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IRB News

IRB and Covid-19

Guidance for Conducting Human Subjects Research During the COVID-19 Pandemic

April 12, 2022


Human subjects studies that require in-person participant contact both inside and outside of clinical settings may continue. This research must adhere to the following guidelines. Below we address (A) On-campus research with Fairfield University students, faculty, or staff as research participants; (B) On-campus research with visitors; (C) Off-campus research, and (D) International research.

A.    On-Campus Research With Fairfield University Undergraduates, Graduate students, Faculty, or Staff as research participants:

Researchers will follow all current University guidelines for student-faculty interactions. These guidelines may include but are not limited to required health checks, COVID-19 testing, physical distancing, hand washing, and use of face masks by both researchers and research participants. Fairfield University strongly recommends that all participants, including the researchers, be fully vaccinated prior to starting any in-person research. University and state policy is continually evolving, and researchers are responsible for staying informed of current guidelines and ensuring that they and members of their research team adhere to them. Researchers can find this information at: https://portal.ct.gov/coronavirus or the Healthy Fairfield site and through official communications from the University administration.

Research that cannot be performed while maintaining physical distancing (e.g. collection of blood or saliva, placement of EEG electrodes, acupuncture) or while using face masks (e.g. speech therapy, therapeutic treatment of the mouth or lips) will be considered on a case-by-case basis. These protocols must address what is being done to ensure both researcher and participant safety (e.g., requiring all researchers and research participants be fully vaccinated or participate in COVID-19 testing, in-person health screenings such as temperature checks, etc.).

All IRB protocols will be asked to:

(1)    Adhere to University requirements for student-faculty interaction (e.g., health checks, COVID-19 testing, physical distancing, handwashing, use of face masks) and ensure that members of research teams involved in in-person contact with research participants are aware of and follow these guidelines.

(2)    Include information in their research protocols about procedures to disinfect devices (e.g., pulse oximeters, EKG measurement devices, blood pressure cuffs, etc.), in between participants, if relevant.

(3)    Note any other safety modifications to protocols (e.g., requiring that all researchers who have in-person contact with research participants are fully vaccinated, noting in your recruitment material that the study is only open to fully vaccinated people).

B.    On-Campus Research with Visitors to Campus:

At this time, visitors are not restricted. Research that involves visitors coming to campus that are not Fairfield University students, faculty, or staff should follow University guidance for visitors to campus, and keep abreast of any changes to this guidance.

As part of the consent process, if the participant is engaging in in-person at an on-campus research site, he or she should also be explicitly informed about the potential for COVID-19 exposure and agree willingly to the visit, even if they have been vaccinated. Each participant should be given the chance to discuss the expected risks and benefits and make an informed decision regarding participation, along with support from the study team prior to their research visit.

C.    Off-Campus Research

Medical facilities: Research in medical facilities such as hospitals, nursing homes, and outpatient clinics must adhere to the COVID protocols established in those facilities.

For off-campus research taking place in medical facilities, state,  “I and members of my research team will adhere to the medical facilities’ requirement for COVID safety.”

Non-Medical Facilities: For research taking place off-campus in non-medical spaces, researchers are expected to adhere to individual state and federal guidelines (i.e., CDC guidelines) regarding physical distancing and face mask-wearing. If the research requires the breaking of physical distancing guidelines, additional requirements for facemasks and/or other protective equipment may be needed (e.g., the use of N95 masks). Researchers are expected to keep abreast of changing state guidelines and how they impact their individual research protocols.

For off campus research in non-medical facilities state “I will adhere to state and federal guidelines (i.e., CDC guidelines) regarding physical distancing and face mask wearing and ensure that members of my research team involved in in-person contact with research participants are aware of and follow these guidelines”. 

D.   International Research

At this time, travel outside the United States may be restricted, and travel countries designated as Level 4 (“do not travel”) by the US State department should be avoided. For additional information, please visit: https://travel.state.gov/content/travel/en/traveladvisories/traveladvisories.html/.

Research protocols taking place outside of the United States should state, I will adhere to all local guidelines regarding physical distancing, testing, vaccination, quarantine and mask-wearing and ensure that members of my research team are aware of and follow these guidelines.”

Preparations for possible suspension of research

COVID-19 presents challenges that can rapidly change. Importantly, any changes made to research protocols, including the need to modify a protocol in light of rapidly changing community conditions, must be submitted to the IRB for approval. These modifications can typically be submitted as amendments to the original protocol. However, in the event of an emergent situation that requires deviation from a previously approved study protocol, principal investigators should act to ensure the safety of themselves and their research subjects, and submit adverse event documentation at a later date.

For additional Fairfield University Health Guidance on Human Subjects Research during COVID-19, please visit the IRB website at www.fairfield.edu/irb

For the most recent information regarding Fairfield University’s COVID-19 guidance, please visit: https://www.fairfield.edu/undergraduate/student-life-and-services/health-and-wellness/health-center/emergencies/coronavirus/