scholarly journals 4186 Single IRB and the CTSI: Liaison Model for the IRB Reliance Process

2020 ◽  
Vol 4 (s1) ◽  
pp. 115-115
Author(s):  
Christine Sego Caldwell ◽  
Amy J. Trullinger ◽  
Scott Denne

OBJECTIVES/GOALS: Navigating the NIH Single IRB Policy has been challenging for investigators, study teams, and Human Research Protection Programs (HRPP). In response, the Indiana Clinical and Translational Sciences Institute (CTSI) created an innovative Single IRB Project Manager role (sIRB PM), uniquely placed within the Indiana CTSI. METHODS/STUDY POPULATION: The Single IRB Project Manager role was created in 2018 by the Indiana CTSI in response to the NIH Single IRB Policy for Multi-Site Research. The role of the sIRB PM is to serve as a liaison between the Indiana University HRPP, lead site, coordinating center, and participating sites when Indiana University serves as the Single IRB. This model has proven useful to both the IRB and lead site, notably in the following ways: At study start-up, the sIRB PM can handle complicated communications among sites and the IRB at the same time the lead site is responsible for many other administrative tasks related to start-up. By absorbing the workload of IRB approval for multiple sites, the sIRB PM provides the lead site more capacity to handle other essential tasks.The sIRB PM translates new terminology and facilitates processes that are new for sites.RESULTS/ANTICIPATED RESULTS: Early assessment of this program is predominantly positive. The sIRB PM currently supports 24 external sites. In an NIA-funded 13 site study, all sites were added within 9 months of initial IRB approval of the protocol. This role fills a gap that benefits: IRB staff by allowing them to fulfill their duties of screening and review while leaving some of the reliance organization to the sIRBPM.Lead PI by allowing them to focus on conducting the research instead of the many administrative tasks required for single IRB review.Participating sites by having a liaison to enter their amendments and reportable events into an otherwise closed IRB software system.All parties by having the sIRB PM manage document organization, storage, and distribution study-wide.DISCUSSION/SIGNIFICANCE OF IMPACT: The CTSI sIRB PM role effectively shifts administrative work caused by the sIRB mandate by merging research coordinator experience with regulatory experience while building upon an existing strong relationship with the HRPP. Future focus is on process education, standardizing pricing structure, and ensuring sufficient budget support in grants.

2020 ◽  
Author(s):  
Lucian Kaack ◽  
Matthias Weber ◽  
Emilie Isasa ◽  
Zohreh Karimi ◽  
Shan Li ◽  
...  

SummaryEmbolism spreading in angiosperm xylem occurs via mesoporous pit membranes between vessels. Here, we investigate how the size of pore constrictions in pit membranes is related to pit membrane thickness and embolism resistance.In three models, pit membranes are modelled as multiple layers to investigate how pit membrane thickness and the number of intervessel pits per vessel determine pore constriction sizes, the probability of encountering large pores, and air-seeding. These estimations were complemented by measurements of pit membrane thickness, embolism resistance, and number of intervessel pits per vessel (n = 31, 31, and 20 species, respectively).Constriction sizes in pores decreased with increasing pit membrane thickness, which agreed with the measured relationship between pit membrane thickness and embolism resistance. The number of pits per vessel affected constriction size and embolism resistance much less than pit membrane thickness. A strong relationship between estimated air-seeding pressures and measured embolism resistance was observed.Pore constrictions provide a mechanistic explanation why pit membrane thickness determines embolism resistance, and suggest that hydraulic safety can be uncoupled from hydraulic efficiency. Although embolism spreading remains puzzling and encompasses more than pore constriction sizes, angiosperms are unlikely to have leaky pit membranes, which enables tensile transport of water.


