COVID-19 Information for Researchers

2021-2022 Research Procedures for Caldwell University Students and faculty

With the roll out of vaccinations, the changes in CDC guidelines, and the relaxation of the state mandates, some in-person research will be allowed to be carried out on campus. The IRB recommends that research projects should be designed for virtual implementation unless there is a strong justification for in-person data collection. These justifications should be clearly spelled out in all initial, renewal, or modification applications that request in-person data collection. Researchers should recognize that in-person research poses an additional potential level of risk/harm to the participant and should carefully consider the ability to effectively mitigate risks such that participant safety and research integrity are assured. Protocols and procedures to mitigate this additional level of risk needs to be outlined in the proposal. 

The following research protocols will be followed at Caldwell University in the 2021-2022 academic year:

• As always, IRB approval is required for any in-person, on-campus human participant research project, whether it is a new study or an existing study being renewed. 
• For research that can be conducted remotely, no additional protocols are necessary, please follow regular IRB guidelines found in the IRB policy and on the website. 
• For research that must be conducted in person, additional protocols and modifications that describe additional COVID-related protections of the research participants and that, at a minimum, align with state, CDC, and institutional guidelines will be required before any research is approved or is allowed to be carried out in person. The IRB will weigh potential risks and benefits to human research participants before approving any protocols and/or modifications.
• To re-open already approved research, the IRB will require all researchers to submit additional safety protocols and amended consent forms to inform the participants of the modifications to the existing protocols. All amended protocols will be reviewed for alignment with state, CDC, and institutional guidelines on social distancing and safe conduct of research. 
• To consider the new protocols, the IRB will require all researchers to submit their safety protocols with their original submission. Consent forms should have an additional section that speaks about informing the participants about keeping them safe during research and about any COVID-related precautions the researchers will be taking in order to keep the participants safe.
• For the applications that request in-person data collection, the researchers must include back up plans should the University go into remote mode during the data collection process. 
•  Additional considerations:
  • The research team should keep a daily log of study participants and any research team members with whom they come in contact, in case this information is needed for contact tracing purposes by local public health officials. To protect confidentiality, logs should not be stored with study data nor linked to a specific study, and they should be destroyed after 30 days.
  • If the study procedures involve use of any shared objects or devices (e.g., pen, computer keyboard, blood pressure cuff), please follow the guidance below.
  • If your study involves a significant risk of viral transmission, (e.g., prolonged close contact between unvaccinated study participants and researchers without effective PPE, etc.), then you must include details in your protocol application about mitigation of risk of SARS-CoV-2 infection, and also include information in the study consent form about this risk and how it will be mitigated. One example of a mitigation strategy could be that participants are required to be vaccinated in order to take part in the study.

This protocol will be reviewed regularly and, if necessary revised based on the local and CDC guidelines. For questions, please contact irb@caldwell.edu.

Cleaning Devices/Objects that Contact Intact Skin

(Adopted from Edgewood College IRB guidance)

Some research procedures require participants to share the use of objects or devices that do not penetrate the skin, such as computers, computer mice, phones, tablets, writing instruments, pedometers, or eye trackers. In general, best practice is to disinfect or sanitize these materials between participant use per device manufacturer guidance and disinfectant manufacturer instructions. The IRB recommends the following common hygiene practices, below, when sharing these objects between participants. Use all disinfectants in accordance with manufacturer guidelines: 

• Encourage participants to wash their hands with soap and water for 20 seconds and dry them before and after using the objects. Though soap and water are usually preferred, commercially prepared hand sanitizer that contains at least 60% alcohol may be substituted. 
• If participants have minor cuts or wounds in the area that will be in contact with the object,have them wear a band-aid or another similar protective cover. 
• If reasonable, have the participants wear disposable gloves or other personal protective equipment. 
• When possible, sheath the object in a plastic sleeve, especially if the object is made of a porous material that cannot be cleaned and sanitized properly or there is prolonged contact with skin. 
• Wipe off any obvious fluids, such as perspiration, between uses. Generally, sweat is not considered to contain materials that may be infectious. Other bodily fluids must be considered as potentially infectious. 
• If the object is constructed of absorbent material, such as fabric or sponge, wash/launder between uses with the highest temperature water allowed. 
• If using blood pressure cuffs, wrap the cuffs over a shirt sleeve or another appropriate material.If that is not possible, wipe the inside of the cuffs clean with sanitizing wipes and dry them before use, and wash periodically using the manufacturer’s instructions. 
• If using an object that uses a liquid gel (such as an ultrasound), sheath the object in a plastic sleeve and use fresh gel for each participant. If not possible to sheath the object, wipe it with a sanitizing wipe or following device manufacturer’s instructions. 
• If an object needs to be disinfected due to frequent touching or potential contamination, consult with the Office of Vice President for Operations prior to use of an appropriate chemical disinfectant to sanitize objects with either  
  • 70-90% ethanol 
  • 1:100 household bleach (or Clorox Bleach Wipes) 
  • ammonium compound such as Cavicide.