Current Guidance and Access to Forms
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COVID – 19 (SARS-CoV-2) IRB Procedure
Updated August 28, 2020: With the understanding that these instructions may change as COVID conditions and guidance changes, the IRB is now accepting applications to resume in-person research.
The University will start releasing the hold on research that requires in-person contact with participants beginning September 8, 2020. The IRB will begin accepting research resumption applications on August 28, 2020. No research may resume without written approval from the IRB. The research resumption application forms and tools can be accessed HERE.
Updated 8/18/20: The hold on in-person research will remain in effect until at least August 28th. At that time, the Office of Research leadership will re-evaluate the current conditions in light of CDC guidance and determine if local conditions allow for a return to face-to-face interactions with our research subjects.
Effective August 17, 2020: The Office of Research has established a process to request a deviation from the University hold on in-person research for teachers and clinicians who are gathering data from human participants with whom they are already in contact as part of their professional obligations. The request form is located here.
The Institutional Review Board (IRB) will accept and forward requests for a deviation to the appropriate university official for approval determination. The IRB will notify researchers of the outcome of the determination.
Effective March 25, 2020: In the context of evolving circumstances regarding COVID-19 and the University focus on the health and well-being of our researchers and research participants, the Georgia Southern University Institutional Review Board, in consultation with the Vice Provost for Research has temporarily revised its procedure as follows:
- Currently approved studies involving face-to-face interactions with participants are being placed on hold until further notice. Once the hold is lifted, research activity may resume as approved. Renewal applications that are due during the hold should continue to be submitted to prevent study closure.
- Currently approved research that can be conducted remotely (e.g., by Web conference, telephone, email or other means) can continue.
- The IRB will prioritize amendments converting or adding remote procedures to existing studies. [ Amendment Form — Use to request an amendment to an approved IRB protocol. (The form must be accompanied by the updated protocol with changes in underlined text. Only include documents that have changed.)]
[Note: After consulting with Georgia Southern’s cyber security staff, we have concluded that Google Forms is not an appropriate platform for surveys with sensitive topics even when “collect email address” and “limit response” options are unchecked. Recommended surveys platforms are (Qualtrics or SurveyMonkey) using their anonymous security setting. Access to the Qualtrics is available on your my.georgiasouthern.edu portal in the Research Resources section.]
Applications already submitted
- New approvals and renewals for studies involving face-to-face interactions with participants will be processed but approval will be held until the temporary hold has been lifted.
- Application and renewal applications for remote research will continue to be processed by the IRB through email during the hold and research may proceed once the approval letter is received by the researcher.
New application submissions
- New and renewal applications for remote research will continue to be processed by the IRB through email during the hold and research may proceed once the approval letter is received by the researcher.
- New applications for future studies involving face-to-face interactions with participants research will continue to be accepted and processed but approvals will be held until the temporary hold has been lifted.
The IRB will continue to function through email and Virtual meetings and process applications normally.
Questions or concerns about IRB procedure should be directed to firstname.lastname@example.org. The IRB office remains open and is providing full-service remotely.
Major Regulation Changes – The New Common Rule:
- Informed Consent Requirements
- Continuing Review
- Single IRB Review
- Broad Consent and related exemptions 7 & 8 will not be implemented at GS because broad consent restrictions are highly restrictive for investigators. In order to comply with the conditions of broad consent, the institution/researcher would be obligated to track data for each subject offered broad consent. In addition, if a participant in the study declined to provide broad consent, future researchers would be barred from obtaining a waiver of consent for secondary research.
USC Key Changes to the Common Rule (16 min video) USC Policies are compatible with GS policies.
Last updated: 8/28/2020