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CSU COVID-19 Procedures for Research with Human Participants

Engaging in Face-to Face Research with Human Participants

Researchers should provide all interested participants with information regarding CSU COVID-19 safety protocols prior to their coming to campus. These protocols can be found here. Researchers should explicitly state that participants should wear a face mask, practice physical distancing, monitor for symptoms, and utilize proper hand hygiene. Researchers may not ask participants if they are vaccinated, or for any proof of vaccination. It is also recommended that researchers also self-screen prior to coming to campus. Researchers will no longer be required to submit a COVID-19 safety plan application to the Research with Human Participants COVID-19 Review Panel (RHPCRP). However, an informed consent statement regarding COVID-19 will still be required. Please see below for details regarding guidance for engaging in research with human participants. For additional questions or concerns regarding research with human participants and COVID-19, please contact RHPCRP@csuohio.edu.

General Procedures
For research with human participants that is being conducted remotely:
  • Log on to Cayuse IRB and attest that research is being performed remotely.
For on-campus face-to-face research with human participants:
  • Log on to Cayuse IRB and attest that you agree to follow CSU COVID-19 Procedures for Research with Human Participants.
  • Submit an updated study informed consent (and assent if necessary) with the COVID-19 statement and any changes to the research protocols as necessary to Cayuse IRB.
For off-campus face-to-face research with human participants:
  • Log on to Cayuse IRB and attest that you agree to follow CDC and site COVID-19 guidelines.
  • Submit an updated study informed consent (and assent if necessary) with the COVID-19 statement and any changes to the research protocols as necessary to Cayuse IRB.
Quick Links
Specific Guidelines
Guidelines for Researchers

Please note - these are the minimum recommendations. Any researcher and/or participant may choose to use advanced PPE under any circumstances, particularly when working with higher risk individuals. To request masks (cloth, surgical, or N95) or face shields, research supervisors/primary investigators should contact Dave Diggins at d.diggins@csuohio.edu or Brandon Dugan at  b.c.dugan@csuohio.edu. Please provide the name, CSU ID#, and PPE needs for each member of the research team. Researchers will be responsible for any additional PPE, including gloves and gowns/lab coats.

  • If the research involves interaction with the participant and can maintain a minimum of 6 feet of physical distance, or is within 6 feet, but with an effective barrier (ex. glass or plexiglass barrier, cubicle), the following PPE should be worn:
    • Research Personnel - N95 mask strongly recommended (cloth mask at minimum)
    • Participant - Cloth face covering
  • If the research involves interaction with the participant within 6 feet without an effective barrier, the following PPE should be worn:
    • Research Personnel - N95 mask strongly recommended (single-use surgical mask at minimum), and face shield
    • Participant - Cloth face covering
  • In the event that wearing a mask would lead to potential interference with the research protocol, such as during heavy physical exertion, or in studies performing observations of facial expressions/body language, etc., a minimum of 6 feet must be maintained between the investigator and any other research participants, as the study permits, and the following PPE should be worn:
    • Research Personnel - N95 mask strongly recommended (single-use surgical mask at minimum), and face shield, and face shield
    • Participant - None during testing phase; cloth mask when able
  • If investigators absolutely must come closer than 6 ft to the research participant while they are performing heavy physical exertion as part of the testing protocols, the following PPE should be worn:
    • Research Personnel - N95 mask strongly recommended (single-use surgical mask at minimum), disposable lab coat*, face shield, goggles and gloves**.
    • Participant - None during testing phase; cloth mask when able

*One may use a reusable cloth lab coat, but it must be washed with bleach between uses with different participants.

** Gloves are generally not recommended in typical public interactions. Instead, frequent handwashing and/or hand-sanitizing is recommended. However, it will be left to the discretion of the researchers whether or not they choose to wear gloves. Please be aware that if a researcher chooses to wear gloves, they should discard old gloves and put on a new pair of gloves frequently (i.e., after each subject, after transiting from one area to another, etc.), and that their hands should be thoroughly sanitized between changing gloves. Here are the recommendations of the CDC on wearing gloves.

For proper donning and doffing of PPE, please see this website.

COVID-19 Consent Statement

All research must be approved by the Institutional Review Board (IRB). For off-site research, site IRB-approved procedures should be followed unless the site does not have an IRB, in which case, CSU IRB procedures should be utilized. Prior to restarting research with human participants, all investigators doing face-to-face research with human participants must submit an amendment to the IRB that includes the following statement on the informed consent:

"COVID-19 is a highly contagious virus.  It has been linked to severe illness, and in rare cases, death. This is particularly true for individuals over the age of 60.  It is also true for those with compromised immune systems. The research team is using reasonable measures following Centers for Disease Control (CDC) guidelines.  This is intended to minimize potential exposure to COVID-19. Given the highly contagious nature of COVID-19, exposure avoidance cannot be guaranteed.  

I understand that my participation in this research may increase my risk of exposure to COVID-19. I accept this risk.  I assume full responsibility for any associated medical care or treatments.   I waive any claim against the State of Ohio for such medical care or treatment.  I waive any claim against Cleveland State University, its Trustees, officers, or employees for any such care or treatment.  I understand I am not waiving my right to claim and collect compensation related to malpractice, fault or blame on the part of the researchers. I will notify a member of the research team should I test positive for COVID-19 within 14 days of research participation. For general CDC guidance for COVID-19, please visit the following site: https://www.cdc.gov/coronavirus"

If performing research with minors with a reading grade level below 8th grade, the following statement should be used on the assent:

"COVID-19 is a virus that can make people sick. It can also spread easily. The study team has rules to help prevent COVID-19. However, there is still a risk that you could get COVID-19. By writing your name on this paper, you show that you understand. This also means you accept this risk. If you get sick, tell your parent/guardian. Also, please let the study team know if you get sick."