Author(s):  
Roberto Simeone

AbstractA simplified model applied to COVID-19 cases detected and officially published by the italian government [1], seems to fit quite well the time evolution of the disease in Italy during the period feb-24th - may-19th 2020.The hypothesis behind the model is based on the fact that in the lockdown period the infection cannot be transmitted due to social isolation and, more generally, due to the strong protection measures in place during the observation period. In this case a compartment model is used and the interactions between the different compartments are simplified. The sample of cases detected is intended as a set of individuals susceptible to infection which, after being exposed and undergoing the infection, were isolated (‘treated’) in such a way they can no longer spread the infection.The values obtained are to be considered indicative.The same model has been applied both to the data relating to Italy and to some regions of Italy (Lombardia, Piemonte, Lazio, Campania, Calabria, Sicilia, Sardegna), generally finding a good response and indicatively interesting values (see chap. 5).The only tuning parameter is the ‘incubation period’ τ that, together with the calculated growth rate κ of the exponential curve used to approximate the early stage data, in this modelization, are in strong relationship with the compartments’ transfer rates.In particular ℛ0 and the numerical value of κ (dimensionless) in this model are linked by the relation: ℛ0 = 1/κ2Revision HistoryRevision # 1Errata corrige in section 1 (Introduction): the equations that summarize the relationship between the parameters were wrong. This revised version contains the correct equations at page 2.The synchronization criteria is updated. No need to use a threshold different to the one used to determine the growth coefficient. The results are now updated with the synchronization point near to the 20% of the maximum value of the cases detected per day: Modifications in section 4 (Model results for Italy). It is appropriate to use an exponential function instead of a logistic function to find the growth rate in the initial phase. Section 4 and the results are now updated.Some non-substantial corrections in the descriptive part.Revision # 2Errata corrige in the system differential equation 6: in the the derivative of S were reported a wrong additional term N. Now the equation 6 is correct.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Michelle M. Vine ◽  
Jocelyn W. Jarvis ◽  
Eunice Chong ◽  
Rachel E. Laxer ◽  
Adam Ladak ◽  
...  

Abstract Background In Ontario Canada, the Healthy Kids Community Challenge (HKCC) is a program intended to reduce the prevalence and prevent childhood overweight and obesity through community-based initiatives to improve health behaviours. Guided by the RE-AIM framework and Durlak and DuPre’s Ecological Framework for Understanding Effective Implementation, the evaluation focused on two objectives: 1) to describe the organization of the program at the community level; and, 2) to identify opportunities for improvement through an early assessment of factors contributing to implementation. Methods Participants (n = 320) – members of the HKCC local steering committee, including the local project manager – completed a cross-sectional survey using SurveyMonkey and descriptive statistics were calculated. A sample (20%) of qualitative open-ended responses was thematically analyzed. Results Results indicated strong respondent agreement that the HKCC enhanced individual knowledge of access to health-promoting programs (88.3%) and messaging regarding healthy behaviours for healthy kids, with less for its effectiveness in reducing weight (53.1%). There was a high-level of adherence to HKCC social marketing messages and overall program structure, with few Local Project Manager reports of adaptations to theme one (9.2%) and theme two messages (15.4%). Fewer Local Project Managers (50%) reported the existence of private partnerships. While most respondents agreed they had the appropriate information to complete mandatory reporting, the usefulness of the HKCC online networking platform was in question (only 47% of Local Project Managers agreed that it was useful). Results reveal sufficient funding from the province to support program implementation, with a moderate level of local political commitment (63% of respondents). Conclusions Results indicate that the HKCC was considered beneficial for enhancing access to health promoting programs, could be feasibly implemented with adherence to centrally-developed social marketing messages, and was amendable to local adaptation. Despite this, few private partnerships were reported. Going forward, there is opportunity to further evaluate factors contributing to HKCC program implementation, particularly as it relates to buy-in from intervention providers, and strategies for forming private sector partnerships to support long-term program sustainability.


2019 ◽  
Vol 9 (3) ◽  
pp. 1-27
Author(s):  
Mario Andres Manzi ◽  
Erika Johanna Caicedo ◽  
Daniel Alberto Cardona

Study level/applicability This case is appropriate for entrepreneurship courses where the topics are generation of business model, business model innovation and shared value. It can be used at undergraduate and graduate levels. Case overview This case addresses the challenges that Mejor en Bici (in English: Best by Bike), a start-up that promotes mobility by bicycle, had to face from 2010 to 2015 at the level of its business model and generation of shared value. The case narrates the main achievements and obstacles in this path of entrepreneurship and how, through this process, a business model should be designed that allows strategic decisions to be taken to achieve sustained growth. In addition, this case examines how from early stages in entrepreneurship it is possible to generate shared value as a strategic component. Expected learning outcomes Identify and present the value proposition of Mejor en Bici to understand where a business model starts. Design and evaluate the business model of Mejor en Bici from an innovation perspective. Apply the concept of shared value in the generation of a business proposal for Mejor en Bici based on their business model. Supplementary materials Osterwalder, A., & Pigneur, Y. (2010). Business model generation: a handbook for visionaries, game changers and challengers. John Wiley & Sons. Pages: 14-44; 56-108; 244-262. Porter, M. E. and Kramer, M. R. (2011). The big idea: Creating shared value. Harvard Business Review, 89, 1-18. Amit, R. and Zott, C. (2012). Creating value through business model innovation. MIT Sloan Management Review, 53, 40-59. Social implications The social implication of this case lies in the motivation and guidance that potential entrepreneurs and students who analyze this case will receive. They can learn from a successful but complex experience how to start a business in a sustainable and responsible way. Subject code CSS 3: Entrepreneurship


