The updated rules for Institutional Review Boards (IRBs) related to research involving human subjects are in effect, both new and seasoned investigators will experience important changes to exempt categories, informed consent, handling biospecimens and the expedited review process.
Since one of the main purposes of the Final Rule is to facilitate the conduct of minimal risk research, investigators will need to comprehend the new federal regulations to fully take advantage and ensure the successful submission of future IRB applications. To assist you in this process, researcher and IRB approval specialist, Esmeralda García Galván, PhD, is conducting a targeted, step-by-step online training session. Dr. Galván provides an advanced look at these major, fast approaching IRB rule changes to help you thoroughly understand their impact on your human subject research.
- Determine whether your study qualifies for an expedited or exempt review
- Clarify the new requirements for written AND oral informed consent
- Simplify the guidelines for screening and recruiting participants
- Pin down whether your study is subject to pre-2018 vs. 2018 requirements
- Revise data collection methods to ensure IRB compliance
- Incorporate more underrepresented groups in your research
- Head off compliance headaches by defining implications related to the definition of biospecimens
- Identify whether your clinical trials must be listed in the registries or not
- Confirm whether your clinical research results will need to be disclosed to subjects
- Easily determine who is responsible for IRB approval given the new multi-institution project guidelines
- And much more…
Who This Is For? This expert-led online training will be of great benefit to both new and seasoned researchers, specifically those who are currently, or are planning, to engage in research involving human subjects.
During this 60-minute online training, Dr. Galván will break down the complex messaging around the new research and human subject protection rules. You’ll identify how you will need to do things differently to meet these new requirements. Additionally, key changes intended to better protect human subjects, easy research, and reduce regulatory burdens will be clarified.
By the end of this training, you will have a complete understanding of the Final Rule and how to take full advantage of it to help ensure the success of your human subject research.
Meet Your Expert: Esmeralda García Galván, PhD
Esmeralda García Galván is a PhD-trained researcher and project manager with over 20 years’ experience in government and higher education sectors, who more recently transitioned to healthcare and clinical research administration and compliance. With her breadth of understanding on the details of research and human subjects’ protection, her greatest joy is empowering other researchers to achieve and surpass their research career goals via education and trainings. Since 2016, Dr. García Galván fulfills this joyful pursuit via her role as Project Manager in Research Enterprise of Ascension Texas - Seton Family of Hospitals.
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How do PI Leader Online Training Sessions Work?
PI Leader sessions provide you with best-in-class expert education and advice to address all of your non-science needs such as grants and funding, lab management, intellectual property, lab animal welfare and many other topics. Our online training (Live or On-Demand) are a cost-effective and convenient way to boost your chances for more funding and lab/research productivity. You can participate in the comfort of your office without incurring travel costs and time.
You have 2 training options depending on your needs that you would select by a drop-down menu after clicking the order now button below:
- ON-DEMAND: This format allows you to access a live recording of the training session. You get the exact same training, Q&A and handouts as the live session, but can listen to it at your convenience.
- CD: The exact same training and handouts are saved on a CD and mailed to you. It takes a little longer, but gives you a little more flexibility.
With both options, your registration includes learning aids such as presentation handouts and other helpful materials.
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