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Effective, Monday, July 6, 2020, Augusta University will enter the second stage of Augusta University’s “phased return of Research.” During phase two, we will continue the expansion of the previously allowed essential research activities (see the announcement from March 23, 2020) and those activities permitted under the first phase of expansion of research (see the announcement from May 29, 2020). In this phase, PI’s in conjunction with their Department Chair (and where appropriate their Dean or Vice President) will determine, and develop a plan for, what research may additionally be initiated/conducted by using the following guidelines and criteria.
o For Basic Science and Animal Research, Phase 2 activities are expanded to include the performance of funded and investigator-initiated projects intended to generate new, confirmatory, and exploratory findings and knowledge.
o For Human Subject Research, Phase 2 activities are expanded to include new non-COVID-19 related studies.
All Basic Science, Animal, and Human Subject Research continues to 1) be expected to be conducted based on the lab’s/research team’s Standard Operating Procedures (SOPs), in accordance with their Biosafety Protocol and other AU/AUHS policies, 2) to be conducted in compliance with the Research guidance provided in the first stage of the expansion of the “phased return to research” at Augusta University dated May 29, 2020, and 3) to be conducted consistent with the AU guidance regarding personnel returning to campus for the 2020 fall semester. This includes, but is not limited to, adherence to social distancing, use of PPE, and handwashing guidance. It should be noted that we continue to remain in a rapidly changing environment; if we, unfortunately, see a further expansion of COVID-19 disease in the community, we may need to revert to more significant restrictions on the conduct of research activities.
Will the IRB Office continue to operate?
Answer: Yes, the IRB Office continues to function. You can call our direct telephone numbers or the general office number (706-721-3110) for assistance at any time during normal business hours. IRB Chairs and reviewers are available to review your submissions, and IRB meetings are being held as scheduled via videoconference. The IRB submission deadlines for full review submissions remain applicable.
Can I place my study on temporary hold during this time?
Answer: Guidance has been published which will provide you information regarding whether your study should be placed on hold. Please see the Guidance Document: COVID-19 and Human Subject Research. IRB submissions regarding temporarily delaying enrollment and/or in-person study interactions are not required; however, you are required to document these actions via a Note-to-File. For studies reviewed by an external IRB, you should confirm reporting requirements with the external IRB.
My protocol involves in person visits. Can I change these to virtual visits?
Answer: If your protocol involves essential and non-essential interactions and you choose to change in-person visits to virtual visits (telephone, videoconference, etc…) to ensure continuity within the study, this would be considered a minor protocol deviation that does not require IRB approval before implementation. You must document this minor protocol deviation via a Note-to-File, which explicitly indicates the reason for the deviation is related to COVID-19 precautions, and retain it in your study records. Minor protocol deviations are reported to the IRB at time of Continuing Review or Annual Report through submission of a Deviation Log. These changes do NOT require prior IRB approval.
Please be aware an amendment must be submitted for prior IRB approval if changing the method of data collection or interaction changes the study from collecting anonymous or de-identified data to collecting identifiable or coded data. Please call the IRB Office (706-721-3110) for consultation if you need assistance making this assessment.
I have a study related to COVID-19 that I need to submit to the IRB. Is this allowed?
Answer: Initiation of clinical trials, emergency use treatment, or expanded access require notification and approval by the Dean of your College, and approval by the Sr. Vice President for Research (email: email@example.com), with adherence to the IRB policies regarding Human subjects research, Emergency Use and Expanded Access (Compassionate Use). If you receive approval to proceed please ensure the study title uses the prefix “[COVID-19]” so that we may ensure timely review of the study.
Does the COVID-19 Guidance for Investigators apply to studies that are reviewed by an external IRB?
Answer: Yes, the guidance applies to all human subject research conducted at Augusta University; however, you must check with the external IRB (reviewing IRB) regarding their reporting requirements related to the guidance.
Am I required to submit the COVID-19 Guidance for Investigators to the external IRB?
Answer: The AU IRB Office has sent the guidance to Western IRB (WIRB), Advarra, and the NCI-CIRB. If your study is reviewed by another external IRB under a reliance agreement, please feel free to share the guidance documents with the lead PI and reviewing IRB.
I need to make changes to my exempt protocol based on the COVID-19 Guidance for Investigators. What should I do?
Answer: Please submit the Exempt Studies Amendment Request Form. The IRB will review your changes and provide you guidance on whether the changes require an amendment.
I am teleworking. Can I take research related files including subject research files from Augusta University site?
Answer: Subject files that contain protected health information (PHI) or identifiable information may not leave Augusta University. You may remove all identifiers and take a copy of subject files with you; however, these files should be retained in a secure location and all copies should be returned to AU and shredded.
We encourage the use of the Human Box folder for storing study-related files, which will allow remote access to these files. Please visit the IRB Office website to request a Human Box folder if your study does not already have one.
What are the approved methods for accessing research related files electronically?
Answer: We encourage the use of the Human Box folder for storing study-related files, which will allow remote access to these files. Please visit the IRB Office website to request a Human Box folder if your study does not already have one.
Will I experience delays in IRB Submissions/Approvals?
Answer: The IRB does not currently project delays during this time; however, please review the COVID-19 Guidance for Investigators as there are restrictions regarding the types of new studies that will be allowed to open.
I have a submission pending IRB approval. What should I do?
Answer: The IRB Office is currently evaluating each pending IRB submission based on the COVID-19 Guidance for Investigators. You should receive correspondence from the IRB within the next week regarding the status of the release of the submission approval.
I’d like to submit a retrospective chart review study. Can I do so at this time?
Answer: Yes, the IRB will review chart review studies that are retrospective in nature.
Can I submit a new study that involves an online survey and no face-to-face interactions?
Answer: Yes, the IRB will review this study as it does not involve face-to-face interactions.
Will the IRB Office still be conducting scheduled audits?
Answer: Yes. As much as possible, research files will be reviewed virtually using institutionally approved methods such as Human Box, conducting a WebEx, etc. Study teams are not expected to start scanning documents and saving files to BOX at this time. If files are not available for an audit electronically, a physical review of the files will be conducted at a later date.
If I am the lead PI of a multi-site study, should the other site(s) follow AU policies and guidelines or the other site’s policies and guidelines?
Answer: Investigators should adhere to the guidelines of AU and the non-AU site should adhere to the guidelines of their institution. However, any disruptions in research activities will need to be reported to the appropriate IRB according to the reviewing IRB policies. For studies in which Augusta University is the IRB of record, a Reportable Event should be submitted in IRBNet noting the protocol deviation(s) and include the study activities that are affected. If there are concerns regarding subject safety, please consult with the AU IRB Office.
I am the lead PI of a multi-site study and I have decided to delay enrollment and study-related activities temporarily. What are my obligations regarding the other sites?
Answer: As the lead PI, you are responsible for notifying all other sites regarding the decision to temporarily delay enrollment and study-related activities. The AU site and the other sites are obligated to following requirements of the reviewing IRB and relying institution.
Need an expert for your upcoming story on COVID-19? Augusta University is ready to help.
These are just some of the donations we are anticipating this week and beyond.