FDA Announces Harmonization Efforts. The FDA has announced two proposed rules that demonstrate their efforts toward harmonizing their human subject protection regulations with the HHS Common Rule for the kinds of research the FDA oversees. The proposed rules address cooperative research and requirements for single IRB review and enhanced requirements for the informed consent process for clinical trials.
The HRPP is no longer accepting submissions in iRIS in preparation for the transition to the new electronic IRB submission system, Cayuse HE. The HRPP and IRB will not be able to review any submissions until Cayuse is launched on October 28, 2022. Please visit the Cayuse Human Ethics Transition page to read more about this process.
The OSU Library has posted a comprehensive guide on complying with NIH's Data Management and Sharing Policy. The policy applies to human subjects research funded by the NIH, will come into effect on January 25, 2023, and will cover grant applications for the January 25, 2023 cycle and all subsequent grant cycles.
The new application form in Cayuse will retain the above changes and also incorporate the following major changes:
FDA Publishes Responses to Good Clinical Practice Inquiries. FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and FDA’s regulations. The agency addresses inquiries related to good clinical practice and human subject protection policies on an ongoing basis. To read the most recent inquiries and responses, please use this link to FDA’s Good Clinical Practice Inquiries.
The Human Research Protections Program will be transitioning to a new electronic submission system, Cayuse, in the fall of 2022. This change is part of a broader effort by the Research Office to improve user experience with the IRB submission process and to integrate research integrity functions with OSU pre-award administration. You can read more about the Research Office plans here.
Please continue to check back here for updated information and as further details and guidance become available, including the go-live date.
The OSU HRPP is pleased to announce we have welcomed two new Analysts to the team! Please welcome Comedy Millar and Sonnary Campbell. You can read more about them here in the April 8 Research Newsletter and the April 1 Research Newsletter.