Listed below are all courses available to University of Minnesota faculty, staff, and students that pertain to training on the conduct of human research.
A SMART Way to Develop Adaptive Intervention Strategies
Group(s): n/a
Description: This course is for research professionals, biostatisticians, and other faculty and clinical professionals who wish to learn about the experimental research design called Sequential Multiple Assignment Randomized Trials (SMART). Learners are introduced to an overview of SMARTS concepts and strategies for designing research trials that provide evidence for selecting and/or improving adaptive interventions used in clinical practice.
Description: Provides researchers an overview of key concepts, IRB policies, standard operating procedures, and checklist developed to ensure these protections for participants with potentially diminished or fluctuating capacity. This course is required for researchers and research personnel that are involved in the assessment of capacity to consent to research for adult research participants.
Association of Clinical Research Professionals (ACRP) Certified Professional (ACRP-CP) Program
Group(s): n/a
Description: ACRP-CP (ACRP Certified Professional) is a new credential formally recognizing professionals involved in all aspects of clinical studies/trials who have demonstrated the knowledge, skills, and abilities to perform ethical and responsible clinical research by passing the standardized ACRP Certified Professional Certification Exam.
Association of Clinical Research Professionals (ACRP) Clinical Research Coordinator Certification
Group(s): n/a
Description: The CCRC credential is awarded to a CRC (clinical research coordinator) who has met eligibility requirements, demonstrated proficiency of specific knowledge and job related skills, and passed the standardized ACRP CRC Certification exam.
The CCRC designation formally recognizes a CRC has met the professional standards set forth by the Academy of Clinical Research Professionals.
Basic Human Subject Protection -- Social / Behavioral or Humanist Research Investigators and Key Personnel
Group(s): n/a
Description: The SBE Basic course provides an introduction to social-behavioral-educational research with a focus on the protection of human subjects. It offers historic and current information on regulatory and ethical issues important to the conduct of research involving human subjects. Case studies are used within the modules to present key concepts.
Description: This course is required annually (once a year) if your job may expose you to bloodborne pathogens and you are required to fulfill the federal OSHA requirement. The topics covered in this training will help you reduce your risk of exposure to bloodborne pathogens in the workplace.
Description: For those of you who wish to be granted card access to the CMRR there are several training requirements that must first be fulfilled. Please visit the following links to the training modules based on the type of access you require. Once you have completed all of the training requirements for your type of access please email a copy of your Personal Training Record and/or Ulearn Transcript, or other documentation citing completion of the training (copy of CPR card/certificate, etc.) along with a completed MR Environment Screening Form (a blank copy will be attached to the completion email you will receive for the CMRR Safety Training) to Michelle Hartwig, the CMRR access coordinator, at mhartwig@umn.edu.
Description: The Clinical Research Professional Development Series is a bi-weekly seminar series for clinical research professionals at the University of Minnesota. Attendees learn about current regulations, best practices, resources, and guidelines pertaining to clinical research at the University, and can network with others. Credit hours are awarded for most seminars. To learn more about the seminars, visit the CTSI's website or email crctrain@umn.edu to be added to the CRC list serv.
Overview:
This bi-weekly professional development and networking series for research
coordinators, nurses, project managers,
regulatory experts, and other staff involved in clinical research focuses on
topics such as current regulations, best practices, resources, and guidelines
pertaining to clinical research at the University of Minnesota.
Who should attend:
Research
coordinators,
nurses, project managers, regulatory experts and other staff involved in
clinical research.
Conflicts of Interest (COI) and Standards Governing Relationships with Business
Group(s): n/a
Description: This short course is about conflicts of interest and the context in which conflicts can arise in a university setting when there is an intersection between an individual's personal financial and business interests and their university-related responsibilities and expertise.
Description: The Essentials for Regulatory Specialists training program is for research professionals that are either new to having a regulatory role within human research or new to the University of Minnesota (<1 year). This program aims to increase knowledge and application of a regulatory specialist role among research professionals at the University of Minnesota.
Description: 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. This blended-style course takes ~25 hours to complete, and covers 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.
Understand and apply the role and essential functions of the research coordinator with a solid understanding of local and federal regulations, and how to operate using Good Clinical Practice.
Who should attend:
Available for newly hired coordinators (1 year or less in role)
Description: This course, developed by the Office for Public Engagement, is a professional development learning journey for community-engaged leaders and learners.
Overview: For more information, please visit the M Engage webpage.
