About
This collection of short videos covers multiple topics related to the Human Research Protection Program in order to provide you with quick and relevant information.
IRB Pro - Information for IRB Members
Video duration: 6 min.
In this video, IRB Members will learn about how to access IRB Pro, how to navigate to find documents, and how to view, select, upload and make corrections to your Reviewer Checklist.
IRB Pro - Information for Reader Viewer Access
Video duration: 8 min.
In this video, those with Reader View Access will learn about how to access IRB Pro, how to navigate to find documents, and how to interpret a document's status.
IRB Pro - Information for Study Tam Members
In this video, Study Team Members will learn about how to access IRB Pro, how to navigate the Study Team home page, how to find your studies and related documents, and how to interpret a document's status. Additionally, this video covers notifications and naming conventions.
Additional Protections for Prisoners in Research
Video duration: 12 min.
In this video, you will learn about policies and procedures used by the IRB-HSR regarding the review of studies involving prisoners.
Consenting Research Participants who do not Read, Speak or Understand English
Video duration: 8 min.
In this video, you will learn about best practices for obtaining and documenting informed consent for non-English speaking research participants.
Video duration: 8 min.
In this video, you will learn about the IRB's continuing review process at UVA, including how to avoid common mistakes.
Comparative Effectiveness Research
Video duration: 5 min.
In this video, you will learn the definition of comparative effectiveness research (CER) and how to evaluate and document the risks and benefits.
Video duration: 10 min.
In this video, you will learn about Data Protection terminology and waivers of HIPAA Authorization.
Video duration: 14 min.
In this video, you will learn about best practices for following the Data Security Plan and Privacy Plan of your study.
Information for Researchers Leaving UVA
Video duration: 5 min.
In this video, researchers leaving UVA will learn steps to take prior to departure, including what to do if you have projects to be transferred, retained at UVA, or terminated. Additionally, the video covers what to do if you are a sub-investigator on a project.
Informed Consent Process for Clinical Research
Video duration: 9 min.
In this video, you will learn that informed consent is a process - not just a signature on a page. This video covers basic concepts and steps of the informed consent process.
Modifying IRB-HSR Approved Protocols
Video duration: 11 min.
In this video, you will learn about the process for modifying IRB-approved protocols. Four types of protocol modification are covered as well as tips for a quick approval.
Recruitment for Clinical Research & the HIPAA Privacy Rule
Video duration: 10 min.
In this video, you will learn about advertising and recruitment for clinical research and how HIPAA impacts the recruitment process.
Reporting to the IRB Part 1: Serious Adverse Events and Unanticipated Problems
Video duration: 19 min.
In this video, you will learn definitions and reporting procedures for serious adverse events and unanticipated problems.
Reporting to the IRB Part 2: Protocol Violations, Noncompliance, and Enrollment Exceptions
Video duration: 12 min.
In this video, you will learn definitions and reporting procedures protocol protocol violations, issues of serious and/or continuing noncompliance, and enrollment exceptions.
Reporting to the IRB Part 3: Data Breaches
Video duration: 8 min.
In this video, you will learn definitions and reporting procedures for data breaches.
Single IRB Review for Multi-Site Studies
Video duration: 32 min.
In this video, you will learn common terminology as well as a study team's responsibility and the steps for submitting to the IRB-HSR for the following situations: 1) When UVA is relying on a Non-UVA IRB, and 2) When UVA IRB-HSR is serving as a Reviewing Single IRB for a multisite study.
Use of Consent and Assent Forms to Enroll Children in Health Sciences Research
Video duration: 14 min.
In this video, you will learn about the issues, challenges, and processes you should be aware of if enrolling children into Health Sciences Research protocols.
Use of Electronic Informed Consent
Video duration: 9 min.
In this video, you will learn about the use of Electronic Informed Consent, including the benefits and challenges, the overall process for obtaining electronic informed consent, and an overview of DocuSign and REDCap.
Writing a Clinical Research Protocol
Video duration: 13 min.
In this video, residents in the School of Medicine will benefit by learning how to write a clinical research protocol.
Writing Consent Forms for Clinical Research
Video duration: 11 min.
In this video, you will learn some tips directly from the IRB for writing better consent forms. It includes information about how you can write more clearly and effectively and provides before and after examples.
Video duration: 6 min.
In this video, you will learn about the PAM Program, including how to prepare for a PAM Review.
Video duration: 13 min.
In this video, you will learn important definitions of source documentation, why it is important, and how to avoid common mistakes.
Clinical Researchers' Roles and Responsibilities
Video duration: 14 min.
In this video, you will learn the roles and responsibilities of Principal Investigators, Study Coordinators, and Sub-Investigators of clinical research at UVA.
Video duration: 13 min.
In this video, you will learn about Good Clinical Practice, including a definition of Good Clinical Practice as well as guidelines for Investigators and information about protocol and amendments, Investigator's Brochure (IB), and essential documents.
Video duration: 12 min.
In this video, you will learn about the the importance of the protocol review process and the items to consider as you review a new protocol.
Criteria for Review and Approval of Research
Video duration: 14 min.
In this video, you will learn about criteria for review and approval of research involving human subjects. You will learn about important concepts such as risk minimization, reasonable balance of risks and benefits, equitable selection, informed consent requirements, data safety monitoring, protection of privacy, and populations requiring additional protections.
Video duration: 6 min
In this video, you will learn about continuation reviews, your role in the review process, questions to ask yourself, and things to look out for.
Video duration: 6 min.
In this video, you will learn what a modification is and when one might be required, what the role of the IRB is during a modification, what the role of the reviewer is.
Adverse Events and Unanticipated Problems
Video duration: 8 min.
In this video, you will learn what an adverse event or unanticipated problem is and how initial and ongoing reviews help meet the goal of protecting the safety and welfare of the subjects who participate in research.
Video duration: 11 min.
In this video, you will learn about in vitro devices (IVDs), how to use IVDs in clinical trials, significant risk devices, and FDA guidance on using IVDs in drug trials.
Video duration: 3 min.
In this video, you will learn about the basics of the Institutional Review Board as an entity, study documents, the history of why IRB review requirements were put in place, and the reason for two different IRB offices at UVA.
Video duration: 5 min.
In this video, you will learn about the term "Verbal Consent" and see some examples of when the requirement for a signature on a consent form can be waived. The video also provides recommendations for how the study team should document verbal consent.
Secondary Data Use in Research
Video duration: 4 min.
In this video, you will learn about the term "Secondary Data" and when using secondary data (sometimes called archival data) for a planned project may be considered Human Subject Research.
Human Subject Research Determination
Video duration: 5 min.
In this video, Investigators will learn how to determine if they are planning a project that may be considered Human Subject Research. The Institutional Review Board (IRB) must review and approve human subject research studies prior to the start of any study activities.
Tracking Study Participants - How to Create and Maintain a Subject Log for Your Research Study
Video duration: 6 min.
In this video, researchers at the University of Virginia will learn how to create and maintain a subject log as part of tracking study participants.
Writing an Informed Consent Form
Video duration: 6 min.
In this video, you will learn about the requirements that should be included when you write an informed consent form for a research study. The video also covers some basic writing tips.
The Consent Process in 5 Phases
Video duration: 4 min.
In this video, you will learn about the purpose of consent, what the researcher's responsibility is, 5-phased process that can help to break it down.
iProtocol: Using the Board Reviewer Checklist
Video duration: 1 min.
In this video, IRB-SBS Board Reviewers will learn how to open and complete the Board Reviewer Checklist.