scholarly journals Scientific Review Committees as part of institutional review of human participant research: Initial implementation at institutions with Clinical and Translational Science Awards

2020 ◽  
Vol 4 (2) ◽  
pp. 115-124
Author(s):  
Harry P. Selker ◽  
Lisa C. Welch ◽  
Elizabeth Patchen-Fowler ◽  
Janis L. Breeze ◽  
Norma Terrin ◽  
...  

AbstractIntroduction:Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs).Methods:SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations.Results:Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3 weeks. For the 60% under review after 3 weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures.Conclusions:The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.

2011 ◽  
Vol 20 (1) ◽  
pp. 115-129 ◽  
Author(s):  
J. DEBORAH SHILOFF ◽  
BRYAN MAGWOOD ◽  
KRISZTINA L. MALISZA

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB).


1995 ◽  
Vol 6 (5) ◽  
pp. 318-319 ◽  
Author(s):  
John Colombo

Recently, Psychological Science published a series of articles on the interplay of ethics and scientific quality in psychological research (Parkinson, 1994, Pomerantz, 1994, Rosenthal, 1994, Sears, 1994) In the first of these, Rosenthal (1994) argued that the ethical and scientific quality of such research are in fact inextricably linked His case was logically tethered to a cost/utility ratio analysis of research Because all research carries with it some expenditure of resources (“cost”), the conduct of research possessing little scientific merit (and thus, presumably, little “utility”) cannot be justified


2021 ◽  
pp. 016264342198997
Author(s):  
Sojung Jung ◽  
Ciara Ousley ◽  
David McNaughton ◽  
Pamela Wolfe

In this meta-analytic review, we investigated the effects of technology supports on the acquisition of shopping skills for students with intellectual and developmental disabilities (IDD) between the ages of 5 and 24. Nineteen single-case experimental research studies, presented in 15 research articles, met the current study’s inclusion criteria and the What Works Clearinghouse (WWC) standards. An analysis of potential moderators was conducted, and we calculated effect sizes using Tau-U to examine the impact of age, diagnosis, and type of technology on the reported outcomes for the 56 participants. The results from the included studies provide evidence that a wide range of technology interventions had a positive impact on shopping performance. These positive effects were seen for individuals across a wide range of ages and disability types, and for a wide variety of shopping skills. The strongest effect sizes were observed for technologies that provided visual supports rather than just auditory support. We provide an interpretation of the findings, implications of the results, and recommended areas for future research.


2021 ◽  
Vol 13 (2) ◽  
pp. 579
Author(s):  
Caroline Reimann ◽  
Fernando Carvalho ◽  
Marcelo Duarte

The present investigation aims study the sustainability of the business model of the Portuguese SMEs operating in the B2B International market analyzing the influence of dynamic marketing capabilities and adaptive marketing capabilities in their international marketing performance. It will also analyze the moderating effects of Competitive Intensity within this international scenario. A quantitative study was developed, using a questionnaire as a research method. In total, 335 valid responses were collected from Portuguese SMEs in June 2020. To test the hypotheses, multiple hierarchical regressions were performed. As for the analyzes involving Competitive Intensity environments, namely low and high intensity, dummies were developed to evaluate the different effects produced by the capacities in the International Marketing Performance. This study shows the positive impact of the dynamic marketing capabilities and adaptive marketing capabilities on the international marketing performance of the surveyed companies, essentially from the product development management, supply chain management, vigilant market learning and open marketing. when in a low competitive intensity environment only dynamic marketing capabilities had a positive effect on performance, but in a high, competitive, intensity environment both dynamic marketing capabilities and adaptive marketing capabilities showed positive effects in relation to performance. This study innovates by bringing international marketing, through two marketing capacities, from the perspective of SMEs that perform B2B activities.


Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 1019
Author(s):  
Barbara Frączek ◽  
Aleksandra Pięta ◽  
Adrian Burda ◽  
Paulina Mazur-Kurach ◽  
Florentyna Tyrała

The aim of this meta-analysis was to review the impact of a Paleolithic diet (PD) on selected health indicators (body composition, lipid profile, blood pressure, and carbohydrate metabolism) in the short and long term of nutrition intervention in healthy and unhealthy adults. A systematic review of randomized controlled trials of 21 full-text original human studies was conducted. Both the PD and a variety of healthy diets (control diets (CDs)) caused reduction in anthropometric parameters, both in the short and long term. For many indicators, such as weight (body mass (BM)), body mass index (BMI), and waist circumference (WC), impact was stronger and especially found in the short term. All diets caused a decrease in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG), albeit the impact of PD was stronger. Among long-term studies, only PD cased a decline in TC and LDL-C. Impact on blood pressure was observed mainly in the short term. PD caused a decrease in fasting plasma (fP) glucose, fP insulin, and homeostasis model assessment of insulin resistance (HOMA-IR) and glycated hemoglobin (HbA1c) in the short run, contrary to CD. In the long term, only PD caused a decrease in fP glucose and fP insulin. Lower positive impact of PD on performance was observed in the group without exercise. Positive effects of the PD on health and the lack of experiments among professional athletes require longer-term interventions to determine the effect of the Paleo diet on athletic performance.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 192-193
Author(s):  
Rinat Cohen ◽  
Gal Maydan ◽  
Shai Brill ◽  
Jiska Cohen-Mansfield

Abstract Family caregivers (FCs) of institutionalized noncommunicative older persons reported multiple unmet communication needs focusing on the need to receive reliable and regular updates on the patient’s condition. We have developed a mobile app for improving communication between FCs and healthcare professionals (HPs), based on 152 interviews with FCs and 13 discussion groups with HPs from four Israeli geriatric facilities. Both parties participated in app planning, tailoring it to their needs and abilities. App use implementation encountered major obstacles including the bureaucratic process concerning signing contracts between the university and software development firms, which hindered the process for a full year; data security department required disproportionate security levels that interfered with user experience and delayed the development process; the study’s definition varied across different ethics/Helsinki committees (Institutional Review Boards; IRBs), which led to different demands, e.g., insurance for medical clinical trials although no drugs or medical device were involved; lack of cooperation by mid-level staff members despite the institutional adoption of the app project; low utilization by HPs resulted in FCs not receiving timely responses. Despite these and other obstacles, we tested app use for 15 months in one facility in a pre-post-design with intervention and control groups, and we have since begun testing it in another facility. FCs who had used the app had positive feedback and wished to continue using it. App use optimization requires implementation planning, assimilating changes in each facility’s work procedures and HP’s engagement and motivation and thus depends on institutional procedures and politics.


2019 ◽  
Vol 26 (7) ◽  
pp. 1607-1625
Author(s):  
Anita Gaile ◽  
Ilona Baumane-Vitolina ◽  
Erika Sumilo ◽  
Daina Skiltere ◽  
Ricardo Martin Flores

Purpose The purpose of this paper is to determine the differences in the values and behaviours of employees and entrepreneurs and to develop guidelines for employers to foster entrepreneurial thinking in their organisations. Design/methodology/approach To determine individual behaviours, the authors used the career adaptability scale developed by Savickas and Porfelli (2012), complemented with the statements regarding relationships in the workplace and reward, designed by Gattiker and Larwood (1986). The individual values were evaluated by Schwartz’s individual value framework. The career success of individuals was defined by income level and job satisfaction. Data from a sample of 473 respondents were analysed using structural equation modelling. Findings This paper reveals that there are differences in the behaviours and the values of employees and entrepreneurs. Employees are more concerned with relationships at the workplace, rewards and confidence, whereas entrepreneurs focus solely on relationships. Self-direction value has a direct positive impact. Universalism, conformism, achievement, stimulation and safety have indirect positive effects on career success for employees. There is no specific individual value driving career success for entrepreneurs. Originality/value This paper follows the recent trends in organisational culture development whereby organisations seek to incorporate the entrepreneurial mindset at all levels of the organisation. Until now, there has been scarce empirical evidence on the differences between entrepreneurial and employee values. This research provides evidence that the value gap between these two distinct groups is considerable enough to question the ability of the average employee to adopt the entrepreneurial behaviour required by modern organisations.


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