The History of Research Ethics and Regulations
By exploring the history of human
subject research, we find the origin of the need for research ethics as well,
sadly in some of the worse examples in our research history. From this
interwoven history emerges the complicated regulatory infrastructure and
ethical dynamic that now governs our clinical research environment. This
course will provide the backdrop of history to highlight the need for all
research personnel to fully understand and conduct research at the highest
industry standards for both regulatory and ethical reasons.
In this course you will learn the following:
- Introduction to Early Research
- Research’s Worst-Case Scenario
- Persistent Problems in Research
- Regulatory Infrastructure
- Reflection and Your Role in Research
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.
Approximately 90 minutes ( 1.5 hours / 1.5 CEU).
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 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.
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.
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.