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IRB Guidance During COVID-19

The IRB recognizes the importance of the safety of Human Subjects Research (HSR) to the campus community and society at large. Continuing HSR during COVID-19 (SARS-CoV-2) is an important function of faculty, staff, and students of the university. 

As of Summer 2022, the Chancellor has directed our campus to be ‘business as usual. Researchers are allowed to engage in HSR with normalcy (before COVID-19) until directed differently. However, as part of our effort to protect human subjects from potential infection risks of COVID-19, we advise researchers who engage in HSR to follow the current IRB COVID-19 prevention guidelines described below.

Current IRB COVID-19 Guidelines

All on-campus HSR at TAMUT must follow the university’s COVID guidelines. Off-campus must comply with the authority of the off-campus research site. 

All personnel, including researchers and human subjects, should stay home if they have any COVID-like symptoms, including fever, cough, or difficulty breathing. 

Anyone who tested positive is strongly requested to report to the university’s COVID prevention team using the COVID-19 portal and follow the CDC’s guidance on self-isolation. 

Anyone with exposure should follow CDC guidance on testing and preventing illness spread. 

All HSR (human subjects research) conducted on our campus must follow the guidance of the university. 

Protective measures

Protective measures such as mask requirement, social distancing, and so on are not mandated but encouraged. 

Vulnerable populations are strongly encouraged to wear masks and practice social distancing even when fully vaccinated or up to date with boosters to avoid contracting new COVID-19 variants.

Hygienic procedures are required. Researchers are required to clean and disinfect high-touch areas in shared spaces (e.g., doorknobs, experiment facilities, desk surfaces, keyboards, etc.), considering disinfectant contact time and dwell time. Researchers should use an EPA-approved disinfectant effective against COVID-19

Researchers are required to have hand sanitizers effective against COVID-19 (at least 60% alcohol content or more) within research facilities. 

Notification in an informed consent form

Researchers to engage in HSR using in-person interactions are required to notify their human subjects of potential risks of COVID contraction before human subjects enter a research site. In addition, researchers should provide personal protective equipment, including masks and sanitizers, if requested. 

Self-screening, Symptom log, and contact tracing

Under no circumstances are researchers to ask or document any medical conditions, symptoms, test results, vaccination status, or health records of any kind.  

More resources

Centers for Disease Control and Prevention
CDC Updates and Shortens Recommended Isolation and Quarantine Period for General Population
CDC Guidance for General Laboratory Safety Practices during the COVID-19 Pandemic
COVID-19 Prevention Actions
CDC Guidance for Cleaning and Disinfecting
U.S. Department of Health and Human Services, Office for Human Research Protections (OHRP) Guidance on Coronavirus
CDC Fully Vaccinated Guidance 

Anyone concerned about the safety of conducting or participating in Human Subjects Research at TAMUT, or observing violations of IRB requirements for safe human subjects research during COVID-19, should contact the IRB Chair at IRB@tamut.edu or 903-223-3009. Confidentiality can be maintained within the context of university, local, state, and federal policies and laws.

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