HHS’ new final rules for Institutional Review Boards (IRB) related to research involving human subjects recently went into effect, and guidance on some specifics are still being issued. Both new and seasoned investigators will see some important changes in IRB processes.
While much of the focus of these new IRB requirements are on biospecimens and clinical trials, the rules also include significant changes to exempt categories, procedures for expedited review, and informed consent. Investigators will need to learn the new procedures for all future IRB applications.
To assist you in this process, researcher and IRB approval specialist, Jo Anne Schneider, Ph.D., is conducting an online training session. Dr. Schneider will outline these major IRB rule changes to help you understand their impact on your research involving human subjects and its IRB approval.
By taking advantage of Dr. Schneider’s online training, you’ll receive an expert breakdown of the new IRB requirements, and her guidance on how you can more easily and effectively comply with them. Here are just a few of the topics that Dr. Schneider will cover in her training session:
- Determine whether your project qualifies for an expedited or exempt review
- Clarify the new requirements for written AND oral informed consent
- Identify whether your clinical trials must be listed in the registries or not
- More clearly determine who is responsible for IRB approval given the new multi-institution project guidelines
Who is this for? This expert-led online training will be of great benefit to both new and seasoned researchers.
During this online training, Dr. Schneider will compare both the old and new IRB rules, and highlight how you will need to do things differently to meet these new requirements. In addition to the items listed above, she will also outline key changes and provide you with the rationale behind them related to clinical trials.
Register for this online training today to secure your compliance with these new IRB rules, and the success of your human subject research.
Meet Your Expert: Jo Anne Schneider, PhD
Dr. Schneider is an associate research professor at George Washington University and Principal at Chrysalis Collaborations. She has successfully developed IRB statements for a wide array of studies since the 1980s. She has written the IRB approval guidelines for college courses and has also advised multiple students about informed consent and IRB statements. She is a specialist in urban issues, social welfare, health and human services, and health projects with hard to reach populations. She has worked with a combination of government, foundations, national member benefit non-profits, community-based organizations, faith communities and marginalized communities (people of color, immigrants/refugees, low income communities, people with disabilities) to develop internationally recognized research. She is also a former American Association for the Advancement of Science (AAAS) Policy and Technology Fellow at NIH. Her recent major projects include the Faith and Organizations Project (www.faithandorganizations.umd.edu), and multiple projects related to social welfare and human services (see www.chrysaliscollaborations.com).
Schneider, J.A. (2006) Special Issue Introduction and Using multi-methods ethnography to promote quality service and understand interactions among organizations: Examples from the Kenosha social capital study and neighborhood settlement house needs assessment and evaluation. In J.A. Schneider (Guest Editor), Research methods best practices. Nonprofit Management and Leadership, 16(4) 387-394 and411-428.
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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 3 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.
- TRANSCRIPT: The expert speaker's words are transcribed into a document and sent to you by email. It takes up to 10 days, but allows you to read the content.
With every option, your registration includes learning aids such as presentation handouts and other helpful materials.
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