COVID-19 and Human Subjects Research

Foremost in the conduct of human subjects research at Touro College is the protection of our subjects.  With the advent of the COVID-19 pandemic, and consistent with the College’s guidance to prioritize public health and safety, the ethical focus of both IRBs at Touro takes on particular resonance—not only for our study participants, but also for our faculty, students and staff involved in human subjects research. 

All federal, NYS, NYC, and Touro COVID guidelines on safety procedures must be followed for any study involving direct physical interaction with subjects; research with participants that takes place outside of NYS or at an off-campus facility must take into account guidelines issued by that state and/or local jurisdiction and off-campus location.  If an off-campus location has more stringent safety procedures in place, then those must be followed while conducting research at that location. Researchers should continue to carefully assess whether participation in their studies puts participants at undue risk of infection, particularly in areas with higher levels of transmission or lower vaccination rates. When feasible, we encourage the use of alternative research methods that reduce or eliminate the risk of COVID-19 transmission.

Touro’s IRB #1 and HSIRB issue the following guidance to all investigators conducting research with human subjects:

• Investigators who have had to temporarily suspend an approved study due to COVID may resume direct work with participants —consistent with guidance issued by the College and any COVID guidelines of off-campus facilities where research takes place.
• If a Touro IRB is not the reviewing IRB for a study, compliance with any more stringent restrictions or requirements established by the reviewing IRB is required.
• Research reactivation plans approved by the college are no longer required, nor is IRB approval of those reactivation plans.
• The guidelines for study participants are the same as for other visitors to campus

Guidelines

Vaccination status

• The Touro College Vaccination Policy must be followed for research activities.
  • At this time, all invited guests and visitors to the Touro campus--including research participants--who are 12 years old or older must show proof of vaccination for COVID-19 or the results of a recent negative COVID-19 test. Principal Investigators are responsible for enforcing this requirement if it applies to their participant population.

• Investigators, staff and students must follow the campus process for showing evidence of their vaccination status or obtaining an exemption.

Symptom screening & testing

• Daily symptom screening during the course of a study is required for both investigators and participants of human subjects research.
• All faculty, staff, researchers, and students conducting human subjects research will need to complete the daily symptom survey touro.edu/covidscreening.
• All in-person participants must be screened for COVID-19 symptoms using the campus screening questions and must be informed about this requirement prior to participating in the study.
  • Investigators should avoid storing participant symptom screening information and must not use it for research.
•  No IRB protocol amendment submission is needed to implement these participant eligibility and screening requirements unless you are revising recruitment or informed consent materials.

Masks

• Investigators and participants must follow Touro College requirements.
• All indoor campus spaces where in-person human subjects research is conducted are subject to the masking requirement.
• Any individual who chooses to do so, may continue to wear face coverings in any setting.
• Investigators must comply with masking requirements at facilities or locations that require the use of masks
• All individuals conducting human subjects research on Touro’s campus--regardless of vaccination status--are required to wear a mask outside (when physical distancing cannot be maintained) and inside campus buildings (except in private, non-shared spaces, or when eating/drinking).

Distancing, Ventilation, & Sanitation

• There are no longer any COVID specific density limits for indoor campus spaces.
• Physical distancing will be followed as much as feasible. Maintain a distance of at least six feet (or as recommended by the NYSDOH/CDC for the infectious agent) from each other. Use a face covering when physical distance cannot be maintained.
• Consider using supplemental HEPA filtration if working indoors with groups from different households or if a project requires individual participants to conduct research activities without a mask.
• Avoid working in crowded spaces and minimize time spent with groups from different households, particularly if the space is poorly ventilated.
• Wash your hands often.

Keep a daily log of study participants who come to campus and any research team members with whom they come in contact, in case needed for contact tracing purposes. 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.

Additional IRB Considerations

• Decisions about bringing volunteers to campus for in-person study visits should be more conservative for people at higher risk for severe illness from COVID-19 per public health guidance. Researchers should take this into consideration as they develop plans for in-person human participant research protocols. For research involving participant populations at higher risk for severe illness, study consent forms may need to include information about this added risk.
• If your study procedures involve use of any shared objects or devices (e.g., pen, computer keyboard, blood pressure cuff), ensure that these items are cleaned and disinfected in between use.
• If your study involves a significant risk of viral transmission, (e.g., respiratory function testing, prolonged close contact between study participants and researchers, 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 to take part in the study.
• Any modifications to IRB protocols (beyond simply adding COVID-19 screening procedures) will require an amendment request to be submitted to the IRB. If you previously amended your protocol to change all in-person activities to remote/virtual platforms and you would now like to shift back to in-person activities, an amendment request will be -required.