Human Subject Research/IRB Trainings

All research team members engaged in human subject research activities are required to complete online training through the Collaborative IRB Training Initiative (CITI). This training is comprised of 13-14 (depending on the focus) required trainings and at least 2 elective modules. These can be completed at one's own pace. Please see our CITI webpage for more information about the required training.

Learning outcomes for this training:

• Understanding of the underlying regulations and ethical principles of human subjects research
• Knowledge of human subject protections with a focus on either biomedical research or social, behavioral and educational research
• Gaining required certification for UO approval to conduct human subject research activities

Link to CITI

This video is an introduction to human subject research and outlines topics that researchers will need when planning or conducting human subject research activities.

Learning outcomes for this training:

• The purpose of an Institutional Review Board (IRB) and Research Compliance Services' (RCS) role supporting human subject research
• What counts as "human subject research" and how to submit the required forms to RCS needed to secure an Exempt determination or IRB approval
• Familiarity with the review process and researcher responsibilities after an Exempt determination or IRB approval is issued
• Familiarity with resources, guides, and forms available, such as those in the Guidance Library and the Forms and Applications page

Conducting Research with Human Subjects

Researchers wishing to conduct research with human subjects must submit a study application through the Research Administration Portal (RAP). This video from Huron - the creator of the RAP - guides researchers through this submission process from the perspective of the researcher, or Principle Investigator (PI).

Learning outcomes for this training:

• Initiating a study submission for IRB review and approval, or an Exempt determination
• Navigating the study smart form
• Finalizing AND submitting a study to RCS (note, this video does NOT cover studies that involve multiple institutions, also known as multi-site studies)

Additional guidance is available in the Human Subjects Research Guidance Library.

Huron Video

This video from the US Department of Health and Human Services Office for Human Research Protections provides an overview of the regulatory requirements associated with human subject research.

Learning outcomes for this training:

• Understanding when research is subject to the federal human subject research protection regulations (sometimes referred to as the "Common Rule")
• Changes made during 2018 to the Common Rule

NOTE: Individual institutions, including the UO, may apply the regulatory requirements differently and/or have additional institutional requirements beyond what is minimally required. Check with RCS regarding specific policies and procedures related to the regulatory requirements covered in this video.

OHRP "When does the common rule apply" Video

In this session, representatives from the US Department of Health and Human Services Office for Human Research Protections discuss what goes into a meaningful informed consent process. Practical examples illustrate how to discern meaningful information for potential participants, and how to present information simply in consent documents and materials to ensure consent processes fulfill their goal of enabling potential participants to make informed decisions about whether to participate in the research.

Learning outcomes for this training:

• Understanding of what is needed to develop informed consent materials for a study
• Considerations to best protect and inform research participants

NOTE: Individual institutions, including the UO, may apply the regulatory requirements differently and/or have additional institutional requirements beyond what is minimally required. Check with RCS regarding specific policies and procedures related to the regulatory requirements covered in this video.

OHRP "Simplifying informed consent" Video

This webinar from the US Department of Health and Human Services Office for Human Research Protections discusses the concept of institutional engagement in human subjects research. It explains how to determine whether an institution is considered "engaged" in human subjects research, and therefore subject to the federal human subject research protection regulations. 

Learning outcomes for this training:

• Understanding when an institution (UO or another institution collaborating in research) is engaged in human subject research
• Defining employees and agents of an institution
• Introduction to Federalwide Assurance (FWA)

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Additionally, individual institutions, including the UO, may apply the regulatory requirements differently and/or have additional institutional requirements beyond what is minimally required. Check with RCS regarding specific policies and procedures related to the regulatory requirements covered in this video.

OHRP "Institutional engagement in human subjects research" Video

This video is an introductory training session highlighting useful features of the IRB submission software called the Research Administration Portal (RAP). We also provide a basic tour of the IRB RAP module from the researcher's perspective.

Learning outcomes for this training:

• Learn how to navigate the RAP system, including how to find your existing studies, how to create a new study, how to communicate using the RAP, and how to submit.
• Hear tips and tricks for using the RAP effectively

RAP 101- Basics Video

The University of Oregon offers online Good Clinical Practices (GCP) training through the Collaborative Institutional Training Initiative (CITI). CITI offers high-quality, peer-reviewed, web-based, research education materials to enhance the integrity and professionalism of investigators and staff conducting research.

GCP content is suitable for research teams involved in clinical trials of drugs, biologics, devices, and social and behavioral research.

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) and GCP FDA Refresher are suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.
• GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) and GCP ICH Refresher are suitable for individuals involved in clinical trials of drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum.
• GCP for Clinical Investigations of Devices and GCP Device Refresher are most appropriate for organizations or individuals who desire a more international-focused GCP curriculum and a more device-focused program. These device courses cover FDA regulation as well as International Organization for Standardization Guidelines ISO 14155:2011.
• GCP – Social and Behavioral Research Best Practices for Clinical Research introduces GCP principles and discusses how they apply to clinical trials using behavioral interventions and social science research, and is designed to help social science researchers meet the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in GCP.

