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Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018

The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019.

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Form Description
118 Designation Do you need to access funds from a grant in order to develop the instruments that you will use with human subjects? If yes, submit this form to the IRB along with your grant application and expected date of IRB protocol submission. Provide the 118 memo that we will provide you to Sponsored Programs so that they can establish the account for your grant. View the Federal RegulationsApplication for 45 CFR 46.118 Designation This designation is only applicable to projects when it is known that subjects will be involved, but definite plans are not available at the time of the human subjects application or grant proposal. This designation is primarily used when funding is needed prior to receiving IRB approval for travel/meetings with collaborators to discuss/create the methodology/instruments to be developed or to hire someone to develop the instruments, etc.