The National Research Act of 1974 ushered in an unprecedented era of legislative and regulatory actions to protect research subjects from harms they suffered as participants in studies like the Tuskegee Syphilis Study. The Common Rule (45CFR46) and FDA regulations Title 21 Parts 50 and 56 have been in effect since 1981, with various additions and modifications since then. Over the ensuing three decades, the conditions leading to the current regulatory framework have changed and "the rules" have had unintended consequences, driving a culture of compliance in which the ethos behind those regulations is often lost, squandering time and resources without evidence demonstrating whether or not these regulatory requirements are effective in achieving the overall objective. Further, the research landscape itself has changed with the advent of multicenter, multinational research as the norm rather than the exception.
This webinar will consider recent proposed changes to the regulatory and legislative environment and efforts to better define the roles of the IRB and the investigator in effectively carrying out their responsibilities. Many claim that the current system must be reformed to make it more effective as well as more efficient, and to focus on the critical determinants of subject protection, to move from a compliance-focused environment to one that balances compliance with conscience. Dr. Koski, the first director of the Office for Human Research Protections, argues that nothing short of a complete redesign will be effective and offers and alternative approach for achieving these goals.*************
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