The training resources on this site will assist you with:

• Understanding basic requirements associated with conducting research with human subjects, including obtaining Institutional Review Board (IRB) approval, or an Exempt determination
• The process associated with submitting an application for IRB review or an Exempt determination  
• Knowing when and how to use resources through Research Compliance Services (RCS)
• Understanding researcher responsibilities when conducting human subject research

Staff from Research Compliance Services are happy to provide class presentations and group or individual consultations. Please email us to request a presentation or consultation. An overview of the UO's resources for submitting a study for IRB review is also explained on the OVPRI's Integrity and Compliance website.

On-Demand 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

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 the Human Subjects Determination Worksheet, the Guidance Library and the Forms and Applications page

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 this PDF (Create a single-site study) and the Human Subjects Research Guidance Library.

This video from 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.

In this session, representatives from the Office for Human Research Protections (OHRP) 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.

This webinar from the Office for Human Research Protections (OHRP) 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.

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

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.

At-Request Trainings

Staff from Research Compliance Services are happy to develop trainings based on a particular group's needs. Trainings can to be delivered in-person or remotely via Zoom. Please contact email us to request a training.