, particularly given institutional review board (IRB) requirements for research conducted with adolescents. This article provides a brief review of the federal regulations that apply to research conducted with adolescents, and describes researchers' experiences of seeking IRB approval for youth cessation research. Twenty-one researchers provided information. The most frequently reported difficulty involved obtaining parental consent. Solutions to commonly reported problems with obtaining IRB approval are also identified. Waivers of parental consent can facilitate recruitment of youths into studies; however, researchers must ensure that their protocols comply with federal regulations when requesting a waiver.     

Do IRBs Pass the Minimal Harm Test?

ABSTRACT— We describe examples of institutional review board (IRB) actions that have delayed or thwarted research that could not conceivably be considered to pose more than minimal risk to participants. We propose three changes to improve the IRB process and reduce both human and financial costs.     

Language and motor abilities of preschool children who stutter: Evidence from behavioral and kinematic indices of nonword repetition performance

Stuttering is a disorder of speech production that typically arises in the preschool years, and many accounts of its onset and development implicate language and motor processes as critical underlying factors. There have, however, been very few studies of speech motor control processes in preschool children who stutter. Hearing novel nonwords and reproducing them engages multiple neural networks, including those involved in phonological analysis and storage and speech motor programming and execution. We used this task to explore speech motor and language abilities of 31 children aged 4–5 years who were diagnosed as stuttering. We also used sensitive and specific standardized tests of speech and language abilities to determine which of the children who stutter had concomitant language and/or phonological disorders. Approximately half of our sample of stuttering children had language and/or phonological disorders. As previous investigations would suggest, the stuttering children with concomitant language or speech sound disorders produced significantly more errors on the nonword repetition task compared to typically developing children. In contrast, the children who were diagnosed as stuttering, but who had normal speech sound and language abilities, performed the nonword repetition task with equal accuracy compared to their normally fluent peers. Analyses of interarticulator motions during accurate and fluent productions of the nonwords revealed that the children who stutter (without concomitant disorders) showed higher variability in oral motor coordination indices. These results provide new evidence that preschool children diagnosed as stuttering lag their typically developing peers in maturation of speech motor control processes.Educational objectives: The reader will be able to: (a) discuss why performance on nonword repetition tasks has been investigated in children who stutter; (b) discuss why children who stutter in the current study had a higher incidence of concomitant language deficits compared to several other studies; (c) describe how performance differed on a nonword repetition test between children who stutter who do and do not have concomitant speech or language deficits; (d) make a general statement about speech motor control for nonword production in children who stutter compared to controls.     

Human Participants Challenges in Youth-Focused Research: Perspectives and Practices of IRB Administrators

The purpose of this research was to understand institutional review board (IRB) challenges regarding youth-focused research submissions and to present advice from administrators. Semistructured self-report questionnaires were sent via e-mail to administrators identified using published lists of universities and hospitals and Internet searches. Of 183 eligible institutions, 49 responded. One half indicated they never granted parental waivers. Among those considering waivers, decision factors included research risks, survey content, and feasibility. Smoking and substance abuse research among children was generally considered more than minimal risk. These findings are consistent with those from a study conducted by Mammel and Kaplan (1995), which investigated IRB practices concerning protocols involving adolescent participants. IRBs and investigators need to become aware of regulations' flexibility to ensure adequate participant protection. Investigators need to limit jargon and assumptions about participants' understanding of research objectives.     

Does language about similarity play a role in fostering similarity comparison in children?

Commenting on perceptual similarities between objects stands out as an important linguistic achievement, one that may pave the way towards noticing and commenting on more abstract relational commonalities between objects. To explore whether having a conventional linguistic system is necessary for children to comment on different types of similarity comparisons, we observed four children who had not been exposed to usable linguistic input - deaf children whose hearing losses prevented them from learning spoken language and whose hearing parents had not exposed them to sign language. These children developed gesture systems that have language-like structure at many different levels. Here we ask whether the deaf children used their gestures to comment on similarity relations and, if so, which types of relations they expressed. We found that all four deaf children were able to use their gestures to express similarity comparisons (point to cat + point to tiger) resembling those conveyed by 40 hearing children in early gesture + speech combinations (cat + point to tiger). However, the two groups diverged at later ages. Hearing children, after acquiring the word like, shifted from primarily expressing global similarity (as in cat/tiger) to primarily expressing single-property similarity (as in crayon is brown like my hair). In contrast, the deaf children, lacking an explicit term for similarity, continued to primarily express global similarity. The findings underscore the robustness of similarity comparisons in human communication, but also highlight the importance of conventional terms for comparison as likely contributors to routinely expressing more focused similarity relations.     

