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 some research activities that involve in-person interactions or interventions with human research participants. Although on May 6, 2020 FSU announced a limited Phase 1 expansion of some research activities, the expansion does not apply to in-person activities involving human research participants. The cessation of in-person activities involving human research participants remains in effect, and applies to all ongoing studies or study procedures (including exempt studies or study procedures) that involve in-person interactions or interventions with human research participants except those that involve:
- 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.
*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 conditions.
Requirements for excepted studies
The IRB has the following requirements for studies that meet the exception criteria above.
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 must include the following procedures. These are not considered modifications to the IRB approved protocol and therefore do not require a Modification application before implementation.
- 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. Check with public health or other authorities to see who may be at higher risk.
- 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).
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).
See the Investigator Manual Appendix 12 for additional COVID-19-related guidance and instructions. To find the Appendix 12, log into RAMP IRB; find Appendix 12 under the IRB, Library and General tabs (scroll down to HRP-503A-12).
This temporary cessation applies to research in all settings, unless the study meets the exception criteria.
All ongoing or new exempt research is also subject to the temporary cessation, unless it meets the criteria for excepted studies.
Reviewed by an External IRB
The temporary cessation applies 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 applies to all sites reviewed by the FSU IRB. The FSU study team should report the pause 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 prioritized 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 under the temporary cessation.
- All other new applications and modifications. These reviews may be delayed, so plan accordingly.