The intent of these procedures is to minimize the risk of COVID-19 disease exposure and to protect the health and safety of all individuals involved in conducting in-person research with human participants. Failure to comply with these procedures may result in the suspension of research.
Summary of restarting human-participants research
Below is an outline of the procedures required to re-initiate research with human participants. Each new and currently IRB-approved study will need clearance to be restarted. Detailed procedures are found following this outline.
For research with human participants that is being conducted remotely:
- Log on to Cayuse IRB and attest that research is being performed remotely
For face-to-face research with human participants:
- Complete CITI COVID-19: Back to Campus training module
- Obtain approval from your Department Chair (or School Director) and College Dean (or designee). Both must sign-off on the CSU COVID-19 Safety Plan for Research with Human Participants
- Submit the CSU COVID-19 Safety Plan for Research with Human Participants to the Research with Human Participants COVID-19 Review Panel (RHPCRP) at RHPCRP@csuohio.edu
- Once approval from the RHPCRP is obtained, log on to Cayuse IRB and attest that research will be done face-to-face. The approval letter from RHPCRP, the CSU COVID-19 Safety Plan for Research with Human Participants, as well as completion certificates of the CITI COVID-19 training module for all study personnel will need to be attached in the “COVID-19” section of Cayuse IRB
- Submit 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
- Research may not commence until final IRB approval is granted*
*Please note that all research activity is subject to change based on federal, state, local, and university requirements and recommendations.
Prior to restarting research with human participants
Any study that can collect data remotely should do so. All research must be approved by the Institutional Review Board (IRB). Face-to-face research with human participants done on-campus must also be approved by the Department Chair (or School Director), and the College Dean (or designee). 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 a modification 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. These measures include social distancing where possible. They also include proper personal protective equipment (PPE) use. Physical contact will be minimized. Strict disinfecting procedures are adhered to. 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 wave 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.”
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 modification 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. Furthermore, all face-to-face studies must submit a CSU COVID-19 Safety Plan for Research with Human Participants to the RHPCRP, and obtain approval prior to submitting materials to the IRB. Additionally, all research team members must complete the CITI COVID-19: Back to Campus training module and submit certificates of completion to 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.
Prior to every visit to campus, all participants involved in human research must complete the “Campus Visit Pre-Screening Checklist.” Research participants must be screened by phone or email within 24 hours of coming to the CSU campus. No one may come to the CSU campus or participate in in-person research if they, or any members of their household, are experiencing the symptoms outlined on the checklist. CSU research personnel must complete the CSU COVID-19 Self-Assessment immediately prior to traveling to campus.
For every visit to campus, research participants must also complete the “COVID-19 Screening Questionnaire” immediately upon arrival to campus. Only participants who answer “No” to all questions may be allowed to participate in face-to-face research that day.
Decisions about in-person visits for people at higher risk should be especially cautious. Screening questions may be altered to include the following:
- Based on what we know now, those at high-risk for severe illness from COVID-19 are:
- People 60 years and older
- People who live in a nursing home or long-term care facility
- People of all ages with underlying medical conditions, particularly if not well controlled, including:
- People with chronic lung disease or moderate to severe asthma
- People who have serious heart conditions
- People who are immunocompromised
- Many conditions can cause a person to be immunocompromised, including cancer treatment, smoking, bone marrow or organ transplantation, immune deficiencies, poorly controlled HIV or AIDS, and prolonged use of corticosteroids and other immune weakening medications
- People with severe obesity (body mass index [BMI] of 40 or higher)
- People with diabetes
- People with chronic kidney disease undergoing dialysis
- People with liver disease
Each research laboratory/room should have a shared electronic schedule (i.e., Google Calendar, Google Docs., etc.) that is accessible to all researchers using the space. Researchers will need to post the times of their research activities on the schedule, and they may not overlap times that other researchers are utilizing the space. Research participants will enter and exit the testing facility through different designated doors if the research facility permits.
All research personnel must take their temperature prior to coming to campus. In the event that they have a temperature of greater than 100.4oF, or if they are exhibiting any symptoms of illness, they must cancel all testing immediately and contact their healthcare provider for appropriate diagnostics. Upon arrival on campus, all research participants should be given a disposable mask if they do not have their own mask, and their temperature should be taken with a touchless thermometer. Anyone with a temperature greater than 100.4oF will not be permitted to partake in research and will be directed to contact their healthcare provider.
Please note - these are the minimum recommendations. A researcher 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 email@example.com or Brandon Dugan at firstname.lastname@example.org. 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 goggles, 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 – Cloth face covering
- 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 – Surgical mask 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 – Surgical mask 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 - Surgical mask, 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.
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 must be followed by both investigators and research participants before and after testing, and during testing if physical contact is made. Please see the this website regarding hand hygiene.
A log of each day’s participants should be recorded and maintained in a secure location. These must be kept for 3 weeks 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.
Reporting Covid Cases
In the event that research personnel or a participant becomes infected with COVID-19, researchers should contact CSU Health and Wellness services immediately, seek medical care as necessary and quarantine until they have been cleared to return to campus by CSU Health and Wellness. 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 be notified and should self-quarantine for a minimum of 14 days and follow any additional guidance from CSU Health and Wellness. Research that is being conducted by the affected researchers will need to be suspended until researchers have been cleared to return to campus.
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.
For questions or concerns regarding research with human participants and COVID-19, please contact RHPCRP@csuohio.edu
- Chair: Emily Kullman
- Members: Elizabeth Goncy, Conor McLennan, Deborah Espy, Joan Thoman, Doug Wajda
- CSU COVID-19 Guidance for Research
- CSU Making the Campus Safe
- CDC COVID-19 Resources
- CDC COVID-19 Information for Building Safety
- CDC Hand Hygiene
- CDC PPE Use
- EPA Approved Disinfectants
- EPA Safe and Effective Disinfectant Use
- OSHA COVID-19 Resources
- Ohio Public Health Advisory System
- Ohio Travel Advisory
- CDC Contact Tracing Plan