Navigate Human Subjects Research Through These ORE Training Sessions

The Office of Research Ethics offers four categories of training for human subjects researchers:

IRB 101 – These sessions are appropriate for new and experienced investigators, including (under)graduate students, faculty, and staff, looking for broadly applicable information regarding IRB processes.

Interactive Workshops – These sessions provide new and experienced researchers the opportunity to work with their peers and IRB staff toward shared goals.

IRB Basics – These sessions are appropriate for new and experienced investigators, including (under) graduate students, faculty, and staff who want to deepen their knowledge of key IRB principles and processes.

Special Topics – These sessions are most useful for researchers with a basic knowledge of IRB principles and processes but who are seeking a deeper level of understanding regarding “special” types of Human Subjects Research (HSR).

IRB 101

An Overview of the IRB Approval Process
This session offers an overview of the IRB approval process. The session begins with a brief overview of the IRB before transitioning into the criteria for approval, levels of IRB review, post-approval considerations, and more. This session ends with a set of reminders. This session runs approximately 60 minutes, including dedicated time for Q&A. Session content and/or time can be tailored or extended to suit your needs.
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Navigating the IRB Submission Process
As part of this presentation, attendees learn tips for developing and submitting applications for IRB review. An IRB staff member will walk through key sections of the IRB application and explain what the IRB looks for during the review process. This session runs 60-90 minutes, including time allocated for Q&A.
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Interactive Workshops

The IRB Application
During this session, attendees will collaborate with other researchers as they work to complete their IRB applications. IRB staff will offer assistance as well as targeted feedback. Bring your computer and your questions! This session runs 60 minutes but can be extended to suit attendees’ needs.
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Informed Consent Materials
Bring your informed consent materials to this interactive workshop! IRB staff will provide a brief overview of informed consent expectations for exempt and nonexempt research. The remainder of the session is for YOU – ask questions of IRB staff, consult with peers, and revise and improve your materials. This session runs 60 minutes but can be extended to suit attendees’ needs.
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Requester’s Choice / You Pick
Have questions and need answers? Stuck on a specific section of the IRB form? Struggling to work through IRB pre-review feedback? This session may be for you! Groups (minimum 5 attendees) can request a workshop focused on an IRB topic of their choosing. This session runs 60 minutes but can be extended to suit attendees’ needs.
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IRB Basics

Does My Study Need IRB Oversight?
This session is the first of a three-part series covering IRB Basics. Here attendees learn what constitutes HSR and therefore requires IRB review. More specifically, an IRB staff member will provide an “inside peek” at the process IRB staff use when determining whether IRB oversight is required. Several examples and case studies will be discussed – attendee interaction is encouraged. Additionally, information about the levels of IRB review (exempt, expedited, full committee) will be provided. Run time: 60-90 minutes, including time for Q&A.
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The Informed Consent Process
Learn about the informed consent process, which includes participant recruitment and the informed consent document. Discussion will include detailed explanation of consent-related regulatory requirements, and a member of IRB staff will offer tips and best practices for designing and obtaining informed consent. This session runs approximately 60 minutes, including dedicated time for Q&A.
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Protecting Human Subjects (Identifying & Mitigating Risks to Participants)
This session includes discussion of risk-related terminology as well as approaches to identifying and minimizing risk in HSR. The session also addresses strategies for protecting participant confidentiality and data security measures. This session runs approximately 60 minutes, with time allocated for Q&A.
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Special Topics

External Collaborations
Research projects often involve collaboration between researchers at ISU and those at other universities. In some cases, formal IRB Reliance Agreements, also called IRB Authorization Agreements (IAAs), may serve to avoid duplicate IRB review. In fact, most federally funded, multi-site research now requires review by a single IRB (sIRB). Join us for an in-depth discussion of IRB oversight options for cooperative and multi-site projects, including the additional roles and responsibilities for PIs leading collaborative research. This session runs 60 minutes, with dedicated time for Q&A.
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Secondary Research
Some research projects do not involve any direct interaction or intervention with human participants but instead make use of existing information or research data. This session includes in-depth discussion of the considerations and PI responsibilities unique to conducting secondary research. This session runs 60 minutes, including dedicated Q&A time.
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Research with Children
Research projects often involve vulnerable subjects such as children. This session begins with an overview of required IRB determinations and terminology unique to research with children. Then, an IRB staffer will facilitate an in-depth discussion of considerations and PI responsibilities when conducting research with children of all ages. Active participation is encouraged. This session runs 60 minutes, including dedicated Q&A time.
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For questions regarding training, contact Dr. Raeann Ritland, IRB Post-Approval Monitor: raeannr@iastate.edu 294-7792.