Good Clinical Practice and Human Research Protections for Biomedical Study Teams - Basic Course
Group(s): Foundations for Research Professionals, Onboarding for Research Professionals
Description: Effective July 1, 2017, all biomedical researchers and research staff involved in the conduct of human research must complete Good Clinical Practice (GCP) training regardless of the level of risk or funding source. In order to meet the National Institutes of Health (NIH) policy requiring GCP training and to enhance the compliance with federal requirements for the conduct of human research, the Human Research Protection Program (HRPP) is implementing this new training requirement.
The following changes were made to the CITI GCP course requirements:
* Human research protections modules from the CITI Basic Biomedical Course were merged into a hybrid GCP course, replacing the stand-alone basic course on human research
protections titled, Good Clinical Practice and Human Research Protections for Biomedical Study Teams.
* The new hybrid GCP course replaces the existing stand-alone basic GCP course on human research protections.
* HIPAA and conflict of interest (COI) modules were removed from the course. HRPP will rely on institutional and organizational training to meet these requirements.
* A Cultural Competence in Research module was added, recognizing the importance of cultural awareness in the conduct of research.
* As part of the GCP course, researchers must select two elective topic-based modules.
Description: The University of Minnesota provides training on the proper handling of health information and information security. This training is required by the HIPAA (the Health Insurance Portability & Accountability Act of 1996) and the University Policy on Protected Health Information. This online training module fulfills the University's HIPAA training requirement.
Overview:
HIP023 Administered by: Health Information Privacy and Compliance Office
This is the required course for faculty, staff, students, and volunteers who are required to take the University's HIPAA training. The course consists of narrated interactive scenarios to teach you about the policies and procedures the University has implemented to protect the privacy of health information. The training should take approximately 30 minutes to complete and you must view all content for the completion to be reflected on your transcript.
Overview
HIPAA Training is required on a regular basis by both University Policy and Federal Regulations. This course fulfills that requirement.
Topics
What Information is Protected by HIPAA,
Permissible uses and disclosures of that information,
Consequences for failing to protect that information,
How to report a breach or a violation of University policy or law, and
How to get additional information about HIPAA compliance at the University.
Who should attend
HIPAA Training is required for all faculty, staff, students, and volunteers who work in areas of the University that have access to PHI, or who support areas that have access to PHI.
Description: This training is for University staff and faculty that routinely ship dry ice, exempt patient samples, or category B infectious substances, all of which require training and specific packaging requirements.
This module covers:
* Hazard classification and how to properly identify dangerous goods
* Packaging, marking, and labeling requirements for dry ice shipments
* Packaging, marking, and labeling requirements for exempt patient specimen shipments
* Packaging, marking, and labeling requirements for Category B infectious substances shipments
* Employee training and record retention requirements
* Security awareness
Description: Required information security awareness training for all new employees and individuals in health care. This course was formerly named University Information Security Awareness Training ISA17 and Public Jobs Private Data (PJPD).
Information Security Awareness Securely Working Remotely
Group(s): n/a
Description: Resources and information on working remotely securely. Contains videos on Creating a Cyber Secure Home, Passwords, and Social Engineering. Contains a tip sheet on Top Five Tips to Securely Work from Home.
Information Security Awareness Training (Required)
Group(s): n/a
Description: Your role at the University of Minnesota gives you access to sensitive information that must be protected. Your access to University systems and resources, such as email, makes you an important guardian of University data. This training will help you understand how to protect your own and the University's data, and how to stay safe online.
This course is the new version of PJPD16 and the new version of ISA17. This course was formerly named University Information Security Awareness Training ISA17.
Choose section SE for self-enrollment. Choose Section 2020 for fiscal year 2020 training.
Informed Consent In Human Research Part 1 - Informed Consent: Recruitment through Documentation
Group(s): Foundations for Research Professionals, Informed Consent in Human Research
Description: Recruiting, developing consent forms, ensuring understanding during the consenting process, and documenting informed consent in human research requires an understanding of regulations and guidelines, key concepts regarding human research, and purposeful communication skills. The ability to conduct the informed consent process in an ethical, professional, and caring manner requires expertise in interpersonal interactions, as well. When human research involves engagement of individuals who are not adults, who may not have full capacity to understand research terminology, who might be vulnerable, or who do not speak our native language, additional knowledge and skill-building is useful to ensure the ethical and safe treatment of those human research participants.
Informed Consent in Human Research Part 2 - Informed Consent with Vulnerable Populations
Group(s): Informed Consent in Human Research
Description: The second session of the Informed Consent in Human Research course focuses on applying those skills to informed consent with vulnerable populations. The pre-work module (Informed Consent with Vulnerable Populations: Regulations and Policies) as well as the second workshop focus on informed consent with three types of vulnerable populations in research:
* Children
* Adults with absent, diminished, or fluctuating capacity to consent
* Other vulnerable populations (for example, pregnant women, prisoners, individuals for whom English is not a first language).
