Failure to comply with human subject informed consent regulations can lead to your research’s “plug being pulled,” or worse expensive legal action - not to mention your career as a credible researcher.
You must also take into account that individual PI liabilities are increasing and so are whistle-blower activities. Accordingly, mastering a compliant informed consent process from the very beginning of your clinical research efforts is essential, but not necessarily easy.
That’s where Dr. García Galván, a PhD-trained researcher and project manager with over 20-years-experience in government and higher education sectors can help. Dr. Galván is currently a Project Manager in the research administration office of Ascension Seton Family of Hospitals. She regularly overcomes difficult clinical trial informed consent issues, and based on her experience has developed a 60-minute online training session.
- Uncover the most common federal compliance informed consent mistakes
- Implement a waiver or alternation of informed consent and still be protected
- Pin down when a short form is the best format for your informed consent
- Prevent coercion allegations with proven informed consent form language
- Successfully take into account your subjects’ location and emotional/psychological capability to lock in consent
- Determine when an informed consent or asset documentation is required
- Master vulnerable population consideration requirements to avoid a costly lawsuit
- Implement proven screening, recruiting and subject eligibility determinations
- Execute informed consent training for your entire research team that ensures compliance
- Determine when verbal consent is acceptable and best for the subject
- Minimize consenting risk associated with human subjects
- Comply with the Revised Common Rule for changes in your consent process
- And so much more…
Adequate informed consent is the only way your research subject can voluntarily agree to partake in your research study. Mastering the informed consent process is a prerequisite for a subject’s participation in your research.
Don’t take the risk of tackling the complex, regulation-driven process of informed consent on your own. Sign up for this upcoming online training, and get step-by-step assistance to help you bulletproof your human subject informed consent and avoid regulatory and legal disasters. Don’t wait, sign up today.
Who Should view:
Principal Investigators, Clinical Investigators, Physician-Scientists, Clinical Nurses, Research Faculty, and any research staff weary of informed consent compliance risks.
Meet Your Expert: Esmeralda García Galván, PhD
Dr. 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 compliance. With her breadth of understanding on the details of research, her greatest joy is empowering other researchers to achieve their greatest successes via education and trainings. Since 2016, Dr. García Galván fulfills this joyful pursuit via her role as Project Manager in the research administration office of Ascension Seton Family of Hospitals. Dr. García Galván previously served seven years at University of Texas at Austin’s Lyndon B. Johnson School of Public Affairs as Senior Grants/Contracts Specialist and Senior Program Coordinator. She received her B.A. in political science from Texas A& M University and both her Master’s Degree in Public Affairs and her Ph.D. in Educational Administration from the University of Texas at Austin.
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How does 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 trainings 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.
PI Leader also offers site licenses and additional connections for your group or institution at discounted prices. And you can purchase recordings of the live sessions as MP4 files, CD-ROMs and/or PDF transcripts.