Understanding Ethical Issues of Research Participation from the Perspective of Participating Children and Adolescents: A Systematic Review

Background The past twenty years have seen distinct shifts in the way the participation of children and adolescents in research is viewed. This has been emphasized by the growing pediatric research enterprise. Additional information on children’s and adolescents’ experiences during research participation is needed to better inform researchers on the ethical conduct of research with this vulnerable population. Aims The objective of this analysis was to examine ethical issues in research with children and adolescents from their perspective as participants, including: assent, parental consent, risk perception, impact of research participation, and incentives. Methods This systematic review was conducted per the Long et al. framework by means of an iterative searching process. Using the key words ‘research ethics’ and ‘child or pediatric or adolescent’, PubMed, CINAHL, and EBSCOhost databases were searched to identify articles. Limitations placed on the original searches were: English language, year of publication between 2003–2014, humans, abstract available, and age birth–18 years. Findings Twenty-three empiric studies were identified and formed the sample. Included studies represented a diverse range of areas of research, methods, settings, sample demographics, authors, and journals. Discussion Even young children demonstrated the ability to understand essential elements of research, although there is variability in children’s level of understanding. Trust was a significant contributing factor to children’s and adolescents’ participation in research, and also shaped their assessments of risk. Research participation was mainly beneficial for children and adolescents. Incentives were mainly viewed positively, although concerns of possible undue influence were expressed. Linking Evidence to Action This systematic review highlights the importance of including the perspectives of children and adolescents and provides researchers and nurse clinicians with best practices for involving children in research

Participant experiences in phase I pediatric oncology clinical trials

Indiana University-Purdue University Indianapolis (IUPUI)Phase I clinical trials (P1Ts) are the first step in testing new medical therapies in humans, and are essential for developing new and innovative therapies for children with cancer. P1Ts are ethically controversial as they are not intended to directly benefit participants, but are particularly controversial for children with cancer who are only able to participate when there is no known curative therapy for their cancer. Benefits of pediatric oncology P1T participation may include improved quality of life (QOL) and hope. Risks may include fostering unrealistic hope, burdening children with additional medical procedures and toxicities, and limiting the opportunity for palliation. The goal of this dissertation was to investigate the P1T participation experience for children with cancer and their parents by: (1) assessing what is currently known about the participation experience, (2) exploring ways to understand and assess treatment burden and QOL during participation, and (3) interviewing parents about the experience of having a child participate in a P1T. Following a review of the literature, two studies were conducted: a longitudinal pilot study of 13 parent and child dyads who enrolled in a pediatric oncology early phase clinical trial at the recruiting institution, and a phenomenological study of 11 parents of children with cancer who participated in pediatric oncology P1Ts. Key findings included a dearth of research on the experiences of children and parents in pediatric oncology P1Ts. Instead, existing research has focused on consent processes. The longitudinal pilot study provided some insight into experiences of children and parents during trial participation, including that there may be time points when parents’ and children’s perceptions of the child’s quality of life substantively differ. Interviews with parents confirmed some of the anticipated benefits and risks of participation in P1Ts, and highlighted parents’ sense of running out of time to find an effective treatment and needing to use time they have with their child well. Specific challenges in conducting this research were participant attrition due to disease progression and the need for multi-site research to obtain an adequate sample

Parental Experiences of Child Participation in a Phase I Pediatric Oncology Clinical Trial: "We Don't Have Time to Waste"

Children with cancer are only eligible for phase I clinical trials (P1Ts) when no known curative therapy remains. However, the primary aims of P1Ts are not focused on directly benefiting participants. This raises ethical concerns that can be best evaluated by exploring the experiences of participants. An empirical phenomenology study, using an adapted Colaizzi method, was conducted of 11 parents' lived experiences of their child's participation in a pediatric oncology P1T. Study findings were that parents' experiences reflected what it meant to have a child fighting to survive high-risk cancer. Although elements specific to P1T participation were identified, more pervasive was parents' sense of running out of time to find an effective treatment and needing to use time they had with their child well. Even though some problems were identified, overall parents did not regret their child's P1T participation and would recommend P1Ts to other parents of children with cancer

