The Human Subjects CITI Online training is divided into two disciplinary categories: Group 1: Biomedical research Investigators and Key Personnel - Basic Course. All HSR modules reflect the revised Common Rule (2018 Requirements). It is the Principal Investigator's responsibility to ensure that the list of personnel in the IRB application is current and those listed as Key Study Personnel maintain current CITI Human Subjects Protection Training. Yes. The case studies in this module illustrate examples of using a risk assessment framework for both social-behavioral-educational and biomedical research. The module also provides detailed information on the procurement, banking, and use of human stem cell lines. Recommended Use: Supplemental ID (Language): 13813 (English), 15949 (Korean) Author(s): Norma Epley, M.S. 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. It stores a true/false value, indicating whether this was the first time Hotjar saw this user. Recommended Use: Required ID (Language): 12 (English), 15936 (Korean), 15889 (Vietnamese) Author(s): Susan Kornetsky, MPH - Children's Hospital, Boston; David G. Forster, JD, MA, CIP - Western IRB; Gary L. Chadwick, PharmD, MPH, CIP - The University of Rochester. It also includes the impact on autonomy, beneficence, and justice that may arise due to research on or with vulnerable individuals or groups. This cookie is set by GDPR Cookie Consent plugin. Provides an overview of the essentials of cultural competence in research. This website uses cookies to improve your experience while you navigate through the website. Defines phase I research as it relates to non-clinical and other phases of research. The purpose of the cookie is to determine if the user's browser supports cookies. This ensures that behavior in subsequent visits to the same site will be attributed to the same user ID. Step-by-Step CITI Instructions for Animal Researchers. Demo a Course Benefits for Organizations Includes resources researchers and their staff members to help identify ethical requirements of their global research partners. Discusses the importance of protecting subject privacy and confidentiality of data, and the implications for population-based surveillance datasets. Defines disasters, emergencies, and conflicts and discusses contemporary disaster management terminology and the unique features of disasters and conflict situations that affect research initiatives. GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials. It concludes with the risks and benefits that are unique to SBR, Recommended Use: Required ID (Language): 4 (English), 15927 (Korean), 1718 (Spanish), 15886 (Vietnamese) Author(s): Deborah Dickstein, MSPH - University of Washington; Celia Walker, MA - Colorado State University (ret. This may impact different aspects of your browsing experience. Identifies routine study designs used to develop the initial safety profile and achieve study objectives in phase I research. This cookie is set by Hotjar. Explore the ethical and policy issues that CRISPR gene editing presents in this engaging webinar. Additional courses that are intended for specific audiences such as institutional/signatory officials, IRB chairs, public health researchers, and Certified IRB Professionals (CIPs) seeking recertification credits are also available. This cookie is used by Google Analytics to understand user interaction with the website. Recommended Use: Supplemental ID (Language): 17358 (English) Author(s): Dex Bilkic, HBSc, MBA - Bayer Inc.; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University. Chan School of Public Health; Barbara Bierer, MD - Multi-Regional Clinical Trials Center of Brigham and Womens Hospital and Harvard (MRCT Center), Vivli, Inc., Harvard Medical School; Joseph Zurba, CISSP, CISA - Harvard Medical School; Tonya Ferraro, MEd - Boston Childrens Hospital; Aaron Kirby, MSc - Harvard Medical School; Anna Suojanen, MPH - Harvard University. 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 current challenges and improvement strategies related to informed consent. We also ensure that Emory-required clinical research training - for coordinators and investigators - is complete before we approve studies. This course offers a comprehensive review of the critical areas associated with IRB and IRB office operations. Case studies are used within the modules to present key concepts. This cookie is set by LinkedIn and used for routing. This is a pattern type cookie set by Google Analytics, where the pattern element on the name contains the unique identity number of the account or website it relates to. HSR courses are comprised of modules that include detailed content, images, supplemental materials (such as, case studies), and a quiz. Recommended Use: Required ID (Language): 6 (English), 15929 (Korean), 1672 (Spanish), 15887 (Vietnamese) Author(s): Jeffrey Botkin, MD, MPH - University of Utah. Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. 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. Covers various technologies and their associated ethical issues and governance approaches. citi training quiz answers effective clinical research management Clinical Research Certification I Blog - CCRPS CCRP Course Blog is one of the top blogs for information on current trends in CRA training, ICH GCP guidelines, and federal regulations. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. Required training for researchers and their study teams if provided via the Collaborative IRB Training Initiative (CITI). Records-based research has its own risks, and researchers who propose to conduct such research must have an understanding of those risks and how to minimize them. Recommended Use: Supplemental ID (Language): 16874 (English) Author(s): Julie Blasingim, BA, MBA, CIP - Elligo Health Research. This webinar reviews how a human research protection program (HRPP) responded to and dealt with the COVID-19 pandemic. It includes a discussion on how to detect UPs and how to report them. Focuses on the role that language plays in developing consent processes and obtaining consent in study populations that do not speak English. CITI - Collaborative Institutional Training Initiative Organizations listed here use "Single Sign On" (SSO) for CITI Program access. The purpose of the cookie is to enable LinkedIn functionalities on the page. Recommended Use: Supplemental ID (Language): 16306 (English) Author(s): Belinda Smith, MS, RD, CCRC - University of Kentucky; Kevin L. Nellis, MS, CIP - Maimonides Medical Center; Ada Sue Selwitz, MA - University of Kentucky. Recommended Use: Supplemental ID (Language): 17638 (English) Author(s): Charles Hennekens, MD, DrPH - Florida Atlantic University; Joanna Drowos, DO, MPH, MBA - Florida Atlantic University. Recommended Use: Required ID (Language): 17464 (English) Author(s): Julie Moore, JD, MS, PA, CIP - University of South Florida; Cristy McGoff, MA, CIP - Harvard University. It also demonstrates how to apply ethical risk-benefit assessments for CEnR, the varying impacts that risks and benefits may have on individual research participants as well as on communities and groups, and strategies for training and educating community members on a research team. Reviews the importance of phase I research on drug development. Presents the framework for informed consent found within the Common Rule (45 CFR 46, Subpart A), including the process and documentation of informed consent. Yes, like all CITI Program educational materials, the modules that make up HSR can be customized to meet the specific needs of your organization. CITI access and instructions Log in to www.citiprogram.org to complete required training. HSR covers the historical development of human subject protections, as well as current regulatory information and ethical issues. This course provides advanced learners a topic-focused course on IRB administration and 4 CE hours for CIP recertification. Basic HSR courses are suitable for all persons involved in research studies involving human subjects (for example, researchers and staff), or who have responsibilities for setting policies and procedures with respect to such research, including Institutional Review Boards (IRBs) and other members of organizational communities where research with human subjects occurs. HSR was developed and reviewed by human subject research experts to help organizations and individuals understand human subjects research protections. This course provides an expansive review of human subjects research topics for biomedical researchers. Describes barriers to participation, the ethical and regulatory mandates for the inclusion of these populations in research, as well as the additional protections that may be used to minimize risk. This cookie is set by Adobe ColdFusion applications. It also discusses protections that need to be afforded to workers/employees. The cookie is a session cookies and is deleted when all the browser windows are closed. It concludes with strategies that researchers can take to reduce the risk of group harms in international research. This includes selecting modules from other CITI Program subjects (for example, Good Clinical Practice, Responsible Conduct of Research, or Information Privacy and Security) when creating a learner group for HSR. This course is designed for individuals new to the investigator role or those seeking a focused, role-based course. Recommended Use: Required ID (Language): 14 (English), 15942 (Korean) Author(s): Reid Cushman, PhD - CITI Program. Designed as an overview and resource for individuals joining an Institutional Review Board (IRB). This module also reviews federal regulations that govern disclosure and management of individual COIs. Provides a foundational training for institutional/signatory officials on their roles and responsibilities as part of an