The Revised Common Rule: New Requirements for Clinical Trials

After much discussion and repeated postponements, the updated Common Rule took effect on January 21, 2019.

The new, widely-revised rule will have an impact on virtually all clinical research procedures, including:

• The definition of research in policies and procedures, which should be updated to reflect the new definition of research with its additional carve-outs
• The definition of “human subject,” which should now include “identifiable biospecimen”
• Procedures and conditions for limited IRB review
• IRB continuing review policy to allow for the new exceptions
• IRB expedited review procedures
• The waiver process to address broad consent
• Screening and recruitment policies.

In The Revised Common Rule report two prominent healthcare attorneys sift through the new rule to mark out every deletion –highlight every addition –interpret every rewording –that clinical research professionals and institutions need to understand to comply. You’ll learn:

• New requirements for consent documents and elements of informed consent
• Broad consent from subjects for secondary research involving identifiable private information and identifiable biospecimens
• Limited IRB review of exempt research, expedited review and the criteria for IRB approval of research
• New and modified exemptions
• SOP updates you will need to make to accommodate Common Rule changes

This report provides a roadmap to future Common Rule compliance, outlining all the new and revised requirements in areas such as:

• Broad consent for secondary research
• Informed consent
• IRB review
• Exemptions
• Cooperative research

Order your copy of The Revised Common Rule: New Requirements for Clinical Trials report and know the impact of revisions on your clinical trials and start planning now.

Who Will Benefit

• Institutional Officials
• Clinical operations staff
• IRB staff and members
• Principal investigators
• Study coordinators
• Clinical research associates