Link to CITI

This video starts with a basic overview of the human research protection framework used at the University of Oregon with some context about who RCS and the IRB are and some of the ethical principles and regulations we all need to navigate. We then focus on what a research plan is, when it is required, how to find resources and other tips for a smooth IRB review process. The latter half of the presentation includes a deep dive on the current research plan guidance and key points to consider while developing one. Pair this video with the Research Plan Guidance for maximum effectiveness.

Learning outcomes for this training:

• Discern the difference between Research Compliance Services (RCS) and the Institutional Review Board (IRB)
• Understand what a research plan is, when it is required, and how to find and use the research plan guidance
• Learn how to interpret the research plan guidance as it relates to your human subjects research so you can develop a clear and complete research plan for review.

How to write a research plan video

This session offers a strategic overview of how Artificial Intelligence (AI) intersects with Human Subjects Research (HSR). After establishing a baseline understanding of key AI terminology, the presenter outlines the regulatory and ethical considerations the Institutional Review Board (IRB) and Research Compliance Services (RCS) apply when reviewing protocols involving AI technologies.

Learning outcomes for this training:

• Distinguish between foundational AI models, including Generative AI, Machine Learning, and Deep Learning.
• Recognize the common errors, biases, and limitations generated by AI tools.
• Assess the vulnerabilities and privacy risks AI introduces to research data.
• Identify additional ethical and safety risks AI poses to human subjects.
• Learn about the pillars of responsible AI integration to research protocols.

AI in human subjects research video

Learn about how to create a new study in the Research Administration Portal (RAP) for IRB review.  Also see the RAP Guidance Index for additional resources. 

Create a New Study Video

Learn how to Add a Comment to your submission in the Research Administration Portal (RAP) to communicate with RCS staff and the IRB about your submission

Add a Comment Video

If RCS and/or the IRB request clarifications, the submission in the Research Administration Portal (RAP) will be editable by the researchers and researchers will be notified via email of the need to address the requested clarifications. Learn about how to edit the RAP Smartform, upload new and/or revised documents, and resubmit once all the requested changes have been made. Also see the Responding to clarification request or modification required notification guidance in the RAP Guidance Index.

Submitting revisions after clarifications requested Video

This video is for students, post doctoral scholars or others who have a faculty advisor who is being asked to complete an ancillary review. This video explains how to set up a faculty advisor ancillary review in the Research Administration Portal (RAP). Also see the Ancillary Review - Instructions for students to add a faculty advisor in the RAP Guidance Index.

Student Ancillary Review Video

Learn how to submit a project in the Research Administration Portal (RAP). Although this is a presentation of how to submit a new study in the RAP, the process is similar to other submission types such as modifications, continuing reviews and reportable new information. Also see the Submit Study Instructions (RAP) in the RAP Guidance Index.

How to Submit Video

This video is for faculty advisors who are working with UO students doing human subjects research. The faculty advisor ancillary review is not required if the Principal Investigator is not a student or a postdoctoral scholar (see the Principal Investigator Eligibility, Faculty Advisors, and Research Personnel Requirements website for more information). This video shows how to complete a faculty advisor ancillary review in the Research Administration Portal (RAP).

Faculty Advisor Ancillary Review Video

Learn how to create a modification to an existing IRB submission to change study team members, other information and documents. For more information about modifications, also see our Modification Review (Amendments) webpage and the Modify Study RAP Instructions in the RAP Guidance Index.

Create a Modification Video

The Study Workspace in the Research Administration Portal (RAP) is a centralized, project-specific dashboard that acts as the "home page" for a single research study. It provides a comprehensive view of all information, activities, and official communication regarding that study, allowing research teams to manage the study throughout its lifecycle. It also contains a diagram of where each submission is in the review process. This presentation provides a tour of the study workspace so researchers can familiarize themselves with the features. For more information about how to prepare submissions in the RAP, see the other videos in our RAP Trainings series and the additional guidance in the RAP Guidance Index. 

Tour of the RAP Study Workspace Video

Learn how to create a continuing review (CR) submission to request the extension of the approval period for your study or a combined modification and continuing review (MODCR) submission which allows you to both modify your study and request the extension of the approval period for your study at the same time. Requests for continuing review should be submitted at least 45 days in advance of the study expiration date.  For more information, also see our Continuing Review and the Continuing Review/Study Closure RAP Instructions in the RAP Guidance Index.

Create a CR or MODCR Video

All studies must be closed once human subject research activities conclude. Learn how to create a closure submission for your project in the Research Administration Portal (RAP). For more information about study closure requirements, also see our Closing Your Study webpage and the Continuing Review/Study Closure RAP Instructions in the RAP Guidance Index. 

Create a Closure Video

Learn how to report new information (RNI) in the Research Administration Portal (RAP). An RNI is needed for all prompt reports including unexpected problems involving risks to subjects or others, non-compliance, participant complaints and breaches of confidentiality. For more information about RNIs, see the Report New Information (Event Reporting) webpage and the Report new information (RNI) guidance in the RAP Guidance Index. 

Create an RNI Video