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Future Use and Ownership of Biospecimens in Human Subjects Research

Ended Nov 10, 2021
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Full course description

Term: Fall 2021

Date: November 11th, 2021

Time: 12:00pm - 1:00pm


Instructor: Kory Trott

Presented By: Scholarly Integrity & Research Compliance (SIRC)



The Federal Policy for the Protection of Human Subjects (45 CFR 46 Subpart A) known as the Common Rule was revised in 2019. In addition to other revisions, the revised Common Rule now includes a requirement that informed consent processes must include one of two statements about the collection of private information or identifiable biospecimens for future Research. The revised regulations also provide two new exempt categories for the storage, maintenance and research use involving identifiable private information or identifiable biospecimens when broad consent has been obtained. The regulatory changes related to the future use and ownerships of biospecimens in the revised Common Rule can be traced to the ethical issues that arose in the treatment of Henrietta Lacks and her biospecimens. This discussion with focus on the ethical dimensions of collecting biospecimines for current and future research.