UF IRB Offers Guidelines for Research Resumption
As UF Research moves to Stage 2 of research resumption, the UF Institutional Review Board (IRB) has provided guidelines for IRB requirements related to research resumption. For more information, please visit the UF Research Resumption Plan and UF IRB COVID-19 Response websites.
- Q: How do I know if my research protocol can resume?
The resumptions of all human subjects research must follow the guidelines found at https://research.ufl.edu/wp-content/uploads/UF-Research_ResumptionPlan_FINAL_rev_0518.pdf and at https://clinicalresearch.ctsi.ufl.edu/covid-19/resuming-hsr-study-activities/
- Q: What changes to my protocol require pre-approval from the IRB before the change is made?
For changes resulting from the COVID crisis to already IRB approved protocols, any research activity that can be changed to a remote activity does not require approval from the IRB (see http://irb.ufl.edu/index/covid-19-resources.html). Any change to a research activity that cannot be conducted remotely must have pre-approval from the IRB before the change can be made. Also, any change to the informed consent process must be submitted and approved by the IRB prior to making the change.
- Q: Is there anything specific we should tell study subjects as we contact them to re-start their research involvement?
Yes, the IRB has provided template language that can be adjusted to fit any research protocol. This should be used regardless of the type of study subject contact (e.g. phone, email, letter). See http://irb.ufl.edu/index/covid-19-resources.html for template.
- Q: What if I am allowed to resume my research and subjects who have already consented want to delay their involvement?
If a study subject does not want to come on site, and there cannot be an accommodation that allows them to continue (e.g. remote visits, further delay in restarting for an individual subject), then the PI should inform the study subject that he/she will be withdrawn from the protocol.
Changes to the Informed Consent Process
Per the IRB’s COVID-19 Investigator Guideline, any change in the method for obtaining informed consent must be approved by the IRB prior to implementation. Please note that the updated informed consent method must be detailed in your protocol and on the Informed Consent Process SmartForm page. For example, your method for distributing the consent to the participants (i.e., via a link in an email for e-consent, or via mail with a stamped return envelope for telephonic consent), and how you will receive the signed form must be detailed. Study procedures and/or data collection cannot begin until a fully signed consent form is received.
Electronic Informed Consent Forms (eIC or eConsent) have been used more frequently to supplement or replace paper-based informed consent processes. Electronic Informed Consent Forms may be used to provide information usually contained within the written informed consent document, evaluate the subject’s comprehension of the information presented, and document the consent of the subject or the subject’s legally authorized representative (LAR). The UF IRB has approved the REDCap version of the eIC process, and confirmed that it meets all local and federal consenting requirements. If you wish to use REDCap as your eIC option, please review our Electronic Informed Consent Forms – eIC Guideline.
For Telephonic Consent, unanticipated telephone consent may be allowed for certain situations, but if you perceive the need for a telephone consent process as a standard part of your research, you will need to submit a revision to your study. For more information and telephonic consent procedures, please review the IRB’s Telephonic Consent Guideline.
For more information, please see the IRB website at http://irb.ufl.edu/. If you have any questions, please email irb@ufl.edu.