HRPP. Learners will be presented with an overview of the risks associated with and the types of review required for records-based research. Included in this discussion are the types of biomedical studies that utilize SBR techniques, along with the kinds of data collected. It includes discussions on time commitment, liability, the role of the IRB chair, and the levels of review. Discusses the historical exclusion of women of childbearing potential and the special requirements for conducting research involving pregnant women and fetuses. Register with CITI Discusses subjects social and economic disadvantage as a potential vulnerability in research. It includes a discussion of each of the permitted categories for research pursuant to 45 CFR 46, Subpart B, involving pregnant women, human fetuses, and neonates, as well as Institutional Review Board (IRB) review requirements and determinations. Covers IRB considerations for the review of mobile app-based research. DO NOT UPLOAD TRAINING CERTIFICATES AS PART OF THE PROJECT DOCUMENTS. Additional subscription charges may apply. 100% Money Back Guarantee Immediately available after payment Both online and in PDF No strings attached. Presents remote consent considerations and scenarios. Describes approaches to monitoring the emerging results of an ongoing study, the different types of study data that are monitored, and the role and operational procedures of independent monitoring groups and how they relate to other study oversight entities. It discusses different types of IRB review processes, including an overview of the essential issues associated with exempt, expedited, and full (convened) IRB reviews. Describes the roles, responsibilities, and activities of public health systems, as relevant to research. Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. Recommended Use: Supplemental ID (Language): 16657 (English) Author(s): Jeremy Block, PhD, MPP - Icahn School of Medicine at Mount Sinai Baruch College, City University of New York. 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. Recommended Use: Supplemental ID (Language): 1321 (English) Author(s): Andrea Rossing McDowell, MS, MA, PhD - Seattle University. CITI Program offers legacy content (upon request) that reflects the pre-2018 requirements of the Common Rule. Recommended Use: Supplemental ID (Language): 19126 (English) Author(s): Laura Odwazny, JD, MA Bioethics - U.S. Department of Health and Human Services; Elizabeth Buchanan, PhD - University of Wisconsin-Stout. Recommended Use: Supplemental ID (Language): 17392 (English) Author(s): Cindy Gates, JD, RN, CIP - University of Miami. Recommended Use: Supplemental ID (Language): 17254 (English) Author(s): Bartha Maria Knoppers, PhD - McGill University; Man H. Zawati, LLM - McGill University. It begins with a short overview of the constituent parts of the GSD community from a broad perspective, continues with a summary of the legal and social/cultural vulnerabilities faced by members of these groups and describes research considerations for members of these communities, and concludes with a discussion on what IRBs and researchers should do with respect to these populations. Used by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This cookie is set by doubleclick.net. It provides a random-number client security token. General purpose platform session cookies that are used to maintain users' state across page requests. This module provides IRB members and administrators with a framework for assessing the risks of technologies, whether the technology is helping conduct the research or is itself the subject of the research. Recommended Use: Required ID (Language): 9 (English), 15932 (Korean), 1498 (Spanish), 16551 (Vietnamese) Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center. The cookie is a session cookies and is deleted when all the browser windows are closed. The U.S. Food and Drug Administration and the U.S. Department of Health and Human Services human subject protection regulations require institutions to have policies and procedures to ensure prompt reporting of unanticipated problems (UPs) involving risk to subjects or others to the IRB, regulatory agencies, and appropriate institutional officials. Phone: (716) 829-3467. HSR Biomed and SBE courses are offered as Comprehensive and Foundation versions. 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. These courses were written and peer-reviewed by experts. Presents examples of vulnerable groups and identifies ethical considerations when including them in research. These modules were approved by the Council for Certification of IRB Professionals (CCIP) as advanced-level and eligible for CIP CE credit. Describes regulatory requirements for a CAPA system in the biotech industry. Also provides detailed information on the procurement, banking, and use of human stem cell lines human... 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