"Dogs on Call": A Community-Engaged Human Subjects Training with Hospital Based Therapy Dog Teams.

Problem: As community-engaged research (CER) methods evolve, Institutional Review Boards (IRBs) must adapt policies to facilitate CER research. This paper describes a novel collaboration between hospital-based therapy dog volunteer teams (CERs), academic faculty, and an IRB. Subjects: CER volunteers delivered a canine-assisted intervention to hospitalized adults in a clinical trial. Methods: IRB members and faculty developed a human subjects protections training tailored to the volunteer handlers' role as study interventionists including an interactive video- and discussion-based training with a knowledge assessment. Findings: Fourteen volunteer handlers were trained. The expedited IRB review period was similar to national average rates (18 days.) Volunteer handlers have conducted 107 research visits with little patient attrition. Conclusion: Tailored human subjects trainings facilitate research with interventions delivered by people who are not typically involved in research. Bespoke CER human subjects training requires collaboration between researchers and IRBs and flexibility in IRB policy regarding CER.

LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial.

INTRODUCTION: There is uncertainty about the advantages and disadvantages of laparoscopic hysterectomy compared with abdominal hysterectomy, particularly the relative rate of complications of the two procedures. While uptake of laparoscopic hysterectomy has been slow, the situation is changing with greater familiarity, better training, better equipment and increased proficiency in the technique. Thus, a large, robust, multicentre randomised controlled trial (RCT) is needed to compare contemporary laparoscopic hysterectomy with abdominal hysterectomy to determine the safest and most cost-effective technique. METHODS AND ANALYSIS: A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation. A within trial-based economic evaluation will explore the cost-effectiveness of laparoscopic hysterectomy compared with open abdominal hysterectomy. We will aim to recruit 3250 women requiring a hysterectomy for a benign gynaecological condition and who were suitable for either laparoscopic or open techniques. The primary outcome is major complications up to six completed weeks postsurgery and the key secondary outcome is time from surgery to resumption of usual activities using the personalised Patient-Reported Outcomes Measurement Information System Physical Function questionnaire. The principal outcome for the economic evaluation is to be cost per QALY at 12 months' postsurgery. A secondary analysis is to be undertaken to generate costs per major surgical complication avoided and costs per return to normal activities. ETHICS AND DISSEMINATION: The study was approved by the West Midlands-Edgbaston Research Ethics Committee, 18 February 2021 (Ethics ref: 21/WM/0019). REC approval for the protocol version 2.0 dated 2 February 2021 was issued on 18 February 2021.We will present the findings in national and international conferences. We will also aim to publish the findings in high impact peer-reviewed journals. We will disseminate the completed paper to the Department of Health, the Scientific Advisory Committees of the RCOG, the Royal College of Nurses (RCN) and the BSGE. TRIAL REGISTRATION NUMBER: ISRCTN14566195.

The safety and effectiveness of low-level light therapy (LLLT) with light-emitting diode (LED) bed system and a novel topical anti-cellulite gel on grades 1-2 thigh/buttock cellulite: a randomized, comparative-controlled split-thigh/buttock IRB study.

BACKGROUND: Cellulite of the upper lateral and posterior thighs and lower buttocks represents a common unwanted condition. OBJECTIVES: The author sought to comparea LLLT-LED bed therapy and a novel topical anti-cellulite gel on one thigh/buttock cellulite vs light therapy for cellulite to the opposite side. METHODS: Eight healthy female subjects were randomly treated with a LLLT-LED bed twice weekly for 20 minutes in prone/supine positions with twice daily application of a novel anti-cellulite gel to one randomized thigh/buttock. RESULTS: At the end of the 3-month trial, skin elasticity increased after combined therapy on one thigh but decreased with only LLLT-LED bed treatments on the opposite thigh. Thighs treated with active gel and LLLT-LED bed, were downgraded to a lower cellulite grade, while monotherapy did not demonstrate any change from their baseline cellulite grading. Changes in thigh circumference did not correlate with either treatments regimens.Subject and investigator questionnaire evaluations at month-3 were assessed as "satisfactory" results. There were no adverse reactions to treatments. CONCLUSIONS: The use of LLLT-LED bed therapy and an anti-cellulite gel demonstrated an efficient alternative in the treatment of cellulite-involved thighs/buttocks over similarly affected thighs/buttocks that were treated only with LLLT-LED bed therapy.

