The Principal Investigator (PI) bears direct responsibility for the implementation and conduct of the research and for ensuring the protection of human research participants. The PI must promptly report any harm or injury (physical, psychological, social, or economic) or unanticipated problems or incidents involving risks to subjects or others to the IRB.
Reports of such adverse events must be reported to the IRB by submitting a Report of New Information in the IRB Portal (irb.ovpr.uga.edu). Unless a different reporting requirement is required by a federal agency or sponsor, an unanticipated problem or event which resulted in a subject’s death, was life threatening, or places subjects or others at greater risk of harm than was previously known or recognized must be reported to the IRB within 24 hours of the principal investigator or any member of the investigative team becoming aware of the event. All other events must be reported to the IRB within 72 hours of the principal investigator or any member of the study team becoming aware of the event.
If you have any questions, please contact the HSO at 542-3199.
Serious non-compliance or major protocol deviations must be reported to the IRB within 5 business days of the investigator’s or research staff member’s learning of the event by submitting a Report of New Information in the IRB Portal (irb.ovpr.uga.edu). See Office of Research Compliance Policy and Procedure for Responding to Allegations of Research Noncompliance.
- Do not modify non-exempt Human Research without prior IRB review and approval except if changes in protocol are necessary to eliminate apparent immediate hazards to the human participants.
- Do not modify exempt Human Research without prior IRB review and approval except if modifications are minor and will not disqualify the research from an exempt determination.
- All human research projects approved prior to January 21, 2019 were approved for specific time periods and required continuing review.
- Upon the effective date of the revised Common Rule, January 21, 2019, only certain new research projects will be approved for specific time periods and require continuing review.
- The revised Common Rule requires continuing review at an interval no greater than one year for research that involves greater than minimal risk to participants.
- The IRB may require continuing review of other projects based on evaluation of population, procedures, and specific risks to participants. The approval period may be 1-3 years.
- When required by regulation or IRB determination, complete and submit a request for Continuing Review in the IRB Portal no later than 30 days before the study expires. The expiration date can be found on the portal record.
- For research that does not require continuing review, the UGA Human Subjects Office will request a Progress Report at intervals appropriate for the research every 1-5 years.
The approval period is the interval between the day that the IRB grants final approval of research, or provides a determination of exemption, and the last day that the research has IRB approval. The expiration date is the first day that the research will no longer have IRB approval. Approval periods range from 1-5 years. Rarely, a project is granted an approval period of less than one year.
The Principal Investigator is responsible to monitor approval periods and submit a request for continuation (a new approval period) at least 30 days prior to the expiration date. All research activities must stop when approval expires (or lapses) unless stopping may cause harm to participants.
When IRB expires before continuing review approval is granted, this is considered non-compliance and must be reported by a Report of New Information (RNI) in the IRB Portal. Lapse of IRB approval may also need to be reported to sponsoring agencies or entities. Multiple instances of lapses in approval may result in an IRB determination of continuing non-compliance which must be reported to the Department of Health and Human Services Office for Human Research Protections and could also result in institutional restrictions being placed on an investigator.
The IRB Portal is programmed to send reminder notifications but these are a courtesy and not a replacement for investigator project management tools. See more information about investigator responsibility in the Investigator Manual on the Policies and Procedures web-page.
The criteria for closure are when enrollment, intervention (if applicable), data collection, and approved analyses of identifiable data is complete. When these criteria are met, the research no longer requires IRB oversight. You can continue to revisit the data to draft publications and do presentations about the project without continued IRB oversight as long as the analyses are consistent with the approved project. If new research questions are formed and new analyses are proposed, a new submission to the IRB for secondary analyses of identifiable data is required. If the data are no longer identifiable (all identifiers and code keys are destroyed), the research no longer involves human subjects and does not require further IRB oversight.
There are a couple of options if the criteria for closure are not met. UGA IRB only has oversight responsibility for research conducted by its agents. Individuals with adjunct appointments or Emeritus status may be considered agents of UGA but department authorization must be obtained for conducting research as a UGA Principal Investigator (see Policy: Principal Investigator Eligiblity.) Otherwise, a new PI must be identified and submitted via modification/version.
If neither of the aforementioned appointments apply, a new PI must be identified and submitted via modification/version before you leave. Particularly when the project involves a graduate student’s thesis or dissertation, it is important to transfer the PI responsibility to another faculty member or to obtain department authorization to continue the responsibility–in both cases, the IRB must be notified via a modification/version submission.
Former UGA employees who will continue to conduct the research after leaving UGA must obtain IRB approval from their new institution before engaging in or continuing human research activities. In some instances a data transfer agreement may be required as well.
If the closure criteria are met, submit a request for closure before your access to UGA systems is deactivated by EITS.