COVID-19 AND HUMAN RESEARCH STUDIES

The U.S. is operating under the national emergency Proclamation 9994 concerning the COVID-19 pandemic and that this national emergency remains in effect until rescinded or terminated by the President of the U.S. Conditions are dynamic and related policies and guidance evolve accordingly. Refer to the materials below to learn more about how you should or may protect persons (whether vaccinated or unvaccinated) involved in any of your in-person research activities. See also the related Federal Register notice.

In-person Human Research

UPDATE: Normal, pre-pandemic research that involve in-person activities with human research participants may resume effective August 1, 2021. Some exceptions apply (see below). Go here for IRB instructions and related resources.

Exceptions

1. Masks are strongly recommended (and may be required in designated healthcare locations).
2. Full COVID-19 vaccination is strongly recommended for all study staff and human research participants (human subjects).
   
3. Unvaccinated persons with a history of COVID-19 disease or exposure. Unvaccinated individuals (study staff or human subjects) who test positive or come in close contact with known COVID‐19 cases shall not be involved in any in‐person activities involving human subjects for at least 10 (ten) days after testing positive or close contact. A vaccinated individual is a person who has completed, at least 10 days before any in-person human research activity, a full FDA authorized or approved COVID-19 vaccination series.
   1. 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 accessible in RAMP IRB under the IRB, Library and General tabs, and also here. 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 resumption of 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.
   2. For CDC guidance about what counts as “close contact” go here.
4. Human subjects must be informed of the exceptions 1-3 above.

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COVID-19-Related Resources

1. 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 
2. COVID-19 Screening: Refer to the CDC Coronavirus self-checker.
3. COVID-19 Vaccination:
   1. A list of FDA authorized or approved COVID-19 vaccinations is available at this FDA COVID-19 Vaccines web page or here: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.
   2. Vaccination Schedule and Use FAQs: https://www.cdc.gov/vaccines/covid-19/hcp/faq.html#schedule.
4. COVID-19 Precautions:
   1. CDC Return to Work: https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/returning-to-work.html#protect
   2. CDC COVID-19 Prevention: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html.
   3. CDC Persons at Higher Risk: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html. 
5. National Institutes of Health (NIH): for NIH COVID-19-related research guidance click here or the July 2, 2020 FAQs.
6. U.S. Food and Drug Administration (FDA): for FDA COVID-19-related clinical trials guidance (updated September 21, 2020 with FAQs) click here.

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IRB Instructions for Human Subjects Protection and COVID-19

Instructions for resumption of normal, pre-pandemic in-person research activities involving human research participants:

1. If your study was previously approved by the IRB:
   1. Pre-pandemic activities that were previously approved by the IRB and for which activities the IRB approval letter stated did not require subsequent modification and IRB review when COVID-19-related restrictions were lifted, may resume; otherwise proceed to 1b and 1c below.
   2. Required modifications.
      1. Research protocols involving in-person research activities must be modified to include a description, in the procedures section of a protocol, about how the FSU COVID-19 precautions noted above under Exceptions 1-3 will be implemented.
         • COVID-19 screening. The protocol shall describe how COVID-19 screening will be conducted before undertaking any in-person activities. For screening tools, consider adapting questions from or using the following COVID-19 screening link: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/coronavirus-self-checker.html (CDC Coronavirus Self-Checker tool).
         • Notifying prospective human subjects. The protocol shall describe how prospective subjects will be notified about the FSU COVID-19 precautions. See section ii below.
      2. Consent materials must be modified to include a statement to the effect that individuals who have not completed a full COVID-19 vaccination and who have or have had COVID-19 or have been in close contact with someone who has COVID-19 within at least 10 days may not take part in any in-person research activity and that prospective subjects will be screened for this purpose, and that for any in-person research activity the use of masks is strongly recommended (and may be required in certain locations) as is a full COVID-19 vaccination. See Resources below for template language.
   3. To modify a current IRB-approved study to substitute remote with in-person activities, log into RAMP IRB and edit your study by submitting a Modification. For step-by-step instructions, refer to the Researcher's Guide to RAMP IRB, under the Create and Submit a Continuing Review or Modification section. Be sure to revise the procedures section in your current protocol, consent materials as may be applicable, and any instruments or measures as necessary.
2. If you have already submitted your study but it is not yet approved by the IRB:
   1. Once in the IRB queue for review, you can only modify a submission once returned to you by the IRB for clarification or modification.
   2. If you'd like your submission returned to you before further IRB review, log into RAMP IRB and use the Add Comment feature (be sure to select the intended comment recipient) to request return of your submission for modification; to avoid confusion, do not withdraw your submission unless you have first submitted such a comment as IRB review may have already commenced.  
3. If you have not yet submitted your study, prepare your submission consistent with the exceptions and instructions noted above, and refer to the resources below. 

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IRB Resources

Resources for researchers that plan to or are required* to include COVID-19 risk mitigation for their in-person study activities: 

1. Log into RAMP IRB to obtain our protocol and consent-related templates and instructions
   1. For instructions and template language, use our HRP-502COVID-Protocol- and Consent-related COVID Template and Instructions document (under the RAMP IRB Library and Templates tabs);
   2. For a template form to share with human research participants, use our HRP-502iC COVID-19-related Information Sheet template in lieu of revising consent forms to include COVID-19-related precautions. 
   3. Check out our COVID-19 and Human Research algorithm (also here outside of RAMP IRB) to obtain a high-level view of select key decision points for review of in-person study activities involving human subjects. The algorithm spans the pathway beginning with a researcher’s submission of their study for IRB review through to FSU human research regulatory approval for the study to begin.     
2. 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.
   • Communications to subjects explaining the cessation in activities or generally discussing the COVID-19 situation. Communications about modifications and changes in procedures must however be prospectively reviewed and approved by the IRB.

To modify a current IRB-approved study to substitute in-person with remote activities, 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).

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 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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*Special Note:

The IRB may impose conditions for approval of research in order to minimize risks (including COVID-19-related risks) to human subjects and others; these conditions are imposed pursuant to the IRB's authority in accordance with federal law at Title 45 of the U.S. Code of Federal Regulations, Part 46 (45 CFR 46), sections 46.109 and 46.111. Institutional officials are prohibited from approving of any study that is not approved by the IRB, including failure to satisfy the IRB conditions and requirements noted above (45 CFR 46, section 46.112).

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