Effectiveness of four deconstructive meditative practices on well-being and self-deconstruction: study protocol for an exploratory randomized controlled trial.

INTRODUCTION: The efficacy of interventions based on mindfulness and compassion has been demonstrated in both clinical and general population, and in different social contexts. These interventions include so-called attentional and constructive meditation practices, respectively. However, there is a third group, known as deconstructive meditation practices, which has not been scientifically studied. Deconstructive practices aim to undo maladaptive cognitive patterns and generate knowledge about internal models of oneself, others and the world. Although there are theoretical and philosophical studies on the origin of addiction to the self or on the mechanisms of action associated with the deconstruction of the self, there are no randomized controlled trials evaluating these techniques in either a healthy population or clinical samples. This study aims to evaluate the effect of three deconstructive techniques by comparing them to mindfulness in the general population. METHODS AND ANALYSIS: A randomized controlled clinical trial will be conducted with about 240 participants allocated to four groups: (a) mindful breathing, (b) prostrations, according to Tibetan Buddhist tradition; (c) the Koan Mu, according to Zen Buddhist tradition; and (d) the mirror exercise, according to Toltec tradition. The primary outcome will be the qualities of the non-dual experience and spiritual awakening, measured by the Nondual Embodiment Thematic Inventory, assessed at pre- and post-treatment and at 3- and 6-month follow-ups. Other outcomes will be mindfulness, happiness, compassion, affectivity and altered state of consciousness. Quantitative data will be compared using mixed-effects linear regression models, and qualitative data will be analysed through thematic analysis and using the constant comparative method from grounded theory. ETHICS AND DISSEMINATION: Approval was obtained from the Research Ethics Committee of Aragon, Spain. The results will be submitted to peer-reviewed specialized journals, and brief reports will be sent to participants on request. TRIAL REGISTRATION: ClinicalTrials.gov NCT05317754. Registered on August 2,2022.

Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study.

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general.

Using the Emanuel Framework to Explore the Ethical Issues Raised in a Participatory Visual Research Project in Rural South Africa.

Participatory visual research can offer critical insight into the experiences of those most affected by health issues. As these methods are increasingly used to research sensitive topics, there is a need for a clear ethical framework to guide best practice on the part of researchers and research ethics committees. Here we reflect on a project where we used digital storytelling as a participatory visual methodology to explore HIV treatment adherence in rural South Africa, with a focus on the ethical issues we encountered during the lifetime of the project. To ground our reflections, we use the framework for ethical research developed by Emanuel et al., and the adaptation of this framework for social science proposed by Wassenaar and Mamotte. We suggest that fellow PVM practitioners and REC members draw on this holistic framework to support the optimal application of PVM in health research.

Improving the Time to Activation of New Clinical Trials at a National Cancer Institute-Designated Comprehensive Cancer Center.

PURPOSE: The time it takes a performing site to activate a clinical trial can directly affect the ability to provide innovative and state-of-the-art care to patients. We sought to understand the process of activating an oncology clinical trial at a matrix National Cancer Institute-designated comprehensive cancer center. METHODS: A multidisciplinary team of stakeholders within the cancer center, university, and affiliate hospitals held a retreat to map out the process of activating a clinical trial. We applied classical quality improvement and Six Sigma methodology to determine bottlenecks and non-value-added time in activating a clinical trial. During this process, attention was paid to time to pass through each step, and perceived barriers and bottlenecks were identified through group discussions. RESULTS: The process map identified 66 steps with 12 decision points to activate a new clinical trial. The following two steps were instituted first: allow parallel scientific committee and institutional review board (IRB) review and allow the clinical research coordination committee, a group that determines university interest and feasibility, to review protocols independent of the IRB and scientific committee approval. The clinical research coordination committee continues to track the activation time, and this framework is used to identify additional improvement steps. CONCLUSION: By applying quality improvement methodologies and Six Sigma principles, we were able to identify redundancies in the process to activate a clinical trial. This allowed us to redesign the process of activating a clinical trial at a matrix comprehensive cancer center. More importantly, the process map provides a framework to maintain these gains and implement additional changes and serves as an example to deploy across the campus and at other similar institutions.