This statement should be read aloud to all participants, and it is imperative to ensure that participants (and guardian as necessary) demonstrate understanding to the investigator of the risks involved.

Measures done to limit the risk of COVID-19 disease exposure, such as screening staff and participants, practicing physical distancing, wearing a mask or other PPE, testing for COVID-19, or reducing the number of individuals in a lab area are not considered part of the research and therefore do not require an IRB amendment to the protocol (unless requested by an external IRB or funding source). However, in the case that exclusion criteria or research protocols are changed due to COVID-19, this must be approved by the IRB.

All research personnel, including faculty, students, or technical staff must not be required to engage in research activities that they are not completely comfortable with.

Cleaning and Disinfecting Guidelines

Any piece of equipment or physical item that research participants make physical contact with should be disinfected before and after each participant. Ensure that your research personnel and participants have access to all necessary supplies, including paper towels, waste baskets, cleaners and disinfectants, and hand sanitizer that contains at least 60% alcohol. Clean and disinfect all surfaces that may have been contacted by participants using EPA approved disinfectants. For a list of these products and instructions on their proper use, please see this website.

To request cleaning and disinfecting supplies (disinfecting wipes and sprays, hand sanitizer, etc.) please contact FAST at (216) 687-2500.

Cleaning refers to the removal of germs, dirt, and impurities from surfaces. It does not kill germs, but by removing them, it lowers their numbers and the risk of spreading infection.

  • Soap and water will be used for routine cleaning of surfaces

Disinfecting refers to killing germs on surfaces. This process does not necessarily clean dirty surfaces or remove germs. But killing germs remaining on a surface after cleaning further reduces any risk of spreading infection. The CDC recommends disinfecting all frequently touched surfaces.

Recommended disinfectants as deemed appropriate by the CDC will be used after each in-person session.  These solutions include but are not limited to:

  • Alcohol solutions with at least 70% alcohol
  • Lysol/Clorox all-purpose cleaner or disinfecting wipes
  • Bleach solutions diluted (1/3 cup bleach per 1-gallon water) - Solution must sit for a minimum of 1 minute on surface.

Most surfaces and objects will only need routine cleaning.  Frequently touched surfaces will need disinfecting.  All objects to be disinfected should be cleaned with soap and water first and then disinfected to further reduce the risk of germs on surfaces and objects.

Frequently touched surfaces have been identified but not limited to the following:

  • All tables, doorknobs, light switches, countertops, handles, desks, phones and keyboards.  (Electronics should only be disinfected with alcohol ONLY)

Proper hand-washing and/or hand-sanitizing techniques is recommended for both investigators and research participants before and after testing, and during testing if physical contact is made. Please see this website regarding hand hygiene.

Reporting Covid Cases

In the event that research personnel or a participant becomes infected with COVID-19, researchers and/or participants should contact their physician or healthcare provider immediately, seek medical care as necessary, and quarantine until they have been  cleared to return to campus by their healthcare provider. Personnel or research participants who were in close contact with the infected individual (close contact = spent >15 minutes within 6 feet of the person) should self-quarantine until contacted by County or City Public Health contact tracers and follow all additional guidance of County or City Public Health contact tracers.

A log of each day's participants should be recorded and maintained in a secure location. These should be kept for 3 weeks in case of a positive COVID-19 test, and then securely destroyed. In the case of anonymous research, data should be collected anonymously. However, participants should be notified that anonymity cannot be assured due to the pandemic and contact tracing procedures. A statement reflecting this will need to be included in the updated informed consent.

In studies involving pediatric or disabled participants, parents/guardians/caregivers, and participants should abide by the above protocol. Clinicians or other non- participants must also follow the above protocol.

Frequently Asked Questions

Can I require members of my research team to get vaccinated? No, you cannot require other research personnel to get vaccinated. You may ask employees for vaccination status, but you may not require proof.

Can I ask participants if they're vaccinated? No, you cannot ask participants if they're vaccinated. It is recommended that you explain CSU safety protocols prior to their visit to campus.

If I'm fully vaccinated, do I have to get tested for COVID-19 or quarantine if I'm exposed to someone who tests positive for COVID-19? As per updated CDC guidelines, if you were in close contact (more than 15 minutes of accumulated time in a 24-hour period) with an individual who had suspected or confirmed COVID-19, you should be tested 3-5 days after exposure, and wear a mask in public indoor settings for 14 days or until you receive a negative test.

If I had COVID-19 and now have antibodies, but I haven't gotten the vaccine, can I follow the guidelines for vaccinated individuals? While you have a high likelihood of immunity, and it is unlikely that you will transmit the virus, you must still follow guidelines for unvaccinated individuals. This is because the CDC has not yet come out with guidelines for individuals with prior COVID-19 infection.

I've been vaccinated but am having COVID-19 symptoms or I have tested positive for COVID-19. What should I do? If you are experiencing symptoms, stay home and seek medical attention. If you are vaccinated and test positive for COVID-19, you should stay home and consult your medical care provider about what actions you should take.

Can I prescreen research subjects for symptoms? Prior to research visits, researchers should ask their participants to either be vaccinated or wear facemasks and physically distance, as outlined in CSU policy. If they are symptomatic, they should be advised to not come to campus or engage in face-to-face research visits.

For additional questions or concerns regarding research with human participants and COVID-19, please contact RHPCRP@csuohio.edu

  • RHPCRP Chair: Emily Kullman
Additional Resources