A new protocol for assessing action observation and imitation abilities in children with Developmental Coordination Disorder: A feasibility and reliability study

AIMS. To develop a new protocol for the assessment of action observation (AO) abilities and imitation of meaningful and non-meaningful gestures, to examine its psychometric properties in children with DCD and typically developing (TD) children. BACKGROUND. For learning manual skills, AO and imitation are considered fundamental abilities. Knowledge about these modalities in children with DCD is scarce and an assessment protocol is lacking. METHOD. The protocol consists of 2 tests. The AO test consists of two assembly tasks. The imitation test includes 12 meaningful and 20 non-meaningful gestures. Items of both tests are rated on a 4-point scale. Twelve children with DCD (mean age 8y3m, SD, 1.30) and 11 TD children (mean age 8y2m, SD 1.52) were enrolled. For inter-rater reliability, intraclass correlation coefficients (ICC) were calculated for the total score, weighted kappa and percentage agreement for single items. Known group validity was assessed by comparison of DCD and TD group (Wilcoxon rank sum test). For construct validity, the mABC-2 test was used. The protocol was adapted and confirmed by an intra and inter-rater reliability study (new sample of 11 DCD children, mean age 7y5m, SD 1.37). RESULTS. Excellent ICCs were reported for intra and inter-rater reliability for the final protocol. A significant difference between DCD and TD group was found for AO abilities (p < .01), for nonmeaningful gestures (p < .001). A significant correlation was reported between the AO test and the mABC-2 test (r = 56;p ≤0.0001). No significant correlations were revealed for the imitation tests. DISCUSSION AND CONCLUSION. The results support the psychometric properties of this protocol. When fully validated, it may contribute to map the deficits in AO abilities and imitation, to evaluate treatment effects of imitation and AO interventions.     

Ethical and Legal Guidance for Mental Health Practitioners Who Wish to Conduct Research in a Private Practice Setting

Mental health practitioners, even when they have research training, rarely contribute to the scientific literature. One reason for this may be that they need help addressing the ethical and legal issues they encounter as they contemplate undertaking research in a clinical practice setting. To address that need, we offer several types of guidance for conducting research in a private practice setting in a way that meets high ethical and legal standards. We describe the situations in which ethical review of a research proposal by a federally registered institutional review board (IRB) is legally required, and identify alternate mechanisms that practitioners can use to obtain an ethical review when a formal IRB review is not required by law. We discuss legal and ethical requirements of conducting single-case studies in a practice setting. We provide a rationale, and free and inexpensive options, for obtaining a formal certificate of training in human subjects research. And we offer guidance for obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from research participants. We conclude with a brief discussion of other legal and professional issues to consider when conducting research in private practice.     

Dynamic balance assessment during gait in children with Down and Prader-Willi syndromes using inertial sensors

Down (DS) and Prader-Willi (PWS) syndromes are chromosomal disorders both characterized by obesity, ligament laxity, and hypotonia, the latter associated with gait instability. Although these shared features may justify a common rehabilitation approach, evidence exists that adults with DS and PWS adopt different postural and walking strategies. The development of an instrumented protocol able to describe these strategies and quantify patients’ gait stability in the current clinical routine would be of great benefit for health professionals, allowing them to design personalized rehabilitation programs. This is particularly true for children with DS and PWS, where motor development is dramatically constrained by severe hypotonia and muscle weakness. The aim of this study was, thus, to propose an instrumented protocol, integrated with the clinical routine and based on the use of wearable inertial sensors, to assess gait stability in DS and PWS children.Fifteen children with DS, 11 children with PWS, and 12 typically developing children (CG) were involved in the study. Participants performed a 10-meter walking test while wearing four inertial sensors located at pelvis, sternum, and both distal tibiae levels. Spatiotemporal parameters (walking speed, stride frequency, and stride length) and a set of indices related to gait symmetry and upper-body stability (Root Mean Square, Attenuation Coefficient and Improved Harmonic Ratio) were estimated from pelvis and sternum accelerations. The Gross Motor Functional Measures (GMFM-88) and Intelligence Quotient (IQ Wechsler) were also assessed for each patient. A correlation analysis among the GMFM-88 and IQ scales and the estimated parameters was then performed.Children with DS and PWS exhibit reduced gait symmetry and higher accelerations at pelvis level than CG. While these accelerations are attenuated by about 40% at sternum level in CG and DS, PWS children display significant smaller attenuations, thus reporting reduced gait stability, most likely due to their typical “Trendelenburg gait”. Significant correlations were found between the estimated parameters and the GMFM-88 scale when considering the whole PWS and DS group and the PWS group alone.These results promote the adoption of wearable technology in clinical routines to monitor gait patterns in children with DS and PWS: the proposed protocol allows to markedly characterize patient-specific motor limitations even when clinical assessment scores provide similar results in terms of pathology severity. This protocol could be adopted to support health professionals in designing personalized treatments that, in turn, could help improving patients’ quality of life in terms of both physical and social perspectives.     

Commentary on "Family dynamics and children in medical research.

