COVID-19 AND HUMAN RESEARCH STUDIES
To minimize COVID-19 and Coronavirus Disease risks to human research participants and to our community, the FSU Office of Research and the Office for Human Subjects Protection (OHSP) announced the immediate cessation effective March 24, 2020 and until further notice of all research activities that involve in-person interactions or interventions with human research participants (including exempt studies or study procedures); some exceptions apply. On June 5, 2020, FSU announced some further exceptions to the cessation, with conditions approved by the Board of Governors of the State University System of Florida. However, the cessation of other in-person activities involving human research participants for which no exception currently applies remains in effect.
The exceptions to the FSU cessation of in-person activities involving human research participants are listed below:
- Studies involving in-person interactions or interventions that comprise or that can be modified to appropriate remote interactions (e.g., web-based, telephone calls, emails) and which interactions and interventions don’t compromise human subject safety;
- A substantial likelihood of direct and meaningful biomedical or behavioral health-related benefit or outcome* for individual human research participants;
- Clinical trials where all in-person interactions and interventions occur only within the context of a necessary clinical care visit and for which continuing interactions and interventions take place only at a licensed health care facility or medical practice office; clinical trial-related activities (such as for example screening, follow-up or safety monitoring) that can be done remotely must be done that way; or,
- Diagnosis, treatment, interventions, or other research activities directly focused on COVID-19 or Coronavirus Disease.
- (NEW, effective June 10, 2020 and until further notice) Studies involving in-person interactions and interventions that conform to required conditions for social distancing, COVID-19 risk mitigation, use of related protocol and consent templates, and exclusion of persons deemed at higher risk for severe illness from COVID-19. Refer to our HRP-502COVID-Protocol- and Consent-related COVID Template and Instructions document here for more details. These conditions are included in the COVID-19-related FSU Fall 2020 Plan (refer to page 20) which was approved by the Florida Board of Governors of the State University System of Florida.
*Substantial likelihood of direct and meaningful biomedical or behavioral health-related benefit or outcome means that participation in the study has a good probability of directly having a meaningful positive impact on the serious medical or serious psychological condition of individual subjects for one or more of the study groups.
- Mitigation or cure of a serious disease
- Significant reduction of serious disease burden
- Treatment or stabilization of a serious medical or psychological condition that is having a significant negative impact on the human research participants.
- Diagnosis of a serious condition that is treatable and that would otherwise not be known to the human research participant
- Pharmacologic or non-pharmacologic self-management for diabetes or cancer symptoms
Examples that do not meet this criterion, unless they are focused on COVID-19 or Coronavirus Disease:
- Most Phase 1 trials of investigational drugs
- First-in-human studies of an investigational drug or device
- In-person interactions for most social and behavioral research
- A descriptive study of drug use among college students
Studies that are subject to this temporary cessation do not need to report the cessation to the FSU IRB but should follow instructions below for modifying study activities if changes will be made to the research procedures to accommodate this temporary cessation.
New studies or study procedures that involve in-person interactions or interventions with human research participants will only be accepted for FSU Institutional Review Board review if the studies meet the above exceptions and conditions, OR if researchers document that such procedures will not be implemented until the FSU cessation is lifted.
Requirements for excepted studies
FSU OVPR and the IRB has the following requirements for studies that meet the exception criteria above.
No persons deemed at higher risk for severe illness from COVID-19, including persons who are 65 years of age older, may be included as participants in any in-person or face-to-face interaction or intervention. Refer to this Centers for Disease Control and Prevention (CDC) link for the list of other persons who may be at risk.
Remote activities as possible. To the extent possible, study activities that can be done remotely should be done that way. For example, this might include screening or follow-up activities.
COVID-19 screening of human research participants and staff, and other preparations, before in-person interactions. All studies that meet the excepted criteria should include the following procedures unless otherwise specified or required, including submission of related study modifications when applicable.
- Avoid all human research participants with confirmed COVID-19 infection or Coronavirus Disease, unless this is the focus of the study.
- Decrease potential exposure for participants and study staff at increased risk of severe illness from COVID-19, such as for example persons who are immuno-compromised. Monitor public health information or guidance to see who may be at higher risk, or refer to our HRP-502COVID-Protocol- and Consent-related COVID Template and Instructions document (under the IRB, Library and Templates tabs, available here, for links and related information.
