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Updating Regulations for Human Subjects Research: The New Common Rule Has arrived! What Changes Are Coming?
Citation:
Nelson, D. Updating Regulations for Human Subjects Research: The New Common Rule Has arrived! What Changes Are Coming? UNC Research Ethics Grand Rounds, Chapel Hill, NC, NC, April 20, 2017.
Impact/Purpose:
Changes are coming in many areas that will impact investigators and IRBs, including informed consent, continuing review, exemptions and multi-site research. This seminar will review the major changes that are coming for IRBs, investigators, and their institutions.
Description:
The “Common Rule” refers to the federal regulations that govern research involving human subjects. These regulations have been largely unchanged since 1981, while the research they cover has continued to evolve. After a 6-year rulemaking process, the Common Rule was revised and published in Jan 2017, with an effective date of Jan 2018. Changes are coming in many areas that will impact investigators and IRBs, including informed consent, continuing review, exemptions and multi-site research. This seminar will review the major changes that are coming for IRBs, investigators, and their institutions.