New "Common Rule" IRB Regulations Information Session
NEW “COMMON RULE” IRB REGULATIONS
Effective January 2018
The scheduled date for the majority of the revisions to the New Federal IRB Regulations is quickly approaching. The 125-page policy governing research involving human subjects involves significant changes to improve protections and streamline the IRB review process. While there is a chance of a one-year delay in implementing some of the provisions, IRBs would likely be able to proceed with implementing several “burden-reducing” changes. The Office of Research Integrity (ORI) is preparing for the upcoming regulatory shift by revising applications, procedure/guidance documents, checklists, and even the new E-IRB submission system to take advantage of regulatory flexibility. The hope is that the E-IRB system, currently in pilot phase, can be launched campus-wide based on the new rule. This would allow researchers to transition to a version of E-IRB that will closely mirror the future of research oversight.
Changes researchers can prepare for include:
- New exempt review categories for low-risk research
- Streamlined continuing review requirement for certain types or stages of research
- Revised consent template to include new elements and reorganize both the document and the process to facilitate a prospective subject’s decision about whether to participate
ORI and the Center for Clinical and Translational Science (CCTS) are continuing to provide education sessions to introduce changes based on the new regulations. Similar to sessions offered earlier this year, the following presentation will provide an overview of the changes that most directly affect research investigators. Additional sessions, including topic-specific workshops, will be offered.
Bring your lunch, Beverages & light refreshments provided.
Registration is required. Please RSVP by emailing firstname.lastname@example.org.
Ada Sue Selwitz, M.A., Executive Integrity/Compliance Advisor,
Office of the Vice President for Research & Co-Director, Regulatory Support and Research Ethics, Center for Clinical and Translational Sciences
Belinda Smith, MS, CCRC, Research Education Specialist,
Office of Research Integrity