A feasibility test of an online intervention to prevention dating violence in emerging adults

Dating violence in emerging adults is a significant problem and few prevention programs based on the developmental needs of this age group have been developed. Our research team developed an online dating violence prevention program called WISER (Writing to Improve Self-in-Relationships) for emerging adults. The program is based on narrative therapy principles and uses structured writing techniques. A single group pre-post feasibility test of WISER was conducted with 14 college women. WISER was demonstrated to be feasible and acceptable and to show promise as an effective program to decrease dating violence in this population

Beyond Data Capture: Using REDCap™ to Facilitate Web-Based Therapeutic Intervention Research

Background Limited guidelines to assist nurse researchers who use web-based interventions are available. Nurses must develop the supporting technology enabling participants to complete study activities and collected data while maintaining data security and participant confidentiality. Objectives To describe how the authors used advanced Research Electronic Data Capture (REDCapTM) functionality to support the data management infrastructure of an interactive, web-based therapeutic intervention. Methods The data management infrastructure for the WISER intervention pilot study consisted of two components: a website for presentation of the intervention and participant account management and a REDCap project for data capture and storage. REDCap application programming interface (API) connected these two components using HTML links and data exchanges. Results We completed an initial pilot study of WISER with 14 participants using the REDCap-based infrastructure. Minimal technical difficulties were encountered. Discussion REDCap is cost-effective, readily available, and through its advanced functionality is able to facilitate confidential, secure interactions with participants, robust data management, and seamless participant progression in web-based intervention research

Designing an Internet Intervention for Emerging Adults Who Experience Troubled Relationships

This article describes how the Internet Intervention Model (IIM) was used as an organizing framework to design a theoretically based Internet intervention for emerging adults who experience troubled intimate partner relationships. In the design process, the team addressed six fundamental questions related to the several components of the IIM. Decisions made regarding the design of the intervention based on the six questions are described. We focus in particular on how the intervention is based on the Theory of Emerging Adulthood and the Theory of Narrative Identity

Understanding Treatment Burden and Quality of Life Impact of Participating in an Early-Phase Pediatric Oncology Clinical Trial: A Pilot Study

PURPOSE: Early-phase clinical trials (EPTs) have led to new, more effective treatment options for children with cancer. Despite the extensive use of EPTs in pediatric oncology, little is known about parent and child experiences during EPT participation. The purposes of this pilot study were to assess the feasibility and preliminary results of having children with cancer and their parents complete measures of treatment burden and quality of life (QOL) concurrent with EPT participation. METHODS: In this descriptive, longitudinal, pilot study, parents and children were followed for the first 60 days of an EPT. Feasibility was assessed by participant enrollment and retention and completion of measures. Measures completed included the following: demographic form (completed at baseline); Diary of Trial Experiences to capture treatment burden (completed ongoing); and PedsQL™ Quality of Life Inventories, Cancer Modules, and Family Impact Module (completed at baseline, post-first disease evaluation, and off-study). Data were analyzed using descriptive statistics. RESULTS: Feasibility goals of enrollment, retention, and measure completion were partially met. Preliminary treatment burden and QOL results are provided. CONCLUSIONS: While QOL assessments may provide insight into EPT experiences, future studies need to be conducted at multiple sites and enrollment goals must account for participant attrition

Knowledge of the signs and symptoms and risk factors of lung cancer in Australia: Mixed methods study

