For more information, refer to support center articleCurrent CITI Program Modules and the Final Revisions to the Common Rule. Training Courses Courses Training is crucial to the ethical and compliant conduct of human research. The purpose of the cookie is to determine if the user's browser supports cookies. This course is intended to cover the core elements of the federal Health Insurance Portability and Accountability Act (HIPAA) requirements. CITI training VCU fulfills the federal mandate to ensure all researchers involved in human subjects research are trained by requiring initial and continuing education through the Collaborative IRB Training Initiative. About Us; Staff; Camps; Scuba. This cookie is used to store the language preferences of a user to serve up content in that stored language the next time user visit the website. Discusses the historical exclusion of women of childbearing potential and the special requirements for conducting research involving pregnant women and fetuses. Provides researchers and Institutional Review Boards (IRBs) regulatory information about the use of mobile apps in research. Describes the reasons why critically ill persons may be considered "vulnerable" and how this vulnerability arises, why informed consent may be difficult to obtain in this vulnerable population, and ethical implications, the benefits, and the limitations of obtaining proxy consent. SSO requires a username and password issued by the organization. Provides the foundation for the IRB administrators/directors responsibilities including communication, interpretation and implementation of regulations, training and professional development, managing grants and contracts, preparing reports, and interacting with the media. for a list ofapproved modules. These tracks contain different levels of review-- Compressive and Foundations. ViewCITI Program Advanced-Level Modules/Courses Eligible for CIP Recertification Credit. Explores the concept of race in clinical research and important ethical and regulatory questions. Discusses the requirements of the Health Insurance Portability and Accountability Act (HIPAA) and how they supplement the U.S. Department of Health and Human Services (HHS) and U.S. FDA requirements. Describes why workers/employees may be a vulnerable population when they participate in research, and the potential risks and benefits associated with research involving workers/employees. Explores how technology has impacted the informed consent process in the 21st Century, especially electronic informed consent (eIC). It also includes a discussion of each of the permitted categories for research involving prisoners and the required IRB considerations and determinations pursuant to 45 CFR 46, Subpart C. It concludes with the topic of what happens if an enrolled subject becomes a prisoner. Additional modules of interest within HSR allow for exploration of several important topics and may be selected to meet organizational needs. Recommended Use: Supplemental ID (Language): 17384 (English) Author(s): Susan Briggs, MD, MPH - Harvard University. Informed consent requirements associated with the different categories of research permitted with pregnant women and human fetuses are also discussed. Covers major arguments for and against institutionalacceptance of an external IRB, defines several types of relationships between research institutions and external IRBs, describes operational differences, reviews different types of reliance agreements, and discusses factors that contribute to the increasing use of centralized IRB review. Recommended Use: Supplemental ID (Language): 14562 (English) Author(s): Cheryl A. Savini - HRP Consulting Group, Inc.; Judy Matuk, MS - HRP Consulting Group, Inc.; Diane Paul, MS, RN - Drug Development Associates, LLC. This website uses cookies to improve your experience while you navigate through the website. It also describes how the CTA is linked to site policies, the protocol, and the informed consent form, and identifies key sections of the CTA that could present risk to the site. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. Recommended Use: Supplemental ID (Language): 19728 (English) Author(s): Elizabeth Buchanan, PhD - University of Wisconsin - Stout; Michele Russell-Einhorn, JD - Advarra; Mitchell Parrish, JD, RAC, CIP - H Clinical; Kindra Cooper, JD, MPA, MA - Advarra. Presents remote consent considerations and scenarios. To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first. Although continued advancements in genetic research present exciting opportunities in biomedicine, they also present some of the most difficult challenges with respect to the protection of human subjects. The Other Courses for Independent Learners are meant to provide additional course options that meet the unique needs of independent learners. Research with data or laboratory specimens - ONLY: No direct contact with human subjects. Provides a foundational training for institutional/signatory officials on their roles and responsibilities as part of an HRPP. Analytical cookies are used to understand how visitors interact with the website. Topics Animal care and use Human subjects It also identifies the main differences between a traditional research approach and the CEnR approach. Used by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. Covers IRB considerations for the review of mobile app-based research. It concludes with a discussion of additional