Gordon and Bonkovsky describe a disturbing case of research involving minors in their article "Family Dynamics and Children in Medical Research." As presented in the case, there is little doubt that the assent obtained from the children was inadequate for the proposed research and that the institutional review board (IRB) failed to assess sufficiently the risk-benefit ratio of the research to the child-subjects.     

IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So,Why and for Whom?

Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations.     

Applying a traumatic stress approach to understanding PCS following pediatric mild TBI

Pediatric traumatic brain injury is a significant public health concern affecting hundreds of thousands of children each year. The majority of children who sustain traumatic brain injuries are classified as having a mild traumatic brain injury, and a subset of these children go on to experience persistent physical, cognitive, and emotional symptoms. These symptoms, known as postconcussive symptoms, can endure for months and even years after injury. The outcomes of mild traumatic brain injury are variable and not well understood for a small percentage of children who experience persistent symptoms. The current article explores the potential influence of children’s posttraumatic stress symptoms on persistent postconcussive symptoms. Despite the high incidence of posttraumatic stress symptoms after pediatric accidental injury, they have not yet been identified as an important factor for consideration in the understanding of pediatric postconcussive outcomes. The article will review the literature on posttraumatic stress and postconcussive symptoms after pediatric injury and consider neurobiological and cognitive factors to propose a model explaining a pathway through which posttraumatic stress reactions may serve as the mechanism for the expression and maintenance of postconcussive symptoms after mild traumatic brain injury. The clinical implications for the proposed relationship between posttraumatic stress symptoms and postconcussive symptoms are considered prior to the conclusion of the article, which acknowledges limitations in the current literature and provides suggestions for future research.     

A comparison of children who receive and who do not receive permission to participate in research

In a study examining children's social competence in elementary school settings, the authors had the opportunity to compare children who received parental permission to participate to children who did not receive permission. Results indicated that children who were not involved in the study were more likely to be viewed by teachers as having unsatisfactory relationships with peers than children who were in the study. The present results suggest that investigators begin reporting the number of children who do not participate in a given study and begin examining whether minors who receive parental permission differ on important dimensions from minors who do not receive such permission. Ethical considerations of the present study are discussed.     

The contribution of functional near-infrared spectroscopy (fNIRS) to the presurgical assessment of language function in children

Before performing neurosurgery, an exhaustive presurgical assessment is required, usually including an investigation of language cerebral lateralization. Among the available procedures, the intracarotid amobarbital test (IAT) was formerly the most widely used. However, this procedure has many limitations: it is invasive and potentially traumatic, especially for children. To overcome these limitations, neuroimaging techniques such as functional magnetic resonance imaging (fMRI) have been used. Again, these methods are difficult to use with children, who must remain motionless during data acquisition. Functional near-infrared spectroscopy (fNIRS) is a noninvasive functional imaging technique that is easily applied to pediatric and cognitively limited patients. It has been used recently in epileptic children for presurgical assessment of expressive and receptive language brain lateralization. The aim of this review is to present the contribution of fNIRS to the presurgical assessment of language function in children with neurological diseases.     

Communication attitudes in children who stutter: A meta-analytic review

BackgroundThis article presents a meta-analytic review of differences in communication attitudes between children who stutter (CWS) and children who do not stutter (CWNS).MethodTo be included in this review, the studies had to include a group of CWS and CWNS between the ages of 3–18 years and a measurement of communication attitudes. The journal articles were identified by using the key words stutter*, speech disfluenc*, fluency disorder*, and stammer* cross-referenced to awareness*, reaction*, attitude*, KiddyCAT, CAT, A-19 Scale, PASS and OASES.ResultsA total of 18 studies met the inclusion criteria for this meta-analysis. The results showed that CWS exhibit more negative communication attitudes than CWNS from the preschool years. The differences between the groups increased with age, but were not influenced by gender.ConclusionThe results indicate that negative communication attitudes can be an effect of stuttering. Key issues requiring further investigation are whether communication attitudes differ as a function of age at stuttering onset and whether communication attitudes influence the development of stuttering.Educational Objectives: After reading this article, the reader will be able to: (a) summarise empirical findings with regard to the relationship between communication attitudes and childhood stuttering; (b) describe the different instruments used to measure communication attitudes; (c) discuss the relationship between communication attitudes, age and gender.     

Children’s suggestion-induced omission errors are not caused by memory erasure

We explored whether children’s suggestion-induced omission errors are caused by memory erasure. Seventy-five children were instructed to remove three pieces of clothing from a puppet. Next, they were confronted with evidence falsely suggesting that one of the items had not been removed. During two subsequent interviews separated by one week, children had to report which pieces of clothing they had removed. Children who during both interviews failed to report that they had removed the pertinent item (i.e., omission error; n = 24) completed a choice reaction time task. In this task, they were presented with different clothing items. For each item, children had to indicate whether or not they had removed it. Significantly more errors were made for those removed items that children failed to report than for those they had not removed. This indicates that children’s suggestion-based omission errors are not due to erasure of memories.     

A plea for pragmatism in clinical research ethics

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.