Human Subject Research and Protection

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A Message from the Course's Instructor

Course Description:

In this course you will learn the following:

  • Learn what human subject protection training requirements exist for federally funded research in the U.S.
  • Fulfill the required human subject protection training requirements required for federally funded US research, enforced by IRBs
  • Define all human subject research terminology in one place (increase learning curve)
  • Dissect the types of human subject research and how they are categorized based on their levels of risk
  • Learn how to assess whether your research qualifies as human subject research and when you should seek IRB approval

Additionally, you will:

  • Review all the regulatory responsibilities for researchers and organizations performing federally funded research in the US
  • Define vulnerable populations and review the extra protections they are understandably afforded in human subject research
  • Find out the exact approval criteria used by IRBs to review human subject research in the US
  • Learn what steps are required to maintain compliance once your human subject research is IRB-approved


Audience

Main Audience: Clinical research and trial professionals responsible for developing, managing or overseeing clinical research at research institutions, pharmaceutical/biotech companies and clinical research organizations.

Course Length

Approximately 180 minutes ( 3.5 hours / 3.5 CEU).


Course Materials

Course workbook and course slides.


Related Topics: Human Subject Protection, Clinical Research Ethics, IRB, Clinical Trial Diversity, Nuremberg, Declaration of Helsinki, Research Ethics, History of Research, Belmont Report


Your Instructor


Edye T. Edens, JD, MA, CIP, CCRP
Edye T. Edens, JD, MA, CIP, CCRP

Joining First Class Solutions, Inc. in 2017, Edye T. Edens serves as First Class Solutions’ Senior Research Compliance Consultant focusing on research compliance and life sciences. Edye is a licensed attorney with an international human rights, research ethics, and health law background.Her consulting services include research administration, healthcare compliance, grants/contracts to IRB, COI, education, privacy, HIPAA, multiple areas of FDA compliance related to drugs, devices, and food; AAHRPP, misconduct and site-level compliance work as it relates to QA, monitoring, and auditing (particularly oncology). Services provided include education and training, program creation and management, or even as a complete outsourcing solution. Additionally, Ms. Edens regularly publishes articles and speaks at regional and national professional research and compliance association meetings, including HCCA, SCCE, PRIM&R, MAGI, AAHRPP, SPARC, RAPS, and AHLA. Previously, while in-house for a decade at Indiana University, she focused on the role of human rights in health and worked at the Human Subject Offices on both the Bloomington and Indianapolis campuses, the Indianapolis Grant Services office, Clinical Research Compliance Office and the Research Integrity Office aiding in quality assurance and compliance matters including managing accreditations, internal auditing, education and managing consultation projects involving outside entities. In 2016, she became the first Quality and Compliance Manager for the IU Simon Cancer Center over all aspects of compliance related to all clinical trials performed at IUSCC, before departing for the consulting world. Educationally, she completed her MA in International Research Ethics in 2012, and was the program manager for a NIH grant to aid in creating a joint international institutional review board (IRB) in conjunction with IU’s existing Moi University medical school partnership in Kenya and the IU Center for Bioethics. She is also a Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), and holds a green belt certification in Lean Six Sigma. Additionally, she teaches at IU’s McKinney School of Law in Indianapolis, and oversees the Hall Center for Law and Health’s Externship Program.


Course Curriculum


  Module II
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  Module V
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  Module VIII
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  Module IX
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  Module X
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  Final Considerations
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Continuing Education

Course takers are encouraged to submit course description, course length and course agenda directly to their specific certification associations to confirm course completion will be accepted as part of their continuing education requirements.

Requirements for SOCRA's Re-Certification Continuing Education for Web Based/Online Coursework:

Agenda AND Certificate of attendance and/or letter signed by supervisor. Course Agenda and Certificate of Attendance (at course completion) will be provided to our course takers.

Requirements for ACRP Re-certification Continuing Education

Please contact ACRP directly with this course title, timed agenda/course overview, and objectives included on this page for their approval as a continuing education course in your re-certification.


Related Topics: Human Subject Protection, Clinical Research Ethics, IRB, Clinical Trial Diversity, Nuremberg, Declaration of Helsinki, Research Ethics, History of Research, Belmont Report

Frequently Asked Questions


When does the course start and finish?
The course is a completely self-paced online course - you decide when you start and when you finish.
How long do I have access to the course?
After enrolling, you have unlimited access to this course for as long as you like and the course is available - across any and all devices you own.
Will I have access to course updates?
Absolutely yes! You will pay only once for this course but you'll receive access to any and all future updates as long as the course is available.
What is the refund policy for courses?
The courses are non-refundable.

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