- Have a protocol for non-contact screening of human research participants and study staff for COVID-19, Coronavirus Disease or high risk of infection. For screening tools, consider the following COVID-19 screening links: https://www.apple.com/covid19/ (Apple/CDC link) or https://covid19chat.clevelandclinic.org/ (Cleveland Clinic link).
- Reduce face-to-face contact with human research participants. This may be accomplished by including barriers or use of alternate, remote communication technology (e.g., web-based communication providers, telephone, email, intercoms) to conduct interviews and obtain data.
- Implement all required and recommended Universal Precautions and use of Personal Protective Equipment (PPE). For Universal Precautions and PPE information, go to: https://www.cdc.gov/coronavirus/2019-ncov/hcp/caring-for-patients.html.
Log into RAMP IRB to obtain our HRP-092 SOP for COVID-19-related risk mitigation planning; you will find the SOP under the IRB, Library and Standard Operating Procedures tabs (scroll down to HRP-092). For guidance, you may use our HRP-350 Worksheet (Research-specific COVID-19 risk mitigation plan); find HRP-350 under the IRB, Library and Worksheets tabs (scroll down to HRP-350).
NEW! For protocol and consent-related templates and instructions, use our HRP-502COVID-Protocol- and Consent-related COVID Template and Instructions document (under the RAMP IRB Library and Templates tabs, also here; for some studies you may use our COVID-19-related Information Sheet template in lieu of revised consent forms, available here).
Modifications. IRB approval is required before implementing any changes to studies except for:
- Changes necessary to eliminate an immediate hazard to subjects or staff. These must be reported within 10 days to the IRB, using the Report of New Information (RNI) process.
- Exempt studies. Modifications are not required for exempt studies unless the change potentially reduces confidentiality and/or data security.
- Communications to subjects explaining the cessation in activities or generally discussing the COVID-19 situation. Communications about modifications and changes in procedures should be prospectively reviewed and approved by the IRB.
Log into RAMP IRB to use our HRP-219 Form (COVID-19 Modification) for COVID-19-related study modifications; you will find HRP-219 under the IRB, Library and General tabs (scroll down to HRP-219). For guidance, you may use our HRP-350 Worksheet (Research-specific COVID-19 risk mitigation plan); find HRP-350 under the IRB, Library and Worksheets tabs (scroll down to HRP-350). For protocol and consent-related templates, use our HRP-502COVID-Protocol- and Consent-related COVID Template and Instructions document (under the IRB, Library and Templates tabs, also here).
See also HRP-103A-12 COVID-19 Considerations for Investigators Conducting Human Research (an Appendix 12 to the FSU Investigator Manual) for additional COVID-19-related guidance and instructions. To find the the appendix, log into RAMP IRB; under the IRB, Library and General tabs, scroll down to HRP-103A-12 COVID-19 Considerations for Investigators Conducting Human Research.
To see the review pathway and decision points for studies that may involve in-person research activities, check out our COVID-19 Algorithm.
This temporary cessation and the exceptions noted above apply to research in all settings, including research taking place at other non-FSU institutions.
All ongoing or new exempt research are also subject to the temporary cessation unless these research meet the criteria for excepted studies.
Reviewed by an External IRB
The temporary cessation and the exceptions noted above apply to all FSU-conducted research, even if reviewed by an external (non-FSU) IRB. Contact your external IRB for required reporting or communications. For multi-site studies, you may need to work with the core or coordinating center, central study site and/or single IRB.
Other sites reviewed by the FSU IRB acting as the Single IRB
This temporary cessation and the exceptions noted above apply to all sites reviewed by the FSU IRB. The FSU study team should report the cessation and exceptions to the non-FSU sites and to the IRBs (or other compliance office, if no IRB) at the non-FSU sites.
Effect on new and pending IRB applications
New applications and modifications may still be submitted for review, will be triaged for review, and are still subject to the temporary cessation unless they meet one or more of the criteria for excepted studies. New applications and modifications are prioritized as follows:
- All new applications and modifications that involve COVID-19 or Coronavirus Disease or their impact on ongoing research.
- All new applications and modifications for activities that are permitted as exceptions under the temporary cessation.
- All other new applications and modifications. These reviews may be delayed, so plan accordingly.