scholarly journals 4507 Developing and implementing a Principal Investigator (PI) primer to improve the conduct of human research at the University of Minnesota

2020 ◽  
Vol 4 (s1) ◽  
pp. 59-59
Author(s):  
Jessica Wright ◽  
Jennifer Maas ◽  
Megan Hoffman
Keyword(s):  
Clinical Practice ◽  
Research Training ◽  
Good Clinical Practice ◽  
Training Needs ◽  
Principal Investigator ◽  
Learning Objectives ◽  
List Type ◽  
University Of Minnesota ◽  
Human Research ◽  
The University

OBJECTIVES/GOALS: 1.Assess the institutional and individual training needs and gaps in the conduct of human research for PIs at the University of Minnesota.2.Define the training program’s learning objectives.3.Develop and implement an in-person training session that addresses the gaps.METHODS/STUDY POPULATION: Establish a planning committeeIdentify required and optional training that is already available for PIs, then determine gapsUnderstand research training needs based on conversations with departmental and human research protection program leaders.Develop learning objectives and curriculum based on Federal and Local regulations, guidelines, and policies.Establish a feedback loop regarding research compliance with the HRPP, to assess trends and ensure continuous improvement.Evaluate the training program’s participants using confidence and satisfaction measures.RESULTS/ANTICIPATED RESULTS: Developed and piloted a 90-minute in-person training program entitled “PI Primer” with the goals of: Increasing awareness and knowledge of the role and responsibilities of the Principal Investigator (PIs) according to the International Harmonization for Good Clinical Practice (ICH-GCP), Federal Regulations (FDA, DHHS, ect.), and University of Minnesota Policies.Identifying root causes for receiving an FDA 483 (inspection findings).Addressing and preventing common inspection findings (CAPA).Describe individual and institutional conflict of interest (COI), and identify the key steps necessary to manage COIs.DISCUSSION/SIGNIFICANCE OF IMPACT: OHRP’s guidance on the “Responsibilities of Investigators” states that it is the Institution’s responsibility to provide human research training on a wide variety of topics to ensure the ethical conduct of research and protection of participants. PI Primer provides an in-person forum for investigators to build upon required responsible conduct of research and good clinical practice training to be able to apply the role and responsibilities of a PI to their own research. PI Primer also establishes a network of PIs in order to enhance connectivity and shared learning.

scholarly journals 2345 An electronic roadmap to customized human research training plans

2018 ◽  
Vol 2 (S1) ◽  
pp. 51-52
Author(s):  
Jennifer Maas ◽  
Megan Hoffman ◽  
Janet Shanedling ◽  
Jason Kadrmas ◽  
Trung Ngo ◽  
...  
Keyword(s):  
Phase I ◽  
Web Site ◽  
Research Study ◽  
Research Training ◽  
University Of Minnesota ◽  
Human Research ◽  
Human Participants ◽  
Study Type ◽  
The University ◽  
Research Professionals

OBJECTIVES/SPECIFIC AIMS: To respond to the need for a simple tool to answer individual researchers questions: Exactly what training do I need to complete for my study and my role? Where can we go to find a comprehensive record of my research training? METHODS/STUDY POPULATION: Identify the factors that determine what training is required for each role (i.e., PI, coordinator, biostatistician) at the University, their role on the research study, type of funding, population being studied and responsibilities/duties on the research team. Develop an inventory of training required according to federal and local regulations and guidelines. Identify other related factors that ensure ongoing compliance for research professionals (i.e., medical licenses, CVs, immunizations, and credentials). Collaborate with programming professionals to explore and confirm the feasibility of such a Web site. Incorporate formal usability and pilot testing as part of the programming design process. Develop User Guide and Marketing and Launch plan for users and supervisors. Implement phased launch of the site with Google analytics, and evaluate the experience of phase I users. RESULTS/ANTICIPATED RESULTS: Three months user data and evaluation results demonstrated: 149 users created Training Roadmaps on the site. Users were from 67 different department codes, with the Department of Psychiatry the primary user. 20 users responded to a survey three months after launch. Research coordinators were the primary focus for phase I and represented almost half of the users. Survey respondents rated the site ease of use and clarity of the site as its greatest benefit. DISCUSSION/SIGNIFICANCE OF IMPACT: In September 2017, CTSI launched a new web-based training tool exclusively for University of Minnesota clinical research professionals who work with human participants, and their supervisors. The Human Research Training Web site is a free, easy-to-use tool to help identify and maintain the appropriate training, certification, credentials, and immunizations needed to perform University of Minnesota research with human participants. The Web site offers the University’s first systematic way to identify which research training is necessary for each research professional, and a system to track and maintain training compliance. Training records and information from the University of Minnesota’s central databases are securely integrated into this tool. Our Web site tool enhances research compliance. Any given study team member’s training requirements vary based on several criteria such as: role at the University, role on the research study, type of funding, population being studied and responsibilities/duties on the research study. The research training Web site generates required and optional training based on individuals’ responses to these questions. This Web site also links to the training, which decreases error in taking the wrong training. Furthermore, it provides completion data for research training and is a repository for vital study information such as: medical licenses, CVs, and credentials. Supervisors are able to view training and credentials. They are alerted when one of their employee’s licenses or certificates are about to expire. Uses-to-date and evaluation feedback have informed the need for a second phase of Web site enhancements. This site will reside in both the CTSI Web site and the HRPP Web site. A link will be sent to all new University research employees upon hiring. The Human Research Training Web site will likely have applicability to other universities in addition to the University of Minnesota.

