Covers various technologies and their associated ethical issues and governance approaches. This course provides an expansive review of human subjects research topics for social-behavioral-educational researchers. 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. Recommended Use: Supplemental ID (Language): 17640 (English) Author(s): Charles Hennekens, MD, DrPH - Florida Atlantic University; Joanna Drowos, DO, MPH, MBA - Florida Atlantic University. Examines the ethical issues of using large datasets (big data) in human subjects research, including informed consent, risk of harm, anonymity, data security, privacy, and confidentiality. It discusses information for both researchers and IRBs in order to begin the process of addressing underrepresentation of older adults in research, while at the same time providing critical information to consider when conducting research with this group. Language Availability: English, Korean, Spanish, French, Suggested Audiences: The module is revised throughout the year as needed. It also includes the impact on autonomy, beneficence, and justice that may arise due to research on or with vulnerable individuals or groups. CITI Program Advanced-Level Modules/Courses Eligible for CIP Recertification Credit. This cookie is set by LinkedIn and used for routing. Describes FDAs regulatory controls for common marketing approval pathways for the classes of medical devices, and explains the Code of Federal Regulations that pertain to medical device approval in the U.S. 888.529.5929 / 9:00 a.m. to 7:00 p.m. / U.S. Eastern Time / Monday Friday, We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. This cookie is set to enable shopping cart details on the site and to pass the data to our learning management system. This course provides an expansive review of human subjects research topics for biomedical researchers. The module also provides detailed information on the procurement, banking, and use of human stem cell lines. The purpose of the cookie is to determine if the user's browser supports cookies. These cookies track visitors across websites and collect information to provide customized ads. Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. 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. Organizations LEARN MORE Provides an overview of the essentials of cultural competence in research. 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. Summarizes the application of ethical principles to public health research, identifies additional ethical challenges unique to public health research, and provides a six-step framework for application to public health problems. The Collaborative Institutional Training Initiative (CITI Program) is dedicated to serving the training needs of colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies, as they foster integrity and professional advancement of their learners. Identifies the research tools and methods in disaster management utilized by public health and medical providers to enhance communication between research teams and disaster responders. Necessary cookies are absolutely essential for the website to function properly. Provides guidelines for conducting disaster and conflict research. This content is designed to introduce and onboard new Institutional Review Board (IRB) community members (also referred to as unaffiliated members). This cookies is installed by Google Universal Analytics to throttle the request rate to limit the colllection of data on high traffic sites. Describes the benefits and challenges of a CBPR approach and strategies for engaging community partners in the research 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. Included in this discussion are the types of biomedical studies that utilize SBR techniques, along with the kinds of data collected. Social & Behavioral Research Investigators: Choose this group to satisfy CITI training requirements for Investigators and staff involved primarily in Social and Behavioral research with human subjects. HSR covers the historical development of human subject protections, as well as current regulatory information and ethical issues. This biomed-focused course provides foundational training covering the major topical areas in human subjects protections. Reviews regulatory requirements for obtaining informed consent in public health research. Recommended Use: Required ID (Language): 16680 (English), 15930 (Korean), 19566 (French), 19563 (Spanish) Author(s): Jeremy Block, PhD, MPP - Icahn School of Medicine at Mount Sinai; Bruce Gordon, MD - The University of Nebraska Medical Center. Prior to the general compliance date (21 January 2019), CITI Program modules reflected the pre-2018 requirements version of the Common Rule. Explores remuneration in research, regulatory requirements regarding remuneration to research subjects, how to distinguish between remuneration and reimbursement, and strategies to reduce the potential for undue influence. Prior to the general compliance date (21 January 2019), CITI Program modules reflected the pre-2018 requirements version of the Common Rule. This ensures that behavior in subsequent visits to the same site will be attributed to the same user ID. 888.529.5929 / 9:00 a.m. to 7:00 p.m. / U.S. Eastern Time / Monday Friday, Additional Courses for Independent Learners, We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. Explores the concept of race in clinical research and important ethical and regulatory questions. The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". 