Learn more about the upcoming changes to the policy for protection of human subjects (Common Rule) and the UGA IRB Portal.
The Federal Policy for Protections of Human Research Participants (aka the Common Rule) has been revised. The revised Common Rule goes into effect on Jan. 21, 2019 and will affect all pending (not approved) and new human research project submissions.
The revised Common Rule will apply to any research project approved on or after Jan. 21, 2019. In order to implement the revised Common Rule without a break in service, UGA is not blacking out any dates and will continue to review pending submissions while applying the revised regulatory and policy requirements. The IRB may ask additional questions before final approval is granted, but you will not have to make a new submission.
The revised Common Rule allow IRBs to transition ongoing research projects if a new review is performed. The UGA IRB is not planning to transition any projects unless a researcher requests it and it is determined to be in the best interest of the subjects.
Yes, the IRB portal will look and function differently after the revised Common Rule becomes effective. Changes include revised look and feel, some new or revised questions in the online forms, and changes to the display of submission attachments.
The changes that are most likely to affect UGA researchers include:
• Benign behavioral interventions with adults may be eligible for exemption.
• Continuing review of some minimal-risk research is no longer required.
• Some projects, such as oral history or journalistic activities, may not require IRB determination or review
• Informed Consent documents must be formatted to feature concise presentation of key information in the first part of the document.
Be aware that the changes are coming, and look for additional information and announcements when UGA policies, forms and other materials have been updated. Spread the word about the changes to others who may need to know this information.
Visit the CITI site for basic information: https://about.citiprogram.org/en/final-rule-resources/#irbimpact
Additional information is provided by the Department of Health and Human Services: https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html
Contact the Human Subjects Office to schedule in-person group sessions (email@example.com or 706-542-3199)
The revised regulations require new and different information to be reviewed by the IRB; therefore, the IRB Portal has undergone significant revisions. Submissions “in review” when the Common Rule became effective are not affected. But draft submissions must be converted to the new submission forms.
- Drafts created prior to 12/21/18 will be discarded. The draft can still be accessed by the study team and information within the forms can be copied and pasted into a new submission draft.
- Drafts created after 12/21/18 can be converted using other methods by the Office of Research staff. If your submission was created after 12/21/18 and you want Office of Research staff to convert it to the new forms, please contact the IRB office (IRB@uga.edu) before 2/21/19. Any drafts not converted by 2/21/19 can still be accessed by the study team and information within the forms can be copied and pasted into a new submission draft.