scholarly journals 4116 Comprehensive training and support for Research Professionals at the University of Minnesota

2020 ◽  
Vol 4 (s1) ◽  
pp. 58-58
Author(s):  
Jennifer Maas ◽  
Megan Hoffman ◽  
Jessica Wright
Keyword(s):  
Informed Consent ◽  
Training Program ◽  
Research Training ◽  
List Type ◽  
University Of Minnesota ◽  
On Line ◽  
Training And Support ◽  
The University ◽  
Training Modules ◽  
Research Professionals

OBJECTIVES/GOALS: Coordinating research studies is multifaceted and requires a foundational level of research knowledge, skills and abilities in order to contribute to high-quality, ethical research projects that adhere to local and federal regulations as well as Good Clinical Practice. Oftentimes, coordinators who are new to research or new to an institution have trouble navigating the research landscape. Departments within the University of Minnesota have limited resources to devote to developing robust training programs above and beyond protocol or department-specific training. Therefore, UMN’s CTSI created a comprehensive training and support program for research professionals at the University of Minnesota. METHODS/STUDY POPULATION: CTSI employs several strategies to provide a comprehensive training program for the University of Minnesota Research Workforce. The offerings are based on the The Joint Task Force for Clinical Trial Competency (JTF). In addition to training programs, valuable resources, materials, and connections are provided to trainees.An Onboarding process for new coordinators that includes a welcome email upon hire that provides resources as well an opportunity to meet face-to-face to get their questions answered about where to start with research training.Foundations for Research professionals, two week (20 hour) training program, provides a foundational level of knowledge to new coordinators via in-person and online training modules.Informed Consent 1 & 2 provides in-person training on the informed consent including the process, documentation, and ethical issues around consenting vulnerable populations.Over 40 on-line research training modules that coordinators can take at anytime.An active list serv that connects >600 research professionals with training updates and opportunities.Bi-weekly seminar series that provides a forum to share current regulations, best practices, resources, and guidelines pertaining to clinical research at the University.An online training “Roadmap” tool that customizes individual research training plans, and includes an inventory of training available.RESULTS/ANTICIPATED RESULTS: 218 research professionals participated in our Foundations blended training program with 191 completing (88% completion rate) the entire training. A comprehensive assessment based on national competencies is completed by all participants at Baseline and Post training. Baseline scores average at 75% and Post scores average at 82% (7% increase). Satisfaction is measured and participants are overall satisfied with the training, 4 out of 5 on a Likert Scale.353 research professionals have participated in our Informed Consent Session 1 & 2 in-person training. Satisfaction is measured and participants are overall satisfied with the training, 4.5 out of 5 on a Likert Scale.Over 190 research professionals have utilized our research on-line training modules.Training participants have been from 27 different departments across the University.The Clinical Research Professional Development Seminar Series has offered over 87 seminars with 4907 total attendees. These seminars are offered in-person and live stream.DISCUSSION/SIGNIFICANCE OF IMPACT: Establishing a comprehensive training program at the University has streamlined the training that research professionals receive across departments. It also ensures that all coordinators have access to research training, a network of other research professionals, resources, and continuing education opportunities.

Coercive measures in italian inpatient units: results from eunomia study

2011 ◽  
Vol 26 (S2) ◽  
pp. 527-527 ◽  
Author(s):  
V. Del Vecchio ◽  
D. Giacco ◽  
M. Luciano ◽  
L. Del Gaudio ◽  
C. De Rosa ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Physical Restraint ◽  
Positive Symptoms ◽  
List Type ◽  
Coercive Measures ◽  
The University ◽  
Severe Psychopathology ◽  
Inpatient Units ◽  
Italian Sample ◽  
Frequent Reason

IntroductionThe use of coercive measures in clinical practice represents a common, but understudied problem in Europe. In 2002–2005, the European Commission funded the study “European Evaluation of coercion in psychiatry and harmonization of best clinical practice” (EUNOMIA), coordinated by the Department of Psychiatry of the University of Dresden and carried out in 12 European countries.ObjectivesThis study, carried out on the Italian EUNOMIA sample, aims to:1)assess the use of coercive measures in five Italian mental health inpatient units;2)identify the patients’ socio-demographic and clinical characteristics associated with the use of coercive measures;3)investigate the effect of coercive measures on the outcome of the patients.MethodsThe Italian sample included 294 admitted patients. Data were collected on coercive measures (physical restraint, seclusion and forced medication)ResultsAlmost 30% of the patients received coercive measures during their hospitalization; in particular, 22% received forced medication, 9% were restrained or fixed by mechanic devices, 7% were seclused. The most frequent reason for prescribing coercive measures was aggression against others. Patients who received coercive measures were more frequently male, with higher BPRS scores and a worse social functioning. At three months after discharge, they showed higher levels of positive symptoms, and reported more negative opinions on the need of hospital admission and on the appropriateness of psychiatric treatments.ConclusionsIn Italy coercive measures are in most of the cases applied to the patients affected by more severe psychopathology and disability.

