The final revisions to the Common Rule (Federal Policy for the Protection of Human Subjects) will become effective on January 19, 2018. Accordingly, HRPO will implement the following changes. Please refer to http://www.hrpo.pitt.edu/CommonRule2018 for information regarding the changes and how to implement them.
Note that the Department of Health and Human Services has not issued any guidance for institutions on how to implement or interpret the New Rule. Policies and procedures may change as a result of evolving interpretations and guidance so be sure to check the website for updates.
- Exempt Studies: Exempt submissions will not be accepted from January 1-19, 2018. During that time period, HRPO will process those exemptions that are in OSIRIS under the Pre-2018 Rule. Effective January 20, 2018, exemptions will be accepted on the new forms and will be processed under the New Rule.
- New Expedited and Full Board studies processed after January 19, 2018 will need to be in compliance with the New Rule. This includes protocols that are submitted to HRPO prior to January 19, 2018 but processed on or after that date.
- Existing studies may or may not require compliance with the New Rule. HRPO will determine the need for studies to transition based on the Decision Tree available on the web site. This tool is not determinative but meant to give an idea to the types of studies that will need to comply. Refer to the Implementation and Transition page for more information.
- Education sessions will be held. Refer to the Events section on the HRPO homepage
Please contact us through email@example.com with questions and put Common Rule 2018 in the subject line.