The Informed Consent with Vulnerable Populations: Applications Workshop provides an interactive opportunity for research professionals to practice applying regulations and policies and informed consent process skills that are applicable to their research with vulnerable populations. In addition, it is intended to immerse them in the challenges and collaborative problem-solving that reflect the reality of research with vulnerable populations. The workshop is two hours long.
Part 2 is comprised of the following components:
Pre-work 3: Ethical Recruitment in Special Populations (online module)
Part 2: In-Person Workshop
Overview:
The goal of the Informed Consent in Human Research course is for research investigators, coordinators and staff to be able to:
Confidently, ethically, and humanely carry out all tasks appropriate to their roles within the research team in the informed consent process for regular and special populations of research participants.
Within this hybrid course, learners will review and practice applying informed consent federal requirements, ICH GCP principles, Minnesota policies, and University of Minnesota guidelines pertinent to informed consent in human research.
The course is comprised of the following components and formats:
Pre-work 3: Informed Consent Guidelines for Research with Special Populations (online module)
Part 2: Facilitated Workshop (2-hour, in-person session)
Online pre-work modules provide interactive overviews of regulations, guidelines, and key concepts. Each concludes with a short learning assessment.
The two workshop sessions are intended for "hands-on" skill-building practice and sharing of participants' experience in both large- and small-group activities.
Outcomes:
Pre-work Module 3
Demonstrate an understanding of regulations and guidelines pertaining to recruitment, the informed consent process, and documentation for studies with vulnerable populations, individuals with diminished and/or fluctuating decision-making capacity, and for other special research populations and circumstances
Part 2
Correctly and appropriately conduct the consent process throughout a research study, with attention to protection of vulnerable populations and/or individuals with diminished or fluctuating decision-making capacity
Consider the diversity of topic, locus, and culture of each research study and its participants, and while maintaining consistent ethical standards adapt the informed consent process in a culturally and ethically competent manner
Reflect upon and generate solutions to real-world challenges and grey areas that investigators and research teams encounter in the informed consent process, focusing on positive results for human participants and maintenance of study goals
Explain methods to evaluate and ensure that the consent process has been understand by and has been beneficial to research participants
Topics:
Pre-work Module 3
Regulations and guidelines for informed consent of special populations and in special circumstances
Part 2
Informed consent of special populations and in special circumstances
Managing informed consent challenges
Evaluating and ensuring an ethical and high quality consent process
Who should attend:
University of Minnesota
Research coordinators
Research staff
Faculty/investigators
K-RO1 Transition to Independence Program
Group(s): Scholarship Programs
Description: The K-RO1 Transition to Independence Program is available to Assistant Professors (in rank less than or equal to 7 years) conducting clinical or translational research and aims to place investigators further on the path to be competitive for RO1 awards.
Description: The program is designed to develop the next generation of translational investigators through a structured training program with a mentored multidisciplinary translational research emphasis.
The KL2 is a three-year program that trains junior investigators to be competitive for NIH independent K- or R01 awards.
Description: In-person and online training from CTSI and its partners are designed to help University of Minnesota faculty members improve their research mentorship skills.
Description: Non-Fairview Employed Research Staff (NERS), in compliance with the Joint Commission's requirements and Fairview policies, must complete the NERS application process to obtain approval for conducting research tasks in Fairview facilities (including accessing electronic health records), unless otherwise noted as exempt from this policy.
Description: OnCore is a clinical trial management system (CTMS) that provides research teams a single, comprehensive system for managing a trial throughout its life cycle. Per Academic Health Center (AHC) requirements, the following types of studies must be entered into OnCore:
Studies under Health and Biological/Medical IRB Application.
Studies under Social and Behavioral Sciences IRB Application (faculty and student).
Studies under Medical Record Chart Review IRB Application with individual subject study specific consent forms.
Any other research studies using Fairview or University of Minnesota Physicians services OR billing to research participant or third party (i.e., insurance). Studies in this category also require individual subject and visit tracking in OnCore.
To gain access to OnCore, please complete and submit the access request form (z.umn.edu/oncoreaccess). Upon receipt of this form, links to appropriate training for your role will be sent.
Description: This course provides a basic introduction to OnCore financial functionality and tracking earned revenue using REACT.
Once this course is complete, a more extensive in-person OnCore financials/REACT training can be scheduled by contacting oncore@umn.edu.