Prioritising African perspectives in psychiatric genomics research: Issues of translation and informed consent.

Psychiatric genomics research with African populations comes with a range of practical challenges around translation of psychiatric genomics research concepts, procedures, and nosology. These challenges raise deep ethical issues particularly around legitimacy of informed consent, a core foundation of research ethics. Through a consideration of the constitutive function of language, the paper problematises like-for-like, designative translations which often involve the 'indigenization' of English terms or use of metaphors which misrepresent the risks and benefits of research. This paper argues that effective translation of psychiatric genomics research terminology in African contexts demands substantive engagement with African conceptual schemas and values. In developing attenuated forms of translational thinking, researchers may recognise the deeper motivational reasons behind participation in research, highlighting the possibility that such reasons may depart from the original meaning implied within informed consent forms. These translational issues might be ameliorated with a critical re-examination of how researchers develop and present protocols to institutional ethics review boards.

Los comités de investigación en salud: su autoridad, responsabilidad fundamental y necesidad de que se sometan a auditorías periódicas.

Research ethics must include theoretical and practical dimensions. The first one is structured by regulations and policies, and the second dimension refers to how the committee interprets and applies those regulations and policies. This article analyses the operation of the committees at a practical level. Given that the evaluation and judgement of research protocols is a process that requires full awareness, its omission entails important implications for health research.

La ética de la investigación debe incluir las dimensiones teórica y práctica. La primera la conforman regulaciones y directrices y la segunda alude a la forma cómo los comités de ética y ética de la investigación interpretan y aplican esas regulaciones y directrices. En este artículo se analiza la operación de los comités a nivel práctico. Dado que la evaluación y el dictamen de los protocolos de investigación es un proceso que requiere consciencia plena, la omisión de esta conlleva importantes implicaciones para la investigación en salud.

Los comités de investigación en salud: su autoridad, responsabilidad fundamental y necesidad de que se sometan a auditorías periódicas / Health research committees: their authority, fundamental responsibility and the need for them to undergo periodic audits

Resumen La ética de la investigación debe incluir las dimensiones teórica y práctica. La primera la conforman regulaciones y directrices y la segunda alude a la forma cómo los comités de ética y ética de la investigación interpretan y aplican esas regulaciones y directrices. En este artículo se analiza la operación de los comités a nivel práctico. Dado que la evaluación y el dictamen de los protocolos de investigación es un proceso que requiere consciencia plena, la omisión de esta conlleva importantes implicaciones para la investigación en salud.

Abstract Research ethics must include theoretical and practical dimensions. The first one is structured by regulations and policies, and the second dimension refers to how the committee interprets and applies those regulations and policies. This article analyses the operation of the committees at a practical level. Given that the evaluation and judgement of research protocols is a process that requires full awareness, its omission entails important implications for health research.

