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.

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 2353

2017 ◽  
Vol 1 (S1) ◽  
pp. 48-48
Author(s):  
Megan Hoffman ◽  
Jennifer Maas ◽  
Lisa Johnson
Keyword(s):  
Clinical Research ◽  
Training Program ◽  
Task Force ◽  
Baseline Assessment ◽  
University Of Minnesota ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
The University ◽  
Post Assessment ◽  
Research Professionals

OBJECTIVES/SPECIFIC AIMS: To increase knowledge and application of clinical research coordinator competencies among Research Professionals at the University of Minnesota. METHODS/STUDY POPULATION: The UMN’s CTSI developed and piloted a Foundations for Research Professionals training program comprised of: a baseline assessment, 7 online modules, 4 in-person training sessions, video and reading assignments and a post assessment, which totaled 30–35 hours of training and covered the following topics: preparing for a study, study management, participant recruitment and engagement, assessing capacity to consent and the informed consent process. This course also provides valuable resources and connections to online references and materials. The competencies for this program were based on work of the Joint Task Force for Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: 30 clinical research professionals completed the pilot program and averaged an increase of 6.5% from baseline assessment to post assessment. Participants were asked to rate their confidence on a variety of role-based competencies at the time of preassessments and postassessments. Trends show an increase in confidence for all competency areas after completion of the training program. DISCUSSION/SIGNIFICANCE OF IMPACT: Developing a workforce of competent research professionals is integral to improve the efficiency, quality, and ethics of research. The Foundations for Research Professionals training program increased knowledge of clinical research coordinator competencies. We will assess impact on application of the competencies 6 months after completion of the program. Our next steps include offering the training program as a 2-week session on an ongoing basis for new coordinators at the University of Minnesota.

From HTS to Phase I: The Institute for Therapeutics Discovery and Development at the University of Minnesota

2014 ◽  
Vol 17 (3) ◽  
pp. 231-240 ◽  
Author(s):  
Peter Dosa ◽  
Gunda Georg ◽  
Vadim Gurvich ◽  
Jon Hawkinson ◽  
Michael Walters ◽  
...  
Keyword(s):  
Phase I ◽  
University Of Minnesota ◽  
The University

Pedagogic Tailoring of a Human Research Ethics Training for Community-Engaged Research With Latinos

2020 ◽  
pp. 152483992095412
Author(s):  
Patricia I. Documet ◽  
William Louth ◽  
Ivonne Smith-Tapia ◽  
Maria Catrina Jaime ◽  
Elizabeth Miller ◽  
...  
Keyword(s):  
Research Ethics ◽  
Research Study ◽  
Health Workers ◽  
Research Training ◽  
Ethics Training ◽  
Pedagogical Tools ◽  
Human Research ◽  
Community Engaged Research ◽  
Human Research Ethics ◽  
Ethics Research

Because of the increase in community-engaged research, several human research ethics trainings for laypeople have been developed. We aim to (1) describe the pedagogical tailoring of a research ethics training for laypeople for a research study where promotores—community health workers—delivered an intervention to increase health care access and promote healthy behaviors among Latinos and (2) present results of the application of the training after 4 months in the field. We tailored a previously developed training to Latino community members implementing a research study. Key modifications included (1) translation (2) use of pedagogical tools, such as cooperative learning, role-plays, and inclusion of cultural preferences. One novel addition was to use dialogues that the trainees enacted and then discussed. We evaluated the training with a posttraining survey with eight community liaisons and 13 promotores implementing the intervention, and a focus group with eight promotores, 4 months after working in the field. Trainees said they felt confident obtaining informed consent, felt the dialogues were realistic and helped them remember what they learned, and wanted more feedback from trainers on their performance. Promotores demonstrated the application of ethical principles beyond the training by discussing the possibility of advertising broadly in social media (justice), the risks and benefits of providing community resources to participants (beneficence), and the university’s role in legitimizing their position as promotores (respect). We conclude that a pedagogically tailored ethics research training for laypeople can be successful and that dialogues to be enacted need to be explored further.

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.

Integrating Legacy Laboratory Information Systems into a Client-Server World: The University of Minnesota Clinical Workstation (CWS) Project

1995 ◽  
Vol 34 (03) ◽  
pp. 289-296 ◽  
Author(s):  
B. H. Sielaff ◽  
D. P. Connelly ◽  
K. E. Willard
Keyword(s):  
Information Systems ◽  
Clinical Decision ◽  
Database Management System ◽  
University Of Minnesota ◽  
Client Server ◽  
Clinical Workstation ◽  
Future Hospital ◽  
The Cost ◽  
The University ◽  
Laboratory Information Systems

Abstract:The development of an innovative clinical decision-support project such as the University of Minnesota’s Clinical Workstation initiative mandates the use of modern client-server network architectures. Preexisting conventional laboratory information systems (LIS) cannot be quickly replaced with client-server equivalents because of the cost and relative unavailability of such systems. Thus, embedding strategies that effectively integrate legacy information systems are needed. Our strategy led to the adoption of a multi-layered connection architecture that provides a data feed from our existing LIS to a new network-based relational database management system. By careful design, we maximize the use of open standards in our layered connection structure to provide data, requisition, or event messaging in several formats. Each layer is optimized to provide needed services to existing hospital clients and is well positioned to support future hospital network clients.

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