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. Foundations courses provide foundational training covering major topic areas in human subjects protections. It provides best practices in creating an accurate, robust submission for IRB review and conducting responsible, ethical research. The training modules required will depend on the research being conducted. It helps in identifying the visitor device on their revisit. For more information on how to ensure CME credit availability for learners at your organization, contactSupport. CITI training must be renewed once every five (5) years. We also use third-party cookies that help us analyze and understand how you use this website. Email: camlesse@buffalo.edu. This cookie is used by vimeo to collect tracking information. This cookie is used to identify the client. The use of such technologies enables researchers to electronically capture research data that could help to control data reliability, ensure data integrity, perform remote monitoring, and comply with the requirements for regulatory documentation. This cookie is set by Adobe ColdFusion applications. The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It was prepared for new U.S. IRB community members; however, it serves as a resource for community/unaffiliated/lay members of other review bodies (such as Independent Ethics Committees) that are generally charged with evaluating research protocols according to local ethical standards and regulations. This content begins with an introduction to the types and complexity of genetic research. This cookie is native to PHP applications. All CITI Program modules affected by revisions to the Common Rule were revised bythe general compliance date (21 January 2019). 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. This course covers the core norms, principles, regulations, and rules governing the practice of research. It is written in lay language and designed to be used by subjects and their family members. Recommended Use: Supplemental ID (Language): 17357 (English) Author(s): Dex Bilkic, HBSc, MBA - Bayer Inc.; JoAnn Pfeiffer, DrSC, RAC, CCRA - Arizona State University. It is designed for new members, but may also be useful for any IRB member who continues to serve on an IRB. All investigators, faculty advisors, and research staff are required to complete the appropriate CITI online training module on Human Subjects' Protection within 48 months before the application date, and to submit the certificate of completion to the IRB with their application (please see below for guidance on completing the appropriate CITI Analytical cookies are used to understand how visitors interact with the website. This seriesalso include refresher course optionsfor both the Biomed and SBE tracks. Required training for researchers and their study teams if provided via the Collaborative IRB Training Initiative (CITI). Presents examples of vulnerable groups and identifies ethical considerations when including them in research. They register anonymous statistical data on for example how many times the video is displayed and what settings are used for playback.No sensitive data is collected unless you log in to your google account, in that case your choices are linked with your account, for example if you click like on a video. Recommended Use: Supplemental ID (Language): 16994 (English) Author(s): Mary Anne McDonald, DrPH, MA - Duke University; Claude-Alix Jacob, MPH - Cambridge Health Alliance; Barbara Bierer, MD - Brigham and Women's Hospital and Harvard Medical School Harvard Catalyst | The Harvard Clinical and Translational Science Center; Jennifer Opp - Brigham and Women's Hospital; Sabune Winkler, JD - Harvard Catalyst | The Harvard Clinical and Translational Science Center. Language Availability: English, Korean, Spanish, Suggested Audiences: Human Subject Protection Staff, Institutional Review Boards (IRBs), Institutional/Signatory Officials, IRB Administrators and Staff, IRB Chairs, Research Team Members, Researchers, Students, Organizational Subscription Price: Included with Human Subjects Research series, available as part of an organizational subscription package or for $1,000 as an add-on to current subscriptions.Independent Learner Price: $249 per person. 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. Describes strategies for enhancing understanding of research among diverse populations and communities during the consent process. The cookie is set by Wix website building platform on Wix website. This cookie is installed by Google Analytics. Excerpted from: The Department of Energy Guidebook Creating an Ethical Framework for Studies that Involve the Worker Community and "Workers as Research Subjects: A Vulnerable Population", Susan L. Rose, PhD and Charles E. Pietri, BA from J. Occup Environ Med. Provides training and insight to researchers, administrators, and institutional review boards (IRBs) regarding added risks and challenges of conducting research with individuals who are engaged in illegal activities or who have undocumented status. CITI is a leading provider of research education training . Recommended Use: Supplemental ID (Language): 16658 (English) Author(s): Bruce Gordon, MD - The University of Nebraska Medical Center. This cookie is used by vimeo to collect tracking information. Refresher courses should be taken in a cycle specified by the organization (for example, Refresher Stage 1: 3 years after completion; Refresher Stage 2: 6 years after completion). The purpose of this cookie is to synchronize the ID across many different Microsoft domains to enable user tracking. This cookie is used to identify the client. Barriers to subject recruitment and special challenges for researchers and institutional review boards (IRBs) in assessing risk of harm and potential benefits in end of life research are also examined. CITI - Collaborative Institutional Training Initiative Organizations listed here use "Single Sign On" (SSO) for CITI Program access. Provides basic information and tools related to IRBs, including an overview of regulatory definitions and requirements, and discusses strategies on how to become a well-informed IRB member. Provides a basic overview of the U.S. Food and Drug (FDA) regulations and responsibilities regarding HUDs. Reviews the diversity, nature, and characteristics of biobanks and associated databases.