scholarly journals Collaborative Autoethnography: An Approach to Deliver Learning Objectives of a Community-Engaged Research Course for Health Science Undergraduates during Pandemic Times

2020 ◽  
Vol 4 (1) ◽  
pp. 72-73
Author(s):  
Angie Mejia ◽  
Keyword(s):  
Qualitative Data ◽  
Health Science ◽  
Learning Objectives ◽  
Learning Objective ◽  
Learning Activities ◽  
Science Majors ◽  
University Of Minnesota ◽  
Engaged Learning ◽  
Community Engaged Research ◽  
The University

In an upper-division, community-engaged course at the University of Minnesota Rochester geared for health science majors, a process was implemented to meet one learning objective in the syllabus (introduction to qualitative data methods) as a response to pandemic-imposed limitations on community-engaged learning activities at UMR. The hope was for one group of students to meet these objectives by engaging in a collaborative autoethnography instead of collecting data in the community.

scholarly journals An algorithm of good clinical practice to reduce intra-hospital 90-day mortality and need for Intensive Care Unit transfer: a new approach for septic patient management

2020 ◽  
Vol 14 (1) ◽  
pp. 14-21 ◽  
Author(s):  
Silvia Spoto ◽  
Sebastiano Costantino ◽  
Marta Fogolari ◽  
Emanuele Valeriani ◽  
Massimo Ciccozzi ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Septic Shock ◽  
Intensive Care ◽  
Clinical Practice ◽  
Length Of Stay ◽  
National Level ◽  
Good Clinical Practice ◽  
Icu Transfer ◽  
Intensive Care Unit Transfer ◽  
The University

Sepsis accounts for 50% of intra-hospital mortality. Septic shock is diagnosed in 2% of patients with half of these needing for Intensive Care Unit (ICU) transfer. An algorithm was applied for mortality, need for intensive care transfer and length of stay decrease. The observational study was performed on 231 consecutive enrolled patients with sepsis or septic shock admitted to the University Campus Bio-Medico of Rome. The algorithm was based on good clinical practice application of antimicrobial stewardship. Data were compared with data from comparable population of National and European surveys. In the study group, the global mortality rate was 26.8% (3.9% was intra-hospital and 23% 90-d mortality), need of ICU transfer was registered in 21.6%, and the median length of stay was 15 days. Globally, intra-hospital and 90-day mortality, were significantly lower than at national level (26.8% vs 63.6%, P<0.0001; 3.9% vs 25%, P<0.0001 and 23% vs 37.5%, P=0.0092). Need for ICU transfer in patients with septic shock was significantly lower than in the English survey (31.9% by vs 80.8% P<0.0001). A significant decrease of intra-hospital, 90-d mortality and need of ICU transfer was achieved.

scholarly journals Understanding Research Development Needs in Capacity Building for NCD Research: The Case of Thailand

2017 ◽  
Author(s):  
N Singha-Dong ◽  
A Bigelow ◽  
P Furspan ◽  
B Rajataramya ◽  
A Villarruel ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Statistical Analysis ◽  
Training Program ◽  
Capacity Building ◽  
Causes Of Death ◽  
Research Training ◽  
Training Needs ◽  
Research Development ◽  
Original Survey ◽  
Significant Support

AbstractChronic non-communicable diseases (NCD) are the most significant causes of death globally. In Thailand, NCDs have increased 10.4% and 11%, respectively, since 2002. Thus, there is a compelling need in Thailand to enhance the capacity for research aimed at improving both NCD prevention and care. A survey was conducted of current multi-disciplinary doctorally prepared faculty (n=115) to determine perceived NCD research training needs. The results of this survey showed that the greatest exposure to NCD was in clinical practice, followed by teaching NCD content, and then research. Few researchers published their findings in journals. All responders reported needing significant support in research design, methods and statistical analysis procedures. These results were used to guide the development of a post-doctoral training program for NCD research in Thailand. After three years of the training program, we found that trainee applicants’ preferences and choices were aligned with the original survey-based planning.

The Effects of Presentation on Noise and Dental Appliances on Speech

1981 ◽  
Vol 24 (1) ◽  
pp. 151-151
Author(s):  
Lillian Glass ◽  
Sharon R. Garber ◽  
T. Michael Speidel ◽  
Gerald M. Siegel ◽  
Edward Miller
Keyword(s):  
Southern California ◽  
University Of Southern California ◽  
University Of Minnesota ◽  
School Of Medicine ◽  
Southern California School ◽  
School Of Dentistry ◽  
The University

An omission in the Table of Contents, December JSHR, has occurred. Lillian Glass, Ph.D., at the University of Southern California School of Medicine and School of Dentistry, was a co-author of the article "The Effects of Presentation on Noise and Dental Appliances on Speech" along with Sharon R. Garber, T. Michael Speidel, Gerald M. Siegel, and Edward Miller of the University of Minnesota, Minneapolis.

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