Behaviors and Attitudes toward the Use of Complementary and Alternative Medicine among Korean Cancer Patients / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: A cross-sectional survey was conducted to explore the current awareness and use of complementary and alternative medicine (CAM), as well as attitudes toward CAM, in patients with cancer and their family members in South Korea. MATERIALS AND METHODS: Between September 21 and October 31, 2017, a 25-item questionnaire regarding CAM experiences among cancer patients and their family members was conducted in 10 oncology clinics in South Korea after institutional review board approval at each institution. RESULTS: In total, 283/310 patients were analyzed. The median age was 60 years, and 60% were male. Most of the patients were actively receiving anticancer treatment at the time of the survey. A total of 106 patients (37%) had experienced a median of two types (interquartile range, 1 to 3) of CAM. Belief in CAM (odds ratio [OR], 3.015; 95% confidence interval [CI], 1.611 to 5.640) and duration of disease (OR, 1.012; 95% CI, 1.004 to 1.020) were independent factors for using CAM in multivariable analysis. Belief in CAM was significantly associated with current use of CAM (OR, 3.633; 95% CI, 1.567 to 8.424). Lay referral was the most common reason for deciding to use CAM, and only 25% of patients (72/283) discussed CAM with their physicians. CONCLUSION: Patient attitudes toward and confidence in CAM modalities were strongly associated with their CAM experiences, and only a small number of patients had an open discussion about CAM with their physicians. A patient education program for CAM is needed.

Biochemical effects and safety of Gum arabic (Acacia Senegal) supplementation in patients with sickle cell anemia

BACKGROUND: Sickle cell anemia (SCA) is a hereditary chronic hemolytic anemia with several clinical consequences. Intravascular sickling of red blood cells leads to multi-organ dysfunction. Moreover, several biochemical abnormalities have been associated with SCA. Gum arabic (GA) is an edible dried gummy exudate obtained from Acacia Senegal tree. GA showed antioxidant and cytoprotective activities and demonstrated protection against hepatic, renal, and cardiac toxicities in experimental rats. We hypothesized that regular intake of GA improves renal and liver functions in patients with SCA. METHODS: Forty-seven patients (5–42 yr) carrying hemoglobin SS were recruited. The patients received 30 g/day GA for 12 weeks. Blood samples were collected before administering GA and then after 4, 8, and 12 weeks. Liver enzymes, total protein, albumin, electrolytes, urea, creatinine, and uric acid were determined in the serum. The study was approved by the Al Neelain University Institutional Review Board and Research Ethics Committee Ministry of Health. The trial was registered at ClinicalTrials.gov (identifier: NCT02467257). RESULTS: GA significantly decreased direct bilirubin level [statistical significance (P-value)=0.04]. It also significantly decreased serum alanine transaminase level after 4 weeks, which was sustained till the 8th week. GA, however, had no effect on serum aspartate transaminase level. In terms of renal function, GA decreased serum urea level but the effect was not sustained after the first month. CONCLUSION: GA may alter the disease severity in SCA as demonstrated by its ability to decrease direct bilirubin and urea levels in the serum.

Institutional Scientific Review of Cancer Clinical Research Protocols: A Unique Requirement That Affects Activation Timelines.

PURPOSE: The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to institutional review board evaluation is unique among medical specialties. We sought to evaluate the effect of this process on protocol activation timelines. METHODS: We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using the χ2 test, Fisher's exact test, Wilcoxon rank sum test, Kruskal-Wallis test, and logistic regression. RESULTS: A total of 226 trials were analyzed. Of these, 77% were industry sponsored and 23% were investigator initiated. The median time from submission to PRMC approval was 55 days. The length of review was associated with trial phase, timing of approval, and number of committee changes/clarifications requested. The median process time was 35 days for those approved at first decision, 68 days for second decision, and 116 days for third decision ( P < .001). The median process time was 39 days if no changes/clarifications were requested, 64 days for one to three changes/clarifications, and 73 days for four or more changes/clarifications ( P < .001). Requested changes/clarifications had a greater effect on industry-sponsored trials than on investigator-initiated trials. CONCLUSION: NCI-mandated institutional scientific review of oncology clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.

Ethical issues on the "synthetic" phosphoethanolamine clinical trial.

Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho. Preclinical safety studies of syn-phospho were also insufficient to support a trial of this investigational drug in cancer patients. Moreover, the ethical approval decision apparently overlooked two previous findings that suggested a possible enhancement of mammary carcinoma cell proliferation by phosphoethanolamine, and an apparent increase in lung metastases (rat implanted tumor assay) by syn-phospho. The syn-phospho risk-benefit ratio is clearly unfavorable and, thus, this trial in cancer patients does not fulfill a key requirement to make a clinical research ethical. There are also concerns regarding whether the study design is robust enough (scientific validity), and the social value of the trial of syn-phospho in cancer patients is questionable.

Ethical issues on the "synthetic" phosphoethanolamine clinical trial / Questões éticas sobre o ensaio clínico da fosfoetanolamina "sintética"

Summary Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho. Preclinical safety studies of syn-phospho were also insufficient to support a trial of this investigational drug in cancer patients. Moreover, the ethical approval decision apparently overlooked two previous findings that suggested a possible enhancement of mammary carcinoma cell proliferation by phosphoethanolamine, and an apparent increase in lung metastases (rat implanted tumor assay) by syn-phospho. The syn-phospho risk-benefit ratio is clearly unfavorable and, thus, this trial in cancer patients does not fulfill a key requirement to make a clinical research ethical. There are also concerns regarding whether the study design is robust enough (scientific validity), and the social value of the trial of syn-phospho in cancer patients is questionable.

Resumo Não obstante a sua aprovação pela Comissão Nacional de Ética em Pesquisa (Conep) em 19 de abril de 2016, um ensaio da pílula de fosfoetanolamina "sintética" (sin-fosfo) em pacientes com câncer levanta preocupações éticas. Uma análise feita por um laboratório contratado pelo Ministério da Ciência, Tecnologia e Inovação (MCTI) revelou que a sin-fosfo continha grande quantidade de impurezas e não satisfazia os padrões de qualidade farmacêutica exigidos para um medicamento experimental. Os ensaios de citotoxicidade com linhagens de células originárias de tumores humanos e testes in vivo em roedores com tumores xeno-enxertados falharam consistentemente em demonstrar uma potencial atividade anticâncer da sin-fosfo. Os estudos pré-clínicos de segurança da sin-fosfo também foram insuficientes para apoiar a realização de um ensaio desse medicamento experimental em pacientes com câncer. Além disso, a aprovação ética aparentemente desconsiderou dois achados anteriores, sugerindo uma possível exacerbação da proliferação de células de carcinoma de mama pela fosfoetanolamina, e um aparente aumento de metástases pulmonares (ensaio de tumores implantados em ratos) pela sin-fosfo. A relação risco-benefício é claramente desfavorável para a sin-fosfo e, portanto, esse ensaio em pacientes com câncer não atende um requisito essencial para que uma pesquisa clínica seja ética. Há também preocupações quanto ao delineamento do estudo ser suficientemente robusto (validade interna), e o valor social do ensaio da sin-fosfo em pacientes com câncer é questionável.

The Trends in Research on the Health of North Korean Refugees

PURPOSE: This study aims to identify the general characteristics, subjects, and methods of research on the health of North Korean refugees through a systematic literature review. METHODS: A total of 140 studies on health were reviewed using the analytical framework developed by the researchers. RESULTS: The quantitative research comprised 90.7% of the studies, whereas the qualitative research were 7.9% of them. Approximately 81.4% of those reviewed have publication dates spanning 2006 to 2015. Only 13.6% of the studies were conducted with the approval of an institutional review board. The subjects of studies were psycho-social health (151.8%), behavioral health (28.5%), cognitive health (15.0%), physical health (12.2%), integrated health (7.8%), and spiritual health (2.8%). Within the quantitative studies reviewed, the most commonly used study design was survey research (86.0%). The two sampling methods used most often were convenience sampling (53.5%) and snowball sampling (19.4%), and the most commonly used data-collection method were questionnaires (94.6%). As for the qualitative studies, the most commonly used study design was phenomenology. CONCLUSION: The results suggested that the reviewed studies focused on physical health more than psycho-social health, and physiological measurement more than questionnaires. Ethical considerations need to be expanded.