The UK Office of Research Integrity (ORI) has developed a guidance document outlining plans for transitioning to/overview of the revised human subject regulations (a.k.a., “the Common Rule”).
The transition to the Revised Federal Policy for the Protection of Human Subjects (Common Rule) has forced the Office of Research Integrity (ORI) and Institutional Review Boards (IRB) to issue a Temporary Freeze on New Initial IRB Applications. Any protocol approved prior to January 20, 2019, must comply with the Current Rule and any protocol approved on or after January 21, 2019, must comply with the Revised Rule.
Based on feedback from researchers, IRB members, and participants from the Informed Consent Workshops, we have made revisions to both the Medical and Nonmedical Informed Consent Template.
The Office of Research Integrity and Center for Clinical and Translational Science will be providing a repeat hands on workshop on informed consent regulatory requirements