© 2016 Crane et al. Background: Lung cancer is the leading cause of cancer death in Australia. There is potential that health promotion about the risks and warning signs of lung cancer could be used to reduce delays in symptom presentation when symptoms are first detected. This study investigated knowledge, attitudes and beliefs which might impact help-seeking behaviour and could provide insight into possible public health interventions in New South Wales (NSW). Methods: A convergent mixed method study design was used wherein data from 16 qualitative focus groups of residents (40+ years), purposefully recruited and stratified by smoking status, age and geography (metropolitan/regional), were compared with a CATI administered population-wide telephone survey (n = 1,000) using the Cancer Research UK cancer awareness measure (LungCAM). Qualitative findings were analysed thematically using NVIVO. Logistic regression analysis was used to investigate predictors of symptom knowledge in STATA. Findings were integrated using triangulation techniques. Results: Across focus groups, haemoptysis was the only symptom creating a sense of medical urgency. Life experiences evoked a 'wait and see' attitude to any health deterioration. Perceived risk was low amongst those at risk with current smokers preferring to deny their risk while former smokers were generally unaware of any ongoing risk. The quantitative sample consisted of females (62 %), 40-65 years (53 %), low SES (53 %), former (46 %) and current smokers (14 %). In quantitative findings, haemoptysis and dyspnoea were the most recognised symptoms across the sample population. Age (<65 years), sex (female) and high socio-economic status contributed to a higher recognition of symptoms. Smoking was recognised as a cause of lung cancer, yet ever-smokers were less likely to recognise the risk of lung cancer due to second-hand smoke (OR 0.7 95 % CI 0.5-0.9). Conclusion: While there was some recognition of risk factors and symptoms indicative of lung cancer, there was disparity across the sample population. The qualitative findings also suggest that knowledge may not lead to earlier presentation; a lack of urgency about symptoms considered trivial, and smoking-related barriers such as stigma may also contribute to time delays in presentation. Public health interventions may be required to increase awareness of risk and emphasise the importance of seeking medical attention for ongoing symptoms

Engaging Clinical Nurses in Research: Nurses’ Experiences Delivering a Communication Intervention in a Behavioral Oncology Clinical Trial

Despite the recognized need for clinical nurses to engage in the conduct of research, little is known about their research experiences. This article describes the experiences of nurses who delivered the communication intervention in a behavioral oncology clinical trial for parents of adolescents and young adults (AYAs) with cancer. A qualitative thematic analysis was conducted of nurse interveners’ (NIs’) reflections on their experiences delivering the communication intervention. Ten data-generating questions were developed to guide NIs’ reflections. Twelve NIs responded via verbal discussions. Six of these also provided written responses. Overall, nurses’ experiences as interveners were powerful and positive, and included time and space to be fully present with patients and families. NIs identified barriers to their involvement in research related to time constraints, administrative support, physical space to privately conduct the intervention, and difficulties maintaining expertise with the intervention. The importance of ongoing collaboration between nurses, unit staff, leaders, and study teams was corroborated. An unexpected finding was the importance of Reflective Clinical Research

Interleukin-17D and Nrf2 mediate initial innate immune cell recruitment and restrict MCMV infection.

Innate immune cells quickly infiltrate the site of pathogen entry and not only stave off infection but also initiate antigen presentation and promote adaptive immunity. The recruitment of innate leukocytes has been well studied in the context of extracellular bacterial and fungal infection but less during viral infections. We have recently shown that the understudied cytokine Interleukin (IL)-17D can mediate neutrophil, natural killer (NK) cell and monocyte infiltration in sterile inflammation and cancer. Herein, we show that early immune cell accumulation at the peritoneal site of infection by mouse cytomegalovirus (MCMV) is mediated by IL-17D. Mice deficient in IL-17D or the transcription factor Nuclear factor (erythroid-derived 2)-like 2 (Nrf2), an inducer of IL-17D, featured an early decreased number of innate immune cells at the point of viral entry and were more susceptible to MCMV infection. Interestingly, we were able to artificially induce innate leukocyte infiltration by applying the Nrf2 activator tert-butylhydroquinone (tBHQ), which rendered mice less susceptible to MCMV infection. Our results implicate the Nrf2/IL-17D axis as a sensor of viral infection and suggest therapeutic benefit in boosting this pathway to promote innate antiviral responses