Research Integrity & Compliance
Please note that the USF IRB remains fully operational. IRB administration, Chairs, Vice Chairs, managers, and staff are all working remotely and can be reached via email. Contact information is provided below.
For the latest updates from USF on the coronavirus and the university’s response, visit www.usf.edu/coronavirus.
USF IRB SARS-CoV-2 Guidance for the Research Community
The health of our community is critically important to us. During this public health emergency, we recognize that many researchers may have questions about what must be reported to the USF IRB and when. As such, we would like to share this guidance about how severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may impact human subjects research and USF IRB reporting requirements.
Should I continue my ongoing study?
At this time, USF remains open and has not placed any restrictions on ongoing research. We strongly advise researchers to continue the risk-to-benefit ratio when considering whether to continue a particular research study. Researchers conducting studies offering minimal benefits to participants should consider temporarily pausing study activities in order to minimize risks to current and potential participants.
When do I need to obtain prospective approval from the IRB to make a change to my currently approved research and how do I do so?
USF IRB policies and procedures require prospective approval from the IRB before making a change to research unless necessary to eliminate apparent immediate hazards to participants. During the SARS-CoV-2 pandemic, Principal Investigators are responsible for determining whether a particular circumstance requires a deviation from the approved protocol to eliminate an apparent immediate hazard. Any protocol deviations made to eliminate an apparent immediate hazardmust be reported to the USF IRB by completing and submitting a Reportable New Information (RNI) SmartForm in BullsIRB within five (5) business days of the study team’s knowledge of the event. How to submit an RNI is outlined in the HRP-103 – INVESTIGATOR MANUAL.
Screening for SARS-CoV-2 is required by my institution, do I need to submit a modification to the IRB to include this in my protocol?
If your institution/clinic is requiring all patients to be screened for the novel coronavirus for clinical purposes, such screening is considered standard of care and does not need to be reviewed and approved by the IRB. If you want to implement novel coronavirus screening into your research protocol, you must complete and submit a Modification SmartForm in BullsIRB and obtain prospective approval before implementing the screening. How to submit a modification is outlined in the HRP-103 – INVESTIGATOR MANUAL.
How do I report deviations related to SARS-CoV-2?
During this pandemic, some studies may experience an increase in minor deviations due to participants’ unwillingness or inability to present for study visits. Minor deviations must be reported to the IRB during a study’s continuing review. Study teams whose studies require continuing review must complete and submit the Continuing Review SmartForm in BullsIRB as outlined in the HRP-103 – INVESTIGATOR MANUAL.
When and how do I report study suspensions or holds?
During the pandemic, some studies may voluntarily halt subject enrollment or participation. This must be reported to the IRB within five (5) business days by completing and submitting the Reportable New Information (RNI) SmartForm in BullsIRB as outlined in the HRP-103 – INVESTIGATOR MANUAL.
How do I contact the USF IRB if I have a question about my research?
USF IRB staff members, Chairs and Vice Chairs are working remotely. If you have an urgent issue on which you need guidance, please send an e-mail to RSCH-IRB@usf.edu and an IRB Manager will respond as quickly as possible. Applications, including initial applications and modifications, are being processed in the order in which they are received. However, if you need to make revisions to your currently approved protocol as a result of SARS-CoV-2 and need prospective IRB approval before implementing the revisions, please send an e-mail to RSCH-IRB@usf.edu and provide the name of the Principal Investigator, study title and protocol number (Pro XXX or Study XXX) and the reason you are requesting an expedited review and we will do our best to accommodate your request.
Other USF HRPP program staff members and ARC team members are also working remotely and can be reached via the following e-mail addresses:
- For information/questions about single IRB review: RSCH-Reliance@usf.edu
- For information/questions about BullsIRB: RSCHfirstname.lastname@example.org
- For information/questions on research-related conflicts of interest (COI): Coi-Research@usf.edu
- For information/questions on HIPAA: email@example.com
- For information/questions on quality assurance: firstname.lastname@example.org