Welcome to the Renovation in IRB Education Newsletter! December 2024 Edition

Hello IRBers, Clinical Research Educators, and Investigators!

Blog Launched in November 2024

In November 2024, the Renovation in IRB Education blog was launched. This blog is a FREE education resources for investigators who conduct research with human participants in various disciplines such as:

• Social behavioral research
• Education research
• Biomedical research
• Clinical research

Whether your position consists of IRB compliance, clinical research coordination, research operations support, or an investigator, I guarantee that you will be enlightened by the content!

Renovation in IRB Education will explore:

• Effectiveness of IRB training outreach efforts
• Assessment of attendee engagement and workshop attendance
• Tips and explanations regarding the IRB submission process
• Complex topics such as FDA clinical trial considerations
• Key takeaways from events related to human subjects research
• Fresh perspectives from subject-matter experts within the human subjects research community
• Highlighted research with human participants from investigators

What are Readers Saying?

The blog currently has 65 subscribers! I encourage you to subscribe to receive updates on posts as they are published. This newsletter will only highlight specific posts and will be distributed on a monthly basis.

Thanks for sharing this! I attended the sessions and I must say, it's impressive how you've compiled all the key takeaways into such a comprehensive blog! It's a great resource for reflecting on the key points and staying on top of important developments in the field. - Neeba Wilson

About the Author

I am an Arizona State University (ASU) alum with a bachelor's degree in accountancy (2014) and biological sciences (2020). Currently, I'm a Compliance Coordinator with ASU who oversees human subjects research (IRB). I started her journey in at ASU in January 2022 supporting IRB, Conflicts of Interest (COI), and Responsible Conduct in Research (RCR). Prior ASU, I was a Lab Manager at Dignity Health where I worked with the clinical research team on informed consent form development and design of 21 CFR compliant databases via REDCap. I also improved policy accessibility, generated animal husbandry SOPs, and managed animal protocol reporting to ensure compliance with IACUC regulations.

Though I have been blessed and fortunate to have worked in different fields as a program analyst and auditor, I am extremely thankful for my work with the U.S. Army Corp of Engineers. Here, I eliminated environmental infractions for Yuma sector projects by 100%. Further, I cross-trained as cost engineer to develop independent government cost estimates and tracked status of cost estimate progress to update program managers. I received two medals: the certificate of appreciation medal and the civilian service achievement medal.

In my free time, I enjoy spending time with my dear friends and family. I love attending educational events and sharing my insights with others. More importantly, I love to build my network at these events.

Educational and Training Considerations

With Spring 2025 semester around the corner, it's time for your institution to engage with the human subjects research community! Whether you're creating new events or going through rotation of standard events your institution hosts, you'll find very important considerations regarding educational outreach, presentation preparation, handout creation, and more below:

• Maximizing Attendance for Your IRB Events via Optimizing Your Educational Outreach Strategies
• Tailoring your IRB Presentation to Fit Audience Needs
• Top Tips for Making Microsoft Word Documents More?Inclusive
• Boost Researchers Efficiency in HSR: IRB Training Video?Ideas
• How to Prevent Zoom Link Problems in Your Remote Outreach Sessions
• Top Survey Design Ideas to Assess Training Effectiveness

FEATURED: FDA Clinical Investigators Training Course (CITC)

Were you able to attend one of the most informative events last year? The FDA hosted the Clinical Investigator Training Course (CITC) on December 10-12, 2024. This highly detailed course provided an overview of clinical research with respect to investigator responsibilities, FDA inspections, and so much more! If you weren't able to attend, you can view my summarized insights for each day below:

• FDA Clinical Investigator Training Course: Day 1 Insights
• FDA Clinical Investigator Training Course: Day 2 Insights
• FDA Clinical Investigator Training Course: Day 3 Insights

What's Coming Down the Pipeline?

Introductory-post Series

This morning, I created a poll where I asked the LinkedIn community for their input on my next series of blog posts. You can select one out of the three options:

1. HSR Basics: Here, I will dive into unethical human rights violations, ethical codes, institutional review boards (IRBs), what constitutes as "human subjects research" (HSR), and regulations in HSR.
2. Show and Tell Series: In this series, I plan to illustrate how to make your application materials IRB-ready! This includes how to effectively write an SBER protocol, a biosciences protocol, secondary data analyses protocol, recruitment materials, and the consent form.
3. Clinical Research Basics: Here, I will dive into the definition of a clinical trial, good clinical practice (GCP), good manufacturing practices (GMP), good laboratory practices (GLP), and regulatory oversight.

For now, if you're an investigator, you can check out my insights on the IRB submission process via the post below:

• Top Tips for Speedy IRB Review: Sharing from Personal Experience

Podcast - Renovation in IRB Education

Have you ever signed up for an hour webinar and thought to yourself, this isn't enough time for a topic so complex. Don't you wish there was a podcast out there where investigators had more time to talk about their research? What about deep diving with a compliance officer about IRB considerations for a specific area of research?

The Renovation in IRB Education Podcast will be available on Spotify early 2025. You can expect each episode at minimum to be at least two hours long. Our first episode will feature Dr. Leena Landmark from Sam Houston State University where we discuss the learning styles myth.