Gaining Clarity: Ethical and Regulatory Considerations and Common Misconceptions in the Use of Human Biospecimens
Date: Thursday, October 25th, 2018
Time: 11 am EST, 10 am CT, 8 am PST, 4 pm CET
The procurement and use of human biospecimens for life science researchers is complex and challenging. Register for this webinar and learn the common misconceptions surrounding the bureaucracy and oversight in the use of human biospecimens. Developed specifically for regulatory personnel and all levels of researchers to gain insight and guidance.
- Views surrounding compensation vs. reimbursement
- Use of non-consented samples (i.e. remnant or waiver of consent)
- Requirements to ensure the ethical collection of non-US samples
- Compare FDA vs. HHS requirements
- Industry-leading best practices BioIVT follows when procuring specimens
- How BioIVT works with you to ensure regulatory oversight
David Forster JD, MA, CIP
Chief Compliance Officer, WIRB-Copernicus Group
Mr. Forster has a J.D. and a Masters in Medical Ethics from the University of Washington. He joined Western IRB (WIRB) in 1996 and is currently the Chief Compliance Officer for the WIRB-Copernicus Group (WCG). Western IRB was one of the first two IRBs to receive accreditation from AAHRPP.
Mr. Forster co-chairs the Secretary’s Advisory Committee on Human Research Protections (SACHRP) Sub-Committee on Harmonization (SOH). He previously served a four-year term as a member of SACHRP, and was a member of the SACHRP Sub-Committee on Inclusion of Individuals with Impaired Decision-Making in Research (SIIIDR). Mr. Forster also serves on the Certified IRB Professional (CIP) Council.
Cathie Miller, PhD
Director of Product Marketing, Personalized Medicine , BioIVT
After beginning her research career at the University of Michigan, Dr. Miller received her PhD at the University of Louisville School of Medicine before completing her post-doctoral fellowship at the Wistar Institute and the University of Pennsylvania. With a career that spans over 20 years at the bench, as well as a Director and a Global Product Manager, all involving the use of biospecimens in the fields of cancer, immunology and virology, Dr. Miller is now Personalized Medicine Director of Product Marketing at BioIVT.