COVID-19 AND HUMAN RESEARCH STUDIES

In accordance with federal law, the U.S. White House issued a letter of intent to have published in the Federal Register a notice of an extension beyond March 1, 2021 of the national emergency Proclamation 9994 concerning the COVID-19 pandemic. As published February 26, 2021, the COVID national emergency proclamation will remain in effect until rescinded or terminated. Go here for the letter and here for the Federal Register notice. 

In-Person/Face-to-Face Human Research is on Hold Until Further Notice

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 activities with human research participants. Then and now some exceptions apply only if certain conditions are satisfied, including those approved by the Board of Governors of the State University System of Florida.

April 14, 2021 UPDATE: The current FSU COVID-19-related restrictions are under revision, primarily to relax certain restrictions provided that certain IRB conditions (to minimize COVID-19 risks to human subjects or others) for approval are satisfied. Release of the revisions is anticipated no latter than the week of April 26, possibly sooner, to include a broad campus-wide communication.

March 8, 2021 UPDATE: The FSU COVID-19-related restrictions on in-person/face-to-face activities involving human research participants remain in effect. Some exceptions apply (e.g., social distancing, use of protective equipment, no remote alternatives), but these exceptions do not apply to human research involving persons aged 65 or more years or persons identified by the CDC as having certain underlying medical conditions. Therefore, in-person/face-to-face activities involving persons aged 65 or more years or persons with certain underlying medical conditions as human research participants are prohibited. FSU Research leadership and FSU medical expert advisors are aware of emerging scientific data about COVID-19 risks, COVID-19 vaccination and evolving federal agency policy pertaining to fully vaccinated persons, and plan to revisit these restrictions within 30 days. 

Exceptions: 

• Studies involving in-person activities* that conform to required social distancing, COVID-19 risk mitigation, and use of COVID-19-related protocol and consent templates. These conditions are outlined in the FSU Fall 2020 Plan (refer to page 20), approved by the Florida Board of Governors of the State University System of Florida. 
• Studies involving in-person activities* that comprise or are modified to only remote interactions and which activities do not compromise human subject safety;
• Studies* with 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 activities occur only within the context of a necessary clinical care visit and which activities take place only at a licensed health care facility or medical practice office; however, clinical trial-related activities (such as for example screening, follow-up or safety monitoring) that can be done remotely must be done that way; and/or,
• Diagnosis, treatment, interventions, and other research activities* directly focused on COVID-19 or Coronavirus Disease.

For all exceptions, refer to the Requirements for Excepted Studies section below.

*No persons deemed at higher risk for severe illness from COVID-19, including persons who are 65 years of age or older, may be included as participants in any in-person or face-to-face activity, including the exceptions noted above. Refer to this Centers for Disease Control and Prevention (CDC) link for the list of other persons who may be at risk.

**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. Examples that may or may not meet this criterion are provided below.

Examples that may meet the criterion:

• • 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 and the above exceptions.

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Requirements for Excepted Studies

FSU OVPR and the IRB has the following requirements for studies that meet the exception criteria above.

1. No persons deemed at higher risk for severe illness from COVID-19, including persons who are 65 years of age or older, may be included as human research participants in any in-person or face-to-face activity. Refer to this Centers for Disease Control and Prevention (CDC) link for the list of other persons who may be at risk.
2. Remote activities as possible. To the extent possible, study activities that can be done remotely must be done that way. For example, this might include screening or follow-up activities.
3. 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 in-person or face-to-face contact with human research participants. This may be accomplished by including use of barriers between human research participants, between study staff, and between human research participants and study staff; use of alternate, remote communication technology (e.g., web-based communication providers, telephone, email, intercoms) to conduct interviews, interventions or obtain data; and minimizing capacity in all study locations to the minimum necessary to accomplish research objectives for study activities involving human research participants. 
  • 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.

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Related Instructions

1. 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).
2. 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 revising consent forms to include COVID-19-related precautions, available here). 
3. 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.

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Other Requirements

Human Research Participants and Study Staff Who Have COVID-19 or Close Contact with Someone Who Has COVID-19

If a human research participant (human subject) or study staff has COVID-19 or has been in close contact with someone who has COVID-19, take the following actions:

1. Immediately suspend any study activity that involves in-person or face-to-face contact between and among human subjects and/or study staff;
2. Take all steps necessary to eliminate immediate hazards to subjects or staff (see related CDC quarantine guidance, and refer to FSU COVID-19 Workplace guidance and the FSU COVID-19 Case Response Protocol);
3. Promptly (as soon as practicably possible, but no later than 10 days of learning about the incident) report this incident to the IRB as a Report of New Information (RNI), using HRP-214 - FORM - Reportable New Information. The form is also accessible in RAMP IRB under the IRB, Library and General tabs. Include in the RNI form specific information about the COVID-19 case, contact or exposure, study suspension and risk mitigation. The IRB may, based upon its review of the submitted RNI, permit in-person or face-to-face study activities that involve human subjects and study staff who do not have COVID-19 or who have not been in close contact with someone who has COVID-19. In such a case, you may resume these activities ONLY AFTER the IRB has notified you accordingly. For additional detailed information and instructions about the above matter, refer to our COVID-19 FAQs here.

For CDC guidance about what counts as “close contact” go here.

Study location

This temporary cessation and the exceptions noted above apply to research in all settings, including research taking place at other non-FSU institutions.

Exempt research

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:

1. All new applications and modifications that involve COVID-19 or Coronavirus Disease or their impact on ongoing research.
2. All new applications and modifications for activities that are permitted as exceptions under the temporary cessation.
3. All other new applications and modifications. These reviews may be  delayed, so plan accordingly.

New studies or study procedures that involve in-person activities with human research participants will only be referred to the FSU IRB for review if the studies meet the above exceptions and conditions, OR if researchers document in their protocols that such studies or procedures will not be implemented until the FSU cessation is lifted.

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Other COVID-19 Resources

1. To see the review pathway and decision points for studies that may involve in-person research activities, refer our COVID-19 Algorithm; plan accordingly.
2. For related National Institutes of Health (NIH) research guidance click here or the July 2, 2020 FAQs. For related U.S. Food and Drug Administration (FDA) clinical trials guidance (updated September 21, 2020 with FAQs) click here.
3. For comprehensive COVID-19 and Coronavirus Disease-related information, visit the U.S. Centers For Disease Control and Prevention (CDC) link: https://www.coronavirus.gov/; visit this CDC link for re-opening gating criteria or https://www.cdc.gov/media/releases/2020/s0520-cdc-resources-open.html 
4. FSU is offering a complimentary online course, COVID-19: Back to Campus, to train researchers and others on COVID-19 safety; click here for access instructions. The course is scheduled to close October 1, 2021.
5. Check out our slide deck for the March 31, 2020 COVID Town Hall, and or get the Zoom audio recording. Due to the date, this slide deck does not incorporate the additional exceptions announced June 5, 2020. 

IRB-related COVID-19 Frequently Asked Questions

See our IRB-related Coronavirus (COVID-19) Frequently Asked Questions (FAQs) by clicking here.

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