Questions about this training? Please contact oncore@umn.edu.
Description: This online, interactive course will provide you with a common, realistic example of a successful recruitment and retention process from the Research Professional perspective. Upon completing this course you will be able to begin developing successful recruitment plans for clinical trials.
Description: The Pathways to Research Program (PReP) provides undergraduate students with knowledge, skills, and experience in translational science and health equity research.
PReP provides an opportunity for students from populations underrepresented in research to begin or advance their research career. Opportunities for travel funds to participate in national and international scientific meetings are awarded on a competitive basis.
Description: The Pre-K Discovery Scholars Program aims to place URM underrepresented in health-related sciences junior faculty on the path to be competitive for NIH K awards.
Description: This training course is a 90-minute, instructor-led session. It combines lecture-style components with case study review and interactive small-group discussion. This course is designed for current or soon-to-be Principal Investigators (PIs) for human research studies, enrollment is limited to the University of Minnesota's policy requirements for who can serve in this role.
The goal of the PI Primer training program is for Principal Investigators to be able to: Understand and apply the role and responsibilities of the PI , gain an understanding of federal regulations & local policies that apply to human research, and learn how to conduct their study according to Good Clinical Practice (GCP).
CE Credits:
Credits Offered: 1.5
American Medical Association (AMA)
The University of Minnesota, Interprofessional Continuing Education designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credits¿¿¿. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Other Healthcare Professionals
Other healthcare professionals who participate in this CE activity may submit their statement of participation to their appropriate accrediting organizations or state boards for consideration of credit. The participant is responsible for determining whether this activity meets the requirements for acceptable continuing education.
Description: This training includes a series of training videos. You will need to watch each of the videos, and complete the corresponding quiz that follows the videos. In total, this should take you 30-40 minutes. For licensing reasons, only U of MN faculty, staff and students will be granted access to create REDCap projects.
Description: This guidebook will help walk you through how to create forms, how to submit to the IRB and how to capture signatures. Please note that REDCap's eConsent is only compliant for 21 CFR Part 11 if you follow the instructions in the guidebook.
Description: Research Ethics provides a brief history and an introduction to ethical issues that pertain to research with human participants. This short module will help you to anticipate and prepare for points during clinical research at which ethical challenges may surface.
Research Ethics Training -- NSF, USDA-NIFA, NIH requirements
Group(s): n/a
Description: The University provides mandatory and supplemental training in ethics and regulatory compliance for any students, faculty or staff who are conducting or supporting research at the University.
Description: New faculty members, postdoctoral fellows, and others serving as principal investigators (PIs) are required to complete online RCR Core Curriculum education and possibly additional courses, depending on their research activities. Graduate students planning to function as PIs should consult with the relevant graduate program office for RCR requirements.
Society of Clinical Research Associates (SOCRA) Certification Program
Group(s): n/a
Description: The Society of Clinical Research Associates (SOCRA) has developed an International Certification Program in order to create an internationally-accepted standard of knowledge, education, and experience by which CRPs will be recognized as Certified Clinical Research Professionals (CCRP¿¿s) in the clinical research community. The standards upon which this certification program is based have been set forth by this organization to promote recognition and continuing excellence in the ethical conduct of clinical trials.
Description: The Translational Research Development Program (TRDP) aims to provide an opportunity for early stage investigators to gain significant experience with clinical and translational research.
The program is available to predoctoral trainees, postdoctoral trainees and medical fellows.
Description: [30 minutes, webinar] In this course, participants will learn the basics of joining and participating in online meetings using Zoom, an online video conferencing system. Participants can either sign up to attend a live webinar, or view a pre-recorded webinar delivered by Zoom.
Description: [1 hour 15 minutes, webinar] In this course, participants will learn the skills needed to host a successful webinar through Zoom, an online video conferencing system. Participants can either sign up to attend a live webinar, or view a pre-recorded webinar delivered by Zoom.
Description: [15 minutes, self-paced online] In this brief overview, participants will learn best practices around using Zoom with Protected Health Information. Health Care Component (HCC) members must complete this training to get access to Zoom.
This website was developed by the following University of Minnesota team:
Designers
Megan Hoffman, MA, Clinical and Translational Science Institute
Jennifer Maas, RN, Clinical and Translational Science Institute
Janet Shanedling, PhD, Clinical and Translational Science Institute
Analyst
Trung Ngo, Clinical and Translational Science Institute
Developers
Jason Kadrmas, Health Sciences Technology - Information Systems
Jacob Johnson, Health Sciences Technology - Information Systems