2020 ◽  
Vol 11 (2) ◽  
pp. 14-26
Author(s):  
Yudha Irawan Kusdinar
Keyword(s):  

ABSTRAKPenelitian ini mengemukakan tentang bagaimana pola komunikasi organisasi darikaryawan di PT. Exaditama Teknologi Kreativa melalu media komunikasi “Slack”.Terdapat tujuan dari penelitian ini untuk mengetahui bagaimana pola komunikasidari pimpinan PT. Exaditama Teknologi Kreativa kepada bawahanya melalui mediakomunikasi “Slack”. Dalam penelitian ini peneliti menggunakan metode penelitiankualitatif dengan pendekatan studi kasus. Teknik pengumpulan data yangdilakukan dengan cara observasi, wawancara dan dokumentasi. Informan daripenelitian ini terdiri dari dua informan kunci dan dua informan tambahan, duainforman kunci ini merupakan dua orang pimpinan atau “Project Manager” dandua orang tambahan ini merupakan karyawan dari PT. Exaditama TeknologiKreativa. Hasil dari penelitian ini menjelaskan bahwa pimpinan PT. ExaditamaTeknologi Kreativa menggunakan pola komunikasi roda dengan jaringan atau alurkomunikasi Downward dan Upward, artinya pimpinan dari perusahaan PT.Exaditama Teknologi Kreativa menjadi pusat dari segala pesan, perintah danarahan terhadap karyawan atau staffnya dengan berkomunikasi melalui mediakomunikasi “Slack”. Pendapat untuk penelitian ini, lebih diutamakan kembalidiskusi baik secara langsung ataupun menggunakan media teknologi komunikasi,sebab jika peningkatan komunikasi didalam organisasi sangat tinggi, makaproduktifitas dan efektifitas yang terjadi dalam organisasi akan berjalan denganbaik.Kata Kunci: Pola Komunikasi, Organisasi, Media Teknologi Komunikasi


2021 ◽  
Author(s):  
David Chartash ◽  
John T Finnell

AbstractIntroductionThe nature of practice in clinical and medical informatics has changed since the last recommended incorporation of the field into undergraduate medical education in 1998. The Regenstrief Institute and Indiana University have been offering a clerkship in clinical and medical informatics since 2008, and post-graduate medical education since the early 1970s.MethodsDrawing on this existing educational program and the expertise at the institute, we developed a clerkship elective to support medical students in learning about the subspecialty in practice, as well as the state of the art in research. Student evaluation of the clerkship and satisfaction with curricular design elements was measured.ResultsA modular inverted classroom curriculum was designed and implemented using learning management systems and instructional technology available at Indiana University. Students were satisfied with the clerkship, and explicitly understood how curricular design contributed to their understanding of material. The curriculum was found flexible for multiple levels of learners, particularly those with advanced mastery of technical skills.DiscussionThis curriculum, and its packaged content to be imported into common learning management systems, offers a state of the art introduction to clinical and medical informatics for medical students, which supports student success and preferences during their clerkship elective period.Educational ObjectivesBy the end of this activity, learners will be able to:’Articulate the scope of clinical and medical informatics within medicineDescribe a problem pertinent to their clinical interests, and how a solution can be supported by health information technology, as well as more generally be assessed using clinical outcome measuresDemonstrate a knowledge of terminologies and standards found in clinical medicine, as well how they integrate to define and describe diseaseDemonstrate an understanding of clinical decision making and the evaluation of discrete choice problems


2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Torstein Nesheim

PurposeThe author aims to explore and provide new insights on the resource manager role in a matrix-like project-based organization. What is the content of this role and the challenges as perceived by role incumbents?Design/methodology/approachThis a case study of a large project department in an industrial organization. The main source of data is interviews with 12 respondents.FindingsThe author describes and analyzes several mechanisms related to the key tasks of resource allocation, competence development and performance appraisals. Key challenges are the magnitude of stakeholders, especially the relationship with the project manager. To cope with these challenges, resource managers engage in extensive networking and recurrent dialog with the project manager. In addition, system knowledge and a sociable personality are perceived to enhance coping.Research limitations/implicationsOne case. 12 interviews were conducted at one point in time. The resource manager is a specific type of line manager, complementing a task (project) manager. Hypotheses and research questions based on empirical findings are identified.Practical implicationsOrganizational structure and the content of managerial roles are important in order to understand HRM challenges and activities in project-based organizations. Networking, relation maintenance and system knowledge and sociable and creative mindsets are key success factors for resource managers in large matrix-like project-based organizations.Originality/valueOne of the few in-depth studies of the resource manager in a project-based organization. A novel organizational context for the study of roles in HRM. A number of suggestions for further research.


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