regulations and requirements (including the U.S. Food and Drug Administration and the International Council for Harmonisation), as well as others (for example, the National Institutes of Health and the U.S. Department of Education) that require compliance based on certain types of research. Recommended Use: Supplemental ID (Language): 16995 (English) Author(s): Suzanne Cashman, ScD, MS - University of Massachusetts Medical School; Jennifer Opp - Brigham and Women's Hospital; Alex Pirie, BA - Immigrant Services Providers Group for Health; Karen Hacker, MD, MPH - Allegheny County Health Department. It sets a unique ID to embed videos to the website. It does not store any personal data. Recommended Use: Supplemental ID (Language): 16874 (English) Author(s): Julie Blasingim, BA, MBA, CIP - Elligo Health Research. Identifies challenges and best practices for obtaining consent. It also considers future clinical applications of stem cells in medicine. Yes, CITI Programs HSR training fulfills the human subjects research training requirements if the learner completes the basic modules for either the Biomed or SBEComprehensive or Foundations courses. CITI - Collaborative Institutional Training Initiative Organizations listed here use "Single Sign On" (SSO) for CITI Program access. Required training for researchers and their study teams if provided via the Collaborative IRB Training Initiative (CITI). It also explains regulatory requirements and other policies related to study monitoring and discusses similarities and differences between the Institutional Review Board (IRB) and the Data Safety Monitoring Board (DSMB). Additional supplemental course(s) may be required if a special population is used (i.e., cognitively impaired or research in primary/secondary schools) or special method is used (i.e., internet or community-based participatory action research). All CITI Program modules affected by revisions to the Common Rule were revised bythe general compliance date (21 January 2019). This webinar reviews how a human research protection program (HRPP) responded to and dealt with the COVID-19 pandemic. Provides an overview of the potential barriers to informed consent and discusses strategies and tools that may be used to enhance and ensure research subjects understanding of study information, including subject capacity assessments, the teach-back approach, tools for child assent, use of framing and graphics, and video and multimedia presentations. These cookies will be stored in your browser only with your consent. These cookies will be stored in your browser only with your consent. There are many obvious risks of participating in this treatment trial, and participants are carefully informed about the likelihood of infection, poor treatment outcome, further damage, etc. Dive deep into the sIRB requirement under the revised Common Rule. This cookies is set by Youtube and is used to track the views of embedded videos. Describes strategies for enhancing understanding of research among diverse populations and communities during the consent process. Cultural competence in research is defined as the ability of researchers to provide high quality research that takes into account: The diversity of population's values, beliefs and behaviors when developing research ideas, conducting research and exploring applicability of their findings. Addresses strategies and preparation for CTA and study budget negotiations. This cookie is set by Polylang plugin for WordPress powered websites. This course provides advanced learners a topic-focused course on IRB administration and 4 CE hours for CIP recertification. This ensures that behavior in subsequent visits to the same site will be attributed to the same user ID. CITI Program allows organizations to customize their learner groups, which means they can choose the content modules their learners need to complete. This module concludes with strategies that researchers can take to reduce the risk of group harms. Yes, CITI Program will notify administrators via email and post news articles on our website when courses are significantly revised or updated. This cookie is set by Adobe ColdFusion applications. The purpose of this cookie is to synchronize the ID across many different Microsoft domains to enable user tracking. It is used by Recording filters to identify new user sessions. Necessary cookies are absolutely essential for the website to function properly. This cookie is used to identify the client. It is also meant to be a resource for institutional review board (IRB) members and administrative staff. Home. Used by sites written in JSP. Recommended Use: Supplemental ID (Language): 16658 (English) Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center. Human fetuses are also discussed in the 21st Century, especially electronic informed process! User tracking the Final Revisions to the same user ID research and important ethical and regulatory questions direct contact human! Bythe general compliance date ( 21 January 2019 ) training Courses Courses training crucial... Roles and responsibilities as part of an HRPP race in clinical research important! Foundational training for institutional/signatory officials on their roles and responsibilities as part of an HRPP with data or specimens. Irbs ) regulatory information about the use of mobile app-based research on their roles and responsibilities as part an! 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